In August 2010, Depuy Orthopedics, the largest maker of replacement hips worldwide, issued a recall of all ASR XL Acetabular Hip Systems made after 2003. According to the New York Times, Depuy ignored early warnings from surgeons and hid negative information about the implants for years. In 2008, a study conducted by Dr. David Langton showed that A.S.R. patients had elevated blood levels of cobalt and chromium. One year later, DePuy publicly announced that it would phase out A.S.R. sales and close the British plant that produced it.
The recall comes after thousands of patients expressed complaints of severe pain and system failure, and amid worries that the implants may be sending metal shavings into patients' bloodstreams. This could potentially put patients at risk for dementia, deafness, and/or heart failure. Since the introduction of the ASR XL Acetabular Hip System in 2003, approximately 93,000 units manufactured by Depuy Orthopedics have been sold and implanted into patients.
Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.
These units are designed for younger, more active patients and designed to last up to fifteen years. However, if the unit is not placed at exactly the right angle, the metal-on-metal design can begin to release metal shavings into the blood stream, potentially causing permanent, even life-threatening damage to the patient. According to Depuy, within five years one in eight patients (12% - 13%) needed a revision surgery which is required when an artificial joint doesn't fit perfectly and causes pain and difficulty walking. These numbers could be much higher.
In some cases, the problems with the A.S.R. required additional painful operations in which the device was replaced with yet another artificial hip. For some, however, the damage to bone, muscles and nerves from the troubled device, which can shed tiny metallic particles, has left them permanently disabled.
