Wednesday, June 27, 2012

Tissue Reactions and Metallosis Tied to Metal-on-Metal Hip Implants

The newest research on the safety and efficacy of metal-on-metal hip implants indicates that recipients of the devices have a significantly increased risk of corrosion, adverse tissue reactions and metallosis. Any of these medical issues can be very serious and may require revision surgery to remove the defective implant. The recalled DePuy ASR hip implant has been found to corrode much faster than the other commonly used types of artificial hip implants—namely ceramic and plastic. That corrosion, in turn, can cause localized inflammatory tissue reactions and lesions including soft tissue masses or tissue necrosis. If the corrosion is advanced, then removal of the implant or revision surgery may be indicated.

The metal femoral heads of the DePuy hip implant device are constructed of cobalt and chromium and rest in a metal acetabular cup made of the same metals. In the past few years serious concerns have risen regarding the excessively high failure rates of the metal-on-metal hip implants as well as the potential for metal toxicity from the metal particles which shed when the ball and cup rub against one another during activity.

Metal Corrosion Leads to Tissue Reactions and Toxicity

Recently a new study published in the Journal of Anthroplasty took a look at the level of corrosion on the femoral heads of the metal-on-metal hip implants as compared to a head constructed of metal-on polyethylene of a comparable size. The metal-on-polyethylene implant uses a synthetic liner as a “buffer” between the femoral head and acetabular cup. The metal-on-metal implant systems have no such buffer meaning the metal parts, constructed of cobalt and chromium, can rub against one another releasing microscopic metal shavings into the body.

When these metal particles enter the bloodstream the patient can suffer a wide range of negative health issues including kidney and liver disease. The findings of the study indicated that the metal-on-metal implants showed significantly higher levels of corrosion which increased over time. The degree of implant corrosion was definitively tied to an increase in adverse tissue reactions among patients. When the corrosion reaches unacceptable levels, revision surgery is required to remove the implant.

A visual grading process was implemented to determine the taper corrosion suffered in 33 femoral heads removed from patients—all from the same manufacturer. Nineteen of the 33 femoral heads were metal-on-metal and nearly half of those exhibited corrosion outside the taper zone. The other fourteen femoral heads were constructed of metal-on-polyethylene, and only one of those showed any sort of corrosion. The metal-on-metal hip implants which had been revised following adverse patient tissue reaction showed higher corrosion than those removed from patients with no tissue problems.

Metal-on-Metal Hip Implant Recall

Medical experts around the world continue to speak out about the safety of the metal-on-metal hip implant, calling for the complete removal of the devices from the market. Yet even following the DePuy ASR recall in August of 2010, other metal-on-metal hip implants remain in use. The orthopedic advisory board of the FDA has responded to concerns by scheduling an upcoming meeting on June 27-28. The committee will review the apparent failure rates of the metal-on-metal hip implants as well as discuss metallosis testing, methods for imaging the implants, relative risks among patients, potential complications and follow-up considerations following implant surgery. The decision may well be whether to demand more rigorous testing and pre-market review requirements for all metal-on-metal hip implants since the data indicates that one out of every eight metal-on-metal implant failed within five years of the original surgery. As many as 6,000 patients in the United States alone are presently pursuing product liability claims against the hip implant manufacturers including the DePuy ASR, DePuy Pinnacle, BioMet M2A-Magnum, and Wright Conserve.

Author: Sullo & Sullo Attorneys

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