Article Says FDA Approval Process is Flawed: Metal-on-Metal Hip Replacement Implants
May 2nd, 2012 tmccoy
Medical devices such as hip implants and pacemakers help to not only keep patients alive, but to improve the quality of their life. However, unlike drugs, which are a subject to a lengthy approval process by the FDA and are constantly monitored once in the stream of commerce, many medical devices are cleared to go to the market without any clinical testing having been done on them. Medical devices also receive very little oversight after approval.
Hip implants are given to people who have advanced arthritis. A hip implant allows hundreds of thousands of people each year to improve their quality of life so that they may walk without pain. Implants usually are made with both metal and plastic. However, in 2005, DePuy Orthopaedics, a subsidiary of Johnson and Johnson, introduced a hip that was only metal. DePuy quickly got clearance for this device through the 510(k) process, by telling the FDA that this new metal on metal hip was ‘substantially equivalent’ to the older plastic and metal hips without ever having conducted clinical trials. The product was put out on the market without ever having been tested to see how the implant would perform in people’s bodies. Testing began only after the implants were on the market.
The DePuy metal on metal hip had a very high failure rate. Almost 50% of patients who received the implant needed revision surgery within six years in order to correct problems. In particular, the metal in the implant was eroding, causing metallic particles to leach into the blood and the tissue surrounding the joint, and causing terrible pain. Depuy’s metal on metal hip was recalled in 2010. It had already been implanted in over 100,000 people.
