Government health authorities in India are launching a criminal investigation into why they say it took so long for a medical device manufacturer to complete a recall of defective hip implants. The device is the DePuy ASR, sold by DePuy International, a subsidiary of Johnson & Johnson.
The devices were recalled worldwide by DePuy in 2010. But in India, a lesser Field Safety Notice was issued. India’s Food and Drug Administration says it doesn’t think the company is being as proactive in India as it has been other countries, including the United States and the United Kingdom.
Nearly 100,000 people worldwide had the DePuy ASR device implanted and thousands have suffered adverse effects. Many have required revision surgery to replace the faulty device with a new one.
DePuy reportedly imported 15,829 of the ASR devices into India; 4,600 of those were implanted into patients. But according to India’s FDA, only 1,295 of those devices have been returned since the recall was issued. That’s what has prompted the Indian FDA to file a criminal complaint.
DePuy said in a statement to an Australian news organization:
“In India as with every other country where the ASR Hip System was sold, the recall was implemented according to the practices and regulations on the country.
“At the time of the recall in 2010, DePuy informed the Drugs Controller General of India (DCGI) of the recall, and we have continued to cooperate with them to help patients ever since.”
DePuy says it has offered reimbursement to patients with ASR hip replacements, but compensation for patients in India has reportedly been much lower than in other countries.