FDA ordered Boston Scientific and Danish device maker Coloplast on Tuesday to immediately halt sale of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse, simultaneously rejecting the premarket approval applications submitted by the only two remaining market players.
The action comes two months after the FDA's Obstetrics and Gynecology Devices Panel agreed that data available was insufficient to determine long-term safety and effectiveness, and that doctors could be more selective in choosing patients.
While the meeting was intended to facilitate discussion on factors like study design and physician training, the agency cited the panel's recommendation that mesh companies must demonstrate superior product effectiveness and comparable safety to native tissue repair at 36 months as grounds for Tuesday's move, saying the manufacturers failed to provide data meeting that standard.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," FDA's Center for Devices and Radiological Health Director Jeff Shuren said in a news release.
Consumer rights advocacy group Public Citizen petitioned FDA to ban the class of devices in 2011. "This action unfortunately comes nearly a decade too late for the thousands of women who have been irreparably harmed," said Mike Carome, head of the organization's health research arm.
The device makers have maintained the safety of the products. Boston Scientific said it is "deeply disappointed" in a statement to MedTech Dive and believes "the inaccessibility of these products will severely limit treatment options" for women with pelvic organ prolapse (POP). A Coloplast spokesperson declined to comment.
At February's panel, Boston Scientific pitched its Uphold Lite Vaginal Support and Xenform Soft Tissue Repair systems and Coloplast presented on its Restorelle DirectFix Anterior product, touting new and improved product design.
The applications were required as part of a 2016 FDA decision to up the regulatory authority over transvaginal mesh, moving it into the highest-risk Class III device category.
That change built on momentum from a similar meeting of the same FDA panel in 2011, which resulted in the agency issuing '522' postmarket study mandates to 34 manufacturers in 2012, including former mesh makers C.R. Bard and Johnson & Johnson's Ethicon, at which point nearly all chose to exit the market.
Moody's Senior Vice President Scott Tuhy downplayed the impact on Boston Scientific, noting the company's global surgical mesh business accounts for about 1% of its total sales, a fraction of which are sold in the U.S. for the transvaginal pelvic organ prolapse repair indication.
Medical societies and provider groups had backed keeping the products on the market as an option for certain patients, and some expressed qualms with the FDA's decision.
Geoffrey Cundiff, president of the American Urogynecologic Society, told MedTech Dive he was "not entirely surprised by the announcement," and supports the superiority standard behind it. Still, he was surprised by how quickly FDA obtained three-year data from the companies and reviewed it following the meeting.
The FDA news release did not, however, specify a path forward for women with pelvic organ prolapse for whom native tissue repair has not been effective. The February panel raised non-inferiority as a potential standard in those cases.
"What's lost here is that ... there are some populations of patients for whom added risk is offset by added durability," Cundiff said, noting that other mechanisms for inserting surgical mesh, such as through a more invasive abdominal approach, have not been taken off the table by FDA.
'The proper thing to do'
Biostatistician Rick Chappell, a panelist who participated in both the 2011 and 2019 meetings, told MedTech Dive he was surprised by FDA's announcement, but said it "seems like the proper thing to do until they get long-term follow-up."
"Then and now they have no reliable evidence about what these devices do," besides in the very short term, he said. At the February meeting, he said he felt he owed it to patients "not to be here in another eight years."
"It was heartbreaking," he said of the patient testimony he heard during his panel tenures.
Symptoms like bleeding and vaginal scarring and outcomes like mesh erosion and recurrent POP are among the effects spurring tens of thousands of lawsuits against manufacturers that are still ongoing.
FDA reported identified 11,274 medical device reports submitted from January 2008 to October 2018 related to mesh for POP, including 10,391 reports of serious injury, 806 reports of device malfunctions, and 77 reports of death.
But a presentation at the February meeting by former FDA manager turned independent device data analyst Madris Tomes showed there may have been more than 69,000 POP mesh-related MDRs as of January 2019, including 393 deaths.
Tomes called Tuesday's decision a "pleasant surprise," but noted FDA's action does not address potential problems caused by mesh indicated for other uses.
Surgical mesh continues to be available for cases of stress urinary incontinence, hernias and breast reconstruction. Her data analysis showed more than 139,000 total MDRs have been filed across all types of surgical mesh.
"I'd like to see them take it a step forward," Tomes said of FDA extending scrutiny across mesh types. "I'm not sure they're ready to go that far yet."
Diana Zuckerman, president of the National Center for Health Research, echoed that idea.
"FDA's requiring clinical trials for mesh used for pelvic organ prolapse was an important first step, but the thousands of patients harmed by surgical mesh clearly show that clinical trials should be required for all types of surgical mesh," she said in an email.
FDA said the companies have 10 days to submit market withdrawal plans to the agency and noted they will still be required to complete follow up with participants in the 522 postmarket approval studies previously mandated by the agency. Shares of Boston Scientific were down about 4.3% Tuesday, while Coloplast stock fell close to 2.5%