Gummy Bear Implants and the Recent (February 2013) FDA Approval of Allergan’s Natrelle 410 Highly Cohesive, Form Stable Anatomic Shaped Textured Breast Implants

There will now be more choices available for women who want or need breast implants… and also more confusion. A “gummy bear” implant refers to a highly cohesive, shaped, silicone gel implant. Because gummy bear implants are semi-solid, they maintain their shape and remain in an upright position. Unlike liquid-filled implants, they are not as likely to wrinkle, fold, or ripple.

Cohesivity is not a black and white issue; there is an endless continuum in cohesive gel from very liquidy to very solid. Both Allergan and Mentor have had their cohesive silicone gel implants on the market since 2006. The term “gummy bear” means more cohesive and “form stable.” Sientra was the first company in the United States to receive FDA approval for their high strength cohesive silicone breast implants. While Sientra also has textured shaped versions of their highly cohesive silicone implants, we have been using their smooth round versions with increasing frequency and achieving excellent results. Allergan’s 410 version is form-stable, anatomic or “tear-drop” shaped, comes in various heights and widths, and has a textured surface to prevent rotation within the pocket.

While Europeans are using these devices frequently for small breast augmentations in the “over the muscle position”, in North America, our culture dictates a different approach to breast contouring. Women here want much larger bra sizes with more superior pole fullness and “under the muscle” positioning is preferred. Textured surfaces in the “under the muscle” position do not improve capsular contracture (scar tissue) rates and can cause problems including a less-natural feel and fluid collections (seromas). Textured implants stick like Velcro, and massage to manage or change implant position after surgery simply doesn’t work, which may increase the risk for implant malposition. In fact, breast implant massage is contraindicated after placement of these implants. Rotation of these implants can cause visible deformity requiring a trip back to the operating room to exchange the implant for a smooth round device. All of the reports (60 cases worldwide) of lymphoma associated with breast implants are with textured surfaced implants. In patients with a sloping chest wall, the edges of the implant can be visible and rippling can occur in certain body positions (traction rippling).

The Form Stable Anatomically Shaped Breast Implant is not the Perfect Implant for Everyone

Who is the ideal candidate for the form stable implants?

• Patients with constricted lower pole breasts
• Patients with chest wall deformity / breast asymmetry
• Breast reconstruction patients
• Patients wanting a natural looking implant that don’t have a lot of breast tissue

Although these implants have been given a lot of media attention, they are probably not indicated for the majority of patients presenting for cosmetic breast augmentation in our region. In addition, because they hold their shape, and don’t respond to gravitational factors, there is much less room for error when placing these devices. If the size choice isn’t perfect, or if the pocket dimensions aren’t precise, rotation of the device can occur, requiring operative intervention to remove the implant and switch it to a round device. These implants feel firmer, and have unchanged shape in various body positions, and let’s face it, that’s just not natural. Women looking for superior pole fullness or roundness may not like the flatter and more natural upper pole shape. Form stable implants also require a much longer incision for insertion, as they are not deformable and can’t be squeezed through small incisions. That means in the majority of cases, they can only be placed using a fairly long (7 cm) inframammary crease incision. Lastly, these implants are not an option in the majority of patients undergoing revisionary operations. Previous implant pockets may contraindicate the use of this device, as these implants require a lock and key fit into the pocket. Expect to pay 20% more for these implants and many women will have to be tracked and enrolled in ongoing studies.
Dr. Hayley Brown MD, FACS
Board Certified Plastic Surgeon
Desert Hills Plastic Surgery Center serving Henderson and Las Vegas, Nevada

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