Florida Today reports that while the FDA considers tougher regulations over medical devices, that decision will come too late for four women from Brevard County, Florida. The four say they were damaged by mesh device implants to treat pelvic floor problems.
“For six weeks, I was walking around with the equivalent of barbed wire inside of me,” said Lisa Smith, the youngest of the four women, all from the Melbourne, Florida area. They are part of about 300 women involved in mesh lawsuits from 34 states.
The FDA on July 13, issued its second warning about surgical mesh saying that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” POP is short for pelvic organ prolapse where the organs fall to the pelvic floor because muscles and tissues are too weak to hold them in place.
One woman tells Florida Today that the mesh eroded her tissue and protruded from her body. The original incontinence problem she used mesh to treat became worse and she lost her job and health insurance.
A West Virginia federal judge can send the cases back to their original jurisdiction for a jury trial or settle the lawsuits.
Four companies make synthetic, petroleum-based mesh, Ethicon, a division of Johnson & Johnson, C.R. Bard; Boston Scientific; and American Medical Systems.
The FDA will convene a panel of experts to discuss medical mesh and other devices September 8 and 9th but in the meantime hundreds of thousands of men and women are implanted with synthetic mesh for pelvic and hernia repair.
Karen Riley, spokesperson for the FDA tells the paper, the mesh is still on the market because some in the clinical community believe it is the best device for select patients. #