ASR, which involves a metal-on-metal implant, was being marketed by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The US FDA denied it approval in August 2009.
From 2004 till then, over 4,700 people in India got the Rs 1 lakh implant. In December 2011, the Maharashtra FDA lodged an FIR against the DePuy director under the Drugs and Cosmetics Act for not following up with these patients. Days later, a Nashik-based businessman approached the FDA to report that his father, 86, had the implant on November 2 and died on December 1.
An FDA official said they had waited for a year but the company “only contacted some 60 people in one year”. “The implant leaked cobalt and chromium... the least the company could have done is to offer free revision surgeries to all who wanted it.”
The Nashik businessman, who did not wish to be named, said: “Within days of the surgery, the area started turning black and my father was in a lot of pain and running a high fever... Even as we waited for reports, he died.”
The company has since moved the Bombay High Court for quashing of the FIR. Officials say they are aware of the death but deny doing that implant.
In an e-mailed response, DePuy said: “DePuy Orthopaedics, Inc communicated the company decision to voluntarily recall the ASR-XL Acetabular System and DePuy ASR-Hip Resurfacing System in August 2010. The majority of ASR hip surgeries have been successful. Since the announcement... DePuy India has provided the necessary recall information to surgeons and sought surgeon support in reaching out to their patients... DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”
A Health Ministry official said they will ask for a report, “but there is no rule that forbids a product not approved by the US FDA from being sold here”.
Among orthopaedic surgeons The Indian Express spoke to, most said none of their patients had reported reactions after being fitted with ASR. Dr Harshvardhan Hegde, director of orthopaedics and joint replacement at Fortis Hospital, said one of his 30-40 patients needed re-surgery after ASR.
Dr Ameet Pispati of Mumbai’s Jaslok Hospital observed, “After the surgery, bone was supposed to grow around the part of the implant in the acetabulum. That did not happen as promised.” Dr S K S Marya of Max Superspeciality Hospital Delhi says none of his 100 patients has reported any signs of metallosis.
WHAT IT INVOLVES
Hip joint: It’s like a ball that fits in a socket
Acetabulum: Or hip bone; this is the “socket” portion
Femoral head: Top of the femur, or thigh bone. The head is the “ball” portion, it rotates within the curved surface of the
ASR involves a a metal liner replacing the acetabulum. In one system, a femoral stem is inserted inside the femur, the femoral head connects to the stem and then fits inside the acetabular cup
Complaint: FDA in Maharashtra says implant leaks cobalt and chromium. ASR denied clearance in US in 2009, but continued by DePuy in India til 2010