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New Guidance About Metal-On-Metal Hip Implants

January 21st, 2013

This week, the U.S. Food & Drug Administration (FDA) released updated safety recommendations for metal-on-metal hip replacement devices. This is the FDA’s most comprehensive set of recommendations to date.

What’s the Problem with Metal-on-Metal Hip Implants?

While all hip replacements pose risks for patients, research has shown that metal-on-metal hip implants carry unique risks. In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running, causing tiny bits of metal to “shed” from the device. Metal can also be released from other parts of the implant where two implant components connect. Any time the metals rub, some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or the soft tissue (e.g., muscle, cartilage) surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).”

Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, the FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.  In addition, the type and severity of physical symptoms and illness seem to be specific to individuals, with different patients having different reactions to the metal particles.

Recommendations for Patients Considering Hip Implants

According to the FDA, people considering a hip replacement should be aware that every hip implant has benefits and risks, and that they should discuss options for surgery or other treatments with their physician.

When discussing your options for hip surgery with a surgeon or physician, some questions you should ask include:

  • What are the benefits and risks of each type of hip implant system (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, and ceramic-on-metal total hip systems, as well as, resurfacing hip implants)?
  • Why is a metal-on-metal hip implant the best for your situation?
  • What are the surgeon’s outcomes and personal experience in performing surgical procedures with metal-on-metal hip implants? If the surgeon recommends a resurfacing hip system, what are the surgeon’s results and personal experiences with the recommended hip resurfacing system?
  • What are the surgeon’s outcomes and personal experience in performing surgical procedures with other types of hip systems?
  • What symptoms can you expect to experience after surgery and for how long?
  • What types of activities, if any, should be limited or restricted with a metal-on-metal hip implant?
  • What results can you expect after surgery with a metal-on-metal hip implant?
  • Which specific symptoms should you report after the surgery?
  • What types of reactions may occur due to the implant and/or metal ions and how would they be evaluated and treated?
  • If you end up with a complication related to the metal-on-metal hip implant, how likely is it that the implant would need to be removed and what would be the consequences?

Metal-on-metal hip implants are usually NOT recommended for some people due to an increased risk of adverse local reactions. These include people who have kidney problems…have allergies or sensitivity to metals…have a suppressed immune system…are currently receiving high doses of corticosteroids (such as prednisone)…or are women of childbearing age.

Recommendations for People Who Already Have Metal-On-Metal Hip Implants

You and your doctor should pay close attention to any signs or symptoms that may be associated with metal-on-metal hip implants. These include:

  • Pain or swelling at or near the hip
  • A change in walking ability
  • A noise from the hip joint
  • Local nerve palsy
  • A palpable mass or lump at the hip
  • Infection
  • Hypersensitivity
  • Skin rash (not just at the hip)
  • Neurological changes, including sensory changes (auditory or visual impairment)
  • Change in psychology (depression)
  • Thyroid dysfunction (neck discomfort)
  • Fatigue
  • Weight gain
The FDA recommends routine long-term follow-up of patients every one to two years, for life. People experiencing symptoms should be seen by a physician every 6 months to monitor the progression of symptoms.
Along with a general physical examination, patients may also receive an x-ray or MRI to look for bone and soft tissue damage. Patients with severe symptoms may also have metal ion testing, although there isn’t necessarily a link between blood ion levels and actual damage–some people may have physical damage without having elevated levels of ions.
When To See an Attorney
HensonFuerst Attorneys has been investigating the legal side of metal-on-metal hip replacement devices for years, ever since DePuy Orthopaedics issued a recall of two of their top-selling hip implants. Since then, other metal-on-metal hip manufacturers have also issued recalls or warnings about their products.
In earlier blogs, we discussed what patients who experience symptoms should do (after they see a physician).

If you know that you have one of the recalled hip replacement devices… OR if you have severe pain around your hip… OR if you have been told that you have a defective hip replacement, call HensonFuerst Attorneys for important information about your rights. You may have a legal case and we will fight to help you collect compensation for the injury caused by the faulty medical device.

What’s most important: DO NOT contact any medical device manufacturer, or SIGN RELEASES OF YOUR MEDICAL RECORDS to any company before you talk with a lawyer. Don’t “register” or attempt to file a claim on your own. Let a lawyer handle everything. Big corporations look out for their own financial interests, not the interests of people who may have been harmed.

If you are worried about your future health, or if you would finally like your questions answered, call us at 1-800-4-LAWMED. Or, visit our website at www.lawmed.com for more information.  At HensonFuerst, your health is at the top of our priority list. We dedicate ourselves to protecting individuals from the greed and callousness of large corporations. Let us work for you.

Life Doesn’t Wait…get help today. Call HensonFuerst.

RESOURCES

Click any of these links for more information:

FDA Guidelines

Stryker Hip Replacement Recall

DePuy Hip Replacement Recall

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury