Okay, so I went to my consultation about a week ago with a plastic surgeon in Chicago IL. I was always told that you need to be 22 to get silicon gel implants, but when talking to the director when looking at sizes, she told me I was able to get silicon gel implants with just signing a waiver, is this true?! Can women below 22 get silicone gel implants in this manner?
Silicone Gel Implants for Women Below 22 Years Old?
Doctor Answers 17
Silicone implants and age requirements
When the FDA reintroduced silicone breast implants for use in cosmetic breast surgery, the restriction put in place was patients had to be at least 22 years of age. The only exception was for patients with severe rippling from a previous breast augmentation or patients requiring them for reconstructive reasons (Polands Syndrome or other congenital breast deformities).
Use of silicone implants for any other purposes than stated above are considered off label uses. This means the implant companies will not support any problems that may occur from from the implants or the surgery.
I have never heard of anyone signing a waiver to get silicone implants under the age of 22. This seems unusual, suspicious and questionable for an ethical board certified plastic surgeon. Make sure it is a consent for surgery and not a waiver prior to proceeding.
Yes, it is.
1. IDEAL implants - these are newly released "hybrid implants" double lumen saline implants made to feel like silicone
2. 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.
You may get silicone implants without restriction.
Now it is clear. While the FDA considers use of silicone breast augmentation in this age group to be off label, this practice is permitted and legal. Some, NOT ALL, manufacturers will not warranty the implants in this situation, so be sure to verify with your surgeon what your particular situation will be.
With regards to signing a waiver, it will be up to each individual Plastic Surgeon to determine how to communicate and document the use of silicone implants in an "off-label" manner.
Best of luck!!
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Silicone Implants & Age Requirements
The vast majority of plastic surgeons don’t use silicone implants on women who are younger than 22. If for some reason, someone under 22 decided to have a silicone breast augmentation it would be considered an off-label use. It’s important to note that many medical products have off label uses. Under these circumstances, it’s probably not unreasonable for patients to sign a permit acknowledging that their implants are being used for off label purposes. It’s important to note that vast majority of patients in this situation will use saline implant or wait until they are 22 years of age to have silicone implants.
Silicone Gel Implants for Women Below 22 Years Old?
Only if it is a reconstructive breast surgery
The only way to get silicone implants in the USA below age of 22 (legally) is to have a reconstructive surgery. This may include severe asymmetry chest deformity and other conditions. I would not trust a physician who want to bend the rules for you - he may want to bend other rules and that may endanger your health
Silicone Implants are only FDA approved for patients over 22
Silicone Implants have been reintroduced and have been approved for Breast augmentation but with some limitations. One of these limitations is that women should be over the age of 22.
While FDA approval is not necessarily law, it represents guidelines for which most medical devices are used. Very often in medicine, physicians will use products for purposes that are not FDA approved. For example, Botox has only been approved for the treatment of the glabella; most patients who use Botox will know that Botox is often used for other facial lines.
However, it is very different to place a semi-permanent medical device that is not recommended by the FDA, particularly if the woman is young and potentially still developing.
Not illegal but not recommended
Many products are used "off label" including botox and fillers. This is something that is left to the judgement of the surgeon and his discussion with his patients. I would not recommend using silicone implants "off label".
Silicone implants in patients under age 22
Silicone implants are approved at this point for unrestricted use in women over the age of 22...
However, they can also be used for the correction of asymmetries and deformities and for the correction of certain problems possible with saline implants, such as visible rippling.
As mentioned, they can be used in women under 22 "off label", which means you have been told this is not an approved use and you understand the recommendation is to use them only in women over 22.
Medically, I know of no reason the implants should function better in women over 22 than in younger women.
Silicone gel implnats and 22
Silicone implants were approved by the FDA for women 22 and older. If you have a breast deformity ( i.e. Poland's Syndrome) then you can probably get them. This has been approved for all women with breast reconstructive needs, but not for primary augmentation in women under 22.