Currently, over 14,000 articular surface replacement (ASR) devices, manufactured by J&Js subsidiary DePuy Orthopaedics, are in use in India. The domestic medical device market is expected to grow over 15% annually to reach $7.8 billion by 2016 from $4.4 billion at present, a Grant Thornton report said.
The ministry has asked orthopaedic surgeons and healthcare professionals not to implant the hip replacement devices in patients in India. Ministry officials said doctors have also been asked to inform all patients implanted with ASR hip replacements about this recall and schedule them for a clinical examination.
The ministry has also directed that all unused ASR hip replacement device should be returned to the manufacturer. For patients presenting symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality, if MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses then revision surgery needs to be considered, according to the ministry alert dated December 9.
Between 2004 and 2010, India imported 15,829 hip implant devices from J&J. In 2010, when J&J initiated a voluntary recall in India, only 1,295 devices were sent back to the company while the remaining continues to be used by orthopaedic surgeons.
Industry experts, dealing with the issue, said that over 90% of the patients are still in the dark about the dangers the implant poses or the global outcry against it. Studies show that the implant metals were leaving debris in the body leading to fluid accumulation in joints and muscles causing pain or discomfort and heightening chances of metal poisoning.
Patients who required revision surgeries within the first five years of implant, complained of symptoms including pain, swelling and difficulty in walking, health ministry officials said.
While as many as 4,700 Indians underwent ASR implants till date, only 280 patients have registered with the ASR helpline put up by J&J and 68 have had to undergo revision surgeries to replace the faulty implant, according to data given by Maharashtra Food and Drug Administration.
DePuy said the company is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary and advised by surgeons. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs.
Last month, J&J agreed to pay compensation of $2.5 billion to settle consumer lawsuits filed by around 8,000 US citizens who sued the company after being fit with faulty hip implants.
In India, however, while the Maharashtra FDA has initiated an investigation after getting complaints from several patients seeking help to get compensation for similar faulty hip implants, there is only one case against the company in a consumer court. Lawyers are also skeptical over the amount of compensation that an Indian patient can expect. It would be only in few lakhs that too after many years of fighting in the consumer courts, said a senior High Court lawyer.