The Rottenstein Law Group is frustrated by the FDA’s failure to take aggressive measures to protect patients from metal-on-metal hip implants despite the negative opinions of the devices expressed by experts at a special meeting convened by the FDA this week.
At the FDA meeting, which took place on June 27 & 28, 2012, an 18-member panel was enlisted to recommend guidelines for monitoring the more than a half-million U.S. patients with metal hip replacements, according to a June 29 Fox News article. The panel members said “there are few reasons to continue using metal-on-metal hip implants amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles,” according to Fox News.
Despite statements like these, FDA regulators neither initiated a recall nor required the discontinuation of the metal-on-metal hip implants that remain on the market, and instead suggested that FDA scientists “want to take more time to sort out the differences between various implants and patient groups before making recommendations,” Fox News reported, adding that “public health advocates say it could take a decade before that information is available.”
“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” Fox News quotes Diana Zuckerman, president of the National Research Center for Women & Families, as having said during the meeting’s public comment session. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
As the advocate of hundreds of patients who allege they suffered serious injuries as result of metal-on-metal hip implants, the Rottenstein Law Group agrees wholeheartedly with Ms. Zuckerman’s comment. The firm’s attorneys believe the only way to adequately ensure hip-replacement patients’ safety is to require that all metal-on-metal hip implants be removed from the market. (So far, only the DePuy ASR hip implant has been taken off the market. Because data from the National Joint Registry of England and Wales showed “a higher than expected revision rate” for that device, its manufacturer recalled it in 2010, according to an August 24, 2010, recall notice that DePuy Orthopaedics issued to clinicians.)
As RLG’s principal, Rochelle Rottenstein, told Medical Device + Diagnostic Industry magazine earlier this week, RLG also believes it’s important to enact legislation making it illegal for medical devices to obtain FDA approval without having been tested on humans simply because those devices are substantially similar to another medical device that the FDA once approved but may or may not have since been taken off the market.
Rottenstein also told MD+D that she believes it’s important for the FDA to start requiring the use of unique device identifiers (UDIs) that would enable the FDA to better track medical device malfunctions. “UDIs are bar-code-like identifiers that the FDA plans to eventually assign to medical devices,” she explained.