Recent FDA warnings regarding the controversial transvaginal mesh implant have resulted in a staunch defense of the device and its safety by the mesh manufacturers. Although the FDA has talked of reclassifying the mesh implant from a Class II to a Class III, requiring much more stringent clinical testing as well as human trials, Boston Scientific, one of the makers of the mesh is strongly urging against that potential change. Boston Scientific continues to assert that mesh products are a viable—and valuable—option for surgeons who treat women with pelvic organ prolapse or urinary stress incontinence. Further, they believe that mesh products offer a safe and effective alternative to non-mesh treatments and that the FDA’s current 510(k) requirements for a Class II device are appropriate for the transvaginal mesh.
FDA Warnings
The first warning issued by the FDA came in 2008 and warned of possible complications associated with transvaginal mesh implants, stating such complications were “not rare”. A more recent warning by the FDA went even further when it contended that it was unclear whether pelvic organ prolapse repair using mesh implants had any real advantage over traditional POP surgery without mesh and could expose patients to potentially serious risks.
Mesh Manufacturer’s Concerns
During the FDA advisory meeting, another maker of the mesh, Cook Medical, filed a letter asking the FDA to consider giving different treatment to meshes made from different materials. This request was based on the theory that there are significant differences between non-absorbable synthetic mesh products as opposed to biologic grafts which are not cross-linked. Another maker of the mesh, Johnson and Johnson—who has come under serious fire recently due to complications from their mesh implants—agreed with prior FDA reports which recommended simple label changes could warn women and their physicians of the potential risks of mesh implants.
Both Johnson and Johnson and C.R. Bard have become the target of over 500 lawsuits filed by women who claimed the mesh used in their POP or SUI surgeries caused serious internal injuries and chronic pain. The lawsuits were a direct result of the over 4,000 adverse event reports which have been filed since 2005. Most all the makers of the mesh devices agreed that any new applications for transvaginal mesh products should be subject to clinical testing, but strongly resisted the proposed reclassification of their mesh product. Johnson and Johnson and Endo Pharmaceuticals suggested that new device versions require clinical trials while existing implants have safety tracking controls. The manufacturers of mesh devices still believe strongly in their product, believing that while it may not be the best resolution for every patient in every case, it nonetheless offers a reliable and safe outcome for many women with pelvic organ prolapse or stress urinary incontinence.
The FDA’s Response
The FDA panel appears to be leaning toward requiring new device applications to undergo more stringent testing while allowing existing mesh products to remain on the market—a kind of grandfather clause for the existing mesh manufacturers. The FDA also strongly cautions physicians to sensibly consider other, more traditional options as well as ensuring their patients are thoroughly apprised of potential mesh complications. Because mesh is considered a “permanent” implant, it is not always possible to completely remove all traces of the mesh when erosion has occurred. In certain cases removal of the mesh may not fully resolve the underlying medical issue. A recent report from the FDA’s Obstetrics & Gynecology Devices Panel recommended moving the mesh implants to a higher risk category stating they may be exposing patients to unnecessary risks while offering few benefits over more traditional surgeries.
Is an FDA Decision on the Horizon?
Should the FDA decide to reclassify the mesh devices as high-risk (as opposed to their present classification as moderate-risk) the manufacturers would fall under significant additional obligations such as receiving approval of manufacturing procedures, being subject to plant inspections and dealing with longer review periods. Changing the current classification of the mesh implant device would also require the FDA to oversee clinical trials conducted by the individual corporations.
In spite of the potential hardships a reclassification would place on manufacturers, many believe that allowing the device to remain in its present classification—meaning any new device must only be as good as the device currently on the market—is simply not good enough to ensure the safety of women. It is unclear when the FDA will render their final decision on the mesh devices, however several mesh manufacturers are feeling the weight of the issue in falling stock prices and additional lawsuits.
Product Defects, Accident and Injury law, Criminal Defense, Traffic Tickets, Family Law at Sullo & Sullo, LLP!
Showing posts with label recall on hip replacements. Show all posts
Showing posts with label recall on hip replacements. Show all posts
Transvaginal Mesh Discussions Part 2: Definitions and Descriptions
What is Vaginal Mesh?
Although mesh was originally used in hernia repairs as far back as the 1950’s, it was not until the 1970’s that gynecologists began implanting this metallic or polymeric screen to reinforce and support weakened muscle and tissue and treat pelvic organ prolapse. In the 1990’s surgeons used the mesh to treat stress urinary incontinence although there was no “official” mesh product available at the time—surgeons simply cut the mesh to fit the surgical needs of their patients. Finally in 1996 a mesh kit was FDA approved for stress urinary incontinence and in 2002 the FDA approved a similar kit for pelvic organ prolapse surgeries. There are currently four types of mesh, including a non-absorbable polyester mesh (most commonly used), an absorbable synthetic mesh, a mesh made only of animal tissue, and there are meshes which are a combination of the three types above. Women who undergo surgery involving transvaginal mesh will generally have a spinal or general anesthetic. Incisions will be made inside the vagina, then the mesh implant will be placed under the vaginal skin with the expectation that the body’s own tissues will grow into the mesh in a matter of weeks, and the weakened tissues will be successfully reinforced.
Bladder Sling vs. Transvaginal Mesh Implant
The bladder sling is used in the treatment of severe urinary incontinence. The materials used in the bladder sling surgery include Teflon, Gore-Tex and fibrous tissues taken from the rectum. The surgery can be done through a small incision in the belly button, vaginally, or abdominally. Many surgeons use the sling procedure for all forms of incontinence which affects some 13 million American adults, most of them women. Just like transvaginal mesh, however, the non-woven mesh bladder slings can not only inhibit the flow of oxygen into surrounding organs, it can block crucial nutrients from making their way past the sling material. This can, in turn, lead to severe pelvic infections and even damage to surrounding organs. Bladder slings can cause many of the same damages that vaginal mesh can, and can negatively impact your future and quality of life.
