Medical Device Recalls Reveal Cracks in Regulatory Procedures, Researchers Say

VIDEO: Replacement body parts that were fast-tracked to market are being recalled.
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Katie Korgaokar was 36 years old when she had her hip replaced. The ball of Korgaokar's ball and socket was shaped like an arrow from Perthes disease -- a childhood condition that blocked the femur's blood supply during her development.

"They had this new, latest greatest hip out there that was going to be perfect for a woman that was smaller," said Korgaokar, who initially hesitated to sign up for such a major procedure. "So I said, whatever you think is best is what we're going to do."

After getting her new hip in November 2006, Korgaokar could hike, ski and ride horses around her Denver home free of pain.

"I wish I'd done it much earlier, because it completely changed my life," said Korgaokar.

But her life soon changed again, when she received a letter last fall stating that her hip was being "voluntarily recalled."

"I thought: that's what happens to cars," Korgaokar said. "It just really seemed like a joke -- you don't recall parts you put in a person."

It was no joke. Korgaokar's hip was being recalled because of a design flaw that her doctor said could leech chromium and cobalt into her body.

"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."

The approval process for medical devices has been the topic of growing scrutiny. Today, a study published in the Archives of Internal Medicine suggests 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.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous premarket approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

Marketing campaigns on TV and online hype the "new and improved products" directly 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."

Speed Versus Safety?

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. The tradeoff, experts say, is obvious.

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