On Wednesday, February 20, 2013, the Allergan 410 shaped, cohesive gel breast implant (commonly known as the “gummy bear” implant) was (finally!) approved by the Food and Drug Administration for use in the United States. This device has been in use for more than 18 years in Europe and Canada, and has been studied in clinical trials in the United States for the past 10 years. On March 8, 2012, Sientra’s entire line of breast implants was approved for use in the United States. Their line, which has been available worldwide for more than 30 years, also includes a shaped cohesive gel implant. The 410 device from Allergan contains a firm gel, while the Sientra implant has a softer cohesive gel. However, both devices are firmer than the traditional, round silicone gel implant.
There are some significant differences between the traditional round silicone gel and the new shaped (or anatomic) silicone gel implants. First, because there is an added dimension of height to the anatomic implant, this device can change not only the size of the breast, but also its shape.
Second, the gel inside the implant is more cohesive, which means that it will feel slightly firmer than a traditional round implant. However, if the implant is cut and squeezed to create pressure-induced displacement of the gel, it will retreat back into its shell and return to its original shape.
Third, because of this additional firmness caused by a more cohesive gel, a slightly larger incision is required for placement, and therefore the infra-mammary incision is generally used. Anatomic implants are textured, as opposed to round devices which can be either smooth or textured. Finally, because of the anatomic shape, any rotation of the implant after surgery may be apparent, and for this reason patients are advised NOT to massage these implants.
There are some definite benefits to patients with the use of anatomic, cohesive gel implants. The Allergan US Pivotal Study showed low rates of capsular contracture, rupture, and implant rippling. However, not all patients are candidates for shaped devices. Specifically, patients who desire a more rounded look with fullness at the top of their breasts are better served by a round implant. Those with very lax skin and drooping of the breasts are also not the best candidates for shaped implants. Patients who are excellent candidates for the new implant shape include those who are undergoing breast augmentation surgery for the first time, patient with tuberous breasts, patients who may have had capsular contracture in the past, and those who wish to change from a saline device to a silicone implant.
The specific implant I recommend for a patient is based upon several factors, including the patient’s breast tissues, anatomy, and preference. Regardless of the implant type and size finally selected, the range of options available makes this a truly exciting time for both patients and surgeons.