Hip Replacement Recall Targets Poisonous Metal
MIAMI (CBS4) - At 36, pain finally pushed Katie Ayers into having a hip replacement.
"It was supposed to be the latest and greatest. It was supposed to be perfect for a younger female and it all sounded great to me," Ayers said.
But the process has been far from a walk in the park. Three years in, Katie was shocked when her artificial hip was recalled.
She learned the metal on metal implant she'd had, can shed tiny particles of metal as they wear.
Ayers said tests showed elevated levels of cobalt and chromium in her blood.
"They don't really know, they being the medical community, what those elevated levels can do to your system," said Ayers.
Reports show Katie's hip, the Depuy A-S-R, failed in nearly one-third of patients in Britain within six years.
As CBS4's Cynthia Demos learned, the device was approved in Europe and Australia first, then in U.S. So the problems started showing up on the other side of the pond first. Now they are here in the U.S.
93-thousand ASR devices were used worldwide, 40-thousand in the U.S. and thousands of them in Florida.
Demos spoke with several lawyers in Florida who are filing lawsuits on behalf of their patients suffering dislocation, revisions, additional surgery, loss of jobs and some permanently disabled. The attorneys told Demos the lawsuits are in their infancy.
The device was recalled by the company last year. Katie has since gotten a new hip replacement.
"I thought I was gonna have 15, 20 years before I had to do it again," she said.
Sadly, that was not the case.
The FDA is targeting all metal on metal hip joints.
Katie's implant given the OK through the FDA's 510 (K) process. That's where devices get cleared for sale faster if they are "substantially equivalent" to existing products.
"The problem is most of these devices have never undergone human testing prior to getting on the market. Hip replacements and knee replacements are unique in that, to really prove that you're good, you need big numbers of patients to walk around on these things for 30 to 40 years," one doctor explained to Demos.
Katie Ayers has her own opinion. "I think there's got to be a better way than what's already out there."
Katie's blood levels are back to normal. But like thousands of others, she worries that damage has already been done.
The Florida attorneys Demos spoke with told her that the lawsuits against Depuy are still trickling in. However, as far as problems with malfunctioning or defective hip replacements in the past... Florida has always led the country in the highest number of lawsuits.
