Senate Committee to Examine FDA's Medical Device Approval Process

April 13, 2011— -- Katie Korgaokar was 36 years old when she underwent an agonizing operation to have hip replaced because of Perthes disease -- a condition that blocked blood supply to her femur during childhood. Little did she know that the procedure was just a warm-up for what was to come.

"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."

A U.S. Senate Special Committee on Aging will today hold a hearing to examine the Food and Drug Administration's medical device approval process. Korgaokar will testify alongside six medical device experts.

Investigations by FDA officials and outside researchers have revealed troubling lapses that have led to device recalls -- sometimes requiring surgery.

A February study published in the Archives of Internal Medicine suggested most medical devices recalled for life-threatening or serious hazards were cleared by the FDA 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.

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.

"If an existing technology can benefit from an upgrade, wouldn't more patients be potentially helped than harmed to get the product to market quickly?" said Dr. Cam Patterson, chief of cardiology at the University of North Carolina and director of the UNC McAllister Heart Institute. "But if a new defect is introduced at some point in the chain, from design to manufacturing to storage to delivery, the outcome for affected patients could be dire."

For implantable devices, like Korgaokar's artificial hip or an artificial heart valve, a recall means an operation.

"If you want to take back a heart valve you have to sit down with a patient and say, look, we have two very different, bad choices here. We can wait until your device fails, or we can go in and do an operation and put a new device in," Nissen said. "Those are very difficult choices."

Korgaokar, now 41, had a second surgery in January to replace her recalled hip -- an ordeal she lamented.

"The first time around, I knew it would hurt and I'd be scared and that it'd fix things that I wasn't able to do, and it did," Korgaokar said. "But the second time around, I knew how much it was going to hurt, so I wasn't really looking forward to it."

Some 93,000 people worldwide received the recalled hip.