The DePuy Orthopaedic metal-on-metal hip replacement ASR device was just placed on a recall alert by the Indian health ministry following global reports of metallosis (metal poisoning) in patients, as well as premature and excessively high failure rate reports.
The high failure rates often point to the need for revision surgery, which involves removing and replacing a defective or failed device with a different device. Revision surgery is typically more complex and costly than original implantation as less tissue and bone mass is available, especially in cases in which area tissue and bone are damaged. Recovery tends to be longer and results are not always better than those expected with the original surgery.
In August 2010, Johnson & Johnson issued a worldwide recall of its ASR all-metal devices. Over 14,000 DePuy ASRs are in use in India today, according to The Financial Express.
The Indian ministry has asked orthopedic surgeons and healthcare professionals there to cease implanting the DePuy ASR devices in patients in that country, and 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 asked that unused ASR hip devices be returned to the manufacturer, writing 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.”
Between 2004 and 2010, India imported 15,829 Johnson & Johnson hip implant devices. At the time of the recall, in India, 1,295 devices were returned to Johnson & Johnson; the rest of the devices are 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 have indicated that most—over 90 percent—Indian patients do not know about the dangers tied to metal-on-metal hip devices and the growing, worldwide scandal involving the implants.
Some 4,700 patients in India have received an ASR metal hip device, yet only 280 patients have registered with the device maker’s ASR help line; 68 have undergone revision surgery, according Maharashtra Food and Drug Administration data, The Financial Express reported.
Earlier this week, Mahesh Zagade, India’s Food and Drug Administration commissioner, suggested that non-governmental organizations (NGOs) start 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 provide increased range of motion when compared to traditional hip replacement devices that are constructed with plastic or ceramic components. Instead, the all-metal hips have been associated with high and premature failure rates; an array of alleged, adverse medical reactions, including increased blood metal ion 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 some 12,000 lawsuits filed in federal and state courts in Ohio, California, and New Jersey, according to a recent Bloomberg.com report. The device maker also recently reached a $2.47 billion settlement to resolve thousands of these lawsuits; that amount may reach as high as $4 billion. The devices were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.