In the very near future, cohesive silicone gel implants will become FDA-approved, as they have been under investigative study for the last seven years. Three manufacturers currently make the gummy bear-like implants. They are, Mentor with the CPG implants, Allergan with the 410 implants and Sientra silicone implants. The Sientra implants as of March 2012 are the first to obtain the FDA approval for their use of shaped form cohesive gel implants. Allergan and Mentor are still under investigational review, however, should be approved within the next several weeks. So far, seven-year studies have shown both wide satisfaction as well as low risk of rupture as well as capsular contracture from the style 410 Allergan gel implants. The name gummy bear has been given to the Allergan 410 implants, as they have increased viscus silicone gel which is thicker, stronger and firmer. The advantages of the cohesiveness of these implants include reduced visibility, palpability, less crease-like forms of the implants. Therefore, the visibility and noticeability of the implant rippling is reduced. The advantage is form the most cohesive, stable gel implant and at the same time a soft, natural feel to the breast. These implants are now available both for reconstruction and for the elective cosmetic nature. The elective nature includes primary augmentation mammoplasty while reconstruction includes both after cancer and mastectomy reconstruction as well as secondary breast enhancement or revision breast augmentation. The shape of these implants also may lead to a more natural appearance to the breast as there are three factors that can be changed, including base lift, vertical height and the anterior/posterior projection. This gives the reconstructive surgeon more possibilities for each individual patient in terms of variability of height, lift and projection. This may also be useful for patients undergoing reconstruction for status post mastectomy, cancer reconstruction as well as those with congenital breast asymmetry, tubular breast deformities and patients with significant ptosis. The rupture rate has been shown through studies since 2006 to be approximately 1.7% after eight years of studies performed in six European countries, including Switzerland, Sweden, Belgium, Denmark, Finland and the Netherlands. 1.7% rupture rate is low as is capsular contracture occurring approximately 5.3% of patients with no cases notable on Baker IV capsular contracture from those six European countries with the use of Style 410 Allergan gummy bear implants.
MRI’s should be performed on the patient postoperatively in order to determine the integrity of the shell of the implants of two to three years. Preoperative mammograms on all patients over 35 years of age should also be performed. Gummy bear implants are simply thicker, more viscous, cohesive gel implants that are textured and have an anatomical shape. They also have greater range of implants in terms of the base width, vertical height and projection. If you look at the Table below, Allergan styles include the 410ML which is moderate height low projection; Style 410FM, full height moderate projection; Style 410 FL, full height low projection; Style 410LL, low height low projection; Style 410MM, moderate height moderate projection; Style 410LM, lower height moderate projection; Style 410FF, full height full projection; Style 410MF moderate height full projection; Style 410LF, low height full projection; 410FX, full height extra full projection; 410MX, moderate height extra full projection; and Style 410LX, low height extra full projection.