Transvaginal Mesh Patch Devices have been linked to severe complications including infection, scarring, and perforation of internal organs. We are working with some of the leading Transvaginal Mesh Patch attorneys in the United States. A claim and/or Transvaginal Mesh Patch lawsuit can be filed on your behalf and there is no fee until you receive an award or a Transvaginal Mesh Patch settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.
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Transvaginal Mesh Devices have been linked to serious and painful complications, including infection, scarring, and perforation of internal organs. If you or one of your loved ones have been harmed due to Transvaginal Mesh, the personal injury attorneys at the law offices of d’Oliveira & Associates, P.C. can help you. You may need to speak with a personal injury lawyer who can assist you in making important personal and legal decisions. If needed, an injury attorney can help you get the compensation you deserve by filing a claim on your behalf.
Surgical mesh is a medical device used to add extra support for damaged tissues. There are many different types of surgical mesh manufactured by different companies. Transvaginal Mesh is made by at least nine different manufacturers, and is used in the vaginal wall to treat conditions that occur after childbirth and pregnancy. The two main conditions that transvaginal mesh is used for are pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions affect millions of women in the United States, and recently surgeons have been using transvaginal mesh to attempt to repair the tissue damage that causes POP and SUI. However, the FDA is warning patients about the mesh because it is failing and causing injuries to implant recipients.
The FDA’s warning stated that the complications associated with Transvaginal Mesh are not rare. The FDA has received thousands of reports of injuries resulting from the mesh. Side effects of the mesh include:
- Recurrence of pelvic organ prolapse
- Recurrence of stress urinary incontinence
- Erosion of vaginal tissue
- Mesh erosion
- Perforation of the bowel, bladder, or blood vessels
- Urinary problems
- Vaginal scarring
- Pain during sexual intercourse
Most patients who have had complications resulting from the mesh needed medical care or surgery, including IV therapy, blood transfusions, drainage of abscesses, or surgery to repair or remove the defective mesh.
Transvaginal Mesh Patch Side Effects
The Transvaginal Mesh Patch is made by at least 9 different manufacturers and is used by millions of women throughout the country. It is a stretchable patch that is implanted on the vaginal wall during a surgical procedure. The Transvaginal Mesh Patch is most commonly used to repairs pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
What’s the Problem?
The problem is that the Transvaginal Mesh Patch side effects and complications have been so numerous and problematic that the FDA has issued 2 advisory warnings about it. The first warning, coming in 2008, was a general advisory warning to medical practitioners and patients, advising them that the Transvaginal Mesh Patch has been linked to many serious side effects.
The 2nd warning, however, contained stronger language and warned of the specific Transvaginal Mesh Patch side effects. These side effects include:
- Urinary problems
- Perforation (holes/punctures) of the bowel, bladder, or blood vessels
- Erosion of vaginal tissue
- Mesh erosion
- Pain during sexual intercourse
- Recurrence of Pelvic Organ Prolapse (POP)
- Recurrence of Stress Urinary Incontinence (SUI)
What is Pelvic Organ Prolapse (POP)?
Pelvic organs may slip out of place (prolapse) when the muscles and ligaments supporting a woman's pelvic organs weaken. Because POP may worsen over time, it often requires a surgical repair. Organs that can be involved when you have pelvic prolapse include the:
- Small Bowel
Pelvic organ prolapse is most often cause by strain during childbirth. Your pelvic organs are normally kept in place by the muscles and tissues in your lower belly. During childbirth, however, these muscles can weaken or stretch. If they don't recover, they can't support your pelvic organs. The symptoms of POP include:
- Feeling pressure from pelvic organs pressing against the vaginal wall. This is the most common symptom.
- Feeling very full in your lower belly.
- Pain in the vagina during sexual intercourse
- Feeling a pull or stretch in your groin area or pain in your lower back.
What is Stress Urinary Incontinence (SUI)?
Stress urinary incontinence (SUI) is losing urine involuntarily (without meaning to) during physical activity, such as coughing, sneezing, laughing, or exercise. SUI can be caused by weakened pelvic muscles that support the bladder and urethra, or because the urethral sphincter is working incorrectly. This weakness is often caused by:
- Injury to the urethra area
- Surgery in the pelvic area
SUI is the most common form of urinary incontinence in women. It is often seen in women who have had more than one pregnancy and vaginal delivery. SUI is also common in women whose bladder, urethra, or rectum wall stick out into the vagina (pelvic prolapse).
