The state FDA has registered a complaint with the Mumbai Police against DePuy, a subsidiary of Johnson & Johnson.
The state FDA has registered a complaint with the Mumbai Police against DePuy, a subsidiary of Johnson & Johnson that manufactured ASR implant, which is used in hip replacement surgery.
A year back, DePuy publicly recalled more than 93,000 articular surface replacement joints worldwide.
The move came after claims of metal debris from wear on the implant leading to a reaction that destroyed surrounding soft tissue and exposed patients to cobalt and chromium poisoning. In other countries, patients were compensated and re-operated. However, no such steps have been taken in India.
The FDA and Mumbai Police now want people to come forward if they have undergone a hip replacement surgery with this company's implant.
Ramrao Desai, senior inspector, Mahim police station, said, “The FDA lodged a complaint with us 15 days back. Under IPC 328, and Drugs and Cosmetics Act 17, 18 and 27, we have registered a case against the company’s director. We request people who have an ASR hip implant to contact us.”
The implant, released in 2003, used a metal cup and socket instead of a plastic or ceramic cup, to replace the hip joint. The company recalled the implants in August 2010 and admitted that 13% of those who received the device worldwide may need revision surgery.
The state FDA has claimed that it doesn’t even have any data on how many patients received the implant in India.
“The police are investigating. Once the implant recipients come forward, we will know how many are affected, and accordingly take action against the company,” said an FDA official.
City’s orthopaedic surgeons, however, had stopped using the implant as soon as the news broke last year.
Dr Pradeep Bhonsle, head of the department of orthopaedics, KEM hospital, said, “The moment the news broke abroad, we decided to stop using the implant, as a precaution. We have not received complaints from the patients on whom the implants were used earlier.”
According to Bhonsle, Johnson & Johnson had stopped the implant’s sale even in India.
Dr Arun Mullaji, president-elect of the Asia Pacific Arthroplasty Society and founder member of the Indian Society of Hip and Knee Surgeons, said, “We had asked all orthopaedic surgeons who had done the surgery using that implant to follow up with the patients. Regular x-rays and blood tests were advised. So far, we have not found any cases like those detected abroad.”
Around 4,700 implants were sold in India, out of which few are in Mumbai. Dr Ameet Pispati, consulting orthopaedic surgeon at Jaslok hospital who had performed a few surgeries using the implant said, “So far, none of my patients have needed a revision surgery. They have been regularly following up; there’s only been excessive wearing out of the implant or parts coming loose. The company has promised to fund the implant recipients’ evaluation tests, and in case it is found giving any problem, the company has agreed to pay for the next surgery too.”
The officials of DePuy in India were not available for comment.
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