If FDA Does Not Govern the Science of Medicine, Why Can't 18 Year Old Get Silicone Implants? Doctor Answers, Tips
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If FDA Does Not Govern the Science of Medicine, Why Can't 18 Year Old Get Silicone Implants?

If most Plastic Surgeons use Medical Devices for off label use, they why can't I get silicone implants? Plastic Surgeons use botox for off-label use and breast implants for off-label,(when they re-use them) so what is the difference?

5 Doctor Answers | Asked by christieNY in NY
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Silicone Breast Implants in 18 year old

Silicone gel implants are FDA approved for women who are 22 years old or older. Using them in a woman younger than 22 years of age is off label use but not illegal. While I can't speak for others, my malpractice carrier will not cover me if I implant them in a woman who is younger than 22 years of age. The age restriction does seem rather arbitrary however.
+1

FDA does have the authority to regulate medical devices.

Hi. You see, the implant manufacturers will not knowingly sell silicone breast implants for use in a women under the age of 22. So the plastic surgeon would have to deceive the manufacturer. A reputable surgeon is not going to do that. So, even though it may not make much sense, I would either get saline implants or wait till you are older (or go abroad!).
+1

Silicone breast implants and age

That is a very good question and I do not have a good answer for you. In fact I do not have a good answer as to why they chose the ages that they did as a cutoff. You certainly could have gel implants but you would need to find a very brave plastic surgeon who would not be afraid of our government and his/her peers.

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+1

18 year old and silicone implants

There is no law against using silicone implants for ladies under 22 years of age. Obviously you should be of legal age and have a full understanding of the FDA guidelines as well as the manufacturer's warranty. Off-label use of FDA approved implants is possible and is done on a limited basis. Many plastic surgeons will refuse to do it but there is no reason a patient can not accept this responsibility. I would encourage ladies to call the FDA and ask them... more
+1

FDA governs devices

You are correct the FDA does not practice of medicine, but they do control medical devices and drugs which include breast implants.
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