Updates on Transvaginal Mesh Dangers

• JAN. 2012 FDA TO RECLASSIFY MESH: The FDA is considering moving transvaginal mesh implants to a higher class of device classification, which is reserved for the most risky of medical devices.
• JAN. 2012 FDA DEMANDS FURTHER TESTING: The FDA mandated that several transvaginal mesh manufacturers must immediately conduct testing of the device’s risk to women. If TVM makers had conducted post-market testing from the beginning, they might have prevented so many women from suffering terrible complications.
• DEC. 2011 EXPERTS LIMIT USE OF MESH IMPLANT: The Committee on Gynecologic Practice has called for doctors to limit the use of transvaginal mesh patches for the repair of POP. This recommendation is based on the high number of painful and serious complications suffered by women who have received the implant. For most women, the benefits are not believed to be worth the risks of transvaginal mesh implants.
• JULY 2011 FDA WARNING: An FDA Safety Alert warned that serious complications associated with the surgical mesh patches are not rare. The Agency announced that the surgical mesh treatment of pelvic organ prolapse may be no more effective than the traditional non-mesh repair, in addition to posing greater risks for the patient. Learn more about a Transvaginal Mesh Lawsuit.

What the Transvaginal Mesh Patch Does

Often, a significant stretching, such as childbirth, may have damaged the tissue of the vaginal wall. The patch is implanted to support internal organs that were once held up by the vaginal wall.

Complications of Transvaginal Patches Include:

• Erosion of the vaginal epithelium
• Serious infection
• Return of pelvic organ prolapse (POP)
• Urinary incontinence
• Severe bleeding
• Bladder perforation

Recent Research Indicates Patches’ Serious Risks

Research published May 2011 in the New England Journal of Medicine reveals negative side effects associated with the transvaginal mesh patch. The study measured the effectiveness of the patch compared to that of colporrhaphy, the traditional treatment of stitching connective tissue in the vaginal wall back together. The study found that the mesh patch had higher risk of harm or defect, including:

• 7x greater risk of bladder perforation than colporrhaphy
• Nearly 2x the risk of urinary incontinence (loss of bladder control)
• 3.2 percent of women required follow-up surgery to correct exposure problems

Nearly 2,000 Women have Filed Transvaginal Mesh Lawsuits Against Manufacturers

These women from across the U.S. have already taken a stand  by filing claims against the negligent manufacturers of transvaginal mesh patches. The suits have a two-fold purpose. They allow women the opportunity to receive much-deserved compensation for their financial losses, as well as physical and emotional suffering. Additionally, filing claims against the irresponsible manufacturers of the transvaginal patches may cause them or the FDA to pull the products from the market, thereby preventing other women from undergoing the same suffering caused by the patches.

Manufacturers include:

• C.R. Bard
• Johnson&Johnson’s Ethicon
• American Medical Systems
• Boston Scientific

Complications have been reported for several other manufacturers of surgical mesh as well including:

• Covidien
• Sofradim
• Caldera
• Mentor Corporation

What You Should Do:

• If you are suffering severe complications, seek medical attention.
• If you are experiencing complications, contact the medical provider or doctor who inserted the patch and ask which manufacturer you have been given. Schedule an appointment to see your physician as soon as possible.
• Contact our law firm by using the form or calling 877-307-4962 to speak with an attorney who will listen to your story and dicuss the broader picture of the dangers, the course of action for replacement and your legal rights. Contact us today; there is no obligation.