A
short time after the FDA approved the Stryker Rejuvenate metal hip implant in
June of 2008, adverse reports from recipients of the implant began coming in.
The implant remained on the market, and in November of 2009 the FDA approved
another Stryker metal hip implant, the ABGII. Both models of the metal hip
implants came in under the FDA 510(k) approval process which allows medical
devices and drugs to gain approval if the manufacturer can prove they are
substantially similar to a device or drug which has already garnered FDA
approval. While in theory this process sounds reasonable, in practice, many of
these drugs and devices were able to be approved based on prior devices or
drugs which also had their own problems.
Problems with the 510(k) Process
In
the case of the Stryker Rejuvenate, it gained FDA approval based on being
substantially similar to the Wright Profemur—which has made the news because of
harm to its recipients. In some cases one defective medical device or drug
after another can find their way onto the market—and into the bodies of
unsuspecting people who likely believe there doctor would not be able to
implant a device into their body unless it were safe. Over 500,000 people in the
United States alone have metal hip implants in their body despite the fact that
a recent FDA panel met to discuss the merits of the metal-on-metal implant and
stated that given the many problems which have surfaced on particular metal
implants, there was really no reason for surgeons to continue to implant the
metal devices.
