FDA proposes new rules for makers of metal-on-metal hip implantsJan 17, 2013
The Food and Drug Administration has apparently seen enough problems with metal-on-metal hip implants.
This week, according to a New York Times report, the agency will introduce a proposal that will require manufacturers of metal-on-metal hip implants to prove they’re safe and effective before they can sell any more of them. Manufacturers must also do the same if they plan on releasing a new model of metal-on-metal hip implant. The proposed rules may take up to a year to put into place as it expects medical device lobbyists to fight the rule or propose alternatives.
The FDA proposal was spurred by the thousands of reports from recipients of metal-on-metal hip implants that the devices failed early, just months or a few years after they were implanted, and required people to undergo costly and painful revision and replacement surgeries to correct those problems.
Close to a half-million people in the U.S. have received an all-metal hip implant in the last decade. A few years ago, at least one out of every three total hip replacement surgeries were conducted in which a metal-on-metal hip implant was used. Tens of thousands of people still rely on a metal-on-metal hip implant every day and in addition to the new rules for manufacturers that the FDA is proposing, the agency also is issuing new guidelines for physicians treating patients with these implants.
Any person who relies on a metal-on-metal hip implant should undergo regular testing and monitoring to determine if metallic ion levels have accumulated in their bloodstream. This is one of the major defects associated with metal-on-metal hip implants. Through normal wear, these implants shed small metallic particles into a recipient’s bloodstream. If unchecked, this can result in dangerous levels of the toxic metals cobalt and chromium accumulating. This can lead to organ and tissue damage and possible other complications that will require additional medical treatments and could result in permanent injuries.
The FDA proposal this week is essentially a condemnation for the agency’s failing 510(k) “fast-track” approval system that allowed so many models of metal-on-metal hip implants to reach the market without ever having undergone one clinical trial for safety and effectiveness. That process allows a medical device maker to get a new product approved if they can prove that it is similar in design to an already-approved device. Dozens of metal-on-metal hip implants flooded the market because of this process and nearly all have been blamed for a high early failure rate.
In addition to the risks of metal poisoning, recipients of metal-on-metal hip implants have also suffered through severe pain, swelling and inflammation at the site of the implant, a popping or squeaking emanating from the site of the implant, or a total device failure that immobilizes them entirely.