Recall Alert Over Johnson & Johnson's DePuy ASR Metal-on-Metal Hip Device Implemented in IndiaDec 13, 2013
The DePuy Orthopaedic metal-on-metal hip replacement ASR device has been put on a so-called “recall alert” in India by that country’s health ministry after worldwide reports of metallosis (metal poisoning) in patients and premature and excessively high failure rates were received.
The high failure rates often point to the need for revision surgery. Revision surgery involves removing and replacing a defective or failed device and replacing that device with a different device. The surgery is more complex and more costly than the original implantation as less tissue and bone mass is available, especially in cases in which there is damage to area tissue and bone. Recovery tends to be longer and results are not always better than what was expected with the original surgery.
In August 2010, Johnson & Johnson issued a worldwide recall of its ASR devices. Today, according to The Financial Express, over 14,000 DePuy ASRs are in use in India.
The Indian ministry has asked orthopedic surgeons and healthcare professionals there to stop implanting the DePuy ASR devices in patients in India, to “inform all patients implanted with ASR hip replacements about the recall alert, and schedule them for a clinical examination,” The Financial Express reported. The ministry also asked that unused ASR hip devices be returned to the manufacturer and wrote in a December 9th alert that, “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.”
India imported 15,829 Johnson & Johnson hip implant devices between 2004 and 2010. At the time of the recall, in India, 1,295 devices were returned to the company; the remaining devices continue to remain in use by orthopedic surgeons, according to The Financial Express.
“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, wrote The Financial Express. Meanwhile, industry experts indicated that over 90 percent of patients in India are unaware of the dangers associated with metal-on-metal hip devices and the growing, worldwide debacle involving the implants.
To date, about 4,700 patients in India underwent ASR implant surgery; however, just 280 patients have registered with the device maker’s ASR help line and 68 have undergone revision surgery, according to data provided by the Maharashtra Food and Drug Administration, The Financial Express reported.
Earlier this week, India’s Food and Drug Administration commissioner, Mahesh Zagade, suggested that non-governmental organizations (NGOs) begin educating patients. "We also need specialized courts and compensation laws in the country to tackle these emerging issues better," Zagade told The Times of India.
The DePuy ASR devices were marketed to last for at least 20 years and to provide increased range of motion over traditional hip replacement devices, constructed with plastic or ceramic components. Instead, the all-metal hip devices have been tied to high and premature failure rates; an array of alleged, adverse medical reactions, including increased blood metal levels and metal poisoning; and mounting litigation. Injury reports also allege dislocations; pain; fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors, to name just some.
Today, Johnson & Johnson faces about 12,000 lawsuits filed in federal and state courts in Ohio, California, and New Jersey.