FDA Approves a New Brand of Breast Implants

A Very Brief History of Breast Implants
Women’s desire for larger breasts—and surgeons’ attempts to deliver them—goes back over 100 years. The first silicone gel-filled breast implant dates from 1961. Thomas Cronin and Frank Gerow, two surgeons from Texas, developed them and the following year performed the first breast augmentation that used them.

In the 1970s and 80s, however, the safety of silicone breast implants came into question due to concerns that the sacs could leak silicone into a woman’s body. In 1992, even though more than a million women worldwide had received silicone implants, the U.S. Food and Drug Administration (FDA) placed a moratorium on the use of silicone implants for cosmetic purposes. (Silicone implants continued to be allowed for breast reconstruction or implant replacement during the moratorium, with the results followed through clinical studies.)

It was 14 years before the FDA approved silicone implants for the general public. Two companies, Mentor and Allergan, led the fight to restore approval, providing extensive evidence of their safety with clinical trials. Finally, in 2006, the FDA re-approved the silicone breast implants of both companies. Since then, Mentor and Allergan have continually improved their implants. Today’s silicone implants no longer contain liquid silicone, but instead use a soft gel that retains its shape even if cut through.

The Latest Developments
That much is old news. What is new is that in March of this year, the FDA approved a new manufacturer’s product, the first since 2006: Sientra Inc.’s Silimed silicone gel-filled breast implant. Silimed breast implants have been used worldwide for 30 years, but only now are they available in the US. The Silimed line of products offer a variety of shapes, including a more anatomical teardrop product, as well as a number of sizes, surfaces, and profiles.

All three manufacturers of silicone breast implants continue to do studies to prove the safety of their products. Time and tests have shown that silicone gel breast implants are indeed safe enough for use in both reconstructive and cosmetic breast procedures. More and more women are choosing to exchange saline implants for silicone gel breast implants because of their superior look and feel.

Will We Use Silimed Implants?
Dr. Michael Cohen, our board certified plastic surgeon at Belcara Health, is look forward to offering Silimed products as an option, once they become more readily available in the marketplace. Currently, Dr. Cohen uses silicone implants from both Mentor (MemoryGel™) and from Allergan (Natrelle®) with excellent results.

Learn more about the differences between saline and silicone breast implants.
Learn more about the breast augmentation procedure.
See before and after photos of previous breast augmentation patients.