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 to remove the products from the U.S. market.
The announcement Tuesday came after years of scrutiny and well over 100,000 lawsuits from women around the world who said the mesh products caused painful complications. Makers of the products include two companies with major operations in Minnesota, Coloplast A/S and Boston Scientific Corp.
Organizers with the patient-activist group Medical Device Problems offered lukewarm praise for the FDA’s action, 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.
Women who were scheduled to have mesh implanted to treat pelvic organ prolapse (POP) will need to discuss other treatment options with their doctors, the FDA said in its announcement. The decision does not apply to similar mesh products used to treat stress urinary incontinence.
Manufacturers said the decision to remove transvaginal mesh products for POP from the market 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 e-mail. The company believes that “the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
Mesh products were originally used in surgery to repair abdominal hernias. Since the 1990s, plastic mesh has been used to treat the common condition of pelvic organ prolapse, which happens when the muscles and tissues supporting the uterus, bladder, or rectum become weak or loose, allowing one or more pelvic organs to drop or press into or out of the vagina, according to the U.S. Office on Women’s Health.
Although the mesh is supposed to reinforce the tissues and prevent prolapse, thousands of women say the treatment led to more pain. The FDA examined thousands of reported injuries and found the most commonly reported problems included severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
Pelvic floor disorders
Though embarrassing to talk about, pelvic floor disorders including POP, urinary incontinence and fecal incontinence affect one in five women in the U.S., with POP alone affecting about 3% of all women. The FDA said about 1 in 8 women will have surgery of some form to repair POP.
Dr. Emanuel Trabuco, chairman of the urogynecology division at the Mayo Clinic in Rochester, said there’s a range of different treatment options for POP, both surgical and nonsurgical, that don’t involve the use of the vaginal mesh “kits” sold by the device companies. He said the overall concern over mesh complications may have unfortunately caused women to avoid any type of care.
“Other treatment options are available to treat stress incontinence and pelvic organ prolapse, and women shouldn’t be scared to talk to their physicians,” Trabuco said. He also noted that the clinical data support the idea that mesh kits for POP have a different risk profile than mesh for urinary incontinence, even though the devices appear similar.
Makers of the devices have been steadily working to settle the litigation around the products, while simultaneously insisting that the products are safe and effective when used as directed.
The FDA has been examining complaints about mesh devices used for POP 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. The devices were previously in a lower-risk category that required far less safety testing to gain clearance.
Boston Scientific and Coloplast opted to submit new premarket applications 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 met and decided 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.
Stock prices drop
Shares of Boston Scientific stock dropped more than 4% to about $36 on the news Tuesday afternoon. Analysts with Leerink Partners noted that although mesh products for POP account for about $25 million, or 1%, of Boston Scientific’s annual sales, investors appeared to be selling the stock out of concern over litigation. Leerink said the sell-off was out of proportion to the risk, because Boston has already settled the vast majority of the roughly 40,000 lawsuits pending against it.
A Coloplast spokesperson declined to comment Tuesday. The affected devices made up about 0.2% of Coloplast revenue. Company stock dropped 3% Tuesday.
The FDA has given Boston Scientific and Coloplast 10 days to submit plans to withdraw the products from the market. The action affects Boston Scientific’s Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and Coloplast’s Restorelle DirectFix device.
The not-for-profit advocacy group Public Citizen, which asked the FDA to ban the devices in 2011, welcomed Tuesday’s action by the FDA but criticized the agency for allowing thousands of women to be hurt long after it knew that the devices had not demonstrated a reasonable assurance of safety.
“Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products,” Public Citizen said in a statement. “If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm.”