FDA Panel Sees “Little Use” for MOM Hip Replacements, Asks for Long Term Studies of Dangers

July 30, 2012, by Michael A. DeMayo

Metal on metal (MOM) hip replacement devices are in the news again. An FDA panel that convened on June 27-28 concluded that they see few, if any reasons, to use these devices. According to the panel’s chair, Dr. William Rohr of Mencocino Coast District Hospital, “I do not use metal-on-metal hips, and I can see no reason to do so.”

Evidence continues to mount showing that these implants break down much earlier than other types of artificial hips they were intended to improve upon. Even more alarming, they also deteriorate, exposing patients to potentially hazardous levels of cobalt, chromium and other metals in the blood. Because of the danger of this metal toxicity, guidelines have been proposed for patients who have already received MOM hip replacements.

Our Charlotte, North Carolina defective hip replacement lawyers noted that the FDA has not yet mentioned taking these devices out of use. This is surprising, considering the multitude of recalls, the 17,000 reports to the FDA about problems caused by these devices, the thousands of lawsuits filed by victims of these implants and their panel’s own findings.

What does this mean to you, if you already have a MOM hip replacement?

We urge you to take this matter very seriously. If you are experiencing pain or inflammation in the hip, please see your doctor immediately for an X-ray as well as blood tests to determine the level of metals in your blood. The pain may be caused by metal particles which have ground off the implant and seeped into the joint. This can damage the surrounding tissue and the bone itself. If your doctor finds that the implant is breaking down too quickly or your health is being endangered by it, we recommend consulting a qualified defective hip implant attorney.

If you have a MOM hip replacement, the FDA panel recommends a yearly X-ray to monitor your situation, whether you are experiencing pain or not. However, this recommendation is weaker than others put in place overseas, such as in the United Kingdom, where regulators also recommend yearly blood tests to check for the presence of dangerous metal toxicity.

The ramifications of elevated metal in the bloodstream over long periods of time are as yet unknown, although preliminary studies suggest there may be links to various neurological problems and heart issues.

The FDA panel pointed out a couple of disturbing facts. There are problems with determining the levels of dangerous metals from common blood tests, and interpreting the results is not cut and dried. No standardized diagnostic kits even exist to test for levels of chromium.

The FDA has asked hip implant manufacturers to conduct long-term, follow-up studies of the over one hundred different MOM hips currently available. They are hoping the studies will provide answers to some important questions, including the effects on the human body of these metal particles. Obviously, a long term study could take a decade or more, leaving many patients at unnecessary risk.

If you have had an MOM hip replacement failure, or are experiencing other complications, we urge you to immediately seek expert medical help and legal help as well. Please contact our North Carolina hip implant law firm today. We provide free case evaluations to individuals experiencing complications from a DePuy or other MOM device.

 
 

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