DePuy Hip Implant Recall Information
Since 2008, the FDA has recevied nearly 400 complaints of failure in the ASR XL Acetabular hip socket system and the ASR Hip Resurfacing partial replacement system. These artificial hip implants were manufactured by DePuy Orthapedics, a unit of Johnson & Johnson. It is estimated that 93,000 people have received the hip implants worldwide.
The ASR hip implants are part of a group of medical devices which use metal-on-metal bearings. Known problems related to debris from this type of device can cause permanent tissue damage and inflammation.
The New York Times reported that "A Remedy is Elusive as Metallic Hips Fail at a Fast Rate".
In continuing coverage, NBC Nightly News (10/4, story 7, 2:15, Brian Williams) reports on "one of the largest medical device failures ever" in the form of "metal-on-metal" hip replacements. Some people who received hip replacements of this type had to have them replaced with non-metal on metal devices after only a few years. "So far this year, the FDA has received nearly 11,000 complaints about metal-on-metal implants. One model...the ASR XL, was recalled in the US last year after reports of a high early failure rate.
Early last year, the British agency that regulates medical devices issued an advisory about the ASR problems. The manufacturer began warning doctors about failures in the hip implant the same month the British advisory came out. Previously, they claimed that they were being phased out due to slow sales.
DePuy received a warning letter from FDA on August 19, 2010. The letter stated that DePuy was marketing products without the required clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The letter also stated that, “a review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law.”
The AP (6/29, Perrone) reports, "Government health experts said Thursday 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 the AP, "the Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million US patients with metal hip replacements." Although the agency "has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices."
Many patients who have received the transplants have reported problems within five years after implantation of the device. If you or a loved one has experienced problems related to the Depuy Hip Implant, please contact us as soon as possible for a free and confidential case evaluation.
Even though DePuy has offered to pay for reasonable costs associated with this recall, it is important that you contact an experienced attorney who specializes in cases where defective medical devices are concerned. Our experience with Guidant and Medtronic defibrillator implant litigation and cases involving numerous drug manufacturers has given us the insight that we need to be effective litigators for consumers with defective medical devices. The experienced group of Attorneys at Hill, Peterson, Carper, Bee & Deitzler will provide you with individual attention and work for you to obtain the compensation that you deserve.