RECALLED DEOUY HIP IMPLANT NEVER HAD FDA APPROVAL

According to an article in the New York Times, the recalled DePuy hip implant was never approaved by the FDA because it fell into an FDA loophole. Beginning in 2005 DePuy, a division of Johnson & Johnson, was allowed to sell and market its ASR XL Acetabular System in the U.S. without FDA approval. According to FDA regulations, certain medical implants such as artificial hips can be sold in the U.S. without undergoing patient testing or clinical trials, as long as the device resembles an already approved implant currently in use. Patients who received the metal on metal hip replacement devices have experienced severe groin pain, difficulty walking, damage to muscles bones and nerves.