Although mesh was originally used in hernia repairs as far back as the 1950’s, it was not until the 1970’s that gynecologists began implanting this metallic or polymeric screen to reinforce and support weakened muscle and tissue and treat pelvic organ prolapse. In the 1990’s surgeons used the mesh to treat stress urinary incontinence although there was no “official” mesh product available at the time—surgeons simply cut the mesh to fit the surgical needs of their patients. Finally in 1996 a mesh kit was FDA approved for stress urinary incontinence and in 2002 the FDA approved a similar kit for pelvic organ prolapse surgeries. There are currently four types of mesh, including a non-absorbable polyester mesh (most commonly used), an absorbable synthetic mesh, a mesh made only of animal tissue, and there are meshes which are a combination of the three types above. Women who undergo surgery involving transvaginal mesh will generally have a spinal or general anesthetic. Incisions will be made inside the vagina, then the mesh implant will be placed under the vaginal skin with the expectation that the body’s own tissues will grow into the mesh in a matter of weeks, and the weakened tissues will be successfully reinforced.
Bladder Sling vs. Transvaginal Mesh Implant
The bladder sling is used in the treatment of severe urinary incontinence. The materials used in the bladder sling surgery include Teflon, Gore-Tex and fibrous tissues taken from the rectum. The surgery can be done through a small incision in the belly button, vaginally, or abdominally. Many surgeons use the sling procedure for all forms of incontinence which affects some 13 million American adults, most of them women. Just like transvaginal mesh, however, the non-woven mesh bladder slings can not only inhibit the flow of oxygen into surrounding organs, it can block crucial nutrients from making their way past the sling material. This can, in turn, lead to severe pelvic infections and even damage to surrounding organs. Bladder slings can cause many of the same damages that vaginal mesh can, and can negatively impact your future and quality of life.
Transvaginal Mesh Discussions Part 3: Problems and Warnings
Problems Caused by Transvaginal Mesh Implants
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.
It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.
Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.
The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.”
The FDA further stated that repairs done with transvaginal mesh rather than the more traditional surgery which did not use mesh had not been shown to significantly improve the results of the surgery or the quality of life in the patient. FDA studies show that over ten percent of all women who undergo transvaginal pelvic organ prolapse repair will experience erosion of the mesh into surrounding tissues or organs within the twelve-month period following surgery. This statistic is considered significant among such surgical implants. The FDA revealed in January of this year that they are considering a recommendation that mesh used in the repair of prolapse of pelvic organs undergo a reclassification from a Class 2 to a Class 3 which would cause manufacturer’s safety requirements to be much stricter.
The FDA also ordered the manufacturers of the transvaginal mesh to conduct new trials and studies to more fully assess mesh safety and the risk of complications. While some consumer organizations have demanded the FDA recall the mesh implants and ban any further promotion of transvaginal mesh, other well-recognized medical organizations have yet to reach a definitive conclusion about discontinuing the use of the mesh implants. While the FDA acknowledges the dangers of the mesh they have not issues a recall and it is highly doubtful that the manufacturers of the transvaginal mesh will issue a voluntary recall. The current FDA warning applies only to transvaginally placed mesh and does not include abdominally-placed mesh or mesh used to correct stress urinary incontinence.
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.
It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.
Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.
The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.”
The FDA further stated that repairs done with transvaginal mesh rather than the more traditional surgery which did not use mesh had not been shown to significantly improve the results of the surgery or the quality of life in the patient. FDA studies show that over ten percent of all women who undergo transvaginal pelvic organ prolapse repair will experience erosion of the mesh into surrounding tissues or organs within the twelve-month period following surgery. This statistic is considered significant among such surgical implants. The FDA revealed in January of this year that they are considering a recommendation that mesh used in the repair of prolapse of pelvic organs undergo a reclassification from a Class 2 to a Class 3 which would cause manufacturer’s safety requirements to be much stricter.
The FDA also ordered the manufacturers of the transvaginal mesh to conduct new trials and studies to more fully assess mesh safety and the risk of complications. While some consumer organizations have demanded the FDA recall the mesh implants and ban any further promotion of transvaginal mesh, other well-recognized medical organizations have yet to reach a definitive conclusion about discontinuing the use of the mesh implants. While the FDA acknowledges the dangers of the mesh they have not issues a recall and it is highly doubtful that the manufacturers of the transvaginal mesh will issue a voluntary recall. The current FDA warning applies only to transvaginally placed mesh and does not include abdominally-placed mesh or mesh used to correct stress urinary incontinence.
Transvaginal Mesh Discussions Part 4: Revision Surgery
Is Revision Surgery a Possibility in Your Case?
The degree of your symptoms and whether or not the mesh has eroded into the vaginal walls or another surrounding organ will likely determine whether you are a candidate for revision surgery. It is important that you discuss your options thoroughly with your physician before deciding to undergo revision surgery to correct the problems caused by your transvaginal mesh implant. Revision surgery can include removal of the mesh completely or corrective surgery to trim or resize the mesh implant. Revision surgery can lead to excessive scar tissue and in some cases may further aggravate the symptoms and it can be difficult to locate surgeons who are willing to perform the revision surgery.
Is Revision Surgery Safe?
Any way you look at it, revision surgery is yet another serious surgery, and while generally not as extensive as the original mesh implant, your recovery time and your risks are equal. The surgeon will be required to make incisions, remove the mesh from surrounding tissues or organs, and suture the incisions. There will be swelling and discomfort, from mild to severe for several weeks, and you will be unable to return to work for at least two weeks. If you typically stand on your feet for long periods of time at your place of employment, it could be even longer before you can return. Many women note that with each successive surgery it can take longer to recuperate, and depending on the severity of the erosion or other medical issues, it could require several surgeries to fully correct your problems. Some women have recovery periods of up to six weeks with lifting restrictions even past the six week mark.
Will the Manufacturer of Your Transvaginal Mesh Implant Pay for Revision Surgery?
While those women whose transvaginal mesh implant has caused them significant medical harm could be eligible to file a lawsuit for damages, they will likely be responsible for all costs associated with testing and revision surgery, at least for the time being. If it is determined, however that they have a strong legal position regarding the flawed transvaginal mesh implant, an experienced personal injury attorney will work hard to obtain the maximum award provided for under the law to offset those expenses. While in theory every woman implanted with transvaginal mesh could have a legal claim, there must generally be specific damages to make litigations worth the financial cost and psychological trauma.
