Is the DePuy Hip Replacement a Dangerous Device?

Atlanta, GAWhen patients first received their DePuy ASR hip replacement device, they likely thought their pain was going to lessen and their mobility problems would be over. But some patients who received that particular metal-on-metal DePuy hip replacement have found that the surgery was only the start of their ordeal. Following the announcement of the DePuy ASR recall, and subsequent DePuy lawsuits, some critics say that the DePuy ASR is a dangerous device.

CBS Atlanta (5/16/12) aired a report on dangerous devices and included information from Consumer Reports, who investigated the use of metal-on-metal hip replacement devices such as the DePuy ASR. According to the CBS report, one patient, Calhoun Police Lieutenant John McGivern, developed a serious infection after his ASR hip was implanted. He was rushed to hospital, fell into a coma, underwent 13 surgeries and has since suffered permanent health problems. His medical bills totaled more than $1 million, but despite the ASR being recalled, DePuy has reportedly refused to pay McGivern's medical bills.

It is not just in the US that the metal-on-metal hip devices have caused controversy. According to WA Today (5/17/12) more than 1,000 patients in Australia have undergone hip revision surgery—surgery to replace an implanted hip device—because of an early failure. Experts say the failure rate for the DePuy ASR hip implants is approximately 25 percent over seven years, which is about five times higher than the normal failure rate.

The US Food and Drug Administration (FDA) has announced that it is having an advisory panel meeting to discuss whether there should be more stringent rules for allowing medical devices on the market. According to The Morning Call (5/10/12), Steven Lorenz—a patient who received a DePuy metal-on-metal hip replacement device—plans to attend the meetings and hopes to speak to the FDA about his ordeal.

Lorenz reportedly had the DePuy ASR XL device implanted in both hips, tested above normal for cobalt and chromium in his system (signs of possible metallosis), and suffers pain in both his hips. Despite being at risk for having the devices fail, and despite already showing signs of metallosis, Lorenz reportedly has yet to find a doctor who will remove the devices because of the complicated nature of revision surgery.

Lawsuits have been filed against DePuy alleging certain DePuy hip implant devices had a high failure rate and that DePuy knew or should have known about that failure rate, but left the device on the market longer than it should have. According to Businessweek (5/1/12), more than 6,000 lawsuits have been filed in state and federal court. Both the plaintiffs and defendants have agreed to hold bellwether trials. The first trial is reportedly scheduled for mid-December 2012, with another trial in January, 2013.

DePuy has responded to all allegations saying it believes it acted appropriately and responsibly.