The Food and Drug Administration's fast track medical device approval process, also known as the 510(k) program, will be the subject of scrutiny this week at a Senate hearing.  The Government Accountability Office is scheduled to address concerns about misuse of the fast-track approval process for the approval of sensitive devices like hip joints and cardiac devices.

The Senate Special Committee on Aging will hear from the Government Accountability Office.  In 2009, the Government Accountability Office had cited the Food and Drug Administration for its misuse of the fast-track approval process.  According to the Government Accountability Office, the Food and Drug Administration has approved at least 67 medical devices through the fast-track process since 2009 alone. 

The concerns over the misuse of the 510(k) process have heightened since the nationwide scrutiny involving Johnson & Johnson’s subsidiary, DePuy Orthopedics’ hip joint devices.  Last year, the company was forced to recall more than 93,000 hip implants for the high risk of revision surgery associated with these.  Thousands of people who were implanted with the devices have chronic complaints of consistent pain, swelling, and other complaints.  These patients were advised to have revision surgery to replace the devices. 

Studies have indicated that the revision surgery rate for these hip implants is approximately 12% over a period of five years.  Revision surgeries that have been performed on some of the patients have revealed horrifying signs of bone damage and degeneration.  Surgeons have found masses of dead tissue around the implant area.  These implants had been approved through the 510(k) process.

The 510(k) process was initially developed for the quick approval of power wheelchairs, catheters and other devices that were sufficiently similar to existing approved devices already in the market.  However, the Food and Drug Administration now uses the fast-track process to clear even critical and sensitive devices, like hip implants and cardiac devices.  The risks of defective medical devices slipping through the cracks of this flimsy program are too great for California pharmaceutical liability attorneys to ignore.