FDA Wants Report on Metal-on-Metal Hip Implant Corrosion RatesAug 14, 2013
The U.S. Food and Drug Administration (FDA) is taking a closer look at the safety of metal-on-metal hip implants, especially the consequences of the metal’s corrosion.
Since the August 2010 recall of the DePuy ASR device started the fallout over metal-on-metal hip implants, the FDA has taken measures to get the troublesome devices off the market and to also provide warnings to prospective recipients of these implants.
New metal-on-metal hip implants are no longer eligible for clearance under the 510(k) fast-track approval process, which allowed so many others to reach the market without proper testing first. The FDA has also required makers of current metal-on-metal hip implants to produce post-market safety data that shows they’re safe to use.
But that’s not satisfying the regulatory agency, according to a report from RAPS.org (Regulatory Affairs Professionals Society). The site says that the FDA is taking on a new two-year study that aims to examine the effects of metal-on-metal hip implant corrosion. The report cites the FDA saying it will “investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted total hip replacements and clinical outcomes.”
To get data on the effects of corrosion of metal-on-metal hip implants, the agency will look at about 250 devices removed from patients to examine wear patterns and how they relate to those who had been implanted with them.
As we’ve been reporting, one of the hallmark drawbacks associated with metal-on-metal hip implants is what happens when they grow worn: they shed into the recipient metallic particles containing cobalt and chromium. In other words, these devices have been linked to soft tissue and organ damage among recipients of these implants.
The FDA’s study hopes to produce a clinical journal article that will analyze which hip implants go through the most wear; what are some of the factors that impact the rate of wear; and what happens to the patient, according to the RAPS.org report. The FDA hopes its study will help guide future use of hip implants.
Makers of metal-on-metal hip implants like the DePuy ASR device are currently facing thousands of complaints filed in courts across the country. Typically these complaints allege that the companies failed to warn the public of the potential dangers of the all-metal implants and that they did not do enough to ensure that these devices were safe before putting them on the market.