The Depuy hip replacement device, the Articular Surface Replacement, manufactured by Johnson & Johnson has been recalled. But, wasn’t it approved by the Food & Drug Administration? Yes, it was approved based on representations by the manufacturer of its safety.
The discussion with the FDA about new devices often goes something like this:
The device I want to market to the American public is “substantially similar” to devices the Food & Drug Administration have already approved for use through other manufacturers products. So, my company should receive approval without the need for clinical testing or other expensive evaluation.
So goes the story told to the FDA by medical device manufacturers on a regular basis. The FDA must take the information, designs and the data about the device provided by the manufacturer and evaluate whether what is being represented as a “substantially similar” device, really is or is not. Often this is a difficult determination for the FDA to make; particularly under its often constrained budget.
In the case of the Dupuy hip replacement device, it appeared “substantially similar” to other devices, but there were some differences that would not become apparent without testing. In this case, the testing happened through implant of the device into the bodies of trusting and unsuspecting patients.
Depuy ASR implants are forged from cobalt chrome and the implant functions with metal against metal impact. One of the problems found through investigations conducted by Dr. Stephen S. Tower, disclosed possibly dangerous levels of cobalt in the blood stream of Depuy implant patients. In addition to hypothyroidism, which can be caused by the cobalt levels, it also exposes patients to possible cardiac complications.
The Depuy implant has demonstrated a higher than expected, in fact higher than acceptable, failure rate and ultimate need for revision surgery than other implants on the market. The failures in these appliances lead to severe pain, inflammation, and death of tissue and bone. Patients require revision surgery leading to longer rehabilitation periods and unnecessary suffering.
It appears that Johnson & Johnson began to learn at least by 2007 or 2008 that the ASR device was manifesting serious failure problems, but continued to aggressively market the implant.
In cases such as this, patients can be at a disadvantage in proving their implant was defective. Often, the patient will be forced to undergo revision surgery, the Depuy implant is removed and a new implant is installed. The manufacturers usually demand the return of the removed implant to them. This leaves the patient without possession of the offending product.
Should you have a Depuy ASR hip implant and are having problems, see your orthopedic physician immediately. Should you require revision surgery, make sure your physician retains the removed implant and returns it to you or maintains it in his records for safe keeping. The most efficient way to allow your surgeon to retain the implant for you is to provide him or her with a letter documenting that request.