On July twenty-eight 2005, the FDA ended a 13 year ban on silicone-gel
breast implants and issued a letter of approval to Mentor Corp
allowing the reintroduction of these controversial implants into the
medical marketplace. This move came about as Mentor Corp. persuaded
the FDA that its newer silicone implants are less dangerous and even
more durable than older versions. The company will employ these
implants only under the following strict safety conditions approved
per FDA guidlines.
- Prospective patients must sign a consent form acknowledging that
they realise the risks of a silicone breast implant including the fact
that they may break and require replacement or even removal.
- Mentor is only allowed to sell silicone breast implants to board-
certified plastic surgeons who complete a successful practical
training program to learn how to insert these implants in a way that
minimizes the odds of tears and breakage.
- Mentor must make and maintain a registry to track the implant
patients long term results.
- Patients must be educated about the fact that if an implant breaks,
the effect of the breakage occasionally does not cause immediate
symptoms. Further, patients are advised to have an MRI after five
years and 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 implant study must be audited by an independent committee.
- The FDA will review the results of the Mentor breast implant program
in five years to verify that the implants are performing as expected.
Based on data from the American Society for Aesthetic Plastic Surgery,
334,052 breast augmentations were performed in the United States in
2004, mostly using salt water filled implants being sold without
restriction. Consumer studies predict that if the silicone breast
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