Silicone Gel Implants for Women Below 22 Years Old?
- Asked by espitzer in Chicago, IL
- 4 years ago
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 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.
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
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.
Recent Breast Implants Reviews
Breast Implants Photos
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.
There is no FDA approval for silicone implants in breast augmentation for women under 22 years old.
In New York, we do not use silicone implants for routine breast augmentation if you are less than 22 years of age. This FDA mandated age cut off does not make a lot of sense, but we must stick to the on-going study protocols.
Silicone gel implants feel the most natural when they work as intended but, under some circumstances, so can saline depending on the the relative size and volume of implants to your natural breast. You should review the pros and cons and the necessities for or against silicone or saline implants vis a vis your goals and risk tolerance. It is possible that saline implants might work for you. If you are set on silicone, depending on your age, you might elect to wait until you fall under the FDA guidelines just so there is no increased liability to you if you develop a problem. That being said, where there is a will, there is a way. As discussed, it is not illegal per se.
Silicone gel breast implants for aesthetic purposes are approved for women over 22 years of age. They can be used in younger women for reconstructive purposes, such as when there is severe asymmetry or congenital absence of one breast.
Why did the FDA put a 22 year cut off in their approval? No one knows for sure. One rumor is that there weren't enough women under 22 in the core ipmlant study, but that isn't true. Besides, there indeed weren't many women over 50 in the study, and it is approved for them.
Another answer I've heard is that some women are still finishing pubertal changes until 22, and the FDA wanted to be sure that all of that had been completed before having surgery.
The likely answer is that it might have been a political concession given by the FDA to social groups opposed to breast implants under any circumstance.
Still, it's odd to me that at four years younger age you can volunteer for the draft and go to war; drink a year younger, and vote four years younger. You can have a breast lift or reduction at age 18 with permanent scars, yet for this they want you to wait until 22. Hmm. Odd.
Anyhow, it is technically possible to get an augmentation with silicone if you are under 22. You can receive them "off-label," if your surgeon explains to you that the FDA has only approved their use in women over 22. It is not illegal for women under 22 to receive them. They just have to have it explained to them that this is an "off-label" use, and it needs to be explained to them that they have had this explained to them and that they understand it.
Silicone implants approved for age 22 and over
As you may know, the FDA re-approved silicone implants in 2006. At that time, they stated that these devices were approved for women who are at least 22 years of age. A reason for this age was not given (to my knowledge), but it is likely that the studies they reviewed were done in women who were at least that age. If you are younger than 22, and you do want silicone implants, I would recommend waiting until then or having saline implants placed if you wan to proceed now. They can always be changed over to silicone implants in the future. Keep in mind that if you sign a waiver, this is probably a waiver from your surgeon's office stating that you were aware that the use of silicone implants in women younger than 22 years is considered an off-label use of the implants by the FDA. If you have a problem with the implants which would normally be covered by a warranty, you probably would not be covered if you've signed a waiver. The choice is ultimately yours, but I think it helps to have all the information. Good luck!
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.