A few months after DePuy Orthopedics, a unit of Johnson and Johnson announced that it would be phasing out the ASR hip implant due to slow sales; representatives of the company have warned doctors that there appears to be a high early failure rate with the device.
Apparently the company has received reports for more than two years that indicate the ASR was failing within a few years of implantation and required expensive and often painful replacement surgery. Many orthopedic experts are shocked that DePuy did not recall the device sooner. Specialists have indicated the device had a design flaw that made it difficult to implant properly. Data has shown for several years that the ASR has failed early much more often than competitors’ devices.
The announcement that DePuy is going to phase out the ASR was met with the proclamation that it is way too late. This device is currently implanted in thousands of patients worldwide, that means thousands of people around the world undergoing needless surgery to replace an implant that has replaced their natural hip.
The ASR is one of several models of implant sold by De Puy that are metal on metal, these products in all of their uses are coming under scrutiny because of the debris from the metal joints that causes inflammation, damages muscles and requires follow up operations to repair or replace the joints.
Good grief, one would think that when a patient has been dealing with pain and misery in their joints that when the time came to replace a hip with an implant that the best possible materials would be used. Who would willingly have an ASR implant put in if they knew they would continue to live with pain and that the joint would have to be replaced within a few years. The FDA has received about 300 complaints about the ASR since January of 2008 in the United States alone. These complaints don’t present the entire problem with this product because many doctors and hospitals don’t bother to report to the FDA about failed implants.
This all leads back to the FDA and the approval for medical products. ASR was approved in 2005 for use in the U.S. in traditional hip replacements; however the product never went through clinical trials and was approved using a regulatory pathway. Simply put, the FDA said sure use this product because you have submitted the correct forms and waded through the red tape. Without testing before approval how can the FDA approve a product to be implanted in people’s bodies?