Update: Cohesive Gel or Gummy Bear Breast Implants
The word is out: “I want my gummies!”
No, we’re not recreating a scene from mommy’s most recent shopping trip. We’re referring to Gummy Bear breast implants – cohesive gel, highly cohesive gel or form stable silicone gel breast implants. Approved for use in Europe and Canada, the FDA still hasn’t OK’d use of these popular breast implant alternatives in the U.S.
Yet, in a recent ImplantInfo poll, 51% of you told us you want your Gummies and are willing to wait for FDA approval of these breast implants before getting breast augmentation surgery. In fact, nearly 800 of our readers took time to weigh in on the issue – which got us wondering…
“When will these women get their gummies?”
Gummy Bear Breast Implants: What Are They?
We were lucky enough to hear from Dr. Steven Teitelbaum (featured on NBC’s Today Show) on this issue in the past. At the time, he confirmed that Gummies were NOT approved by the FDA in 2006, though that’s what breast augmentation consumers were led to believe.
“Given (demand),” he told us recently, “some manufacturers and some physicians (implied) they offered highly cohesive gel silicone breast implants. Of course, ‘Gummy Bear’ is not a medical term and there is no steadfast definition of what (that) means. However, the breast implants patients refer to when they say ‘Gummy Bear’ have not been approved.”
Dr. Teitelbaum also helped us define what Gummy Bears are – and aren’t:
- “Gummy Bear” is not an official term – it’s slang
- The term refers to the implants’ stickiness, ability to retain form & soft texture
- All silicone gel breast implants are cohesive (vs. highly liquid, like saline/water)
- Gummies emerged in the ‘90s as an alternative to ‘70s & ‘80s silicone implants
- “Cohesive” does not suggest that silicone is not a liquid or may not leak, even though most people think that’s the case; here, “cohesive” suggests stickiness
While Gummies are not on the market, plastic surgeons can now offer different forms of cohesive gel silicone breast implants which are FDA-approved and deliver great results.
“Today’s silicone gel breast implants are far more cohesive, less likely to leak and less likely to spread than the more ‘liquid’ implants of the ‘70s and ‘80s – the type of silicone that gave breast implants a bad name.”
And, the FDA has allowed manufacturers to run clinical trials on Gummy Bears.
“Trials test for safety and efficacy,” Dr. Teitelbaum explained. “The FDA will use the results to decide if the implants should be approved for general use. Since it is a study that demands a lot of paperwork and compliance, it is only open to a few surgeons.”
Dr. Teitelbaum and others use a limited number of them in qualified patients and track the outcomes. Which begged the question – what’s his opinion so far?
“These form-stable implants are longer lasting and maintain a more attractive and predictable shape. The gel they’re made of is less liquid-like and more solid-like than even today’s other cohesive silicone gel implants.”
Gummy Bear Breast Implants: Why the Controversy?
Dr. Teitelbaum said almost all form-stable breast implants are anatomical in shape. Round form-stable breast implants exist, in Europe, but are only used in a limited number of cases because they have extremely round profiles.
Another controversial point is whether “Gummy” is always applied appropriately. Less cohesive, “soft touch” varieties are one example in which he said it is not.
Dr. Teitelbaum said the advantages of Gummy Bears may include:
- Breast Implant Shape – Ability to retain a distinct shape, resist gravity, etc.
- Capsular Contracture – Hardening of scar tissue is infrequent
- Folds/Rippling – Gel doesn’t shift, so shell collapse & folds are uncommon
- Unlikely to Leak – Breaks are uncommon & any loose gel caused by a leak tends to stay within the capsule around the implant
Dr. Teitelbaum said the disadvantages of Gummy Bears may include:
- Breast Augmentation Cost – They cost more than saline & other cohesive silicone gel breast implants
- Breast Augmentation Incisions – Placement of these implants requires longer incisions
- Rotation – When anatomically-shaped implants rotate, distortion occurs
- Shape – Implant shape should be considered very carefully before placement
- Feel – In some patients, these feel firmer than other silicone gel breast implants
- Gel Fracture – Fracture of the relatively firmer silicone gel has occurred in rare cases, but it’s not yet clear whether gel fracture holds significance
Those pros and cons don’t necessarily apply to other silicone gel breast implants – which are cohesive in nature, too, but not as cohesive as Gummy Bears.
Gummy Bear Breast Implants: Worth Waiting for?
For those of you anticipating FDA-approval and release of Gummy Bears, we asked Dr. Teitelbaum whether they’re worth the wait.
“These implants can be very helpful for patients who do not just want to be larger, but need an improvement in their shape,” he explained. “The upper edge tapers more gradually than round implants and may create a less distinct border in some patients. They may also be less likely to ripple in thin patients.”
There’s the peace of mind, too, which some patients get from knowing they’ll have the newest cohesive gel breast implants available – ones which may last longer.
“Worth waiting for?” he posed. “Only you can answer that for yourself. Hopefully, they are just around the corner – perhaps in the middle of 2012. But, many people have predicted imminent approval of gummy bear implants for years.”
Gummy Bears, FDA Approval & A Few Final Words
Dr. Teitelbaum said FDA approval hinges upon product safety.
“The FDA’s job is to be sure that medical devices sold to the public are safe for them,” he explained. “When fiascos like those with PIP (French implants which were filled with industrial-grade silicone) happen, it delays the process because it worries everyone.”
“But the data from (Gummy Bear) implants are better than for any other implant to date. It seems inevitable that they will get approved.”
If you’re interested in breast reconstruction and/or breast augmentation surgery, consult with an experienced, board-certified plastic surgeon. If you’re promised Gummy Bears, ask for specifics. While you’re at it, ask to see breast augmentation before and after photos.