WASHINGTON -- Makers of trouble-prone implants used to surgically repair women's pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.
The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a "high-risk" medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If finalized, the change would require manufacturers to prove that their mesh products are safe and effective before they can be sold.
Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who've had children -- and often the cause of embarrassing bladder leaks. The most common technique for implanting the mesh involves a surgical insertion through the vagina.
The FDA's proposal comes nearly three years after the agency first concluded that women getting mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 per cent of women experienced mesh erosion within 12 months, meaning their mesh had gradually worn through the vaginal wall into the surrounding tissue or organs. More than half of these women require follow-up surgery to remove the mesh -- sometimes two or three procedures.
Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," said William Maisel, chief scientist for the FDA's device centre.
The first mesh products received fast-track approval from the FDA because they were deemed similar to mesh long used in hernia surgeries. At the time the FDA classified all pelvic mesh as a "moderate-risk," device, not subject to the rigorous testing of high-risk implants. Under Tuesday's proposal, companies would have to submit clinical data proving their devices are safe before gaining FDA approval. The agency will take comments on the plan for 90 days.
Injuries caused by pelvic mesh are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.
Attorneys representing women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.
In February, U.S. District Court Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded J&J destroyed thousands of documents regarding development of its pelvic mesh implants, but said there was no proof that was done intentionally. The documents would include reports on patient testing of the mesh implants and could show whether participants suffered serious complications.
Other manufacturers of pelvic mesh include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.
