On May 6th, 2011, the FDA sent 145 orders to 21 companies that make metal-on-metal
artificial hip systems asking them to conduct a further study on the safety
of their devices. Manufacturers have 30 days to submit a research protocol
to the FDA that addresses specific safety issues related to these devices.
Patients with the metal-on-metal replacements have developed serious health
problems related to particles of metallic debris, specifically, cobalt
and chromium, that are shed by the metal replacements. The FDA reports
that the metal ions in the blood stream may have caused illnesses elsewhere
in the body, including effects on the heart, nervous system, kidneys and
thyroid gland. Patients who have received a metal-on-metal hip implant
are warned to pay attention to symptoms like chest pain, shortness of
breath, numbness, weakness, change in vision or hearing, fatigue, weight
gain, change in urination habits, and pain or swelling at or near the
hip joint. Additionally, though the implants are designed to last 15 years,
the British Orthopaedic Association reports that the failure rate within
five years after implant ranges from 12 to 15 percent.
The largest producers of hip implants are Johnson and Johnson, Zimmer,
Stryker, Biomet, and Wright Medical. Johnson and Johnson currently has
more than one thousand lawsuits filed against it for its hip replacements.