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 Vaginal Mesh Complications. Show all posts
Showing posts with label Vaginal Mesh Complications. 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 1: Medical Conditions Which Precipitate the Use of Transvaginal Mesh
Pelvic Organ Prolapse (POP):
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur. The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening.
The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.
What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.
Women who have undergone a hysterectomy to remove their uterus may be at a higher risk as the other organs subsequently have less support and may prolapse. Women who have suffered extended periods of recurrent constipation or chronic coughing can be more likely to develop pelvic organ prolapse and medical conditions such as diabetes can also be a factor. Small or moderate amounts of urine can be lost in cases of pelvic organ prolapse even with normal physical activities such as walking, laughing or coughing. In short, many women will develop some level of pelvic organ prolapse which can range from the mildly uncomfortable to the severely painful. In some cases the pelvic organ prolapse will actually get better on its own with time, although this is not the norm.
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur. The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening.
The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.
What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.
Women who have undergone a hysterectomy to remove their uterus may be at a higher risk as the other organs subsequently have less support and may prolapse. Women who have suffered extended periods of recurrent constipation or chronic coughing can be more likely to develop pelvic organ prolapse and medical conditions such as diabetes can also be a factor. Small or moderate amounts of urine can be lost in cases of pelvic organ prolapse even with normal physical activities such as walking, laughing or coughing. In short, many women will develop some level of pelvic organ prolapse which can range from the mildly uncomfortable to the severely painful. In some cases the pelvic organ prolapse will actually get better on its own with time, although this is not the norm.
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.
Transvaginal Mesh: A Brief History of the Problematic Implant
While the past three years have brought an influx of complications and problems related to the transvaginal mesh implant, the device has actually been in use for over half a century. Surgical mesh made of metallic or polymer screens was developed for use in abdominal hernia surgeries in the 1950’s, however gynecologists soon saw the advantages of using the mesh in the surgical repair of stress urinary incontinence and pelvic organ prolapse. These problems are relatively common among women who have had children, undergone a hysterectomy or are post-menopausal. During such events, the muscles and ligaments which surround the pelvic organs can weaken, allowing those organs to slip out of their natural place, or prolapse.
FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.
Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.
FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device. Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.
Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.
Today’s Mesh Implant Devices
There are four types of surgical mesh on the market today, the most common of which is made of a non-absorbable polyester or polypropylene mesh and used in most female urology surgeries. Other types include an absorbable, synthetic mesh, a mesh made of animal tissues and a mesh which is a combination of the other types. As many as half a million women each year undergo POP or SUI surgeries each year; in 2010 some 75,000 had POP surgery using the mesh in a transvaginal application while more than 200,000 had the procedure for stress urinary incontinence. There is a less common version of these procedures in which the surgeon implants the mesh through the abdomen and is believed by the FDA to produce fewer complications.
2008 Public Health Notification
The FDA issued a public health notice in October of 2008 in which they acknowledged a mistake in issuing a prior notice which called mesh problems “rare.” In the 2008 notification, more than a thousand adverse events were definitively associated with surgical mesh implants used in POP and SUI surgeries for the period from 2005-2007. From January, 2008 through December, 2010, the FDA received nearly three thousand more reports of complications from the mesh. Even when taking into consideration the fact that it is fairly common for adverse event reporting to increase following an FDA safety notification, the numbers were felt to be unduly high.
Mesh Use Today
Today many problems such as recurrent prolapse, mesh erosion, pain, infection, bleeding, urinary problems and pain during sexual intercourse are being reported. The FDA believes that such problems commonly occur within a year of the original surgery, and patients who experience complications may be subjected to multiple surgeries in order to successfully remove the mesh implant. After careful consideration the FDA advisory committee has suggested that the current transvaginal mesh products will remain on the market however more stringent warnings for use will be issued. Future products of this type will be forced to undergo stricter testing in order to be granted FDA approval.
FDA Approves Surgical Mesh for Abdominal Surgeries
Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.
Transvaginal Use of Mesh
Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.
FDA Approval for Transvaginal Use
Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device. Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.
Unexpected Problems Arise
Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.
Today’s Mesh Implant Devices
There are four types of surgical mesh on the market today, the most common of which is made of a non-absorbable polyester or polypropylene mesh and used in most female urology surgeries. Other types include an absorbable, synthetic mesh, a mesh made of animal tissues and a mesh which is a combination of the other types. As many as half a million women each year undergo POP or SUI surgeries each year; in 2010 some 75,000 had POP surgery using the mesh in a transvaginal application while more than 200,000 had the procedure for stress urinary incontinence. There is a less common version of these procedures in which the surgeon implants the mesh through the abdomen and is believed by the FDA to produce fewer complications.
