The U.S. Food and Drug Administration is scheduled to discuss whether or not to make metal-on-metal hip implants subject to more rigorous testing at a two-day expert advisory panel meeting on June 27-28, 2012.
Metal-on-Metal Hip Replacement Controversy
After years of controversy surrounding these implants, the FDA is starting to take the issue seriously. Numerous studies of metal-on-metal hip replacements show a higher failure rate than implants made of other materials, including a recent study released by the National Joint Registry of England and Wales. It showed that, after five years, 6% of metal-on-metal hip replacements needed additional surgery to replace or repair them, as compared to roughly 2% of people with ceramic or plastic systems. Last May, the FDA ordered manufacturers of metal-on-metal implants to collect more safety data on the devices, including data related to metal ion concentrations in the blood stream.
Common patient complaints with metal-on-metal hip replacement failure include:
- Metal breaks from constant weight-bearing stress
- Fractures near the artificial joint
- Artificial joint dislocation and instability
- Loosening of the attachment between the bone and artificial device
- Pain, stiffness, and infection due to loosening of attachment between device and bone.
Metal-on-Metal Hip Replacement, Metallosis, and Cancer
Outside of the high failure rate for these metal-on-metal replacements, there is a potentially more serious problem. The design of the systems leaves the metal ball and cup to abrade against one another, causing particles of chromium and cobalt to shed from the parts and enter the patients’ tissues and bloodstream.
This build-up of metal debris in the soft tissues is called metallosis, and can lead to the formation of pseudocysts (collections of fluid and dead tissue), which can destroy the surrounding muscle and bone.
In addition, recent studies link cobalt and chromium debris to an increase in the risk of cancer (particularly in the kidneys and bladder), and an increase in the risk of genetic damage.
The capper on all of this is that companies like DePuy Orthopaedics, Inc., a subsidiary of global giant Johnson & Johnson, have known this for years and have only recently decided to recall the ASR hip system from the U.S. marketplace (while still marketing the hip system to patients overseas).
What You Can Do if You’ve Had a Metal-on-Metal Hip Replacement
The problem with metal-on-metal hip implants is not limited to the DePuy ASR implant. If you were implanted with another device, including the DePuy Pinnacle hip, Zimmer Durom cup, or other metal-on-metal device, please visit our page on Defective Hip Replacement Recalls & Hip Surgery Lawsuits for more information, and contact us for a free consultation.