Johnson & Johnson hip implant case questions safety of patie
A committee looking into the alleged faulty hip implants by a subsidiary of Johnson & Johnson (J&J) has said the company showed negligence. It has recommended that the government amend rules governing medical devices to ensure that there is better patient safety, compliance by device makers.

Case Background:

In the year 2006 DePuy International Limited a subsidiary of Johnson & Johnson (J&J) registered its orthopaedic implants (ASR) for import and marketing in India. Many patients who received these implants started experiencing serious adverse reactions and had undergone revision surgeries prematurely.

Due to this issue, the company did a voluntary recall of ASR in 2010. So the ASR was recalled globally as well as from India.

Later the Ministry of Health and Family Welfare in 2017 constituted a high powered committee under the chairmanship of Dr. Arun Kumar Agarwal, Ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi to examine the issue of faulty ASR.

The committee submitted its report in February and made it public on the MOHFW website this Tuesday. In its report, the panel said the company did not take any corrective action for patients suffering because of these implants.

Recommendations by the Committee:

- It has recommended a compensation of Rs 20 lakh per person

- The faulty hip implant reimbursement programme be extended till at least August 2025 since the average lifespan of orthopaedic hip implants is 15 years

- Establishment of an independent registry for tracking usage of high-risk medical devices by MOHFW, Government of India

- A detailed guidance document should be prepared by the Central Drugs Standard Control Organization (CDSCO) for the effective recall of medical devices by the manufacturer or importer

No of patients:

Worldwide a total of approx. 93000 people were implanted with ASR out of which 4700 patients are from India.

Read the complete recommendations given by the committee here:

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