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FDA Approves Conditional Silicone Breast Implants

On Wednesday 4/13/05, the FDA health advisors recommended removing the 13 year old ban on silione-gel breast implants. This move came about as Mentor Corp. persuaded the FDA that its newer silicone implants are much more safe and durable than older versions. The company may use these implants only under the following safety conditions set forth by the FDA. Prospective patients must sign a consent form acknowledging that they understand the risks of a silicone breast implant including the fact that they may break and require replacement or removal. Mentor may only sell silicone breast implants to board-certified plastic surgeons who complete a special hands-on training program to learn how to insert the implants in a way that minimizes the odds of it breaking.

Mentor must create and maintain a registry to track the long term results patients have with the implants. Patients must be educated about the fact that if an implant breaks, the effect of the breakage generally does not cause immediate symptoms. Further they are advised to have an MRI scan after five years and every two years thereafter to check for breakage. Mentor must conduct a 10 year study to determine the percentage of breast implants that will break in that time. The study must be reviewed by an independent data monitor.

The results of Mentor's breast implants will be reviewed by the FDA in five years to verify that the implants are performing as expected. Silicone-gel breast implants began selling in 1962 and were banned in 1992 amid health fears. Research since then has shown that they do not cause serious diseases like cancer or lupus but that they can cause infection and scar tissue if they leak and are untreated. Approximately 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States in 2003 - the vast majority using salt water filled implants that are sold without restriction. It is estimated that if the silicone breast implants return to the market, 200,000 women may have them installed within the first year. ZZZZZZ .


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