The FDA today issued a pair of proposed orders that would increase regulatory oversight of controversial pelvic mesh products, responding to a long-running public uproar about the implants’ potential for harm to women.
If finalized, the orders would bump the surgical mesh, used for transvaginal repair of pelvic organ prolapse, from the lower-risk class II up to class III devices, requiring that manufacturers submit premarket approval applications for evaluation by the FDA. The agency today opened up a 90-day comment period on the proposal.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," FDA medical device deputy director of science and chief scientist Dr. William Maisel said in prepared remarks. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."
The FDA proposal comes in response to years of concerns about pelvic mesh, culminating with a recent call for the resignation of Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky. A consumer advocacy group called the Corporate Action Network launched a "Johnson & Johnson Hurts Women" initiative, buying internet ads, distributing videos and coordinating efforts in a comprehensive public campaign to take Johnson & Johnson to task.
"We are building a movement of activists to ensure that women are properly compensated for their injuries. We are working to put an end to Johnson & Johnson’s continued marketing of dangerous medical devices and continued disregard for health and safety."
Fellow advocacy group Public Citizen has been calling for years for the recall of pelvic mesh devices, citing them as an example of the failure of the FDA’s fast-track 510(k) review pathway.
Pelvic mesh, or POP devices, have been the subject of scrutiny for years. The FDA in 2011 issued safety communications about complications associated with the implants, saying that they may expose patients to unnecessary risk without offering clinical benefit above safer options. The agency’s Obstetrics and Gynecology Devices Panel recommended even then that the devices get high-risk treatment from reviewers. Lawsuits began piling upright away.
In January 2012 the FDA ordered mesh manufacturers to conduct postmarket surveillance studies. Johnson & Johnson’s Ethicon subsidiary, C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX) and American Medical Systems Holdings were among the companies ordered to submit data on their POP implants.