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Doctors seek national registry of implants

Maitri Porecha New Delhi | Updated on September 17, 2018 Published on September 17, 2018

A national registry is crucial to access pooled data on various types of implants, cutting across hospitals, so that surgeons can make better decisions on which implant to use and which to be wary of   -  istock.com/xmee

J&J hip-implant fiasco: Panel to look into compensation claims

Private doctors from reputed hospitals have called for the establishment of a national joint replacement registry for better record-keeping of medical implants and drugs. The demand follows the Johnson and Johnson (J&J) ASR hip implant fiasco.

Raju Vaishya, Senior Joint Replacement Surgeon, Indraprastha Apollo Hospital, and President of the Indian Cartilage Society (ICS), said it was an irony that although about 4,700 patients received the ‘faulty hip implants’ in India, over 3,600 of them remain untraceable.

Casualties

Of all patients who were implanted with metal-on-metal prosthesis, which is believed to have caused leaching of metal ions in a sizeable chunk, four have died till date, the central expert committee has noted. The committee report was made public earlier this month.

“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. 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,” said Vaishya.

Also, doctors consider the US Food and Drug Administration (US-FDA) approval for an implant to be the gold standard and use it without a second thought, as domestic data on success or failure of implants in Indian patients is unavailable.

Regulatory nexus

A documentary in this regard on NetFlix, The Bleeding Edge, exposed the loopholes in the way pharma companies get approvals from the US-FDA. Medical devices do not undergo rigorous scrutiny for efficacy and side effects as drugs do. Most US-FDA commissioners have, before or after their official postings, have served in pharma companies. Not many Indian orthopaedic surgeons know this fact.

“We rely on international doctors’ and pharma company recommendations on which implants to use. Also, some doctors in our hospital are reluctant to the idea of mandatory sharing of data as failure rates of the concerned hospital are highlighted, which leads to bad publicity,” said a senior surgeon from Indian Spinal Injuries Centre, New Delhi.

Rahul Gupta, Additional Director, Brain and Spine Surgery, Fortis Escorts Heart Institute and Research Centre, New Delhi, said that more catastrophic failures of medical implants and devices are “almost guaranteed” to happen because there have been no significant regulatory reforms in India.

A national registry is crucial to access pooled data on various types of implants, cutting across hospitals, so that surgeons can make better decisions on which implant to use and which to be wary of. Currently, there is no provision under the law for doctor associations and the government to keep such a registry.

“At the next meeting of the Drug Technical Advisory Body, we will nake the recommendation to introduce such a registry. International systems are well-designed, compared with ours,” said Eswara Reddy, Drug Controller General of India.

Recall of the controversial hip implants became global in August 2010 after data from a study indicated that the five-year failure rate of the product was approximately 13 per cent and may be up to 49 per cent, Vaishya had written in a letter to the editor of Journal of Arthoplasty way back in 2013.

Patient complaints

Patient complaints were emerging globally, including India, yet Union Health Ministry only reacted in 2017 to set up a committee to investigate it. It submitted the report in February this year, recommending at least ₹20 lakh compensation for each patient, and reimbursement by the company for all the costs related to their revision surgeries till August 2025.

At the first meeting of the Central expert committee after the report submission, doctors will analyse applications of 18 patients who have applied for compensation to verify their claims, Reddy said.

Published on September 17, 2018
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