Patients Largely Unaware of Metal-on-Metal Implant DangersDec 11, 2013
Despite its global recall in 2010, many patients remain unaware of the alleged dangers associated with the ASR metal-on-metal hip implant device manufactured by DePuy Orthopaedics, a unit of the global health care giant, Johnson & Johnson.
In fact, less than 10 percent of some 4,500 patients in India have contacted Johnson & Johnson’s redressal agency, according to The Times of India. Because of this, India’s Food and Drug Administration commissioner, Mahesh Zagade, has 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.
Physicians informed the 280 patients of the premature and unexpectedly high ASR failure rates, not the other way around, which was surprising given that researchers were discussing the unusually elevated revision surgery rates associated with the DePuy ASR devices well before the recall, according to The Times of India. Still, before the recall, some surgeons continued to implant patients with the ASRs and patients did not appear to mind. Now, experts are asking if patients should be so trusting about the medical devices they receive.
In one case, a banker explained to The Times of India that his mother was implanted with the ASR and no options were given for other devices. "I was told this was the best implant in the market. I had known the surgeon for over five years, so I did not even consider taking a second opinion," he said. He noted that he never conducted his own research on the ASR. A senior doctor from a Mumbai public hospitals told The Times of India, "It is ironical, but people do more research before buying a mobile phone or television set than for an implant that will remain inside them."
The all-metal hip devices have been the focus of growing controversy because of unusually high and premature failure rates; the many alleged, adverse medical reactions, such as increased blood metal levels; and mounting litigation. In addition to increased blood ion levels, injury reports allege dislocations; pain; metallosis (metal poisoning); fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors, to name just some.
Of concern are patient allegations that metal debris shed from the chromium and cobalt hip device leads to tissue death and increased blood metal ion levels. Many believe that it is the devices’ metal components that are the culprit. It is believed that the components rub against one another during normal, daily activities, such as walking. The movement releases small metal shards into patients’ bodies, specifically into their blood streams and area tissue. This is what is believed to raise blood metal levels and what leads to toxicity.
When the August 2010 recall was implemented, 93,000 ASR hip implant devices were recalled globally. At that time, the firm reported that 12 percent of the devices failed within five years; internal Johnson & Johnson documents, however, indicated a 37 percent failure rate after just 4.6 years. The ASR received U.S. Food and Drug Administration (FDA) approval in 2005.
The DePuy ASR devices were marketed to last for at least 20 years and were also marketed as providing increased range of motion over traditional hip replacement devices, which are constructed with plastic or ceramic components.
Today, Johnson & Johnson is facing approximately 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 recently reached a $2.47 billion settlement to resolve thousands of lawsuits; the settlement amount could reach as high as $4 billion. U.S. District Judge David Katz, in Toledo, Ohio, is coordinating the federal litigation and the settlement requires Judge Katz’ approval. Prior to this accord, J&J lost one trial, won one trial, and scheduled seven additional trials over the ASR devices. The devices were constructed in two similar models—the ASR XL Acetabular System and the ASR Hip Resurfacing System.