Women who have suffered organ damage which requires mesh replacement or revision surgery or those with ongoing and harsh symptoms such as vaginal tissue erosion, recurrence of the original pelvic organ prolapse, urinary issues, scarring on the vaginal walls or chronic pain during sexual intimacy can definitely prove specific and ongoing damages. Your attorney will determine whether medical malpractice was the cause of your medical damages or whether they relate specifically to the mesh implant. If your issues began soon after your surgery, it is more likely they are related to physician error than to the mesh implant. If the problems began six months or more following your surgery, it is probable they stem directly from the mesh implant. In any case, if you feel you have suffered because of a transvaginal mesh implant you should immediately contact a reputable, experienced personal injury attorney for further assessment of your specific situation.
The degree of your symptoms and whether or not the mesh has eroded into the vaginal walls or another surrounding organ will likely determine whether you are a candidate for revision surgery. It is important that you discuss your options thoroughly with your physician before deciding to undergo revision surgery to correct the problems caused by your transvaginal mesh implant. Revision surgery can include removal of the mesh completely or corrective surgery to trim or resize the mesh implant. Revision surgery can lead to excessive scar tissue and in some cases may further aggravate the symptoms and it can be difficult to locate surgeons who are willing to perform the revision surgery.
Is Revision Surgery Safe?
Any way you look at it, revision surgery is yet another serious surgery, and while generally not as extensive as the original mesh implant, your recovery time and your risks are equal. The surgeon will be required to make incisions, remove the mesh from surrounding tissues or organs, and suture the incisions. There will be swelling and discomfort, from mild to severe for several weeks, and you will be unable to return to work for at least two weeks. If you typically stand on your feet for long periods of time at your place of employment, it could be even longer before you can return. Many women note that with each successive surgery it can take longer to recuperate, and depending on the severity of the erosion or other medical issues, it could require several surgeries to fully correct your problems. Some women have recovery periods of up to six weeks with lifting restrictions even past the six week mark.
Will the Manufacturer of Your Transvaginal Mesh Implant Pay for Revision Surgery?
While those women whose transvaginal mesh implant has caused them significant medical harm could be eligible to file a lawsuit for damages, they will likely be responsible for all costs associated with testing and revision surgery, at least for the time being. If it is determined, however that they have a strong legal position regarding the flawed transvaginal mesh implant, an experienced personal injury attorney will work hard to obtain the maximum award provided for under the law to offset those expenses. While in theory every woman implanted with transvaginal mesh could have a legal claim, there must generally be specific damages to make litigations worth the financial cost and psychological trauma.
Women who have suffered organ damage which requires mesh replacement or revision surgery or those with ongoing and harsh symptoms such as vaginal tissue erosion, recurrence of the original pelvic organ prolapse, urinary issues, scarring on the vaginal walls or chronic pain during sexual intimacy can definitely prove specific and ongoing damages. Your attorney will determine whether medical malpractice was the cause of your medical damages or whether they relate specifically to the mesh implant. If your issues began soon after your surgery, it is more likely they are related to physician error than to the mesh implant. If the problems began six months or more following your surgery, it is probable they stem directly from the mesh implant. In any case, if you feel you have suffered because of a transvaginal mesh implant you should immediately contact a reputable, experienced personal injury attorney for further assessment of your specific situation.
Transvaginal Mesh: Are There Safer Alternatives?
In light of the recent lawsuits filed against manufacturers of transvaginal mesh implants, many are wondering whether a safer alternative to using the potentially risky mesh exists. Mesh has been used since the 1950’s, primarily for hernia surgeries which are performed abdominally. Surgeons began expanding the use of the mesh to include surgeries on women for pelvic organ prolapse or stress incontinence. Women who had given birth multiple times, undergone a hysterectomy or were in menopause often experienced difficulties when their internal organs prolapsed as a result of the overstretched muscles and ligaments. The mesh once used solely for hernia repair was now being simply cut to a different size or shape and used in these POP and SUI surgeries, where surgeons fashioned the mesh into a support for the prolapsed organ. As time passed, the surrounding tissues would grow into the mesh, creating a permanent solution to keeping the organs in their place.
Complications from Transvaginal Mesh
After decades of using the mesh in transvaginal applications, complications from the mesh began surfacing. After carefully reviewing adverse event reports as well as the handful of studies done on the safety of the mesh implants the FDA issued a safety warning in 2008 declaring that complications from the mesh implants were not as rare as once believed. In the past several years over 4,000 women have reported complications from the mesh, primarily a particularly serious issue known as erosion when the mesh works its way through the vaginal wall and even into other surrounding organs. Other complications include infection, chronic urinary tract infections and pain, ranging from moderate to chronic and severe.
Is There a Safer Alternative?
A wide range of research has been done regarding the benefits of one type of surgery over the other, with most results indicating that the use of mesh implants in POP or SUI surgeries is not superior to more traditional methods. Similarly, an FDA review of the scientific literature regarding vaginal mesh use in surgeries taking place between 1996 and 2011 found that transvaginal repair with mesh improves neither the end result nor the quality of life when compared to traditional, non-mesh repairs. One study, published in The New England Journal of Medicine found that the mesh approach rendered more effective relief of symptoms, however noted a higher incidence of subsequent complications from the mesh surgeries. Over 300,000 POP and SUI surgeries are performed each year in the United States, however many of the women undergoing these surgeries are not fully informed of the alternatives to mesh surgery as well as the possible complications.
History of Pelvic Organ Prolapse Surgery
For over five decades surgeons have been performing a procedure to repair pelvic organ prolapse which includes an abdominal incision and using the woman’s own tissues to tack up and hold the dropping pelvic organs where they should be. This procedure generally required a hospital stay of several days as well as a recovery time which could be as long as several months. Later, a device known as a laparoscope was used in POP surgeries. The laparoscope is a length of tube with a camera on one end. When it is placed inside the body, the laparoscope allows the surgeon to repair the damage without making large incisions in the abdomen. When using this device the scope and instruments are inserted through small holes in the body, the procedure is outpatient and recovery time is about two weeks. Using mesh in the surgeries can be done either through an abdominal incision or vaginal incision although the failure rates tend to be higher in those procedures done vaginally.
