Why Must You Be 22 to Receive Silicone Breast Implants?

Question

I read that you have to be 22 to get silicone implants (or that it's recommended). Either way I would like to know why that is?

Larry S. Nichter, MD, MS, FACS · Answer

The US FDA has made it difficult for patients below the age of 22 to get silicone implants. There are two great options to consider if you are considering implants: 1. IDEAL implants - these are newly released "hybrid implants" double lumen saline implants made to feel like silicone2. I will place silicone implants in patients under 22 yrs old but first have an informed consent and have them sign a waiver that they are aware that they are being used in  "off label' FDA use. #IDEALimplants#breastaugmentation#breastimplants

John K. Wakelin III, MD, FACS · Answer

The FDA's criteria for silicone implants over the past few years are for women over 21 years old for cosmetic breast augmentation. However, there are circumstances where use of a silicone breast implant is appropriate for a patient younger than this. It would be best to meet with a board certified Plastic Surgeon to discuss what type of implant would be best for you.

Gregory T. Lynam, MD · Answer

It is a FDA guideline as is the reccomendation for interval MRI breast exams for checking to make sure the implants are not ruptured. This is why for most young females I place saline implants under the muscle using a one inch incision in the arm pit. No breast scars are a nice feature of this procedure. See our web page for before and after results

Tom J. Pousti, MD · Answer

In my opinion, there is no good reason why there is an FDA  mandated age of 22 for patients to receive silicone breast implants. There are many patients under the age of 22 who would ( based on their body type and the advantages of silicone breast implants) benefit from the use of silicone gel breast implants. Unfortunately, the use of these implants for these younger patients will negate the breast implant manufacturer warranty.

	I hope this helps.

Barry L. Eppley, MD, DMD · Answer

This is a U.S. FDA requirement to the manufacturers of breast implants. Since the approving clinical studies of silicone implants did not include patients under 22 years of age (deliberately), this means that their commercial approval must exclude younger patients. Violation of this regulatory requirement places both the implanting surgeon and the manufacturer at risk for FDA sanctions and fines. In addition, should a patient under age 22 receive silicone implants, the manufacturer's lifelong warranty of them would be an invalidated.

Steven Schuster, MD, FACS · Answer

There is absolutely no good reason for 22 other than the FDA said so! For some reason they decided that that is a good age in spite of everything recommended by the American Society of Plastic Surgeons to the FDA.

Why Must You Be 22 to Receive Silicone Breast Implants?

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