Medical experts seek formation of a national joint replacement registry

With Johnson and Johnson embroiled in a controversy over its alleged 'faulty' hip implants, medical experts have asked the government to establish a 'national joint replacement registry' to regulate medical implants and drugs for patients' safety.

An expert panel, constituted earlier by the Union Health Ministry to probe complaints of "faulty" ASR hip implant devices, in its report has said the pharma giant "suppressed" facts on the harm of surgeries which were conducted on patients in India using "faulty" hip replacement systems.

"It is strange that although about 4,700 patients received the 'faulty hip implants' in India, over 3,600 of them are 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," said a statement quoting Dr Raju Vaishya, senior joint replacement surgeon, Apollo Hospital, Indraprastha, and president of Indian Cartilage Society (ICS).

He said incidentally there is no government body like a national joint replacement registry in our country, though the formation of such a body was suggested years ago.

"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," Dr Vaishya said.

The statement quoted Vaishya saying he had voiced and highlighted the issue of 'faulty hip implants' in 2012 through a letter published in The Journal of Arthroplasty. The letter was said to have been written in response to a research paper published by a team of orthopaedic surgeons of AIIMS -- Hip Resurfacing Arthroplasty in Inflammatory Arthritis: A 3 to 5 Year Follow-up Study.

Dr Atul Srivastava, secretary, Indian Orthopaedic Association (IOA), also agreed to the idea of setting up of 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 can be stopped.

The expert panel of the Health Ministry had also suggested that the firm pay compensation of around Rs 20 lakh to the affected patients.

Some of the patients who had suffered due to faulty implants had questioned the panel's recommendation of the paltry amount, saying it was like "rubbing salt on their wounds."