FDA on Tuesday ordered two remaining manufacturers of vaginal mesh implants to immediately stop selling and distributing the products in the United States, citing safety concerns.
Background
Millions of women across the world have received mesh implants for transvaginal repair of pelvic organ prolapse since the 1990s. FDA in 2002 approved the mesh implants as moderate-risk devices, but in 2016 the agency moved the mesh implants into the high-risk category.
Studies have found up to 15% of women with mesh implants encounter problems. For instance, several woman have said the mesh implants led to bleeding and discomfort during sex. However, removal of the device is not recommended in every case.
The complaints have spurred several lawsuits against mesh manufacturers, including Boston Scientific, Coloplast, C.R. Bard, and Johnson & Johnson, Reuters reports. Overall, more than 100,000 plaintiffs have sued mesh implant manufacturers in federal court.
Johnson & Johnson and several other manufacturers already have stopped selling vaginal mesh implants. FDA said some of the manufacturers removed their implants from the market in 2018 because they did not submit premarket approval applications to demonstrate their products were safe and effective.
FDA orders manufacturers to cease sales of vaginal mesh implants
FDA on Tuesday said it has ordered the two remaining manufacturers that sell vaginal mesh implants in the United States, Boston Scientific and Coloplast, to immediately stop selling the products. FDA said it issued the order after the companies failed to show the products are safe and effective for long-term use.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said, "In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair [pelvic organ prolapse] ... [W]e couldn't assure women that these devices were safe and effective long term."
FDA said the companies have 10 days to submit plans to remove the products from the U.S. market.
The agency said women with vaginal mesh implants should continue receiving regular checkups and do not need to have the device removed if they are not experiencing problems.
FDA noted that the order does not apply to surgical mesh intended to treat hernias or incontinence. The order only applies to surgical mesh implants intended to treat pelvic organ prolapse, the agency said.
Reaction
Boston Scientific said it is "deeply disappointed" by FDA's decision to remove the products from the market, but it will work with FDA to determine the company's next steps. The company said, "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."
Coloplast said the order affects only one of the company's products and declined to comment further on FDA's order, Reuters reports.
Shanin Specter, a lawyer who has won cases against manufacturers of vaginal mesh implants, said, "This is a good step forward. But mesh used to treat stress incontinence also continues to devastate thousands of women, and the FDA should act decisively there, too" (Sibi Joseph/Jagadeesh Babu, Reuters, 4/16; Perrone, AP/Sacramento Bee, 4/16; FDA release, 4/16; Bloomberg/Los Angeles Times, 4/16; Kaplan/Goldstein, New York Times, 4/16).