As Transvaginal Mesh Lawsuit Numbers Increase FDA Cracks Down On Mesh Devices

April 04, 2016 – – TheProductLawyers.com reports on recent crackdowns by the Food and Drug Administration concerning the safety of mesh devices. According to a report by The Pittsburgh Post-Gazette, the devices will face new scrutiny by the Food and Drug Administration as a result of thousands of injuries that have been reported by women who used the devices.

Manufacturers of pelvic mesh, such as Johnson & Johnson, C.R. Bard, Boston Scientific, Cook Medical, and Coloplast, will have to submit new applications that show how the devices are safe and effective, according to the article.

The devices were approved by the FDA in 1996 for use in procedures for stress urinary incontinence in women. It was then approved later for treatment of pelvic organ prolapse in 2001. Since then, thousands of women have filed lawsuits that have been combined in several multidistrict litigation panels claiming that the device causes severe side effects that the manufacturers failed to adequately warn them about. Side effects reported by women filing suits include bleeding, infection, organ perforation, recurrent incontinence or prolapse, severe vaginal or pelvic pain, inability to engage in sexual intercourse, vaginal shrinkage, mesh erosion through the vagina, and neuro-muscular problems.

The FDA has reported that in 2010 alone, about 300,000 women went through procedures in the U.S. to treat pelvic organ prolapse and about 260,000 surgeries for stress urinary incontinence. One out of every three surgeries performed to treat pelvic organ prolapse involved the use of mesh. In 2010, 80 percent of surgeries done on women to treat stress urinary incontinence was done with mesh, according to the FDA.

As these cases are expected to accumulate, lawyers at Banville Law are working to ensure that those individuals who have been treated with transvaginal mesh are able to explore their legal rights fully. Qualifying individuals may be entitled to legal action and substantial financial compensation. The firm is currently offering free case evaluations for interested parties.

For more information, or to ask questions about transvaginal mesh, contact Banville Law by calling 888-997-3792.

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