March 22, 2013 ~ Friday night, March 22, Public Broadcasting (PBS) looks into the U.S. Food and Drug Administration (FDA) oversight of medical devices and how so many enter the market with little review and oversight.
The 510(k) process allows devices on the market after the manufacturer requests clearance from the FDA and names a “predicate device” which may be a similar device, even if it’s been recalled. The 510(k) approval process is used for up to 90% of medical devices entering the U.S. market.
Many defective devices including metal-on-metal hips, stents, defibrillator leads ans surgical mesh have been approved through the 510(k) and have injured thousands of Americans.
Correspondent Dr. Emily Senay interviews Linda Gross at her home in Watertown, South Dakota who talks about how a ‘minimally invasive’ surgery involving the Prolift surgical mesh, made by Johnson & Johnson.
You can leave your comments on the PBS website here.
De. Senay was interviewed on MSNBC this morning, here.
Clearly the journalists have no idea about surgical mesh and the FDA review process. Your comments can be added there too.