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Silicone Breast Implants: A History
Breast augmentation involves the insertion of silicone or saline implants into the breasts in order to improve their size and shape. Silicone implants, consisting of a silicone outer shell filled with a viscous silicone gel, are extremely popular due in large part to their naturalness of appearance and feel as well as their durability. In my practice, they are used for virtually all the breast augmentations that I perform.
There are numerous silicone implants available that include differences not only in size but also in profile, shape, shell surface type (smooth or textured), gel firmness, and shell thickness. Some of these options are a result of relatively recent developments in implant technology though implants have continued to evolve and improve with research and experience over time.
Plastic surgeons Thomas Cronin and Frank Gerow introduced the first silicone breast implant in Houston, Texas. It was made of a thick elastomeric envelope filled with thick gel. Timmie Jean Lindsey, age 36, became the first woman to undergo breast augmentation with silicone implants.
New silicone implants with thin outer shells providing a feel that more closely simulated natural breast tissue were developed. However, because the outer shells were thin, these implants were more susceptible to rupture and loss of integrity.
Breast implants with elastomer-coated shells and thicker silicone gel were manufactured to reduce the risk of implant rupture. Anatomically shaped (tear-drop) implants with textured shells were developed and thought to produce a more natural breast slope.
Polyurethane-coated silicone implants became popular due to their noted reduction in the incidence of capsular contracture (which is the development of hardness in the breasts as a result of firm scar tissue forming around the implants). Their usage was discontinued in the U.S. by the FDA in 1991 due to concerns that a breakdown product of polyurethane was considered to be carcinogenic though there was no spike in the development of breast cancer in those with this implant type.
1992 – 2006
The FDA placed a ban on the usage of silicone gel implants for primary breast augmentation in large part due to political pressure from certain interest groups (and without scientific evidence) that these implants were responsible for connective tissue diseases. However, silicone breast implants were still able to be used in breast reconstruction, breast lifts, and secondary breast augmentation surgery as long as the patients agreed to be enrolled in an FDA-directed clinical study.
2004 & 2005
Studies reported low incidences of capsular contracture and improved medical safety and efficacy of cohesive silicone gel implants.
Finding no evidence linking silicone breast implants to connective tissue disease and that they were, in essence, clinically safe for usage, the FDA removed the restrictions on the usage of cohesive silicone gel implants. Once again, they were available for widespread use.
The FDA released a report on the safety of silicone implants that stated implants are relatively safe but not meant to last a lifetime.
Sientra, the third major breast implant manufacturer, had its portfolio of Silimed-brand silicone gel breast implants approved by the FDA for implantation.
Newer designs and sizes continue to be introduced in the United States by the three implant companies – Allergan, Mentor, and Sientra.
If you are interested in breast augmentation with saline or silicone implants, please schedule your consultation with breast enhancement specialist Dr. Steven H. Turkeltaub. Call (480) 451-3000 today, or fill out our online contact form for more information.