Biomet, Zimmer, Stryker, and Johnson & Johnson: Metal on Metal Hip Replacements
The FDA has asked Johnson & Johnson, Biomet, Wright, Stryker, and about 20 other companies to study whether their implants unsafely raise the level of metal in the body to unsafe levels.
Arguably, the FDA is behind the 8-ball a bit. Over a year ago, the UK version of the FDA issued a medical device alert that included blood tests and imaging of metal-on-metal hip replacement patients. The FDA says that it is hard to figure out a patient's metal ion levels. Still, the FDA also says that some research shows metal-on-metal hip replacements increased metal levels in the patient's blood to the point that it effected the thyroid, nervous system, and the heart.
Ultimately, setting aside the question of imaging risks for a second, I really can't figure out why the FDA does not fall in line with the UK on this. How risky is a blood test?
