Personal Injury Lawyer Blog Providing
Info in Miami & Nationwide

"Colson Hicks Eidson is recognized as one of the top litigation firms in the country, handling local, national and international litigation for a wide range of clients." - Chambers USA


If You Were Exposed To Water At Marine Corps Base Camp Lejeune In North Carolina, Submit Your Information By Clicking Here. Or Contact Us At: 305-476-7400

Why is the FDA Approving Harmful Medical Devices?

March 15, 2012
Colson Hicks Eidson

The controversial DePuy hip replacement device made it to the market without undergoing the strict protocol of testing reserved for medical devices. How did this happen? It made it to the market by the federal Food and Drug Administration’s (FDA’s) 510(k) program, which uses similar devices already on the market as a benchmark for the effectiveness of a new device. In the case of the DePuy hip implant, components broke down inside patients’ bodies, requiring pain and additional surgeries.

The prestigious New England Journal of Medicine (NEJM) wants the FDA to get rid of the 510(k) program for certain medical devices. The NEJM said that newer devices are more complex and that regulators cannot assume their safety and effectiveness. The NEJM article used the DePuy implant to demonstrate what happens when devices go through the 510(k) program without clinical trials.

The FDA policy behind the 510(k) program is to promote innovation and get devices to the market faster in order to help patients. Critics of the program have pointed out that manufacturing dangerous devices serves neither the medical industry nor the patients. The NEJM article said that federal regulators are essentially creating jobs that manufacture harmful medical devices.

Do you know someone injured by a medical device?

Colson Hicks Eidson – Florida attorneys