Medical Device Review Process
The decision to get a hip implant is not something people take lightly. If someone does make that decision, they shouldn’t have to worry that the hip implant hasn’t been sufficiently tested for potential defects. A study published in the Archives of Internal Medicine, however, suggests that most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely. It doesn’t take much imagination to realize that an expedited review process, or no review process at all, could lead to disastrous consequences. The DePuy ASR Hip Implant recall is a prime example. So how does a defective implant slip through the review process?
Dr. Steven Nissen and his colleagues examined the number of medical device recalls between 2005 and 2009 and determined which regulatory pathway they had taken — 510(k) or the more rigorous premarket approval process. What they found is cause for serious concern. Out of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k). Another eight were exempt from FDA regulation. The 510(k) review process is far less comprehensive and if a device is shown to be substantially similar to one already on the market, the 510(k) pathway allows its makers to bypass the PMA pathway’s rigorous preclinical testing and inspections.
In fact, according to Dr. Nissen, "Some 80 percent or so of devices being recalled were actually never fully clinically tested in people."
Part of the problem stems from marketing campaigns that promote the untested products to patients.
"Since patients are exposed to new products through direct-to-patient marketing, they assume these products have been time-tested and well-established," said Dr. Andrew Pearle, an orthopedic surgeon at Hospital for Special Surgery in New York City. "But often there is little clinical data to support the marketing claims."
A Patient’s Story
One patient, 41-year-old Katie Korgaokar, found out the devastating effects of a scaled down review process after she received a DePuy ASR Hip Implant. She had Perthes disease and was need of an implant. She thought she was getting a new lease on life with the implant, but was shocked when she found out the hip implant had been recalled because of a design flaw that her doctor said could leech chromium and cobalt into her body.
Click here to see video of Korgaokar.
"You put your faith in the doctor and the companies that make these products because they’re the experts," Korgaokar said. "It’s just beyond me to think that things can get approved that really don’t work. It leaves me speechless."
Not an Isolated Incident
But the recall had additional implications. Korgaokar had to have a second surgery. Korgoakar, however, is not alone. Around 93,000 patients worldwide received the recalled hip implant. Many of them will also have to undergo revision surgery.
In September 2009, the FDA asked the Institute of Medicine to review the 510(k) process. The FDA then simultaneously established two internal committees to make recommendations for making the system better. The internal committees suggested 55 changes to the process in August 2010, but a plan announced in January only had 25 of those changes.
Moreover, the FDA isn’t conceding that Nissen’s study reveals a problem with the review system.
"The devices that were evaluated via this program, over 19,000 of them serve the American public very well and they’re safe. There are some occasional devices, for which we issue recalls or advisories. And that’s appropriate," an FDA spokesperson said.
The current review system is insufficient to protect consumers. Consumers are supposed to be able to count on a rigorous review process before they make serious decisions concerning their bodies. Learning that some of the devices marketed were never actually fully tested in people doesn’t exactly instill confidence. The current review system, or lack thereof, is extremely disconcerting and it is critical that consumers are aware of the potential dangers of marketed devices. In order to protect yourself, it is crucial that you do your due diligence. Check and see if the device you are considering has a proven track record or is new to the market. You should also research the past failure rate of the product. Taking these precautions isn’t foolproof, but it is a big step in the right direction to protect your health.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer in 2017, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys.