FDA Orders New Safety Studies of Vaginal Mesh Devices

The U.S. Food and Drug Administration is asking several manufacturers of transvaginal mesh implants to conduct in-depth research regarding the safety of these devices.

The FDA issued the order to 33 medical device manufacturers, including Johnson & Johnson, C.R. Bard, Boston Scientific and American Medical Systems. All four of these companies are currently facing numerous lawsuits from women who say they suffered serious complications after receiving a mesh implant.

Surgical mesh was first developed in the 1950s to treat hernias but the product was adapted in the 1990s to treat women who suffer from pelvic organ prolapse (POP). Pelvic organ prolapse is an uncomfortable and sometimes painful condition that can cause the uterus or other reproductive organs to sag or bulge downward through the pelvic floor. This condition is also linked to stress urinary incontinence and typically affects women who’ve experienced childbirth, significant weight gain or hysterectomy.

The FDA first issued a safety communication regarding the devices in 2008 after receiving numerous complaints from women about adverse side effects. Adverse event reports continue to be submitted to the FDA.

A 2010 study on the safety of the implants had to be abandoned after 15 percent of the participants developed some degree of erosion in the mesh implant. In July 2011, the FDA issued an updated safety communication after another study suggested that the risk of serious injury or even death associated with transvaginal mesh was substantially high.

The companies named in the order are now being asked to provide as much as three years worth of data on the safety and effectiveness of vaginal mesh implants. Medical experts and consumer advocacy groups have been urging the FDA to take a closer look at devices while the number of lawsuits being filed against their makers continues to grow.

The Johnson & Johnson Company currently faces numerous lawsuits involving its Ethicon Gynecare System. C.R. Bard is also being sued over its Avaulta mesh system. The plaintiffs in the litigation allege a wide range of side effects, including severe pain, bleeding, swelling, tissue damage, blood vessel damage, infection, difficulty urinating, painful intercourse and other complications. With an estimated 300,000 women receiving one of these implants each year, the number of lawsuits is expected to increase.

While the FDA has not stated any plans to issue a recall of these devices, this latest step may be an indication of the future of the implants. If you or a loved one was injured by transvaginal mesh, you need to contact a qualified personal injury attorney right away to discuss your claim.

The law firm of Nadrich & Cohen LLP is currently investigating cases from women in all 50 states and we are eager to speak with you. Call our Injury Hotline at 1-800-718-4658 today to schedule your free initial case evaluation. There is never a fee unless we recover a judgment on your behalf. Call now to put our vaginal mesh injury specialists to work for you.

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