Allergan Style 410 Implants for Breast Reconstruction - A Prospective Study in Efficacy, Safety, and Symmetry.

Introduction: Implant based breast reconstruction is performed with both saline and silicone. In 2001 a study began using a novel implant made of highly cohesive silicone gel in anatomic shape. It differs from others because it holds its anatomic shape and forces tissue to conform to the implant. Methods: 212 consecutive patients who underwent reconstruction with Allergan 410 cohesive gel anatomic implants were prospectively enrolled over a 12-year period. Complications and satisfaction rates were recorded. Results: Average age was 48.5 and average BMI 24.1. Bilateral reconstruction was performed in 83% of patients. Long-term follow up was achieved in all patients and averaged 3.3 years (0.5-10.2 years). The overall complication rate was 19.8%, most were minor complications such as rippling (9.4%) and asymmetry (4.2%). Major complications included infection (2.4%), malposition (1.4%), capsular contracture (0.9%), seroma (0.5%), extrusion (0.5%), and implant rupture (0.5%). The rate of implant related reoperation, excluding cancer recurrence, was 9.0%, consisting of implant replacement (5.7%), implant removal (1.9) and implant repositioning (1.4%). Patient satisfaction averaged 4.83 (range 2-5) on a 5-point scale. Surgeon satisfaction averaged 4.9 (range 2-5). Conclusions: Allergan 410 cohesive gel anatomic implants have a favorable risk profile in reconstruction with excellent patient and surgeon satisfaction. This novel implant allows for a paradigm shift in implant-based breast reconstruction. Surgeons can now use an implant to help shape the final contour of the breast mound rather than rely on mastectomy flaps and suture techniques to create aesthetic contours needed to create an attractive breast reconstruction. (C)2016American Society of Plastic Surgeons

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