July 29, 2011
Katherine Ayers had hip replacement surgery five years ago. She was doing great until her implant was recalled.
"They wanted me to come in to have my metal levels checked for chromium and cobalt in my blood," she said. "Sure enough they were elevated."
Ayer's implant was approved through the FDA's 510 K process, a program the Institute of Medicine now finds flawed. Devices that go through this process get approved faster because companies just need to show their devices are similar to ones already on the market.
"The problem is most of these devices have never undergone human testing prior to getting on the market, so the human testing is done after they're implanted in people," said Dr. Steven Nissen of the Cleveland Clinic.
The FDA asked the Institute of Medicine to do this report. The agency says it will not eliminate the faster process, but will ask the public to weigh in.
A recent study shows more than 100 devices were recalled between 2005 and 2009, affecting tens of thousands of patients.
"You want to ask a lot of questions of your doctor," Nissen said. "How long has the device been on the market? How much testing did it undergo? What do we know about its safety and effectiveness?
After metal from Ayers' hip implant started eroding in her body, she had second surgery six months ago.
"Having to have a bigger incision and have more things cut into again it just was a lot longer recovery," Ayers said.
Her blood levels are back to normal, but she worries about the damage that may have been done.
The Advanced Medical Technology Association, whose members produce medical devices, disagrees with the report and says abandoning the current program would be a disservice to patients and public health.
PO Box 4508