Product News and Recalls

Consumer group calls for reform of FDA approval process

The independent nonprofit Consumer Reports has undertaken a national campaign to change the process by which the federal Food and Drug Administration approves medical devices, according to a report in the Chicago Tribune.

Consumer Reports says the agency’s approval of metal-on-metal hip implants and transvaginal mesh implants – both of which have led to thousands of reported cases of debilitating health problems — illustrate why reforming the process is necessary.

According to the Tribune, Consumer Reports President Jim Guest sent an email blast to 1 million Americans earlier this year in which he wrote: “It’s a nightmare scenario … The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.”

The problem is a fast-track process known as pre-market notification, or 510(k), which allows devices that were never safety tested in humans to be approved, because the manufacturers claimed they’re “similar” to devices already on the market.

The Institute of Medicine, a nonprofit organization that provides medical advice to policy makers and the public, calls the process “fatally flawed.”

The article mentions Johnson & Johnson’s 2010 recall of hip implants manufactured by subsidiary DePuy, which failed at a higher-than-expected rate. Patients were left with pain, joint dislocation, and systemic damage to the nervous system, thyroid and heart.

It also mentions surgical mesh implants, used to treat pelvic organ prolapse, which were approved based on their similarity to a device that was recalled in 1999.

The article quotes Jaye Nevarez of Lakewood, Colo., who cannot walk because of nerve damage she attributes to a transvaginal mesh implant.

“I’m in pain every day, all day long, day after day, and it doesn’t go away,” Nevarez is quoted as saying.

If you’ve received a DePuy metal-on-metal hip transplant, or if you had a mesh implant and suffered injury, contact Lopez McHugh for a free consultation.

See the report here: http://www.chicagotribune.com/health/sns-rt-us-consumer-medicalbre82c0uw-20120313,0,7273394.story?page=1