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Silicone Implants

FDA Press Release

FDA Approves Silicone Gel-Filled Breast Implants After In-Depth Evaluation Agency Requiring 10 Years of Patient Follow-Up

Silicone gel breast implants have undergone changes over time to meet increasingly sophisticated consumer expectations. The very first silicone breast implants used thick shells and contained firm gel. The second generation of implants introduced in the late 1970's had thinner shells and used less firm gel to address concerns of patients and surgeons who believed that implants were too firm, palpable and visible.

In the mid 1980's, concerns related to rupture rates of the second generation thinner-shelled implants led manufacturers to introduce a third generation of implants. The shell and gel of these implants are slightly thicker, but still soft. The new silicone gel implant is more cohesive and therefore is less likely to leak into the tissues than the old liquid filled silicone gel implants.

At Ennis Plastic Surgery in Florida, we know breast implants. Make us your source for the latest, most accurate information. You can ask a doctorask a doctor online or ask a patientask a patient with actual experience with breast augmentation surgery.

View Before & After Photos


The advantages of silicone implants are numerous. They offer a much softer feel and allow women with small breasts to have larger enhancements without the problems of rippling that can occur with saline implants.

Before & After Breast Implant Revision Before & After Breast Implant Revision

This patient had very little breast tissue and underwent a submuscular breast augmentation with saline implants by an outside surgeon. The patient was unhappy with the rippling that occurred when she leaned forward. She subsequently underwent an implant exchange from saline to silicone at Ennis Plastic Surgery and as you can see in the right hand picture, the rippling was significantly improved.

Is silicone safe?

This is a common question patients have about silicone implants.

The controversy surrounding silicone gel-filled implants centered largely around what happens to the gel filling if the implant shell ruptures. A group of women alleged that this errant gel caused autoimmune and connective tissue diseases. The FDA removed silicone-filled breast implants from the market in 1992 as a result of these claims. After a thorough investigation, the FDA could find no connection between silicone breast implants and connective tissue or autoimmune disease. As a result, the agency re-approved silicone gel-filled implants in 2006. Now, silicone breast implants are approved for women of all ages who need breast reconstruction and for women aged 22 and older seeking breast augmentation.

In 1997, the Department of Health and Human Services began one of the most extensive research studies in medical history by appointing the Institute of Medicine of the National Academy of Science (IOM) to examine potential complications of silicone breast implants. In 2006, after rigorous scientific review, the US Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by 2 companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The silicone breast implant has quickly become the implant of choice for most patients.

Many scientific studies and data reviews have been conducted to determine whether silicone gel-filled implants are unsafe. Many of the studies that were examined retrospectively, ultimately proved to be faulty because there was not enough, or the wrong kind of, information gathered. Ultimately, however, not a single study has concluded that silicone breast implants positively cause any serious and permanently detrimental medical conditions.

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