2008 Public Health Notification
The FDA issued a public health notice in October of 2008 in which they acknowledged a mistake in issuing a prior notice which called mesh problems “rare.” In the 2008 notification, more than a thousand adverse events were definitively associated with surgical mesh implants used in POP and SUI surgeries for the period from 2005-2007. From January, 2008 through December, 2010, the FDA received nearly three thousand more reports of complications from the mesh. Even when taking into consideration the fact that it is fairly common for adverse event reporting to increase following an FDA safety notification, the numbers were felt to be unduly high.
Mesh Use Today
Today many problems such as recurrent prolapse, mesh erosion, pain, infection, bleeding, urinary problems and pain during sexual intercourse are being reported. The FDA believes that such problems commonly occur within a year of the original surgery, and patients who experience complications may be subjected to multiple surgeries in order to successfully remove the mesh implant. After careful consideration the FDA advisory committee has suggested that the current transvaginal mesh products will remain on the market however more stringent warnings for use will be issued. Future products of this type will be forced to undergo stricter testing in order to be granted FDA approval.
Transvaginal Mesh and the FDA: How the Food and Drug Administration
Surgical Procedures Using Mesh
Mesh has been widely used in a variety of surgeries since the 1950’s, and was originally approved for use in abdominal hernia surgery. Surgeons began altering the size and shape of the mesh devices, using them in women’s surgeries for pelvic organ prolapse and stress urinary incontinence. It was not until 1996 that the mesh was approved specifically for SUI surgeries and 2002 when it was approved for POP surgeries.
Mesh Complications
The FDA issued their first public health alert in 2008 detailing the potentially serious complications associated with the transvaginal placement of surgical mesh when used to repair pelvic organ prolapse or stress urinary incontinence. The agency then updated the original warnings stating that mesh complications in transvaginal repair of pelvic organ prolapse were actually not all that rare. They continued the warning by stating that when compared to traditional, non-mesh repairs for pelvic organ prolapse, there are no apparent benefits to using mesh.
To date, the FDA has received as many as 4,000 reports of serious complications associated with the mesh implant, particularly when used in the transvaginal repair of pelvic organ prolapse. These reported complications cover the period from January, 2005 through December, 2010, with almost three-fourths of those in the past three years. Many believe the numbers will continue to climb; a 2009 review in the International Urogynecology Journal stated the complication rate from use of vaginal mesh was from 7%-25% with those who smoked increasing that already high risk of complications as much as three times.
Clinical Trial Stopped
Following the FDA’s warnings, a 2010 clinical trial which compared traditional surgical procedures used in repairing pelvic organ prolapse to transvaginal mesh procedures was halted before completion due to complications in over 15% of the patients whose surgery included mesh. The primary complication was mesh erosion, a serious and even potentially fatal medical injury which typically requires one or more surgeries to correct and repair. Regarding this study one of the lead authors of the report stated that in the end not only were there more complications, but the mesh didn’t prove to work any better than traditional surgery.
Is Inappropriate Selection of Patients an Issue in Mesh Damages?
Some believe that one of the primary problems in the mesh controversy is the criteria used to select patients for the transvaginal mesh surgery which repairs pelvic organ prolapse. Because the mesh device seemed so promising for women suffering from pelvic organ prolapse it may have been inappropriately used for younger, active women who could have received greater benefits from alternative types of non-vaginal surgery. Mesh surgeries are more appropriate for use in older, less sexually active women who either cannot undergo abdominal surgery or who has suffered a recurrent prolapse after a past surgery.
Approval for J & J Mesh Based on Recalled Device
The 2008 FDA warning regarding complications associated with transvaginal placement of mesh included specifics regarding the Bard Avaulta mesh product. C.R. Bard, Inc., the makers of the Bard Avaulta mesh, sent out a recall of the mesh in 2005, urging physicians to stop using specific versions of the product which could potentially break and cut through internal organs and tissues. The recalled device, known as the Kugel patch, created a storm of controversy when some Bard executives said they knew about serious injuries which were potentially caused by the device. Several fatalities were even believed to be potentially related to use of the Kugel patch. C.R. Bard maintained they acted responsibly, however FDA officials found discrepancies and inconsistencies in the manner in which the devices were traced and analyzed.
