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...
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