Half of Johnson & Johnson hip implant users unaware of defects

MUMBAI: Eight years after the faulty Johnson & Johnson hip implants were recalled in India and abroad, more than 51% of Indian users continue to be in the dark about the defective device and its far-reaching health implications. The absence of a tracking system may now prove costly as the government strives to reach out to over 2000 implant users across India.

An estimated 4,500 patients were fitted with 4,700 articular surface replacement (ASR) implants before the recall; some had undergone bilateral surgeries. Till date, DePuy, a subsidiary of J&J, said it has reached out to 2,300 of 4,500 patients through 400 hospitals, surgeons and independent service providers. Around 12% of the patients who have been traced required revision surgeries.

Implant recipient Vijay Vojhala, who has been fighting against the pharmaceutical giant, said he traced other patients though police reports and by filing RTIs with the Food & Drugs Administration. He said the government did little over the years to exert pressure on company and hospitals. “The company’s claim that 2,300 patients have been traced should also be scrutinized,” he said. The Maharashtra FDA, the first government agency to begin a probe against J&J in 2012, too, struggled to get patients.

Industry experts say a company sells implants to distributors, who, in turn, sell to hospitals and individual surgeons. “Distributors then collect information about how many implants have been sold and revert to the company, which most often does not insist on patient details barring their names or bills,” said Yadav Shetty, who deals in medical devices. Another supplier said the Drugs and Cosmetics Act states everyone in the buying and selling chain is supposed to retain bills.

The indifference of surgeons has come in for heavy criticism in the episode. “It’s impossible that doctors cannot track their patients,” said Vojhala. Dr Arvind Goregaonkar, president, Bombay Orthopaedics Society, though, said tracking can be next to impossible in public hospitals, where patients often come from other states. “Six of my seven patients who got the implant at Sion Hospital are lost to followups,” said Goregaonkar. Often implants are brought to surgeons directly in operation theatres. “In such cases, the sticker for each component is pasted on the patient’s discharge card.” Implant registries have been a non-starter in India, said Dr Pradeep Bhonsale, who co-founded Indian Society of Hip and Knee Surgeons. “We record bar codes of every implant so the outcome too can be studied.” But less than 500 surgeons have joined them.

A Depuy spokesperson said, “Due to patient privacy laws in India, the company cannot directly contact patients. We have to approach them via doctors and hospitals. We have hired two third party organisation to aid in the process.”