The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the agency reclassified them as high-risk in 2016, the FDA said. As part of the reclassification, manufacturers were required to obtain premarket approval (PMA) applications, the agency’s most stringent device review pathway.
The FDA found that Boston Scientific and Coloplast failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh (native tissue repair), leading it to conclude that “these products do not have a reasonable assurance of safety and effectiveness.” It gave the companies 10 days to submit their plan to withdraw these products from the market.
“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 POP. 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 Center for Devices and Radiological Health, in a prepared statement. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
Gynecologists began implanting surgical mesh for abdominal repair of POP in the 1970s and, in the 1990s, for surgical repair of POP. The FDA cleared the first mesh device for transvaginal repair of POP for use as a class II moderate-risk device in 2002. That use has been under fire for years as women filed lawsuits complaining of pain, excessive bleeding and loss of sexual function. The FDA said it saw a “significant increase” in the number of adverse events reported about various manufacturers’ pelvic mesh products, which have also have been subject to repeated recalls and lawsuits that have yielded multi-million-dollar settlements. The agency issued its first safety communication about pelvic mesh in 2011.
Media investigations published in the past year — including Netflix’s July 2018 documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ Implant Files have also drawn greater public attention to patient problems with pelvic mesh and other medical devices. Former FDA analyst Madris Tomes, now CEO of medtech safety software company Device Events, said she was pleased by the agency’s move.
“There are similar issues with hernia mesh but perhaps doctors will better understand that native tissue repair should always be the first choice,” Tomes said in an email to MassDevice.
“We are deeply disappointed by the FDA’s decision on our premarket approval applications (PMAs) for the Uphold LITE vaginal support system and the Xenform soft tissue repair matrix, and believe 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,” said Boston Scientific spokeswoman Kate Haranis in an email to MassDevice. “Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”
Coloplast declined to comment on the ban.
In 2018, reports surfaced that Johnson & Johnson (NYSE:JNJ) tried to stop health authorities in France from publishing a report that warned against the use of untested pelvic mesh devices.
Ireland also temporarily suspended all transvaginal mesh procedures for the treatment of stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals last year. The country said that the suspension would stay in place “until a set of conditions to mitigate the risks of injury are met.”
A recent FDA transvaginal mesh advisory panel agreed that vaginal mesh products should continue being offered as an option to women with pelvic organ prolapse, but that improvements were needed, both in depth and length, for both premarket and postmarket studies of the devices, MedTech Dive reported. Premarket approval studies should follow patients out to at least 18 to 24 months, while postmarket studies should follow patients to five years, the panel agreed.
Boston Scientific shares dropped from $38.09 to $35.64 on the news before 1 p.m. Eastern time before recovering slightly.