Indian State FDA Institutes Probe into DePuy ASR Hip RecallOct 22, 2013
India’s Maharashtra state Food and Drug Administration (FDA) has recommended that the country’s Central Bureau of Investigation (CBI) assume control of a probe into the recall of DePuy Orthopaedics’ ASR hip implants – in an effort to help support the best interests of the more than 4,500 patients in India currently implanted with DePuy metal-on-metal hips.
The Maharashtra FDA took this action on the grounds that the medical device maker had failed to take the proper measures to inform patients about the potential harm and injury that could result after having ASR implant surgery, Pharmabiz.com reports.
Over 4,500 ASR hip implant surgeries were performed in India from May 2004 to August 2010, when the product was recalled. DePuy, a unit of Johnson & Johnson, announced the recall on August 24, 2010, based on reports of patients’ pain caused by release of cobalt and chromium ions from the hip’s metal components. About 8 to 9 percent of patients had to undergo revision surgery because of component loosening, bone fractures, and dislocation of the joint.
According to documents DePuy submitted to the Maharashtra FDA, of 280 patients who received DePuy hips, 68 patients required revision surgery (25 per cent), according to Pharmabiz.com. Sixty-three of the 68 suffered pain and 10 patients reported painful conditions like difficulty walking, joint loosening, and inability to bear weight on the implant side.
In the United States, thousands of lawsuits brought against DePuy allege that faulty design causes the metal-on-metal hips to fail prematurely. In many instances, the rubbing of the hip’s metal components against one another releases toxic metal debris into patients' bodies, causing pain and eventually necessitating revision surgeries to remove and replace the implants. Revision surgery is often more complicated and risky than initial hip replacement because patients have suffered bone loss and damage to surrounding tissue.
The Maharashtra FDA undertook its probe with the knowledge that the DePuy ASR hip had been recalled in the U.S., the U.K., and Australia. The Drugs Controller General of India (DCGI) has canceled DePuy Orthopaedics’ import license and registration certificate, Pharmabiz.com reports.