Comparing Traditional Surgery to Mesh
One study contrasted traditional prolapse surgery with mesh surgery in nearly 400 women; over half of the women were chosen for surgery using the mesh implant while the other women underwent more traditional surgery methods. The outcome of the study indicated that while there were better outcomes with respect to prolapse symptoms when the mesh was used, there were significant complications from the mesh both during the surgery and later. One surgeon noted that although the new transvaginal mesh surgery offered clear advantages over traditional surgery methods, the risk of complications from mesh made it imperative that the patient be fully informed and that all pros and cons be carefully weighed.
The Burch Procedure
A procedure known as the Burch procedure has been found to be a safer surgical alternative to transvaginal mesh implants in the treatment of stress urinary incontinence. This procedure uses the more traditional method of suturing the ligaments surrounding the bladder to hold up the tissues beside the urethra and can be done via an incision in the abdomen, laparoscopically or vaginally, and although the Burch procedure does not appear to be more effective than mesh, it may alleviate the safety concerns of using mesh implants.
The FDA will soon make their decision about whether the mesh devices need to be subjected to more stringent rules and regulations however in the meantime the lawsuits continue to stack up.
Complications from Transvaginal Mesh
After decades of using the mesh in transvaginal applications, complications from the mesh began surfacing. After carefully reviewing adverse event reports as well as the handful of studies done on the safety of the mesh implants the FDA issued a safety warning in 2008 declaring that complications from the mesh implants were not as rare as once believed. In the past several years over 4,000 women have reported complications from the mesh, primarily a particularly serious issue known as erosion when the mesh works its way through the vaginal wall and even into other surrounding organs. Other complications include infection, chronic urinary tract infections and pain, ranging from moderate to chronic and severe.
Is There a Safer Alternative?
A wide range of research has been done regarding the benefits of one type of surgery over the other, with most results indicating that the use of mesh implants in POP or SUI surgeries is not superior to more traditional methods. Similarly, an FDA review of the scientific literature regarding vaginal mesh use in surgeries taking place between 1996 and 2011 found that transvaginal repair with mesh improves neither the end result nor the quality of life when compared to traditional, non-mesh repairs. One study, published in The New England Journal of Medicine found that the mesh approach rendered more effective relief of symptoms, however noted a higher incidence of subsequent complications from the mesh surgeries. Over 300,000 POP and SUI surgeries are performed each year in the United States, however many of the women undergoing these surgeries are not fully informed of the alternatives to mesh surgery as well as the possible complications.
History of Pelvic Organ Prolapse Surgery
For over five decades surgeons have been performing a procedure to repair pelvic organ prolapse which includes an abdominal incision and using the woman’s own tissues to tack up and hold the dropping pelvic organs where they should be. This procedure generally required a hospital stay of several days as well as a recovery time which could be as long as several months. Later, a device known as a laparoscope was used in POP surgeries. The laparoscope is a length of tube with a camera on one end. When it is placed inside the body, the laparoscope allows the surgeon to repair the damage without making large incisions in the abdomen. When using this device the scope and instruments are inserted through small holes in the body, the procedure is outpatient and recovery time is about two weeks. Using mesh in the surgeries can be done either through an abdominal incision or vaginal incision although the failure rates tend to be higher in those procedures done vaginally.
Comparing Traditional Surgery to Mesh
One study contrasted traditional prolapse surgery with mesh surgery in nearly 400 women; over half of the women were chosen for surgery using the mesh implant while the other women underwent more traditional surgery methods. The outcome of the study indicated that while there were better outcomes with respect to prolapse symptoms when the mesh was used, there were significant complications from the mesh both during the surgery and later. One surgeon noted that although the new transvaginal mesh surgery offered clear advantages over traditional surgery methods, the risk of complications from mesh made it imperative that the patient be fully informed and that all pros and cons be carefully weighed.
The Burch Procedure
A procedure known as the Burch procedure has been found to be a safer surgical alternative to transvaginal mesh implants in the treatment of stress urinary incontinence. This procedure uses the more traditional method of suturing the ligaments surrounding the bladder to hold up the tissues beside the urethra and can be done via an incision in the abdomen, laparoscopically or vaginally, and although the Burch procedure does not appear to be more effective than mesh, it may alleviate the safety concerns of using mesh implants.
The FDA will soon make their decision about whether the mesh devices need to be subjected to more stringent rules and regulations however in the meantime the lawsuits continue to stack up.
Transvaginal Mesh Complications and Corrective Procedures: The Long Road to Recovery
In the past few years more and more women are coming forward to report complications—some of them quite severe—which resulted from surgeries involving the use of transvaginal mesh implants. Mesh has been implemented in surgeries as far back as the 1950’s, when it was used in hernia repair over the more traditional suture repair, with excellent results. In fact, when the mesh procedure was used there was a significantly lower recurrence of the hernias.
Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases. Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.
Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.
If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.
Chronic Pain
Pain which results from the transvaginal mesh implant can be very difficult to treat, and is typically a result of the placement of the mesh rather than the specific material of the mesh. If the mesh implant is too small or requires attachment near the pudendal nerve, then there may be moderate to severe pain for the first two months following the surgery and in some cases for much longer. If the pain persists longer than two months or if it radiates down the leg then surgical intervention will likely be required to alleviate the pain. Back pain and lower abdominal pain are named by the FDA as complications of the transvaginal mesh implant. If the pain is related to tension, or the mesh being too tight and pulling on the surrounding ligaments and muscles, the surgeon may have to open up the original incision, cutting the higher attachment points of the mesh implant. If tension is not the cause of the pain, treatment can be more difficult and could include injections or surgical release of the pudendal nerve—a highly skilled surgery which is currently performed by only a few surgeons across the nation.
Different Types of Mesh
Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Women Suffering from Mesh Complications
Prior to the FDA issuance of warnings regarding the potential complications of the mesh implant, many women suffered in silence, too embarrassed to speak out. Over 4,000 women have come forward—with many more expected—to speak out about the serious symptoms they have suffered as a result of their transvaginal mesh implant. Some women have undergone multiple surgeries in an attempt to prevent further pain and suffering. Not only have these women had to have the mesh from their original surgeries removed, but have then required further corrective surgeries to repair the damage done by the mesh. If you or a loved one has suffered harm from the mesh implant it’s important that you first speak with an experienced and reputable physician then find a highly qualified attorney to discuss your potential case with.
Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases. Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.
Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.
If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.
