This comes after 'faulty hip implants' made by a private company were put inside 4,700 patients of which 3,600 could not be traced
Owing to untraceable medical implants, experts have urged the government to establish a 'National Joint Replacement Registry' to regulate medical implants and drugs for patients' safety. This comes after 'faulty hip implants' made by a private company were put inside 4,700 patients of which 3,600 could not be traced.
"While the Johnson & Johnson Company has said that only the hospitals would have this data, the patients remain untraceable.
"Incidentally, there is no government body like the 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 timely action on the 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, President, Indian Cartilage Society, and a Senior Joint Replacement Surgeon.
The Metal on Metal prostheses (ASR) was manufactured by a subsidiary of J&J and secured approval for sale and use for patients in India in 2006. In December 2009, the product was recalled in Australia due to an unacceptable incident of early complications related to these artificial hip joints.
This recall became global in August 2010, yet India waited until 2017 to create a committee to investigate the matter. 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 costs related to their revision surgeries till August 2025.
Dr Atul Srivastava, Secretary, Indian Orthopaedic Association (IOA) also agreed to the idea of setting up 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.
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