August, 2010 saw a recall by DePuy and Johnson and Johnson of their ASR XL Acetabular Hip System as well as the ASR Hip Resurfacing System. The recall came after the FDA received an alarming number of adverse event reports from ASR recipients. Johnson & Johnson then acknowledged that the ASR hip implant products had a higher-than-normal failure rate after data revealed that over 12% of ASR recipients required revision surgery within a relatively short amount of time. The reasons given by DePuy for the ASR recall and high failure rate included loosening or misalignment of the implant, infection, bone fracture, dislocation, metal sensitivity and pain.
The ASR became available to the public in July of 2003 and it is believed that over 93,000 patients across the globe received an ASR hip system or hip resurfacing system. The ASR hip implant systems implement a metal-on-metal ball and socket. While the all-metal implant offers somebenefits over all-plastic or all-ceramic implant(such as a higher resistance to everyday wear)an all-metal hip with an inherently defective design can lead to a wide variety of complications not seen in plastic or ceramic counterparts.
When metal ions are released into the surrounding tissues or into the bloodstream, the body is at risk of a variety of serious medical conditions which will continue to worsen as cobalt and chromium continue to build up in the body. While not targeting the ASR specifically, a study reported on in the the Journal of Bone and Joint Surgery stated that patients with all-metal implants (like the ASR) had cobalt levels thirty-nine times higher than normal and chromium levels twenty-eight times the normal levels. Some DePuy ASR recipients have tested at levels even higher of cobalt and chromium. Metallosis symptoms include:
- Emotional disturbances such as depression, anxiety and irritability
- Cardiovascular, renal, neurological and thyroid issues
- Chronic pain, from moderate to severe
- Loss of balance and dizziness
- Hearing and vision disturbances
- Gastrointestinal disorders
- Skin problems
- Muscle tissue degeneration
- Severe inflammation
- Memory loss
- Pseudo tumors
It is likely that any patient implanted with an ASR all-metal hip implant will experience some level of metallosis resulting from cobalt and chromium buildup, therefore it is extremely important that all ASR recipients—or recipients of any all-metal hip implant—speak with their doctor about the risks of metallosis and have regular blood tests done to monitor the cobalt and chromium levels in their body. It is advisable that ASR recipients also speak to a highly experienced legal professional who can assess the facts of their particular implant.