Gummy Bear Breast Implants: The Next Breast Thing?

Reviewed by Grant Stevens, MD, FACS

They're not even on the market yet in the United States, but gummy bear breast implants are already being touted by some as the next wave in breast augmentation and breast reconstruction surgery.

In clinical trials in the U.S. for the last decade and still awaiting approval by the Food and Drug Administration (FDA), highly cohesive gel, form-stable (a.k.a. "gummy bear") breast implants are available just about everywhere else. They combine the safety of saline breast implants with the natural feel of silicone breast implants.

Silicone is a naturally occurring element found in sand, quartz and rock that can be manufactured in the form of oils, gels and solids.

As their name implies, silicone gel breast implants are filled with a thick, liquid silicone gel. They're popular for their natural look and feel, but if the implant shell ruptures, the gel may slowly leak out into the pocket and cause problems in the breast area.

Gummy Bear implants

Highly cohesive gel implants take the concept of a silicone implant a step further. They're manufactured as a solid mass of silicone gel that's created by adding a cross-linker to the liquid gel to produce a tighter molecular bond. 

The result is similar in consistency and feel to the small, rubbery-textured and gelatin-based gummy bear candies, hence the nickname. Cut a wedge out of a cohesive gel implant and it will maintain its shape, which is why these devices are described as being more "form stable" than their less cohesive silicone gel cousins. Put another way: if the shell ruptures, the gel will not migrate. This is considered a safety plus.

Invented in the early 1990s and widely used throughout the world since 2000, highly cohesive gel implants are currently considered "investigational devices" by the FDA. Four brands are being studied in the U.S.: Allergan's 410, Mentor's CPG, and Silimed/Sientra's Nuance and Enhance.

Women in the U.S. who are interested in cohesive gel implants must be accepted into one of several clinical trials.

The Pluses and Minuses of Cohesive Gel Implants

Any medical device or procedure has its advantages and disadvantages, including gummy bear breast implants. Here are some points to ponder when deciding if it's worth waiting until they're widely available or if another type of implant may better suit your needs right now:

Pluses:

Shape and Feel: Not only do highly cohesive, form-stable gel implants feel soft and supple, but they maintain their anatomical (teardrop) shape well and their edges blend into the surrounding breast tissue, resulting in a very natural contour.

No Visible Implant Line: Form-stable means no folds or rippling because the gel does not shift from one area of the implant to another, as occurs with the more water-balloon-like saline implants.

No Leaking: Fold lines weaken a breast implant shell, which can cause a rupture. Although a cohesive gel implant shell could theoretically crack open, it's less likely to do so than the shells of more flexible saline and silicone gel implants. And if it should rupture, the cohesive gel filler will maintain its shape and not leak out.

Less Risk of Capsular Contracture: Capsular contracture is a painful and potentially disfiguring condition that occurs when scar tissue tightens around breast implants. The exact cause is unknown. In countries where cohesive gel breast implants are currently available, including Canada and some European nations, studies indicate that capsular contracture occurs less often with cohesive gel implants than with other types of implants, but the jury is still out on this.

Minuses:

Shape and Feel: “Gummies” are so form-stable that they impart their shape on the breast. Consequently, a woman and her board-certified plastic surgeon need to be in agreement on the shape and look they're going for. If they're aiming for a rounder-shaped breast, the tear drop shape of the cohesive gel implant isn't the best option. That said, one company, Sientra, is developing a round gummy bear implant. Similarly, highly cohesive, form-stable gel implants feel firmer than their silicone gel cousins, and this may be an issue for some women.

Incision Size: Again, since cohesive gel implants are form-stable, they cannot be squeezed through small incisions like saline implants. Typically, an incision between 1 ¾ and 2 ¼ inches (4.5 to 5.5 cm) is required to insert a gummy bear implant. This generally rules out periareolar (around the areola) and TUBA (belly button) incisions and makes a transaxillary (armpit) incision very difficult, leaving an inframammary incision (in the fold under the breast) the most likely choice.

Rotation: Anatomically shaped implants such as the gummy bear implant project more on the bottom than on top, mimicking the shape of a natural breast. If an anatomical implant rotates because the pocket holding it is too loose, it causes a distorted appearance that does not occur with round implants. This is considered a rare but possible complication that requires revision breast augmentation surgery to correct.

Cost: Because they are not yet on the market in the U.S., gummy bear implant costs can only be estimated. However, the implants used in the clinical trials are several hundred dollars more per pair than silicone gel implants, which are already considerably more expensive than saline implants.

If you decide that gummy bear breast implants are worth the wait — and if the FDA approves their use in the U.S. — you'll want to choose an experienced, board-certified plastic surgeon who is well versed in their use to perform your breast surgery. In all likelihood, that will mean a plastic surgeon who participated in one of the clinical trials. Start your search for the right surgeon now.

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About the Reviewer of This Article

Grant Stevens, MD, FACS, is the Medical Director for Plastic Surgery Associates in Marina del Rey and Palos Verdes, California, and Medical Director for the Marina Outpatient Surgery Center. Dr. Stevens is an active member at Daniel Freeman Marina Hospital, where he formerly served as chairman of the Department of Surgery. He is board certified by the American Board of Plastic Surgery and actively participates in 17 local, state, national and international plastic surgery societies. Dr. Stevens is a Fellow of the American College of Surgeons and was the Co-Director of The Breast Center at Los Angeles Daniel Freeman Marina Hospital. Dr. Stevens coined the term "gummy bear gel implants" and is involved in the clinical trials of these implants. He is also a medical advisor for Breastimplants4you.com.

[page updated May 7, 2011]