Early in 2012, Consumer Reports President Jim Guest wrote in an email blast to 1 million Americans stating that the implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you. He wasn’t blowing things out of proportion either.
For decades, certain devices have been cleared by the FDA without the manufacturers ever having to test them in human beings in clinical trials, which take time and money.
The fast-track approval process is known in the industry as Pre-market Notification, or 510(k), named for the numbered section of the Food, Drug and Cosmetic Act. Here is a quick list of all medical device recalls listed at the fda now.
Consumer Reports’ advocacy arm, Consumers Union, would not disclose how much money it is spending on efforts to change the medical device approval process, but says its campaign is a top priority. The campaign was launched late last year at its annual Patient Safety Summit.
The Institute of Medicine, a nongovernmental, nonprofit organization that provides medical advice to policy makers and the public, characterized the 510(k) approval process as “fatally flawed” and said it should be scrapped.
The FDA, for its part, believes that the current device-approval process could stand some improvement. Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said 510(k) should not be eliminated, but thought changes to the process were in order.
Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled — 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market,” he wrote.
Current Cases in court now
Surgical mesh — used to repair or reinforce soft tissue where there is weakness, for such procedures as pelvic organ prolapses — has also been a subject of major recalls, including products by Boston Scientific Corp and J&J. Almost every synthetic mesh device on the market today cleared through the 510(k) process was based on the ProteGen mesh, manufactured by Boston Scientific, even though it was recalled in 1999.
Jaye Nevarez, of Lakewood, Colorado, said she never would have had J&J’s Gynecare surgical mesh implanted in her body four years ago had she known how easy it was for products to gain approval and how severe the complications could be.
At age 50, Nevarez cannot walk because of nerve damage that she believes is a consequence of mesh erosion.
I’m alive. I function, but I don’t function well. I’m in pain every day, all day long, day after day, and it doesn’t go away. It’s not worth it,” said Nevarez, who is suing J&J.
Most patients would have made a different decision if they had known how easy it was for products to gain approval and how severe the complications could be. Do you think the system will change? Or do you think the lobbyists that control Congress will prevent any chanes that cut into their bottom line?
The bigger question is are the people willing the pay the increase to have higher standards in the implants? We already know that medical bills can kill you.