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.
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Showing posts with label In late 2010. Show all posts
Showing posts with label In late 2010. Show all posts
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.
The ASR Acetabular System falls far short of other total hip replacement systems. Here's how.
In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.
What a Hip Implant is Up Against
Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).
hip1
As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.
These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.
For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.
When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.
As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System. Read more ....
Johnson Takes $3 Billion Hit on Hip Recall
Johnson & Johnson took quarterly charges of more than $3 billion, largely related to the recall of artificial hips, and gave a 2012 earnings forecast below analysts’ estimates on Tuesday.
The company’s DePuy Orthopedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.
The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.
“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.
The company forecast 2012 earnings of $5.05 to $5.15 a share, compared with the consensus Wall Street view of $5.21.
William Price, a company spokesman, said most analysts had not factored in damage from the stronger dollar.
Johnson & Johnson reported better-than-expected fourth-quarter earnings, helped by favorable taxes and sales of new prescription drugs. The company earned $218 million, or 8 cents a share, in the quarter. That compares with $1.9 billion, or 70 cents a share, a year earlier, when it also took charges for recalls of hip replacement devices.
Excluding special charges, Johnson & Johnson earned $1.13 a share. Analysts had expected $1.09, Thomson Reuters said.
Johnson & Johnson, which is based in New Brunswick, N.J., said global sales rose 3.9 percent in the quarter, to $16.26 billion, slightly below analysts’ target.
Source : nytimes
Depuy Hip recall attorney | asr hip lawsuit | depuy pinnacle hip replacement dangers | hip recall lawsuit help
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