Chronic Pain
Pain which results from the transvaginal mesh implant can be very difficult to treat, and is typically a result of the placement of the mesh rather than the specific material of the mesh. If the mesh implant is too small or requires attachment near the pudendal nerve, then there may be moderate to severe pain for the first two months following the surgery and in some cases for much longer. If the pain persists longer than two months or if it radiates down the leg then surgical intervention will likely be required to alleviate the pain. Back pain and lower abdominal pain are named by the FDA as complications of the transvaginal mesh implant. If the pain is related to tension, or the mesh being too tight and pulling on the surrounding ligaments and muscles, the surgeon may have to open up the original incision, cutting the higher attachment points of the mesh implant. If tension is not the cause of the pain, treatment can be more difficult and could include injections or surgical release of the pudendal nerve—a highly skilled surgery which is currently performed by only a few surgeons across the nation.
Different Types of Mesh
Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Women Suffering from Mesh Complications
Prior to the FDA issuance of warnings regarding the potential complications of the mesh implant, many women suffered in silence, too embarrassed to speak out. Over 4,000 women have come forward—with many more expected—to speak out about the serious symptoms they have suffered as a result of their transvaginal mesh implant. Some women have undergone multiple surgeries in an attempt to prevent further pain and suffering. Not only have these women had to have the mesh from their original surgeries removed, but have then required further corrective surgeries to repair the damage done by the mesh. If you or a loved one has suffered harm from the mesh implant it’s important that you first speak with an experienced and reputable physician then find a highly qualified attorney to discuss your potential case with.
Transvaginal Mesh: Is an FDA Recall on the Horizon?
Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.
It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials. A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.
FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:
Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.
Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.
Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.
Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.
Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.
When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.
When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.
As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.
The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.
FDA Recommendations for Women Considering POP Mesh Surgery
The FDA recommends that women who are considering pelvic organ prolapse surgery using mesh should be fully aware of the potential risks and complications of mesh implants. Women should also know that having a surgery using mesh could potentially increase the risk for additional surgeries should there be mesh-related complications, and in some patients additional surgeries fail to resolve the pain or other medical issues. Ask your doctor about alternatives to mesh surgery, and if you decide transvaginal mesh surgery is right for you, make sure your surgeon has extensive experience in performing the procedure.
If you’ve already undergone POP surgery using mesh, you must notify your healthcare provider if you have any complications or symptoms such as persistent pain, infection, or persistent bleeding. If you believe you have suffered harm from the use of a mesh device, it’s important that you seek knowledgeable counsel regarding your rights and your potential for filing a lawsuit against the manufacturer of the device.
It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials. A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.
FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:
Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.
Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.
Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.
Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.
Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.
When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.
When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.
As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.
The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.
FDA Recommendations for Women Considering POP Mesh Surgery
The FDA recommends that women who are considering pelvic organ prolapse surgery using mesh should be fully aware of the potential risks and complications of mesh implants. Women should also know that having a surgery using mesh could potentially increase the risk for additional surgeries should there be mesh-related complications, and in some patients additional surgeries fail to resolve the pain or other medical issues. Ask your doctor about alternatives to mesh surgery, and if you decide transvaginal mesh surgery is right for you, make sure your surgeon has extensive experience in performing the procedure.
If you’ve already undergone POP surgery using mesh, you must notify your healthcare provider if you have any complications or symptoms such as persistent pain, infection, or persistent bleeding. If you believe you have suffered harm from the use of a mesh device, it’s important that you seek knowledgeable counsel regarding your rights and your potential for filing a lawsuit against the manufacturer of the device.
Transvaginal Mesh Lawsuits: What You Need to Know
If you are a woman who has had a surgery in the past for stress urinary incontinence or pelvic organ prolapse, and you think your surgeon might have used a mesh implant during that surgery, you need to know the facts surrounding the mesh products. While highly similar mesh products have been used in surgical applications for decades—primarily in hernia surgeries—it was not until 1996 that mesh was approved for use in SUI surgeries and 2002 when the mesh was FDA approved for use in POP surgeries. Up until that time surgeons simply adapted the mesh used in hernia surgeries to suit other surgical applications.
Flaws in the Approval Process?
The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues.
Mesh Manufacturers on the Hook?
The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”
What are the Complications of Transvaginal Mesh?
While there are other possible factors related to complications from transvaginal mesh implants—smoking, age, menopausal status, the presence of hormone replacement therapy, a woman’s body mass index and whether the woman suffers from diabetes—these factors have not definitively been shown to link directly to the mesh complications. The primary complication suffered by women who have undergone a transvaginal mesh implant is erosion of the mesh into the surrounding vaginal walls or other organs. This mesh erosion can lead to serious infection, bleeding, chronic and severe levels of pain in the back and abdomen, persistent urinary tract infections and pain during intercourse. If a physician determines the mesh has eroded it will be necessary for the patient to undergo one or more surgeries to correct the erosion. In some cases women have required multiple surgeries, and in other cases surgeons are unable to completely alleviate the pain.
More Women Coming Forward
It appears that over 4,000 women have come forward with adverse reports of damage from the transvaginal mesh implant. Because of the nature of the product, it is believed there are many more women who have suffered, but have not come forward because they are uncomfortable discussing problems and complications of this nature. The truth is, this is a problem which impacts literally millions of women. Half of all women who have had children will suffer some level of prolapse over the course of their lives. As many as ten percent of women will require surgery for pelvic organ prolapse, meaning a substantial portion of those were likely subject to the mesh implant. Many women believed their complications had subsided only to have them return, some even worse than they were originally. Women should not have to suffer in silence, and more women are coming forward to speak out against manufacturers who did not give women’s health and futures the proper consideration.
Do You Have a Case?
Lawyers around the nation are filing suits against the manufacturers of the mesh used in POP and SUI surgeries on behalf of women harmed by the device. Many of these women have already suffered subsequent surgeries to remove the mesh from the pelvic tissue and to further treat the complications from the mesh defects. Many more women will require more surgeries in order to regain some semblance of their former quality of life. The majority of the lawsuits which have already been filed are against C.R. Bard and Ethicon which is a Johnson and Johnson subsidiary. If you have had ongoing and severe symptoms of mesh erosion and are facing more surgeries to correct the problem, you likely have specific damages and should consult a reputable, experienced attorney to evaluate your case.
Flaws in the Approval Process?
The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues.
Mesh Manufacturers on the Hook?