Is “Substantially Equivalent” Good Enough?
Even though the Kugel patch was recalled, Johnson and Johnson subsequently gained approval for their own mesh device based on its precursor—the Kugel patch. Approvals of medical devices based on an assessment that they were “substantially equivalent” to a previously approved device may be one flaw in the system which has allowed a potentially harmful device to be implanted in thousands of women. Johnson and Johnson’s approval from the FDA for their vaginal patch was predicated on the claim they were substantially similar to the recalled Kugel patch—presumably without the design flaws. Currently Johnson and Johnson has at least 600 vaginal mesh lawsuits in the works against the giant corporation; when you consider that as thousands of women received vaginal mesh implants in the past year alone, those numbers are expected to grow.
Transvaginal Mesh Applications Declared “Experimental” in 2007
In February of 2007—prior to the FDA’s public health alert in 2008—the American College of Obstetricians and Gynecologists issued a bulletin on pelvic organ prolapse. This bulletin warned both physicians and their patients to consider the vaginal mesh procedure to be experimental, and that patients who consented to the procedure should be made aware of that fact. They went on to say that because there was both limited data as well as frequent changes in the mesh products which were being marketed—particularly regarding the material the mesh was constructed from—that women considering having the mesh surgery should be aware of the potential risks and complications.
Some seven months later, the same group issued a second bulletin with a much softer warning, and with the word “experimental” mysteriously gone. In this bulletin women were only warned that because of the limited data and changes in marketed products as well as potential mesh erosion, patients should only consent to surgery with this understanding. Because “experimental” procedures are rarely covered by insurance, it has been speculated that the potential of losing large amounts of money resulted in the change in wording.
Is a Flawed Approval System to Blame for Mesh Complications?
Although the current FDA approval system has been in place for over three decades, the Institute of Medicine—for one—believes the government should abandon this medical device approval system because it offers little safety assurance for patients. The medical device industry is currently a $350 billion dollar industry which covers everything from pacemakers to contact lenses. Although this advice is not binding upon the FDA, it could prove that Americans want tighter standards for medical device manufacturers who have benefitted financially from less safety scrutiny than their peers in the industry. Most new prescription drugs are required to go through rigorous clinical trials to prove definitively that patients benefit from the medication—and that there are no serious side effects. On the flip side, most medical devices, including mesh, must only show they are similar to a device which is already on the market. It is only the truly brand new innovations which are required to undergo safety testing. The FDA defends the system in place stating they have been working for over a year to make the approval process for medical devices more predictable and less bureaucratic—changes which would be scrapped if the entire system is revamped.
Does the 510(k) Approval System Need an Overhaul?
This 35-year old process, known as the 510(k) process has some wondering if it really protects Americans to the fullest extent possible. While the FDA is not in favor of eliminating the procedure, they are open to proposals for improvement. FDA officials point out that they are already subject to criticism from manufacturers of medical devices who believe the agency is too slow in clearing new devices, driving up costs and even forcing smaller companies out of business. The 510(k) system was created by Congress in 1976 with a goal of granting quicker approvals to devices which were substantially similar to medical devices already on the market.
The system was originally intended to be a temporary means of grandfathering in medical devices which had been used for decades however over time became the standard in launching new medical devices. Today, nearly 4,000 devices are cleared each year under the present 510(k) system while only around 50 devices are approved under a more stringent system of human testing. While the 510(k) system is not considered inherently unsafe, there must be more safeguards in place to protect patients from harm. Although the FDA is battling a multi-million dollar lobbying effort by medical device manufacturers, they may have a stronger position due to the fact that reports of pain, bleeding and infection with the mesh implants are up 500 percent since 2008.
Class II vs. Class III
Prior to the convening of the September 8th panel regarding the adverse reports of the transvaginal mesh implant, the FDA recommended that transvaginal mesh products be reclassified to a Class III (high risk) rather than their current Class II (moderate risk). A Class II device is approval under the abbreviated 510(k) process while a Class III classification would give the FDA stronger controls over the clinical studies conducted before marketing the product. Obviously the mesh industry wants to maintain their Class II status, arguing that additional studies and labeling changes on mesh implants are sufficient to safeguard the health of women. Re-classifying the mesh implants as high risk would require them to undergo approval of manufacturing procedures, inspections of their device plans and a longer review period.
