‘Gummy-Bear’ Breast Implants Approved for Use in the United States
The new implant has been available in Europe for more than a decade.
Late last month, the U.S. Food and Drug Administration (FDA) approved a new breast implant that is teardrop shaped, or “anatomically” shaped, which will theoretically have a significantly lower chance for leakage because its consistency is highly cohesive silicone gel. This implant, made by Allergan, is called the Natrelle 410 has been nicknamed the “gummy-bear” implant and has been available in Europe for several years already. The implant is approved for increasing breast size and breast reconstruction in women 22 years of age and older. The “gummy-bear” implant is specifically designed to retain its shape, instead of conventional silicone gel implants that are slightly more liquid in consistency.
This approval is the cumulation of a long history of breast implant use in this country. The FDA based its approval on data from a seven year study where 941 women received the Natrelle 410 implant. They reported the implant to be safe with most complications reflecting those found in previous breast implant studies. Natrelle 410 has been on the market oversees since the 1990’s but at that time silicone implants were banned by the FDA. In 2006, the FDA reapproved the use silicone breast implants in the U.S. but because the Natrelle 410 was technically considered different, it was subject to further evaluation.
Last year, another implant company, Sientra, received FDA approval for their Silimed–brand portfolio of round and shaped silicone implants. These have also been used outside the U.S. for approximately 30 years. In 2012, 72 percent of breast augmentations performed in the U.S. used silicone implants, an increase from 19 percent in 2006, the year the FDA’s ban on silicone implants was lifted.
Breast implants remain as popular as ever. But even though Allergan received FDA approval, according to ABC News, they will still be required to conduct a series of studies on the long-term safety of the new implants. The decade-long study will follow approximately 2,000 women.