WASHINGTON (AP) - 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 adopted, the change would require manufacturers to submit studies demonstrating that their 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. 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 the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh - sometimes two or more 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 center.
The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.
The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. 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 establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.
Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.
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.
Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.
“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.
J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.
Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.
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