The main symptom of stress incontinence is losing urine without your control. It may occur when you:
- Have sexual intercourse
- Take part in physical activity
Transvaginal Mesh Patch Medical Studies
Transvaginal Mesh Patch Devices are currently made by multiple manufacturers and are used in millions of women today. However, the question that many medical experts and practitioners are asking is: Should these transvaginal mesh devices even be on the market?
When the FDA first approved transvaginal mesh, it went through an approval process referred to as a 510(k). The significance of this process is that little to no safety testing was done because all that is required for approval under 510(k) is a showing of substantial similarity to a previously approved product. Therefore, very little is known about the long-term effectiveness and overall safety of the transvaginal mesh patch. Because of this, many medical experts/ practitioners have gone on record in medical journals/publications with very strong statements against the widespread use of transvaginal mesh patch devices.
Though each individual expert phrases the opinion in a slightly different way, the overall message is that, because of the extreme lack of knowledge related to transvaginal mesh and the severe complications its causing to women everywhere, the patches should be treated as experimental and restricted to use in investigative trials only. Medical experts around the country believe that if patients consent to the use of the transvaginal mesh patch, that consent should be based on the patient’s knowledge that the mesh device is an experimental device, and very little is known about its long term safety and effectiveness.
These reports and opinions have apparently reached the ears of the FDA, who have now released many advisory warnings about the transvaginal mesh patch, and have even reiterated previous warnings so that patients and the entire medical community are aware of the complications that continue to arise.
Transvaginal Mesh Patch Lawsuits
When the FDA first approved transvaginal mesh, it went through an approval process referred to as a 510(k). In order to gain approval, all that is required under 510(k) is a showing of substantial similarity to a previously approved product. Therefore, little to no testing was done. That explains why very little is known about the long-term effectiveness and safety of the transvaginal mesh patch. It also explains why many women in the United States have experienced severe complications and subsequently filed transvaginal mesh patch lawsuits.
Though no class action suits have currently been filed, many individual lawsuits have been filed against the varying manufacturers of transvaginal mesh. These manufacturers include:
- C.R. Bard, Inc.: Sold under the names Pelvitext, Pelvilacem, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, and Avaulta.
- Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT
- Boston Scientific: Sold under the names Pinnacle Posterior Pelvic Floor Repair Kit, Advantage Transvaginal Mid-Urethral Sling System, Obtryx Transobturator Mid-Urethral Sling System, Prefyx Mid U Mesh Sling System, Polyform Synthetic Mesh, Uphold Vaginal Support System, and Prefyx PPS System.
- American Medical Systems: Sold under the names Elevate, Perigee and Apogee
The FDA has repeatedly warned patients and the medical community about all the risks associated with the transvaginal mesh patch. Part of the reason for this may be the outcry from prominent members of the medical community, pleading for the transvaginal mesh to be recalled. Another large part is the thousands of adverse reports the FDA has received about complications from the transvaginal mesh patch. With all the reasons for deeming the transvaginal mesh patch to be defective, plaintiffs in the current transvaginal mesh lawsuits are seeking money damages for the following losses:
- Additional Surgery/Surgical Repairs
- Out-of-pocket medical expenses
- Lost wages
- Emotional distress
- Pain and suffering
- Loss of quality of life
- Loss of ability to have sexual relations
- Spousal loss of consortium
If you feel as though Transvaginal Mesh Patch has injured you, please contact an experienced defective device attorney right away.
In order to prove that you have an injury that should be compensated for by the manufacturer, you must prove either that you did not receive adequate warnings, the device was defective in the condition it was put on the market in, or that this form of the device that you used was in some way defective. The next thing that you have to prove is that the device caused the side effect or disease that you were diagnosed with.
To prove this, people need many different experts and medical opinions. You will need the opinion of your physician and medical experts. There are experts that are brought in to prove that the device is in fact defective. These lawsuits are very time-consuming and detailed but if you have one, you deserve to be compensated for your injuries. Hiring an experienced Transvaginal Mesh attorney can help you make important personal decisions regarding moving forward with your claim.
