Transvaginal mesh devices have been linked to severe complications including infection, scarring, and damage of internal organs. Our firm is working with experienced attorneys all across the country who can file a transvaginal mesh lawsuit on your behalf and will charge you no legal fees until you receive a settlement or award. Feel free to contact us toll free or online for your free legal consultation.
Surgical mesh is a device used to add extra support for damaged tissues. There are many different types of surgical mesh manufactured by different companies. Transvaginal mesh patches are made by at least nine different manufacturers and used in the vaginal wall to treat conditions that occur after childbirth and pregnancy. The two main conditions these patches are used to repair are pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions affect millions of women in America, and recently surgeons have been using mesh to try and repair the tissue damage that causes POP and SUI. However, the FDA is warning patients about these mesh patches because they are failing and causing injuries to those recipients that get the implant.
Transvaginal Mesh Patch Side Effects
The FDA’s warning stated that complications associated with this device are not rare. The FDA has received thousands of reports of injuries resulting from the mesh, including side effects such as:
- 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 experiencing complications due to the mesh need medical care or surgery, including IV therapy, blood transfusions, drainage of abscesses, or surgery to repair or remove the defective mesh.
Transvaginal Mesh Lawsuits
Though no class action suits have currently been filed, many individual lawsuits have been filed against the varying manufacturers of transvaginal mesh. The major companies continue to face consolidated multi-district lawsuits that are separate but coordinated. Here is the list of the ongoing lawsuits:
- 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)
With all the reasons indicating that this mesh device is defective, plaintiffs in these lawsuits are seeking monetary damages to cover additional surgery/surgical repairs, out-of-pocket medical expenses, lost income, emotional distress, pain and suffering, loss of quality of life, loss of ability to have sexual relations, and spousal loss of consortium.
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 about the product, that the device was defective in the condition it was put on the market in, or that the device that you used was in some way defective. The next thing you must prove is that the device caused the side effect or disease that you were diagnosed with.
To prove these elements, people need many different experts and medical opinions. For instance, you will need the opinion of your physician and other medical experts. Experts may be brought in to prove that the device is in fact defective. These lawsuits are very complex and time-consuming, but if you have a valid claim, you deserve to be compensated for your injuries.
Transvaginal Mesh Patch Medical Studies
When the FDA first approved these mesh patches, it went through an approval process referred to as a 510(k). Under this process, very minimal safety testing was done because all that is required for approval 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 this device. As a result, many medical experts/practitioners have gone on record in medical journals and other publications voicing very strong statements against the widespread use of transvaginal mesh patch devices.
Though each individual expert phrases their opinion in a slightly different way, the overall message is that, because of the extreme lack of knowledge related to this product and the severe complications it is 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 its use, 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 pertaining to the product, and have even reiterated previous warnings so that patients and the entire medical community are aware of the complications that continue to arise.
About Transvaginal Mesh Patch Companies
While many companies manufacture and market the mesh patch, there are several large companies that have faced the most intense criticism from the FDA and the 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 this product.
- 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
In 1996, the FDA first approved Boston Scientific’s ProteGen mesh patch. Soon after, the FDA began approving similar mesh patches produced by Johnson & Johnson and other companies without testing or running trials because the new mesh patches closely resembled the original, approved version. While the FDA was approving more and more mesh patches by more companies, Boston Scientific was forced to recall its product – the very product that 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 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 women across the country had had them implanted for periods of over ten years already. In fact, in 2010 alone, 10,000 women underwent a vaginal mesh surgery to repair a pelvic organ prolapse.
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 product. This announcement came as the Johnson & Johnson subsidiary Ethicon is facing complicated litigation already in a couple of federal district courts.
In letters to the courts (read them here and here), Johnson & Johnson announced that Ethicon intended to stop “commercializing” four of its transvaginal mesh brands. It has asked the FDA for 120 days to allow it to cease marketing these brands while doctors and patients explore other treatment options.
According to one spokesman for Ethicon, this is a voluntary move. The company is quick to stress that this is not a recall of the four brands of product 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 devices 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 have requested that these orders be put on hold while the decision to stop marketing is reviewed by the FDA.
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Contact the Law Offices of d'Oliveira & Associates
If you or a loved one has been injured from use of a transvaginal mesh patch, you may want to speak with a personal injury attorney regarding a potential claim. An injury lawyer familiar with the ongoing investigation of these devices may be able to help you make important personal and legal decisions. d’Oliveira & Associates is working with qualified lawyers across the country who can help you with your case today.
Call d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.