Hip Implant Devices Subject of New FDA Safety Update By Tod Aronovitz | 01/25/13 | 0 Comment

Safety concerns about hip implants, particularly the metal-on-metal type of medical device, prompted the Food and Drug Administration (“FDA”) to issue proposed rules requiring medical evidence documenting claims of safe usage.

Patients who have a metal-on-metal hip implant, or who are considering hip implant surgery, may want to read new safety information published by the FDA as part of its ongoing review process.

Orthopaedic surgeons, health care providers, and hip replacement patients can all find useful resources on the FDA’s web portal for Hip Implant Medical Devices. Some key findings are outlined below.

Hip Implant Failure Rates Examined

As reported in The Wall Street Journal, a 2012 Lancet article states “metal-on-metal total hip replacement failed at high rates.”

Recalls of hip implant devices in the past five years have been initiated by Johnson & Johnson’s DePuy unit, Zimmer Holdings, and Smith & Nephew PLC, according to the Journal.

Recommendations for Patients Considering Hip Implants

  • Be aware that every hip implant has benefits and risks
  • Discuss your options for hip surgery with your surgeon

If you are thinking about hip implant surgery, click on the link to read the FDA’s questions to ask your doctor about hip implant surgery.

Recommendations for Patients with Metal-on-Metal Hip Implants

  • If you are not having any symptoms and your orthopaedic surgeon believes your implant is functioning appropriately, you should continue to routinely follow-up with the surgeon every 1 to 2 years.
  • If you develop new or worsening problems such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or change in your ability to walk, contact your orthopaedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your physician know you have a metal-on-metal hip implant.

About Metal-on-Metal Hip Implants

There are two types of metal-on-metal hip implants:

  • Traditional total hip replacement systems
  • Resurfacing hip systems

Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys. The various metal pieces in these implants rub against each other during normal walking or running, which can cause small particles of metal to break loose and become embedded in surrounding soft tissue or near a bone. This condition is referred to as an “adverse local tissue reaction” (ALTR) or an “adverse reaction to metal debris” (ARMD). Adverse side effects may include skin rashes, hearing or vision impairment, and depression, according to the FDA.

If you are a patient with a metal-on-metal hip, click on the link for the FDA list of FAQs on Metal-on-Metal Hip Implants.

The FDA may require manufacturers of metal-on-metal total hip replacement systems to submit pre-market approval (PMA) applications. Click on the link to read the FDA proposed rule for hip replacement system pre-market approval.

Talk to your doctor about your specific condition, either pre- or post-surgery.

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