Silicone Gel Breast Implants in Patients Under 22
I aced my calculus final and I can vote but I can’t choose my breast implants?
I recently had a 20 year old patient in my office who really wants silicone gel breast implants and she is soooo thin that saline implants will not likely give her the natural look she wants. This is the information I gave her from a recent issue of Aesthetic Society News:
Silicone Implants in < 22 year olds.
Bob Archer, Esq., General Counsel to ASPS. Aesthetic Society News, Winter 2015.
“Several members have asked whether it is legal or not for a 20-year old patient to receive silicone implants for aesthetic breast augmentation. Answer: Legal.
FDA states that silicone implants “are indicated for females for: Breast augmentation for women at least 22 years old…..and Breast Reconstruction.”* Any drug or device with an FDA label may be used off-label unless specifically prohibited. Since FDA has labeled silicone implants for females 22 years and older, you may implant them in females < 22 years of age, and all males, as a legal off-label use. Manufacturers will not honor their warranties for off-label use, however, so be certain your patient knows and gives informed consent.
Since an implant in a 22 reconstructive patient doesn’t behave any differently than in an <22 aesthetic patient, why do manufacturers not honor their warranties for the <22 aesthetic patients? It reduces their legal risk, simply put. Implant manufacturers and our surgeons are all in the business of reduction risk. This is the manufacturers’ way of saving some money, thanks to FDA’s <22 distinction, even if it only applies to 1 or 2% of the patient population.
If your patient asks whether silicone implants are safe for women <22, the answer is yes. The FDA has approved silicone implants for women of all ages for breast reconstruction, so they are obviously safe for aesthetic implantation as well. Is there a rational, medial reason this distinction? Probably not. More likely it was motivated by social policy.
<22 reconstructive patients have a medical need for implants so as to assist their physical and psychological recovery. <22 aesthetic patients cannot claim medial necessity, no matter how strong their psychological desire. FDA is thus attempting to effect social change: by not giving its labeled blessing to under 22 years of age aesthetic breast augmentation patient, FDA is likely hoping such patients will wait to assure they are making a mature choice. Since age is no guarantee of maturity, document in you file your aesthetic patient’s presence and demeanor, as well as any influence being exerted by friends and family members.”
* www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM245623.pdf.
Thanks for reading! Dr. Lisa Lynn Sowder
@lisalynnsowder
