FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.
The FDA ceded that it shares some of Public Citizen’s concerns about the medical devices, but ruled that a recall and ban of permanent transvaginal mesh implants isn’t yet necessary. The agency noted that it’s already taking action to shift the devices to a higher-risk category, bumping pelvic mesh from a Class II to a Class III devices subject to greater regulatory oversight.
In addition to warnings issued in 2008 and 2011 about the potential dangers of the device, the FDA has also convened an advisory committee meeting to consider reclassification of the devices and has ordered post-market surveillance for all permanent transvaginal mesh implants, the federal watchdog agency said.
Public Citizen, founded by Ralph Nader, filed an FDA petition in 2011, asking the FDA to ban the marketing of all existing non-absorbable surgical mesh products indicated specifically for transvaginal repair, order all manufacturers to recall the products and require all future transvaginal mesh devices to be classified as Class III devices and submitted as premarket approval applications.
The product is used to treat pelvic organ prolapse (POP), which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
"Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life," Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group said at the time. "Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."
"There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death," the FDA said in its formal response this week. "FDA does tentatively agree that reclassification of the device from class II to class III (PMA) is warranted to mitigate the risks to health associated with ,use of surgical mesh indicated for transvaginal POP repair."
Pelvic mesh devices have been the subject of much public outcry over concerns that they may do more harm than good, especially since the FDA’s 2011 warning that the implants may expose patients to unnecessary risk.
The controversy has expanded over the years, with patient and consumer groups calling for recalls and for action against medical device makers responsible for manufacturing the devices. Last month the Corporate Action Network asked state Attorney Generals to investigate Johnson & Johnson (NYSE:JNJ) and its leadership for potential misconduct related to the manufacture and sale of pelvic mesh devices.
Earlier this year, Scotland’s regional health boards agreed to suspend use of transvaginal mesh implants pending an investigation into complaints that the devices scar women for life.