Since silicone implants were re-introduced eight years ago in 2006, they have gradually returned to their dominance over saline breast implants. With a more natural feel, lack of a deflation risk and being longer lasting, they have numerous advantages over saline-filled devices. But despite their commercial availability they are not available to all women who desire breast augmentation. By the manufacturer’s guidelines they are restricted to women who are at least 22 years or older.
This silicone breast implant restriction runs into a frequently posed question by younger patients…why can I not have these type of breast implants if I am younger than 22 years old? What could possibly be the difference between the breasts of a 20 year old vs a 22 year old? Why would saline implant be allowed but not silicone implants.
This is both a frequent and understandable question as human anatomy clearly shows that they are no physical differences. This is not a biologic issue but a regulatory one. It is presumed by many surgeons that the FDA mades this stipulation to the manufacturers because patients under 22 years of age were never included in the clinical trials that served as the basis for their approval. However the clinical data showed that such young females were indeed part of the silicone implant study group for all manufacturers. So the decision by the FDA to restrict silicone implants by age seems a bit perplexing but nonetheless a stated regulation.
While this age restriction exists, some plastic surgeons do provide silicone breast implants to women under 22 years old. They take the position that this merely represents off-label use and within the province of the physician’s discretion and judgment. Conversely, many other plastic surgeons will not place silicone implants in these younger women as a strict adherence to the regulatory stipulations. Which one is right?
The answer is simply unknown. It is ultimately up to the plastic surgeon and what they feel in is the best interest of their patients and what their liability exposure is. At the least, patients under 22 years of age need to know of the manufacturer’s stated age restrictions and whether placing them at this age may affect the manufacturer’s warranties of the implants. (lifelong implant replacements) It is not clear what position the manufacturer’s take on this issue.
Dr. Barry Eppley