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MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA
During the two days, panel members heard a mind-boggling array of words and phrases to describe the damage to bone, tissue, and blood resulting from MoM devices:
Tribocorrosion, trunnions, fracture of resurfacing systems, edge wear, microseparation, pseudotumors and asceptic lymphocytic vasculiis-associated lesions, voltage effects, infections, post-operative nerve palsy, prosthesis loosening, implant breakage or fracture, femoral neck fractures and heterotopic ossification, loss of mobility and pain, and mechanically assisted corrosion, to name just a few.
Starting a decade ago, newer MoM devices were seen as a safer alternative to prostheses made of polyethylene or ceramic, which wore out faster, and which released particles that could accumulate in local tissue and erode the bone.
Metal devices, which would last longer, held a promise to solve that problem, because they were seen as more appropriate for younger people who wanted to remain active in their 60s and 70s and beyond without having to undergo a revision surgery.
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Comments are moderated. Please be patient.
carol (7/6/2012 at 3:36 PM)
The panel has said that they won't ban the devices, but they did have recommendations for more limited use. They said that people who show signs of failure (swelling, pain, etc.) should have X-rays and blood testing for metal ions, a guideline that UK regulators already issued awhile back. They also said that the FDA should provide some kind of reference range for the metal ion tests, since there is currently no standard