Product News and Recalls

Consumer Reports: Medical device approval process deeply flawed

A new issue of Consumer Reports includes an investigation into the process by which the federal Food and Drug Administration reviews medical implants for approval.

The report concludes that most medical devices aren’t tested before being implanted in patients’ bodies. The situation amounts to what’s essentially a large-scale medical experiment carried out on unwitting test subjects, made up of members of the public.

“For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue,” the report states.

It outlines a system in which medical devices are approved based solely on their alleged similarities to other devices that were already on the market. And it finds that many of those “similarities” are highly questionable.

As an example, the report cites mesh implants surgically implanted to treat pelvic organ prolapse, a condition where organs drop out of their normal position in the pelvis. Transvaginal mesh devices are ostensibly based on an earlier mesh approved decades earlier to treat hernias. But the original device was implanted in a different part of the body using a completely different process, and has been involved in a recall.

Consumer Reports includes an interview with a Texas woman who underwent eight surgeries to get her transvaginal mesh removed after it caused her torturous pain and left her with nerve damage.

The report also profiles an orthopedic surgeon from Alaska who received an all-metal hip implant from DePuy Orthopaedics, only to end up in constant pain due to the device’s early failure. DePuy eventually instituted a worldwide recall of that type of implant because of its high failure rate and the injury it was causing patients.

Contact Lopez McHugh for a free case evaluation if you received a DePuy Orthopaedics hip implant or a transvaginal mesh implant, and suffered injury or complications as a result.

See the Consumer Reports article here: http://www.consumerreports.org/cro/consumer-reports-magazine/May-2012/medical-devices.html