In light of growing concern over all-metal hip implants around the world, the FDA asked a panel of experts for advice on the devices. Their response: Why risk it?
The FDA hasn't said anything about pulling devices from the market, but it is looking for guidance on how to monitor patients who have received metal-on-metal implants.
Over a two-day hearing, the 18-member panel examined data from around the world on the metal implants, pointing out that the devices break down at higher rates than plastic- or ceramic-coated models and that the resultant metal flakes in the bloodstream can lead to medical complications, The Associated Press reports. Doctors on the panel were clear: The benefits of metal-on-metal implants hardly outweigh the risks they carry. As meeting chairman Dr. William Rohr, of Mendocino Coast District Hospital, said, there's no compelling reason to use them.
Physicians nationwide would seem to agree. As the AP notes, doctors are using the all-metal devices less and less. In 2010, just 27% of implanted hip replacements were metal, down from 40% in 2008. The reason? Growing concern over the tech's safety. In 2010, Johnson & Johnson ($JNJ) recalled nearly 100,000 of its DePuy ASR implants after high rates of failure, and, as panelists pointed out, the FDA has received about 17,000 reports of problems with the devices over the past decade or so. In the U.K., reports that all-metal implants were three times as likely to require repair or replacement led to an outcry among watchdog groups.
To this point, the FDA had largely remained silent on the issue, only last year asking devicemakers, like J&J and Stryker ($SKY), to investigate reports of metallic materials slipping into the bloodstream as a result of implant wear and tear. Now, however, the issue has the agency's attention, and the FDA might begin recommending stricter post-op examinations of implant recipients.
- read the AP story