FDA Set to Discuss Risks and Benefits of Metal-on-Metal Hip Replacements

An advisory committee of the U.S. Food and Drug Administration (FDA) is set to discuss the risks and benefits of metal-on-metal hip replacements at a two-day meeting on June 27-28, 2012. The Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee is bringing together expert scientific and clinical advice, as well as patient and practitioner recommendations to get a comprehensive idea of the risks and benefits of the devices. The agency is considering whether to make the metal-on-metal (MoM) systems subject to more rigorous testing and premarket review requirements. Manufacturers of artificial hip implants, especially DePuy, have been under fire for the high failure rate of their products.

Over 1,000 lawsuits and complaints have been filed about the ASR, which was installed in about 37,000 patients in the U.S. and about 93,000 world-wide

In May 2011, the FDA issued an order for twenty-one manufacturers of artificial hip devices, including Johnson & Johnson, to conduct post-market studies of hip implants, citing medical reports of "a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland." In February 2012, the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published a Medical Device Alert with updated advice on the management and monitoring of patients implanted with MoM hip systems.

DePuy and other manufacturers of artificial hips have faced mounting testimonies and studies saying that the devices are prone to fail and may cause more pain and suffering than other remedies. DePuy, a subsidiary of Johnson & Johnson, is dealing with problems with multiple of their artificial hips, including both the ASR and the Pinnacle. The DePuy ASR (Articular Surface Replacement) metal-on-metal hip implant was first offered in the United States 2005, but was recalled in August 2010 after reports of higher-than-expected failure rates and possible metallic poisoning. Over 1,000 lawsuits and complaints have been filed about the ASR, which was installed in about 37,000 patients in the U.S. and about 93,000 world-wide. In addition, DePuy faces over 560 lawsuits related to its all-metal Pinnacle hip implant.

It has been alleged that some metal-on-metal hip manufacturers did not adequately warn patients of their high failure rates, leading to serious injuries and suffering. Those who are eligible to file lawsuits against the manufacturers could possibly receive compensation for medical expenses, lost wage and pain and suffering. To learn about your legal options as a metal-on-metal hip implant recipient, do not hesitate to fill out the free, no-obligation case review form on the right.