Metal on Metal Hips
Metal-on-metal hip implants have been a frequently used option for patients facing hip joint replacement. A metal-on-metal total hip implant is a medical device that consists of a shell, ball, and stem, all of which are made of metal. This type of hip implant was also marketed to younger patients, since metal was supposed to last longer than other materials.
Currently, there are two available types of metal-on-metal hip options: (1) the total hip replacement implant and (2) the total resurfacing hip implant. The total hip replacement option is used more commonly in the United States, while the total resurfacing hip option is used mainly in other countries.
The traditional metal-on-metal total hip replacement option is composed of a metal ball, a metal femoral stem, and a metal cup. According to the U.S. Food and Drug Administration (FDA), as of December 31, 2010, the agency has cleared 175 metal-on-metal hip submissions for marketing, primarily through reliance on a provision of the 510(k) process by the FDA. Most of these submissions were submitted as modifications to previously approved components. This process allows for clearance of components that are “substantially equivalent” in terms of safety and efficacy to those already on the market. This controversial approval system does not require pre-market studies.
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