New “Gummy Bear” Implants Approved

Tag Archives: breast reconstruction

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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Breast cancer is the most prevalent cancer among women today, possibly affecting one out of every eight women. Many women make a complete recovery from breast cancer, and breast reconstruction can be a very helpful step in that process.

Breast reconstruction can be done at the time of a mastectomy (immediate reconstruction) or at some point afterwards (delayed reconstruction). It may be accomplished by the use of a breast implant, the body’s tissues, or a combination of the two. The breast reconstruction procedure and products that are right for you will vary depending on desired outcome, personal preferences and clinical factors.

Breast reconstruction using the body’s tissue without the use of implants is called autologous flap surgery. It uses a combination of skin, fat, and/or muscle that is moved from areas such as the abdomen, upper back, upper hip, or buttocks to the chest, where it is shaped into a new breast. Not every woman is a candidate for this type of breast reconstruction, and it is best to discuss the pros and cons of these procedures with your surgeon.

You can hear women who have undergone breast reconstruction talk about their personal experiences here.

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