Gummy bear implants, the newest type of silicone breast implants, are currently only available to U.S. patients who are participating in clinical trials at select plastic surgery centers. Are these women lucky to be the first to get their hands (or chests) on this innovative new implant design? Or will the long term results disappoint?
At this time, cohesive gel implants have been used outside the United States for about ten years with fairly good outcomes. However, the FDA will make the final call on whether these are approved for widespread use here in the states. After suddenly removing silicone gel implants from the market and then re-approving them later, the FDA is likely to be cautious in its approach to approving a new device in this category. This increased scrutiny isn’t a bad thing from a patient safety standpoint; but it does mean there may be a significant wait before these fifth generation implants are readily available to all women who want them. Right now, surgeons participating in the clinical trials are reporting both benefits and drawbacks of the “gummy bear” implant.
Why the New Gummy Bear Design?
The manufacturers of these implants want to show through the current clinical trials that cohesive implants are superior to saline and silicone gel filled implants in several ways.
- They hope that a stable filler material that retains its form will help keep the breast in the desired shape over time as well. Currently approved implants tend to conform to the shape the surrounding breast tissue and gravity impose on them over time. A gummy implant might keep the breast looking perkier. The shell shouldn’t develop ripples or folds over time since the filler is not liquid.
- Saline and silicone gel implants can both rupture. A saline implant will tend to deflate noticeably while silicone may leak slowly (making the flaw hard to detect). Since the gummy interior of a cohesive gel implant doesn’t ooze, it would tend to stay intact even if it does break. This doesn’t mean silicone can’t potentially be dispersed through the body in very small amounts even from a gummy implant. However, silicone hasn’t been shown to have a negative effect on the body; so this concern may not end up being a problem.
- Complications from excessive scar tissue formation might be less common with cohesive implants. The evidence is sparse on this point and the mechanism by which capsular contracture would be minimized with a gummy bear implant is unclear.
Challenges Associated With Cohesive Gel Implants
Even plastic surgeons who say they find the gummy bear silicone breast implants superior to previous designs admit that it does pose its own set of challenges during augmentation surgery. Techniques used for traditional implants don’t necessarily work with these firmer implants. The cohesive gel implant has to be placed in exactly the right position. The gummy implants currently being tested at plastic surgery centers in the United States are teardrop shaped. This means they have a definite top and bottom. They have to be oriented correctly on the vertical axis and positioned at the correct height on the chest and the proper distance from the sternum. Otherwise, they will look asymmetrical. With fluid filled implants, there’s a little more “wiggle room.”
The surface of the cohesive gel implant is textured so it will grip onto the surrounding tissue during healing to keep it from rotating out of position. This means the pocket that is created has to be sized carefully so there’s not a lot of extra space. At the same time, the actual incision is bigger than that required for a traditional implant. The material can’t be manipulated to fit through a very narrow opening. Most patients require an incision about 5 centimeters long located along the bottom crease of the breast to receive a gummy bear implant. For women who prefer a scar in the armpit, around the areola or in the belly button, these new silicone breast implants won’t be a preferred option.
Can You Participate in a Clinical Trial?
There are currently cohesive silicone gel implants from three different manufacturers being used in clinical trials in the United States. The devices being tested are: Allergan 410, Mentor CPG, Silimed/Sientra Nuance and Enhance. To be involved in a clinical trial, you need to be living near enough to one of the participating plastic surgery centers to have regular follow up visits over a ten year period. Right now, there are only about half a dozen states (including California and Texas) that have one or more centers participating in these trials.
The exact candidate requirements vary from one study to the next. So, if you have your heart set on gummy implants, your best bet is to find a participating surgeon who is currently accepting new enrollees and schedule an exam to find out if you qualify. Otherwise, you will need to wait to see if the FDA makes these available in the future or go ahead and move forward with a traditional implant. Fortunately, regular silicone gel implants have improved a great deal in the last couple of generations of design. You may find that these will suit you just fine.