New Delhi: The Central Drugs Standard Control Organization (CDSCO) has asked medical directors, orthopaedic surgeons and healthcare professionals not to implant US-based DePuy Orthopaedics’ ASR (articular surface replacement) hip replacement devices in patients in India.
The move follows global reports that mentioned metal poisoning and high failure rate of the product. 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.
The CDSCO has also directed that all unused ASR (articular surface replacement) hip replacement device should be returned to the manufacturer. Doctors have also been asked to “inform all patients implanted with ASR hip replacements about this recall and schedule them for a clinical examination”.
Between 2004 and 2010, India imported 15,829 hip implant devices from DePuy, a subsidiary of US-based Johnson & Johnson (J&J). In 2010, when DePuy 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, reports FE.
“Patients who reported problems with the DePuy ASR systems and required revision surgeries within the first five years post-surgery presented with a variety of symptoms including pain, swelling and difficulty in walking,” according to a CDSCO alert dated December 9. [Read the full alert]
“A small number of patients implanted with these systems may also develop progressive soft tissue reactions to the metal debris generated as the metal components wear out over time. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones and nerves around the hip,” it said.
“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,” the alert added.
On November 19, DePuy Orthopaedics, announced a US settlement, valued at $2.5 billion, to compensate eligible ASR patients (approx. 8,000 patients) in the country who had surgery to replace their ASR hip, known as revision surgery.