Silicone Gel Breast Implants Reapproved by the FDA in 2006 Columbus OH
Whether or not you can get silicone gel breast implants depends on your age. In November of 2006, the Food and Drug Administration (FDA) reapproved silicone gel breast implants for the general population for cosmetic breast augmentation. Prior to that, starting in 1991, only patients who were undergoing breast reconstruction or those with certain breast anomalies from birth could obtain silicone gel implants as part of a national silicone implant study.
Most breast implants that were inserted prior to 1991 had a very thin silicone gel filling as well as a very thin silicone shell. As a result, small amounts of silicone gel could leak through the shell; not enough to significantly change the size of the implant, but enough to cause a local tissue reaction increasing the incidence of capsular contracture (firm scar tissue around the implant). These were referred to as ‘low bleed’ implants. In 1991, a concern was raised that this small amount of free silicone gel could potentially cause certain immune system diseases such as rheumatoid arthritis, lupus, scleroderma and fibromyalgia. Over the ensuing fifteen years, numerous studies were performed looking at the incidence of these conditions in women with silicone implants and in women without implants. Findings revealed that there is no difference in the incidence of these diseases in these two groups which was enough evidence for the FDA to put silicone gel breast implants back on the market.
At this time, patients must be 18 years of age to undergo breast augmentation with saline filled implants and 22 years old to get silicone gel breast implants. Once again, under certain circumstances, those rules can be broken for particular medical conditions which affect natural breast development resulting in absent or abnormal breast growth. It is unclear as to why those particular ages were selected by the FDA.
Saline vs Silicone
The decision to choose silicone or saline breast implants can be a difficult one. Patients who have a reasonable amount of breast tissue without very thin skin frequently opt for saline implants because of the advantages of lower cost, shorter incision, lower risk of capsular contracture and the relative ease of determining when a saline implant has ruptured because of the loss of volume and obvious change in breast size. As these individuals have a reasonable amount of tissue to cover up their implants, the disadvantages of saline implants are less likely to be noticed such as rippling along the edge of the implant and an implant feel that is less natural than soft silicone gel implants which have a consistency more similar to natural breast tissue.
Those patients who have very little breast tissue are more likely to experience the negative effects of saline implants and, therefore, tend to choose silicone gel to obtain a more natural feel and to reduce the risk of implant rippling. The potential downsides of silicone gel implants include higher cost, slightly longer incision, a somewhat higher risk of capsular contracture and more difficulty in determining when an implant has lost its integrity as the size of the breast changes very little with a silicone implant rupture.