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FDA to Metal Hip Makers: Provide a Safety Data.

The Food and Drug Administration (FDA) is asking metal hip manufacturing companies for a safety data regarding the products they have. There have been concerns of cobalt and chromium ions released into the bloodstream.

True enough, there are metal particles from hip implants that can circulate into the bloodstream. However, it is still uncertain whether there is a remarkable elevation in the levels of metal particles that cause serious health problems. The FDA has taken action and requested the metal hip manufacturers to find it out.

The Food and Drug Administration has filed an order on May 6 to 21 wherein companies that manufacture metal-on-metal hip systems should do some research on the safety of their devices. Cobalt and chromium may be a problem in the bloodstream.

According to the FDA's website, metal in the blood can cause problems. The agency claims that minuet numbers of patient experienced problems in their heart, thyroid gland and nervous system. These problems may have been brought about by the metal ions circulating in the bloodstream.

In the article, Concerns about Metal-on-Metal Hip Implant Systems, it doesn't state how grave the risk is. Different individuals have different reactions to the metal particles in various ways. At the present time, it is not feasible to identify who will experience a reaction, the type of reaction that would happen; the severity of the reaction and the occurrence of the reaction. Needless to say, over time, the metal particles surrounding the implants will cause damage to the tissue surrounding the implant and joint. Also, it will also bring damage to the bones.

When it comes to total hip replacements, it consists of three metal parts namely the ball, cup in the hip bone and the stem in the femur. Say for example a patient feels pain, swelling, difficulty in walking; orthopedic surgeons will have to check out the metal levels with the help of blood tests. They will have to remove the fluid from the joint with the help of a needle or by imaging the joint.

Like any other surgeries, hip replacement surgery could bring risks to a patient. Also, metal-on-metal replacements will have much more risks. So once the patient develops a general change in health post-operation, he should consult his doctor immediately.

 

 
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Publication:International Business Times - US ed.
Date:May 12, 2011
Words:380
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