The FDA must sort through the dizzying array of opinions and facts regarding the safety, efficacy and potential reclassification of the transvaginal mesh implants and must also make critical decisions regarding further clinical studies prior to making their final determination. In the meantime a national group of surgeon’s stated the transvaginal mesh devices should only be used in a limited number of carefully chosen women, and only by highly trained physicians in the procedure. While Johnson and Johnson continues to maintain that its vaginal mesh product is safe, women must become their own health advocates and make sure they have all the facts before agreeing to a transvaginal mesh procedure. Women who have suffered severe complications as a result of a mesh implant may face multiple surgeries and may never fully recover from the damage done. As we wait for a decision from the FDA, it is likely that more women will be coming forward regarding the damage done by a mesh implant.
Mesh has been widely used in a variety of surgeries since the 1950’s, and was originally approved for use in abdominal hernia surgery. Surgeons began altering the size and shape of the mesh devices, using them in women’s surgeries for pelvic organ prolapse and stress urinary incontinence. It was not until 1996 that the mesh was approved specifically for SUI surgeries and 2002 when it was approved for POP surgeries.
Mesh Complications
The FDA issued their first public health alert in 2008 detailing the potentially serious complications associated with the transvaginal placement of surgical mesh when used to repair pelvic organ prolapse or stress urinary incontinence. The agency then updated the original warnings stating that mesh complications in transvaginal repair of pelvic organ prolapse were actually not all that rare. They continued the warning by stating that when compared to traditional, non-mesh repairs for pelvic organ prolapse, there are no apparent benefits to using mesh.
To date, the FDA has received as many as 4,000 reports of serious complications associated with the mesh implant, particularly when used in the transvaginal repair of pelvic organ prolapse. These reported complications cover the period from January, 2005 through December, 2010, with almost three-fourths of those in the past three years. Many believe the numbers will continue to climb; a 2009 review in the International Urogynecology Journal stated the complication rate from use of vaginal mesh was from 7%-25% with those who smoked increasing that already high risk of complications as much as three times.
Clinical Trial Stopped
Following the FDA’s warnings, a 2010 clinical trial which compared traditional surgical procedures used in repairing pelvic organ prolapse to transvaginal mesh procedures was halted before completion due to complications in over 15% of the patients whose surgery included mesh. The primary complication was mesh erosion, a serious and even potentially fatal medical injury which typically requires one or more surgeries to correct and repair. Regarding this study one of the lead authors of the report stated that in the end not only were there more complications, but the mesh didn’t prove to work any better than traditional surgery.
Is Inappropriate Selection of Patients an Issue in Mesh Damages?
Some believe that one of the primary problems in the mesh controversy is the criteria used to select patients for the transvaginal mesh surgery which repairs pelvic organ prolapse. Because the mesh device seemed so promising for women suffering from pelvic organ prolapse it may have been inappropriately used for younger, active women who could have received greater benefits from alternative types of non-vaginal surgery. Mesh surgeries are more appropriate for use in older, less sexually active women who either cannot undergo abdominal surgery or who has suffered a recurrent prolapse after a past surgery.
Approval for J & J Mesh Based on Recalled Device
The 2008 FDA warning regarding complications associated with transvaginal placement of mesh included specifics regarding the Bard Avaulta mesh product. C.R. Bard, Inc., the makers of the Bard Avaulta mesh, sent out a recall of the mesh in 2005, urging physicians to stop using specific versions of the product which could potentially break and cut through internal organs and tissues. The recalled device, known as the Kugel patch, created a storm of controversy when some Bard executives said they knew about serious injuries which were potentially caused by the device. Several fatalities were even believed to be potentially related to use of the Kugel patch. C.R. Bard maintained they acted responsibly, however FDA officials found discrepancies and inconsistencies in the manner in which the devices were traced and analyzed.
Is “Substantially Equivalent” Good Enough?
Even though the Kugel patch was recalled, Johnson and Johnson subsequently gained approval for their own mesh device based on its precursor—the Kugel patch. Approvals of medical devices based on an assessment that they were “substantially equivalent” to a previously approved device may be one flaw in the system which has allowed a potentially harmful device to be implanted in thousands of women. Johnson and Johnson’s approval from the FDA for their vaginal patch was predicated on the claim they were substantially similar to the recalled Kugel patch—presumably without the design flaws. Currently Johnson and Johnson has at least 600 vaginal mesh lawsuits in the works against the giant corporation; when you consider that as thousands of women received vaginal mesh implants in the past year alone, those numbers are expected to grow.
