New York, NY (PRWEB) June 29, 2012
The Rottenstein Law Group, which represents clients with injuries allegedly caused by hip replacement devices, 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.
DePuy Pinnacle hip implants and DePuy ASR hip implants are among the metal-on-metal hip replacement systems that have allegedly caused patients serious injury. The Rottenstein Law Group maintains a DePuy Hip Replacement Lawsuit Information Center at http://www.depuyhipreplacementlawsuit.com. The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the DePuy Pinnacle failures.
If you received a DePuy hip implant and you believe it caused you to suffer dangerous side effects, visit the Rottenstein Law Group's DePuy Hip Replacement Lawsuit Information Center.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner.
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The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
321 W. 44th Street
New York, New York 10036
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle (at) rotlaw (dot) com