FDA Approves ‘Gummy Bear’ Breast Implant

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ID-10097782Women who are considering breast augmentation surgery have an increasing number of options when it comes to implants. For years, patients could choose between saline and traditional silicone gel devices, both of which have their own pros and cons. And now, the FDA has approved a brand new, high-strength silicone gel implant, one that is form-stable and mimics the look and feel of a natural breast.  Due to their propensity to hold their form and semi-solid consistency resembling the gummy bear candy, they’ve been coined “gummy bear” implants. Mentor’s CPG form breast implants were recently approved by the FDA, joining the ranks of Allergan and Sientra, which also manufacture high-density silicone gel implants.

Are gummy bear implants the future of breast enhancement surgery?

According to a news release issued by the FDA, the agency based its approval on seven years of data gathered from 941 patients. These new cohesive gel or form-stable breast implants aim to improve upon older generations of silicone gel devices that were prone to leaking and had higher rupture rates. Breast enhancement continues to top the list as one of the most sought after types of plastic surgery among Americans, with almost $1 billion spent on breast augmentation each year. The American Society of Plastic Surgeons reports that nearly 300,000 women underwent cosmetic breast surgery last year – up a whopping 45 percent since 2000.

But are “gummy bear” breast implants really safe, and what purported benefits and risks do women need to consider before surgery?

High-strength silicone gel implants have been used in Europe since 1995, but have only recently been available in the U.S. Compared to older silicone models the new gummy bear implant is much firmer and supposedly matches the natural teardrop shape of the breast. And unlike liquid saline or smooth silicone gel, these devices are reportedly less likely to wrinkle, fold or ripple. The manufacturers also claim the devices feel soft to the touch and look much more natural, and aren’t prone to the hardness associated with overfilling that can occur with saline implants.  And lastly, due to their high density and unique texture, some suggest that a woman’s risk of developing a capsular contracture around the implant could be reduced.

What are the risks of high-strength silicone gel implants?

Potential risks and drawbacks of form-stable gel implants include rotation of the implant inside the breast, which may distort the teardrop shape, placing the thicker part on top rather than the bottom. And because the silicone gel is denser, plastic surgeons may need to use a longer incision during surgery. Recipients have given mixed reviews on the gel’s consistency – some love the feel, while others dislike the added firmness. And like any other type of breast implant, the gummy bear carries risks of infection, rupture, bleeding and other complications.

While the latest line of cohesive gel implants has both proponents and detractors in the cosmetic surgeon community, the reality is that clinical trials are still in the early stages, and will require another two decades to determine long-term risks. Whether women are contemplating the new gummy bear implants or one of the older saline and silicone versions, the most important step is consulting with a reputable plastic surgeon that can explain the benefits and risks of each and help patients make a more informed decision.

Author Bio:

Ava Lawson is a freelance writer focusing on topics such as health, medicine, and cosmetic surgery. You can see more of Ava’s writing about plastic surgery here.

“Image courtesy of adamr / FreeDigitalPhotos.net”.

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