The FDA’s medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.
Lawsuits claiming negligence against mesh-makers have also implicated the FDA’s review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.
Boston Scientific Corp.’s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.
"The FDA got caught with their pants down," California pelvic surgeon Thomas Margolis told the news service. "The ProteGen should have told them, ‘Wait a minute, all of these mesh systems are bad.’"
The bad news for the watchdog agency is still more critical scrutiny, on top of the high-profile metal-on-metal hip implant recalls by J&J subsidiary DePuy Orthopaedics, which has spawned its own raft of lawsuits. Analysts have estimated that settlement of those cases could cost JNJ up to $1 billion.
Medtronic Inc.’s (NYSE:MDT) 2007 Sprint Fidelis recall, another sore spot for the FDA’s review system, was implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor."
Transvaginal mesh, Depuy’s hips and Medtronic’s Sprint Fidelis were all cleared through the FDA’s 510(k) device review fast-track.
Concerns about transvaginal mesh were used as an archetype for grievances with the 510(k) system at last month’s public meeting on the Institute of Medicine’s audit of the FDA’s device review process. The meeting followed the IOM’s controversial report concluding that the 510(k) broken was too broken to be fixed and should be discarded entirely.
"Patients across America are being put at risk by life-threatening medical devices implanted for a non-life threatening condition: Weakened or torn tissue," Lana Keet, president of patient advocacy group Truth in Medicine, told the CDRH at a public meeting last month. "You don’t usually hear of someone dying of a hernia or incontinence or pelvic organ prolapse. But patients do die at alarming rates from the 510(k)-cleared medical device, synthetic surgical mesh."
The mesh hullabaloo stems from a July report by the FDA’s Obstetrics & Gynecology Devices Panel. The group recommended bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.