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FDA Orders Makers to Study Transvaginal Surgical Mesh

Posted on January 9, 2012

It seems sort of backwards. With an estimated 300,000 synthetic surgical mesh operations in 2010 for female pelvic organ prolapse and incontinence, you’d think the Food and Drug Administration (FDA) would understand the complications associated with the medical device.

But now Bloomberg reports the FDA has sent a letter to 31 medical device and mesh manufacturers requiring them to order three years of clinical trials on safety and effectiveness. This comes after the FDA announced last July that there had been a five-fold jump in injuries and deaths tied to synthetic mesh.

The manufacturers include Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems, Covidien, and Endo Pharmaceuticals Holding, among others. How did these devices get on the market without any testing? Under the current approval process, known as 510(k), a medical device can be approved for sale if it is equivalent to a similar device already for sale. There are no clinical trials required. Last September, an FDA panel recommended transvaginal mesh be reclassified to Class III, so that trials for safety and efficacy would be a required part of the approval process. It only makes sense for a device to be permanently implanted in the body. But manufacturers like the 510(k) process because it saves them time in research dollars and money.

Patient advocates have been raising the profile on mesh injuries related to pelvic organ prolapse and incontinence and for men suffering from a hernia mesh injury. The medical mesh device is a petroleum-based plastic that is known to erode, cause infection, shrink, and perforate nerves and organs. Thousands of women have reported adverse events or complications to the FDA’s database, which is thought to reflect a very small percentage of actual injuries and deaths.

If you or a loved one is suffering and has had synthetic surgical mesh implanted, it might be the cause of such complications. The symptoms are vast and varied and often a mesh removal is the only thing that will allow you to recover your health. Farah & Farah’s Jacksonville surgical mesh injury lawyers are talking to women who are suffering to seek compensation through a product liability action which will allow for the recovery of medical expense, lost wages, and pain and suffering.

Source: http://www.businessweek.com/news/2012-01-05/j-j-c-r-bard-must-evaluate-safety-of-vaginal-mesh-fda-says.html