New “Gummy Bear” Implants Approved

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In February, the FDA approved Allergan’s Natrelle 410 form-stable, shaped breast implant for general cosmetic use. This implant, also known as the “Gummy Bear Implant,” is considered by many plastic surgeons to be superior due to its firm composition–it actually feels like a gummy bear.

According to CBS News, plastic surgeons and patients have been waiting over ten years for this implant to be approved. This is the latest in a generation of silicone implants that may provide a more natural “tear-drop” look compared to other silicone options. The implants contain more cross-linking in the silicone gel than earlier models which makes it more cohesive, which in turn makes the implants firmer.

The FDA’s approval was based on seven years of data collected from 941 women. Side effects are similar to other breast implants, including tightening of the area around the implant, the need for re-operation or removal, an uneven appearance or infection. The investigators also observed cracks in some of the implants, which is characteristic of the silicone gel and is unique to this implant.

The pros of the new implant: They give a more anatomical-looking, natural result and they are less prone to leading to wrinkling and visible edges that other implants may cause. The downsides: Some women may not like the added firmness, and the implant requires a slightly larger incision. The implant may be especially beneficial for women who have survived breast cancer and are undergoing reconstruction.

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