The DePuy artificial hip is known as Articular Surface Replacement, or A.S.R. It was designed to give the patient more natural movement in the hip and promoted to be a break through design. However, this has not shown to be true. Unfortunately for consumers, implants don’t have to go through extensive testing before they receive the approval from the Food and Drug Administration, which drugs and other products do. Implants can be distributed without such testing, especially if there is already a similar implant on the market that patients are using.
“You basically are testing these devices in an uncontrolled way on a large number of people,” said Dr. Sydney M. Wolfe, The Public Citizen’s Health Research Group critic and long time FDA critic director. After receiving the hip replacement, many patients developed an inexplicable pain. When surgeons went to replace the implant, they discovered a mysterious mass, a side effect that might have been accounted for if the product had undergone extensive testing. The mysterious mass was of dead tissue located near the thigh of some patients.
The Johnson & Johnson unit responsible for the device, DePuy Orthopedics, then conducted interviews with doctors in response to these findings, explaining that the artificial hip was failing and warning that many surgeons were abandoning it. This retroactive evaluation of the product represents one of the greatest failures of the lackadaisical laws regarding medical device evaluation.
The ASR System recall was finally announced last August by Johnson & Johnson. According to designs, the ASR Hip System was supposed to last for at least 15 years. However, recent evidence of its high failure rate, often after only two years, prompted this recall from the pharmaceutical giant. “We believe we made the appropriate decision to recall at the appropriate time given the available information,” DePuy said in a statement clarifying their actions.
However, many professionals criticized the company’s handling of consumer complaints over their product. In early 2010, amid mounting complaints and data from Australia about the product’s high rate of failure, the company announced they would phase out the product. However, the company simply said this phasing out was the result of poor sales, never mentioning the strong evidence showing the product posed significant dangers. Therefore, the faulty device continued to be sold last year, continuing to be seen as a viable replacement system. It was not until strong pressure from the FDA and medical experts showed its high rate of failure that the full recall was initiated. “When it is clear to the orthopedic community that a company has not been honest, that is a problem,” said Dr. Stephan Graves, Australia’s registry’s director.