The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”
What are the Complications of Transvaginal Mesh?
While there are other possible factors related to complications from transvaginal mesh implants—smoking, age, menopausal status, the presence of hormone replacement therapy, a woman’s body mass index and whether the woman suffers from diabetes—these factors have not definitively been shown to link directly to the mesh complications. The primary complication suffered by women who have undergone a transvaginal mesh implant is erosion of the mesh into the surrounding vaginal walls or other organs. This mesh erosion can lead to serious infection, bleeding, chronic and severe levels of pain in the back and abdomen, persistent urinary tract infections and pain during intercourse. If a physician determines the mesh has eroded it will be necessary for the patient to undergo one or more surgeries to correct the erosion. In some cases women have required multiple surgeries, and in other cases surgeons are unable to completely alleviate the pain.
More Women Coming Forward
It appears that over 4,000 women have come forward with adverse reports of damage from the transvaginal mesh implant. Because of the nature of the product, it is believed there are many more women who have suffered, but have not come forward because they are uncomfortable discussing problems and complications of this nature. The truth is, this is a problem which impacts literally millions of women. Half of all women who have had children will suffer some level of prolapse over the course of their lives. As many as ten percent of women will require surgery for pelvic organ prolapse, meaning a substantial portion of those were likely subject to the mesh implant. Many women believed their complications had subsided only to have them return, some even worse than they were originally. Women should not have to suffer in silence, and more women are coming forward to speak out against manufacturers who did not give women’s health and futures the proper consideration.
Do You Have a Case?
Lawyers around the nation are filing suits against the manufacturers of the mesh used in POP and SUI surgeries on behalf of women harmed by the device. Many of these women have already suffered subsequent surgeries to remove the mesh from the pelvic tissue and to further treat the complications from the mesh defects. Many more women will require more surgeries in order to regain some semblance of their former quality of life. The majority of the lawsuits which have already been filed are against C.R. Bard and Ethicon which is a Johnson and Johnson subsidiary. If you have had ongoing and severe symptoms of mesh erosion and are facing more surgeries to correct the problem, you likely have specific damages and should consult a reputable, experienced attorney to evaluate your case.
Transvaginal Mesh: The Types of Surgeries Which Use this Controversial Device
As more information comes to light regarding the potential safety issues of the transvaginal mesh implants, women across the nation have more questions regarding the device. The FDA has yet to make a final determination on how mesh devices will be approved in the future and whether the current manufacturers will be subject to more rigorous scrutiny regarding the mesh device. It appears that there are now thousands of women coming forward with stories of adverse events following their transvaginal mesh surgery leading the FDA to require sterner warnings regarding use of the mesh. Physicians are being warned to strongly consider alternative or more traditional surgical methods in repairing pelvic organ prolapse and stress urinary incontinence and women are urged to be fully informed of potential risks before undergoing transvaginal mesh surgery.
Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place. As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.
Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.
For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.
Surgical Types and Issues
The goal of surgery is to provide the necessary support for your pelvic organs, and mesh is used in an attempt to reduce the risk of recurrence of the prolapse. Mesh typically offers a longer-lasting repair when all goes well and is successful in at least 80% of the POP surgeries it is used in. What the patient must remember is that mesh is a synthetic material and becomes a permanent part of the body.
The mesh has tiny holes which allow the body’s own tissue to grow into it, providing the necessary support framework. Women undergoing the surgery may have either general or regional anesthesia; incisions are made by the surgeon inside the vagina, and the surrounding tissues are strengthened with stitches. The mesh will be placed under the vaginal skin, and the tissues of the body will grow into the mesh within 3-4 weeks which provides the reinforcement needed for the weakened tissues.
Complications of Transvaginal Mesh Surgery
The complications of the mesh surgery result primarily from mesh erosion, meaning the mesh erodes into the vaginal walls or into other organs. This erosion can lead to severe—or in rare cases, even fatal—consequences, and typically requires another surgery to correct the erosion and remove the mesh patch. Women who have suffered mesh erosion from the transvaginal mesh surgery may experience repeated infections, chronic abdominal or back pain or urinary tract problems, and depending on the severity of the erosion could require multiple surgeries.
If the use of mesh has caused you to have severe complications, it is important that you first take care of your health then consult a reputable attorney who can evaluate the facts of your mesh surgery and determine whether you have a potential case.
Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.
Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place. As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.
Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.
For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.
Surgical Types and Issues
The goal of surgery is to provide the necessary support for your pelvic organs, and mesh is used in an attempt to reduce the risk of recurrence of the prolapse. Mesh typically offers a longer-lasting repair when all goes well and is successful in at least 80% of the POP surgeries it is used in. What the patient must remember is that mesh is a synthetic material and becomes a permanent part of the body.
The mesh has tiny holes which allow the body’s own tissue to grow into it, providing the necessary support framework. Women undergoing the surgery may have either general or regional anesthesia; incisions are made by the surgeon inside the vagina, and the surrounding tissues are strengthened with stitches. The mesh will be placed under the vaginal skin, and the tissues of the body will grow into the mesh within 3-4 weeks which provides the reinforcement needed for the weakened tissues.
Complications of Transvaginal Mesh Surgery
The complications of the mesh surgery result primarily from mesh erosion, meaning the mesh erodes into the vaginal walls or into other organs. This erosion can lead to severe—or in rare cases, even fatal—consequences, and typically requires another surgery to correct the erosion and remove the mesh patch. Women who have suffered mesh erosion from the transvaginal mesh surgery may experience repeated infections, chronic abdominal or back pain or urinary tract problems, and depending on the severity of the erosion could require multiple surgeries.
If the use of mesh has caused you to have severe complications, it is important that you first take care of your health then consult a reputable attorney who can evaluate the facts of your mesh surgery and determine whether you have a potential case.
Does Age Play a Role in Transvaginal Patch Complications?
In light of the many adverse events seen among women who have undergone transvaginal mesh surgeries in the past few years, the FDA is considering more stringent controls over approval of the device. Surgeons currently perform as many as 300,000 pelvic organ prolapse and stress urinary incontinence surgeries every year, a large portion of those using mesh in the procedure.
Who Suffers From Pelvic Organ Prolapse?
Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP. Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.
Is A Woman’s Age a Factor in Pelvic Organ Prolapse?
