FDA has ordered Boston Scientific (Marlborough, MA) and Coloplast (Humlebaek, Denmark) to cease the sale and distribution of their surgical mesh products used in transvaginal repair of pelvic organ prolapse (POP). The ban, announced on April 16, follows numerous reports of patients suffering major health problems associated with surgical mesh over the course of many years. The Netflix documentary The Bleeding Edge and a report on 60 Minutes last year brought renewed public attention to the safety of these devices. Now, FDA has acted, but in the eyes of some patient groups, it’s too little, too late.
In its April 16 news release, FDA said that it had determined that Boston Scientific and Coloplast had not demonstrated a reasonable assurance of safety and effectiveness for these devices. This is the “premarket review standard that now applies to [these devices] since the agency reclassified them in Class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S.,” wrote FDA. The companies now have 10 days since the agency announced the ban to submit their plan to withdraw these products from the market.
Plastic mesh has been used to treat POP, which occurs when the muscles and tissues supporting the pelvic organs weaken or become loose, since the 1990s. Upon reclassifying the device to Class III in 2016, the FDA wrote in a news release that it had seen “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.” 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.
Most synthetic vaginal mesh is made with polypropylene. Researchers at the UK University of Sheffield say that they have developed a polyurethane-based material that is better suited to this application because of its flexibility and likeness to human tissue. Their research was published in February 2018 in the Journal of Neurourology and Urodynamics.
Boston Scientific and Coloplast market three surgical mesh products for transvaginal repair of POP, said FDA, and in reviewing the PMAs, the agency found that they failed to provide an adequate assessment of the long-term safety of the devices or to demonstrate their long-term benefit compared with using native tissue.
Patient advocacy group Medical Device Problems applauded the decision but felt it should have been made sooner. "These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement,” said the group in a statement posted on its website. It also noted that FDA’s announcement “serves to highlight the structural defects in the 510(k) approval process and serves as a warning for all other medical devices approved through this same pathway . . . that might not meet the basic litmus test of reasonable safety and effectiveness." The group cited hernia mesh and breast and hip implants as devices that merit greater scrutiny.
Indeed, last week France banned textured and polyurethane-coated breast implants, which have been linked with a rare form of cancer. FDA has investigated the link between these types of breast implants and anaplastic large cell lymphoma but has not called for their removal from the U.S. market.