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.
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.
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.
The study must be reviewed by an independent data monitor.
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.
