Product News and Recalls

FDA cautions surgeons implanting all-metal joints

Members of a U.S. Food and Drug Administration panel that recently discussed metal-on-metal artificial hip implants said they wouldn’t recommend that patients get them, although the FDA as a whole has so far stopped short of an official ruling on the devices.

Still, the FDA Website has a section advising orthopedic surgeons who are performing metal-on-metal hip implantation surgery. And the FDA’s recommendations clearly reflect concerns about the devices shedding toxic metal debris in patients’ bodies – a widely reported side effect – as well as their tendency to break down after only a few years.

Metal-on-metal hip implants, unlike earlier plastic and ceramic models, have both a ball and a socket coated in a combination of cobalt and chromium.

The FDA’s recommendations say surgeons shouldn’t implant the devices in:

  • Patients with known moderate to severe renal insufficiency
  • Patients with known metal sensitivity (e.g. cobalt, chromium, nickel)
  • Patients with suppressed immune systems
  • Patients currently receiving high doses of corticosteroids
  • Females of childbearing age

The FDA says surgeons who are getting informed consent from patients receiving the devices before surgery should ensure that the patients understand:

  • The alternative treatment therapies along with their respective risks and benefits.
  • The potential risks associated with metal-on-metal systems which include but are not limited to: elevated metal ion levels in the joint and blood; development of local inflammatory reactions and lesions including soft tissue masses and tissue necrosis; development of potential systemic events related to elevated metal ion levels; the potential for and risks of revision surgery.

And after surgery, the FDA recommends that surgeons “review with the patient or caregiver the signs/symptoms of potential local and systemic adverse events which may result from reaction to metal debris.”

If you’ve received a metal-on-metal hip implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a lawyer familiar with the devices to discuss your legal rights.

See more information here:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm#considerations-before