Voluntary recall doesn’t imply hip implant was faulty, says J&J
DePuy International, a unit of J&J, says the company’s actions concerning the product were ‘appropriate’ and ‘responsible’
New Delhi: Johnson and Johnson (J&J) Pvt. Ltd on Thursday said the voluntary recall of its controversial hip implant does not mean it is faulty.
The metal-on-metal acetabular surface replacement (ASR) implant, known as DePuy ASR, was sold in India by DePuy International, a unit of J&J.
A DePuy spokesperson in India said the company’s actions concerning the product were “appropriate” and “responsible”.
“It is also important to note that a voluntary recall doesn’t imply that the product is ‘faulty’ nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the spokesperson said in a statement.
The hip replacement device was recalled in India in the wake of global reports of metal poisoning and high failure rate. In the US, J&J had agreed to pay a compensation of $2.5 billion to around 8,000 US citizens who had sued the company following faulty hip implants.
Last year, Union health ministry had set up a committee under former dean of Maulana Azad Medical College Dr Arun Agarwal. The committee submitted the report, recommending compensation for the patients.
The committee found that the firm was “evasive” in providing the information and least cared about those who are living an immobile life and forced to bed. It also blamed the company for the “faulty” device.
In August 2010, the company voluntarily recalled 93,000 ASR implants worldwide after the National Joint Registry of England and Wales reported that 13% of patients implanted with an ASR ended up needing revision surgery.
In 2013, the Maharashtra Food and Drug Administration (FDA) filed an FIR against De Puy Orthopaedics Inc. on the grounds that it had not taken proper remedial measures to inform patients in India who had undergone the implant surgery.
According to the expert committee report, approximately 4,700 ASR surgeries were carried out in India from 2004 to 2010, out of which only 882 patients could be traced by the ASR helpline.
DePuy, however, says it doesn’t have access to data on patients who have received an ASR hip implant due to patient confidentiality regulations and they could trace 2,300 patients who underwent ASR surgery in India.
“As a result of all the above outreach efforts, to date we have, through surgeons, hospitals and independent service providers, demonstrated outreach to more than 2,300 patients who underwent ASR surgery in India,” the statement added.
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