Transvaginal Mesh Applications Declared “Experimental” in 2007
In February of 2007—prior to the FDA’s public health alert in 2008—the American College of Obstetricians and Gynecologists issued a bulletin on pelvic organ prolapse. This bulletin warned both physicians and their patients to consider the vaginal mesh procedure to be experimental, and that patients who consented to the procedure should be made aware of that fact. They went on to say that because there was both limited data as well as frequent changes in the mesh products which were being marketed—particularly regarding the material the mesh was constructed from—that women considering having the mesh surgery should be aware of the potential risks and complications.
Some seven months later, the same group issued a second bulletin with a much softer warning, and with the word “experimental” mysteriously gone. In this bulletin women were only warned that because of the limited data and changes in marketed products as well as potential mesh erosion, patients should only consent to surgery with this understanding. Because “experimental” procedures are rarely covered by insurance, it has been speculated that the potential of losing large amounts of money resulted in the change in wording.
Is a Flawed Approval System to Blame for Mesh Complications?
Although the current FDA approval system has been in place for over three decades, the Institute of Medicine—for one—believes the government should abandon this medical device approval system because it offers little safety assurance for patients. The medical device industry is currently a $350 billion dollar industry which covers everything from pacemakers to contact lenses. Although this advice is not binding upon the FDA, it could prove that Americans want tighter standards for medical device manufacturers who have benefitted financially from less safety scrutiny than their peers in the industry. Most new prescription drugs are required to go through rigorous clinical trials to prove definitively that patients benefit from the medication—and that there are no serious side effects. On the flip side, most medical devices, including mesh, must only show they are similar to a device which is already on the market. It is only the truly brand new innovations which are required to undergo safety testing. The FDA defends the system in place stating they have been working for over a year to make the approval process for medical devices more predictable and less bureaucratic—changes which would be scrapped if the entire system is revamped.
Does the 510(k) Approval System Need an Overhaul?
This 35-year old process, known as the 510(k) process has some wondering if it really protects Americans to the fullest extent possible. While the FDA is not in favor of eliminating the procedure, they are open to proposals for improvement. FDA officials point out that they are already subject to criticism from manufacturers of medical devices who believe the agency is too slow in clearing new devices, driving up costs and even forcing smaller companies out of business. The 510(k) system was created by Congress in 1976 with a goal of granting quicker approvals to devices which were substantially similar to medical devices already on the market.
The system was originally intended to be a temporary means of grandfathering in medical devices which had been used for decades however over time became the standard in launching new medical devices. Today, nearly 4,000 devices are cleared each year under the present 510(k) system while only around 50 devices are approved under a more stringent system of human testing. While the 510(k) system is not considered inherently unsafe, there must be more safeguards in place to protect patients from harm. Although the FDA is battling a multi-million dollar lobbying effort by medical device manufacturers, they may have a stronger position due to the fact that reports of pain, bleeding and infection with the mesh implants are up 500 percent since 2008.
Class II vs. Class III
Prior to the convening of the September 8th panel regarding the adverse reports of the transvaginal mesh implant, the FDA recommended that transvaginal mesh products be reclassified to a Class III (high risk) rather than their current Class II (moderate risk). A Class II device is approval under the abbreviated 510(k) process while a Class III classification would give the FDA stronger controls over the clinical studies conducted before marketing the product. Obviously the mesh industry wants to maintain their Class II status, arguing that additional studies and labeling changes on mesh implants are sufficient to safeguard the health of women. Re-classifying the mesh implants as high risk would require them to undergo approval of manufacturing procedures, inspections of their device plans and a longer review period.
The FDA must sort through the dizzying array of opinions and facts regarding the safety, efficacy and potential reclassification of the transvaginal mesh implants and must also make critical decisions regarding further clinical studies prior to making their final determination. In the meantime a national group of surgeon’s stated the transvaginal mesh devices should only be used in a limited number of carefully chosen women, and only by highly trained physicians in the procedure. While Johnson and Johnson continues to maintain that its vaginal mesh product is safe, women must become their own health advocates and make sure they have all the facts before agreeing to a transvaginal mesh procedure. Women who have suffered severe complications as a result of a mesh implant may face multiple surgeries and may never fully recover from the damage done. As we wait for a decision from the FDA, it is likely that more women will be coming forward regarding the damage done by a mesh implant.
Subscribe to:
Posts (Atom)