The article in The Chicago Tribune almost reads like a horror story, especially if you have been implanted with an artificial heart valve called the annuloplasty ring. This is often recommended for patients even though the rings were put into a classification with sutures and hearing aids and no longer have to undergo any premarket approval before being implanted in a patient’s body.
But the new rings have more deaths associated with their use than any other device in their class, according to the article. The paper went through Food and Drug Administration (FDA) adverse events records to find out whether patient safety is being compromised. It turns out Advanced Medical Technology Association, or AdvaMed, which represents medical device companies, petitioned the FDA in 1997 to have the device downgraded with virtually no premarket scrutiny by claiming the valves were “substantially equivalent” to a medical device already on the market. That way the manufacturer, Edwards Lifesciences, did not have to fund years of premarket clearance and testing. The heart valve joins other implantable devices such as defibrillators and surgical mesh that are cleared through the regulatory agency with a wink and a nod.
When the annuloplasty rings were put in a new class, dozens of new models were introduced, which also did not have to undergo clinical trials. Ironically, Edwards Lifescience didn’t submit the rings for FDA clearance, yet the company did apply for a patent and claimed that there were at least 40 different ways the rings were different from rings already on the market. Substantially equivalent and different all at the same time?
The Institute of Medicine is looking into the tail wagging the dog federal review process for some medical devices that clearly put a manufacturer in charge and the FDA is expected to rewrite some of its rules. In the meantime, if you or a loved one have been injured by a defective medical device or other product, an experienced Florida defective medical device lawyer can begin the process of determining if the device underwent any critical review by the agency, or just received a rubber stamp of approval.
