Talking Off the Label: Breast Implants and Age
Women of varying ages come to our practice in Scottsdale for breast augmentation. Women between the ages of 18 and 22 often wonder if they can get silicone breast implants despite FDA regulations. In order to fully answer this question, I need to preface my post with a little background information on breast implants.
The FDA has approved silicone and saline breast implants for breast augmentation and reconstruction contingent on age. Saline breast implants are approved for breast augmentation in women age 18 and older, while silicone breast implants are approved for women age 22 and older. However, for breast reconstruction, the FDA has approved silicone implants for women of any age.
However, many plastic surgeons choose to use silicone implants in patients under the age of 22. This is called “off-label” and it’s perfectly legitimate and very common. FDA approval means that a device has gone through numerous controlled studies and it’s been deemed safe under the conditions of those studies. In the case of silicone breast implants, choosing to use them in patients under the age of 22 isn’t unethical or even risky, but it can limit legal liabilities and warranties on the implants. When it comes to off-label use, the FDA leaves it up to the professional judgment of the surgeon to decide what’s safe and appropriate.
If you’re younger than 22 and you want silicone breast implants, discuss your options with your plastic surgeon.