While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.
Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.
Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?
In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.
How Long Does it Take for Complications to Become Apparent?
Although every surgery and every woman is different, the majority of the mesh erosion problems seemed to develop at least a month post-op. Those who had the surgery via an abdominal incision became aware of erosion problems at around fifteen months, while those who had vaginal incision placement took only an average of four months to realize there were problems. Many women did not report the problems they were experiencing for longer periods of time, either due to embarrassment in discussing the issues with their doctor, or because they believed their problems would resolve in time.
How are Erosion Complications Treated?
Chronic pain, infections or an erosion of the mesh following a pelvic organ prolapse surgery usually requires subsequent surgeries. The typical treatment is to excise the mesh through an incision in the vagina, then re-sewing of the vaginal tissues. Women who only had a small area of erosion were additionally treated with a topical estrogen cream following the surgery. If the vaginal erosion was due to the insertion of a mesh sling, the sling will have to be removed, however this procedure can cause the original symptoms of pelvic organ prolapse to return.
The FDA believes that the number of women coming forward with adverse reports from transvaginal mesh is a significant cause for concern and advises women who have had the surgery to continue with regular check-ups and to notify their doctor if they have any unusual bleeding, discharge or pain. The future of the mesh patch is unclear at this point, however the lawsuits continue to mount.
Who Suffers From Pelvic Organ Prolapse?
Women who have gone through childbirth multiple times as well as those who have undergone a hysterectomy or are going through menopause all seem to be more susceptible to pelvic organ prolapse. Additionally, those with a family history of pelvic organ prolapse could be more likely to suffer from POP. Although pelvic organ prolapse is generally a progressive condition which worsens and causes more serious symptoms, in some cases it does not progress and may actually improve with time. When estrogen levels diminish during and after menopause, pelvic organ prolapse is more likely to occur due to the fact that estrogen assists the body in making collagen, a protein which strengthens the supportive pelvic tissues. When there is less collagen in the body, the supportive tissues in the pelvis are more likely to appear, therefore when estrogen decreases, POP becomes more likely.
Is A Woman’s Age a Factor in Pelvic Organ Prolapse?
While older women will be more likely to suffer from POP simply by virtue of the fact that the connective tissues in the pelvic region have had more time to stretch and they have likely gone through childbirth and possibly even menopause or a hysterectomy, the surgery is also performed on women in their forties after giving birth multiple times. One particular study—done in 2002 which involved nearly 700 participants who received the transvaginal mesh patch—resulted in almost universal satisfaction following the procedure.
Some questioned the validity of these results since over four-fifths of the participants were post-menopausal and the average age was nearly 64. This is considered a relatively narrow group of study participants, especially in light of the fact that the procedure is often done on women of childbearing age following the stress of multiple pregnancies. It is likely that the older women were having much more serious symptoms of pelvic organ prolapse as a result of many years of downward gravity on the pelvic ligaments, therefore the relief they received from the surgery could have been more significant.
Who is Most Likely to Have Problems Following a Transvaginal Mesh Implant?
In one of the most comprehensive studies done to date, including nearly twelve thousand women, nearly ten percent of those had some sort of erosion of the implanted mesh within twelve months of the surgery, regardless of whether synthetic or biologic mesh was used in the surgery. It was found that factors which could predispose women to erosion problems included being a smoker or having a hysterectomy simultaneously with their POP surgery. Overall health is also a significant factor in surgery results. When a vaginal approach was used to place the mesh—as opposed to an abdominal incision—there tended to be more adverse results. Older women tended to have more incidences of mesh erosion, even though they were the group who reported the greatest satisfaction with the surgical results. Low estrogen levels—which typically occur in older women—were a factor in erosion as were the size of the mesh implant and the surgical technique variations or skill of the surgeon. Women who kept their uterus during the procedure appeared to have a lowered risk of erosion complications.
How Long Does it Take for Complications to Become Apparent?
Although every surgery and every woman is different, the majority of the mesh erosion problems seemed to develop at least a month post-op. Those who had the surgery via an abdominal incision became aware of erosion problems at around fifteen months, while those who had vaginal incision placement took only an average of four months to realize there were problems. Many women did not report the problems they were experiencing for longer periods of time, either due to embarrassment in discussing the issues with their doctor, or because they believed their problems would resolve in time.
How are Erosion Complications Treated?
Chronic pain, infections or an erosion of the mesh following a pelvic organ prolapse surgery usually requires subsequent surgeries. The typical treatment is to excise the mesh through an incision in the vagina, then re-sewing of the vaginal tissues. Women who only had a small area of erosion were additionally treated with a topical estrogen cream following the surgery. If the vaginal erosion was due to the insertion of a mesh sling, the sling will have to be removed, however this procedure can cause the original symptoms of pelvic organ prolapse to return.
The FDA believes that the number of women coming forward with adverse reports from transvaginal mesh is a significant cause for concern and advises women who have had the surgery to continue with regular check-ups and to notify their doctor if they have any unusual bleeding, discharge or pain. The future of the mesh patch is unclear at this point, however the lawsuits continue to mount.
Patients With Defective DePuy ASR Hip Implants
HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.
Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body's natural recuperative ability.
The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.
To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.
A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”. These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.
If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.
Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body's natural recuperative ability.
The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.
To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.
A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”. These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.
If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.
The ASR Acetabular System falls far short of other total hip replacement systems. Here's how.
In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
Many patients who received a DePuy hip implant have suffered heavy metal poisoning. But what does that really mean?
As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.
One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.
For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.
Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.
The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.
Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.
One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.
For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.
Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.
The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.
The DePuy ASR XL Acetabular hip replacement system was FDA approved - which might be more cause for worry than relief.
Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
Bone deterioration is associated with disease; soon, it may also be linked to the DePuy ASR XL Acetabular System. And for good reason.
As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.
When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.
The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body's own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.
Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.
Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System's poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.
Another problem is the surgery itself. An uncemented implant requires the surgeon to insert the cup of the hip implant into the hip socket, called the acetabulum. This means some of the bone in the socket must be scraped away to make room for the implant. This is part of any hip implant surgery, but since the DePuy implants only lasted a few years before they were recalled, patients are now forced to undergo hip revision surgery before that bone has had enough time to recover from the initial surgery's trauma.
