(It Doesn’t Really Matter As Long As Patients and Surgeons Stop Buying the Defective Implants!)
While it would certainly be nice to have a government that moved swiftly to recall defective drugs and medical devices from the market, we do not live in that world – at least in the United States. Why is the FDA so reluctant to flex its muscles?
For several decades now, the Food and Drug Administration has acted more like the older best friend than the parent that a naughty teenager needs when faced with difficult ethical questions. The fact that the funding of the FDA is tied to user fees paid by the very same companies over which the FDA exercises authority only serves to complicate this relationship further. In the past, there was also a great deal of political influence throughout the Agency which often created a “disconnect” between the scientists who raised safety concerns and the political appointees who managed the drug safety organization.
These deep-rooted issues first came to light during scandals over the fast-tracked approvals of Avandia, Vioxx, and other drugs, which were responsible for tens of thousands of patient injuries and deaths. A similar controversy is starting to brew over metal-on-metal hip implants, as no one can ignore than 17,000 adverse event reports that have been filed with the FDA by patients who have suffered premature device failure, unrelenting hip pain, metallosis, pseudotumors, and other serious and debilitating injuries.
This week’s Advisory Panel hearing before the FDA included some of these recurring themes. While patients and safety advocates are calling for the removal of defective metal-on-metal implants from the market, reports from the hearing indicate that a recall is the furthest thing from the minds of manufacturers and regulators.
Given the significant testimony at the hearing by physicians who noted that there was little reason to implant metal-on-metal hip implants in any patient, one can only hope that pure economics (decreased demand = decreased sales) will force medical device manufacturers to phase out this poorly-conceived product line and focus their efforts on true innovation in designing hip implant products that truly provide more benefits than risks to patients. Bloomberg news reports quoted Dr. William Rohr of Mendocino, who chaired the FDA meeting: “I do not use metal-on-metal hips, and I can see no reason to do so.”
Hopefully, other orthopedic surgeons are listening more to Dr. Rohr than the medical device sales force. When that happens, patient safety will be improved and metal-on-metal implants will experience a “market withdrawal” (the closest thing to a product recall that we can expect in this country).