FDA Prepares to Examine Hip Implant Failure


. By Heidi Turner

The US Food and Drug Administration (FDA) is preparing to hear from experts concerning hip implant failure concerns later this month. The administration is convening an advisory panel to discuss issues surrounding the use of metal-on-metal hip replacements, which have been linked to a high rate of hip replacement failure. Hip implant failure lawsuits have been filed against some of the companies that make the devices.

According to the FDA (3/29/12), metal-on-metal hip replacement systems have special risks in addition to the usual risks associated with hip replacements. Those risks include a chance of metallic debris coming loose from the hip replacement and being absorbed by the surrounding tissue. Although surgeons take steps to prevent this from happening, some patients could experience severe consequences, including high levels of cobalt and chromium.

"Different people will react to these metal particles in different ways," the FDA announced. "At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint."

Among the consequences of metal debris is an increased risk of hip implant failure, caused by a reaction to the metal debris. The FDA notes that the reaction could cause the hip implant to become loose or cause the patient pain, which could require revision surgery to replace the new device. Furthermore, patients could develop problems with their heart, nervous system or thyroid.

Symptoms of problems with the metal-on-metal hip devices include pain in the groin, hip or leg, limited mobility or pain when walking, and swelling in the area of the hip joint. Symptoms of health complications include chest pain, shortness of breath, numbness or weakness, fatigue, weight gain and change in urination habits.

The FDA is now gathering information about the issues associated with metal-on-metal hip implants. An advisory panel will convene later in June, 2012, to discuss the issues surrounding use of the devices.

Patients who have metal-on-metal hip implants should contact their doctor if they suspect they are having problems with their hip replacement devices.


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