Hip revision surgery is much less likely than initial hip replacement surgery to succeed. With damaged bone mass, the chance of success is even lower.
In essence, the weaker the bone, the less likely it is that each successive hip replacement surgery will succed. With complications of metal poisoning, metallosis, and trauma to the surrounding bone and tissue, the circumstances for a revision surgery are far from optimal.
If you have a DePuy ASR XL Acetabular System and you are concerned about compensation for the medical trauma you've experienced, we'd like to help answer your questions and advise you of your legal rights.
When undergoing hip surgery, there are generally two options for a hip implant: cemented and uncemented. Cemented implants, which involve attaching the implant directly to the surrounding bone by means of a specially constructed bone cement, have been used since the 1960s. Uncemented implants were introduced in the 1980s. The ASR XL Acetabular System is an uncemented implant.
The idea behind an uncemented implant is that healthy bone can grow into its surface, thus holding the implant in place by means of the body's own materials instead of a foreign cement. Medical professionals hoped that this design would mean the patient could have a more active life since the concern of gradually wearing away the cement would be eliminated. Cementless total hip replacements are recommended for younger, more active patients and have shown, so far, better results in long-term studies.
Obviously, healthy bone is essential for an uncemented hip implant. Without healthy bone growth, the hip implant will not be secured into the rest of the skeleton and will not function as a replacement for the removed hip.
Evidence is showing that the DePuy ASR XL Acetabular System may cause serious bone deterioration in a number of ways. One of the most significant is osteolysis, which occurs when the body reabsorbs bone as part of an autoimmune response. Osteolysis has been noted as a side effect of many total hip replacement systems; the more debris that is released into the body, the more common osteolysis becomes. Metal-on-metal hip implants were thought to have less likelihood of debris because they are made of harder materials, but the ASR XL Acetabular System's poor design caused significant friction and a great deal of metal debris, raising the risk of osteolysis.
Another problem is the surgery itself. An uncemented implant requires the surgeon to insert the cup of the hip implant into the hip socket, called the acetabulum. This means some of the bone in the socket must be scraped away to make room for the implant. This is part of any hip implant surgery, but since the DePuy implants only lasted a few years before they were recalled, patients are now forced to undergo hip revision surgery before that bone has had enough time to recover from the initial surgery's trauma.
Hip revision surgery is much less likely than initial hip replacement surgery to succeed. With damaged bone mass, the chance of success is even lower.
In essence, the weaker the bone, the less likely it is that each successive hip replacement surgery will succed. With complications of metal poisoning, metallosis, and trauma to the surrounding bone and tissue, the circumstances for a revision surgery are far from optimal.
If you have a DePuy ASR XL Acetabular System and you are concerned about compensation for the medical trauma you've experienced, we'd like to help answer your questions and advise you of your legal rights.
DePuy offers to remove ASR XL Acetabular System - in exchange for waiving your right to compensation.
If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.
What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.
They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing.
Hip Revision Dependent on Loss of Patient Rights
DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."
Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.
Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."
In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.
What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System."
If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.
The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.
They're lawyers.
What's Wrong With DePuy Having Access to Your Hip Implant Records
To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.
It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.
If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.
In the knee replacement case, DePuy's defense avoided talking about any of these issues.
Instead, they pointed the blame at the patients.
The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.
But mostly, they blamed the patient.
What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.
They're going to claim that you did. Read more .....
What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.
They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing.
Hip Revision Dependent on Loss of Patient Rights
DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."
Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.
Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requested medical information after the revision surgery."
In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.
What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System."
If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.
The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.
They're lawyers.
What's Wrong With DePuy Having Access to Your Hip Implant Records
To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.
It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.
If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.
In the knee replacement case, DePuy's defense avoided talking about any of these issues.
Instead, they pointed the blame at the patients.
The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.
But mostly, they blamed the patient.
What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.
They're going to claim that you did. Read more .....
Hip Implant Failure
HOUSTON—In late August 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced a voluntary recall of two of its metal-on-metal hip replacement devices — the ASR Hip Resurfacing System and the ASR XL Acetabular System. The recall was issued after the U.S. Food and Drug Administration (FDA) received upwards of 500 patient complaints about early system failure, and a British study confirmed that nearly 12 percent of those who received the implants required corrective procedures, called revision surgeries, within five years.
If you or a loved one are among the 93,000 people worldwide who received the ASR Hip Resurfacing System or ASR XL Acetabular System, there are some important details that you should be aware of.
While it is normal to experience pain immediately following a metal-on-metal hip replacement surgery, if the pain persists or returns after a period of time, it may be a sign that the implant has failed. Patients who have received faulty ASR hip implants have reported symptoms such as:
Swelling or pain in the effected hip or surrounding areas
Difficulty walking or pain in the hip when doing so
Grinding or popping noises originating in the hip area
Inflammation or infection in the affected hip
Dislocation or improper positioning of the implant
DePuy implant patients who experience one or more of these symptoms are encouraged to consult their doctor immediately, as a revision surgery may be required or advisable. Symptoms can be caused by several problems, including:
Loosening of the implant when the device is not attached in the correct position to the bone
Dislocation of the implant components
Bone fractures at the hip
Metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together
The known risks of failure of DePuy ASR hip implant devices are clear and substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before at the earliest possible time. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.
If you or a loved one are among the 93,000 people worldwide who received the ASR Hip Resurfacing System or ASR XL Acetabular System, there are some important details that you should be aware of.
While it is normal to experience pain immediately following a metal-on-metal hip replacement surgery, if the pain persists or returns after a period of time, it may be a sign that the implant has failed. Patients who have received faulty ASR hip implants have reported symptoms such as:
Swelling or pain in the effected hip or surrounding areas
Difficulty walking or pain in the hip when doing so
Grinding or popping noises originating in the hip area
Inflammation or infection in the affected hip
Dislocation or improper positioning of the implant
DePuy implant patients who experience one or more of these symptoms are encouraged to consult their doctor immediately, as a revision surgery may be required or advisable. Symptoms can be caused by several problems, including:
Loosening of the implant when the device is not attached in the correct position to the bone
Dislocation of the implant components
Bone fractures at the hip
Metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together
The known risks of failure of DePuy ASR hip implant devices are clear and substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before at the earliest possible time. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Subscribe to:
Posts (Atom)