Facing FDA Demands, Johnson & Johnson to Stop Selling Transvaginal Mesh
Facing 522 orders for additional studies, Johnson & Johnson announced on June 4 that its Ethicon subsidiary was ceasing to market four brands of its transvaginal mesh patches. This announcement comes as Johnson & Johnson subsidiary Ethicon is facing complicated litigation in Federal District Court in West Virginia and state action in New Jersey.
In letters to the courts (read them here and here), Johnson & Johnson announced that Ethicon, one of its subsidiaries, intends to stop “commercializing” four of its transvaginal mesh brands. It has asked the Food and Drug Administration (FDA) for 120 days to allow it to cease marketing these brands so that doctors and patients have time to explore other treatment options.
According to one spokesman for Ethicon, the subsidiary of Johnson & Johnson that sells these patches, this is a voluntary move. The company is quick to stress that this is not a recall of the four brands of transvaginal mesh products currently on the market or implanted in women across the country. Ethicon and Johnson & Johnson “continue to have confidence in the safety and efficacy of these products,” said the spokesman. “Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.” There is currently no recall of these products at any level, either from the company or from the FDA.
Part of the commercial viability of these transvaginal mesh products may be based on continued safety concerns brought up by the FDA’s office of Surveillance and Biometrics. According to the letters, there are 522 orders requiring additional studies of these products. Ethicon and Johnson & Johnson has requested that these orders be put on hold while the decision to stop marketing is reviewed by the FDA.
For more on this story, click here.
Transvaginal Mesh Patch About Companies
While there are many companies that manufacture and market dangerous transvaginal mesh patch devices, there are several large companies that have faced the most intense criticism from the both FDA and medical community, the most reports of severe side effects, and the most lawsuits against them. Although separate, American Medical Systems, the Johnson & Johnson subsidiary Ethicon, Boston Scientific, and C.R. Bard are all facing large coordinated multi-district lawsuits against them for the production and sale of the dangerous devices.
American Medical Systems mesh patches included the Elevate, the Perigee, and Apogee devices. Mesh patches manufactured by Boston Scientific included, among others, the ProteGen, Pinnacle Pelvic Floor Repair Kits, the Advantage Transvaginal Mid-Urethral Sling System, and the Prefex systems. Ethicon, a Johnson & Johnson subsidiary, sold the popular Gynecare line of mesh patches that includes the Gynecare, the Gynecare Prolift, the Gynecare Promisa, and Gynecare TVT. The products manufactured by C.R. Bard were the Pelvitext, Pelvisoft BioMesh, Pelvilacem, and the Avaulata.
In 1996, The U.S. Food and Drug Administration first approved the Boston Scientific ProteGen mesh patch. Soon after that, the FDA began using the 501(k) fast track approval of mesh patches produced by Johnson & Johnson and many other companies without testing or running trials because the new mesh patches closely resembled the original ProteGen by Boston Scientific. During the time when the FDA was approving more and more mesh patches by more companies, Boston Scientific was forced to recall its product – the very product the other companies were basing theirs’ on in order to get fast approval – because of an increasing amount of reports of severe side effects and complications.
Finally in 2011, after years of continuous adverse events and reported injuries, Boston Scientific, J&J’s Ethicon, C.R. Bard and American Medical System had to recall their products after another FDA mandate. Although the FDA has issued the recalls, the mesh patches were such a popular means to combat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) that woman across the country got them implanted for over ten years. In fact, in 2010 alone, 10,000 women underwent a vaginal mesh surgery to repair a pelvic organ prolapse.
The major companies continue to face consolidated multi-district lawsuits that are separate but coordinated. Here is the list of the ongoing litigation against each of the respective companies:
- In re Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (MDL 2326)
- In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2327)
- In re C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2187)
- In re American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2325)
Contact the Law Offices of d'Oliveira & Associates, P.C
If you believe that you or one of your loved ones have been injured by Transvaginal Mesh, you may want to speak with a personal injury attorney regarding a potential claim. An injury lawyer familiar with new developments in the investigation of Transvaginal Mesh may be able to help you make important personal and legal decisions. d’Oliveira & Associates, P.C. is working with some of the leading lawyers in the country who are handling these cases.
Please contact the law offices of d'Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.