Given the ‘faulty hip implants’ of Metal and Metal prosthesis made by Johnson & Johnson (J & J) that were put inside some 4,700 patients, four of who died, and 3,600 of whom could not be traced, medical experts urge the government to establish a national joint replacement registry to regulate medical implants and drugs for the patients safety.
Dr. Raju Vaishya, Senior Joint Replacement Surgeon, Indraprastha Apollo Hospital, and President of Indian Cartilage Society (ICS) said that it is ironical that although about 4,700 patients received the ‘faulty hip implants’ in India, over 3,600 of them remain untraceable. The J & J Company has said that only the hospitals would have this data. However, it is not difficult to identify these patients from the hospital data, where these joints were supplied.
“Incidentally, there is no government body like National Joint Replacement Registry in our country, though the formation of such a body was suggested, many years ago. But, the Central Drugs Standard Control Organization (CDSCO) did not take any timely action on this matter, despite knowing the problems related to these implants since at least 2010. It is, therefore, a gross regulatory failure, on the part of our Government Regulatory Authorities” said Dr. Raju Vaishya.
Dr. (Prof.) Raju Vaishya, said that he had voiced and highlighted the issue of ‘faulty hip implants’ in 2012 through a letter published in The Journal of Arthroplasty. This letter was written in response to a research paper “Hip Resurfacing Arthroplasty in Inflammatory Arthritis: A 3 to 5 Year Follow-up Study” by a team of Orthopaedic surgeons of AIIMS.
Dr. Atul Srivastava, Secretary, Indian Orthopaedic Association (IOA) also agreed to the idea of setting such a national body, which may be called National Joint Replacement Registry or National Healthcare Data Storage and Management Committee so that the use of faulty implants or medical devices should be stopped.
Dr. Rahul Gupta, Additional Director, Brain and Spine Surgery, Fortis Escorts Heart Institute & Research Centre, New Delhi said that more catastrophic failures of medical implants & devices are “almost guaranteed” to happen because there have been no significant reforms on the way in India, which regulates medical implants.
Dr. R. N. Kalra, Medical Director of Kalra Hospital & SRCNC, New Delhi said that there are established systems in most developed countries where the doctors and patients can register their opinion and complain about any adverse effect of any implant or drug. Hence, the government authority can immediately know, if there is any flaw in them but in India, there is no such apparent system.
The Metal on Metal prostheses (ASR) was manufactured by a subsidiary of J & J and secured approval for sale and use in patients in India in 2006. In December 2009, the product was recalled in Australia, due to an unacceptable incidence of early complications related to these artificial hip joints. This recall became global in August 2010, yet India waited till 2017 to set up a committee to investigate it. It submitted the report in February 2018, recommending at least Rs. 20 lakh compensation for each patient, and the reimbursement by the company for all the costs related to their revision surgeries till August 2025.