After years of advocacy by injured patients, the U.S. Food and Drug Administration has ordered the makers of mesh devices for the repair of pelvic organ prolapse, or POP, to remove the products from the U.S. market, including mesh sold by Coloplast A/S and Boston Scientific Corp.
Women who were scheduled to have mesh implanted to treat pelvic organ prolapse will need to discuss other treatment options with their doctors, the FDA said in an announcement Tuesday. The decision does not apply to similar mesh products used to treat stress urinary incontinence.
Organizers with the patient-activist group Medical Device Problems offered lukewarm praise for the FDA's decision, saying it took too long to happen and did not go far enough.
"These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement. We feel the announcement, while a step in the right direction, also does not go far enough; it does not address other mesh devices that are causing similar life-altering injuries," wrote Amanda Dykeman, the Illinois-based founder of Medical Device Problems.
Manufacturers say the decision to remove transvaginal mesh products for POP may have negative effects for some patients.
"We are deeply disappointed by the FDA's decision on our premarket approval applications," Boston Scientific spokeswoman Kate Haranis said via email. The company believes that "the inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives."
A Coloplast spokesperson declined to comment Tuesday.
Plastic mesh products have been implanted since the 1990s to strengthen internal pelvic tissues that weaken naturally as women age, but scores of women have complained that their devices led to more pain in the long run.
The half dozen makers of vaginal mesh products have attracted more than 100,000 lawsuits from women around the world. Makers of the companies have been steadily working to settle the cases, while also insisting that the products are safe and effective when used as directed.
The FDA has been examining complaints about mesh devices since at least 2011. In 2016, the agency moved the devices into its highest-risk category of surgical products, forcing the manufacturers to decide whether to fund new studies to meet the higher standards for safety and effectiveness, or pull out of the market.
Only Boston Scientific and Coloplast, both of which have major operations in Minnesota, opted to submit new premarket applications, or PMAs, to the FDA to show that their products were at least as safe and effective as native-tissue repair.
Then in February, the agency's expert panel on the devices said the FDA should require manufacturers to present evidence that mesh has a superior level of effectiveness to native tissue repair at 36 months, and a comparable level of safety.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," said Dr. Jeffrey Shuren, director of the FDA's medical device division, in the announcement.
The agency has given Boston Scientific and Coloplast 10 days to submit plan to withdraw the products from the market.
The action affects Boston Scientific's Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair System, and Coloplast's Restorelle DirectFix Anterior device.
Boston Scientific spokeswoman Kate Haranis said via email Tuesday that patient safety is the company's highest priority, and that the company plans to work closely with the agency "to understand its direction and determine next steps."
Tuesday's decision applies only to cases in which mesh is implanted transvaginally to strengthen tissue walls and prevent organs from prolapsing into the vagina. It doesn't apply to mesh products used to treat stress urinary incontinence.
