Shaped versus Round Silicone Breast Implants in Breast Reconstruction: Prospective Data Through 8 Years
David A. Caplin, M.D.1, Emily Garcia, Ph.D.2, John Canady, M.S., M.D., D. Sc. (hon), F.A.C.S., F.A.A.P.2.
1Parkcrest Plastic Surgery, St Louis, MO, USA, 2Mentor WW, LLC, Santa Barbara, CA, USA.
The availability of different styles of silicone gel implants, including softer, round implants and shaped, “form-stable” implants, offer a variety of choices for women undergoing breast reconstruction. Accordingly, there is growing interest in the association of implant type with key safety and aesthetic outcomes. The purpose of this analysis was to characterize the long-term clinical outcomes associated with round and shaped silicone breast implants in women undergoing primary breast reconstruction.
The MemoryGel™ (NCT identifier NCT00753922) and MemoryShape™/CPG™ (NCT identifier NCT00812097) Core studies are non-randomized, open-label clinical trials designed to assess the long-term safety and efficacy of round and shaped breast implants, respectively. The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method. Cox regression analyses were conducted to examine whether specific patient, device, and surgical characteristics are risk factors associated with clinical outcomes. Global patient satisfaction was assessed by asking the patient if she would decide to have the breast implant surgery again.
The overall baseline demographics of women undergoing primary breast reconstruction who were implanted with round devices (N=251) was comparable to those of women with shaped implants (N=191), as well as the general US population of women undergoing reconstruction procedures utilizing breast implants. Compared to women with round implants, those with shaped implants had comparable incidence rates for reoperation, Baker Grade III/IV capsular contracture, and implant removal, but significantly lower rates of infection (Figure). Similarly, women with round and shaped implants experienced comparable rates of cosmetic complications (asymmetry, hypertrophic scarring, ptosis, and wrinkling). The most common reasons for the 123 reoperations performed through 8 years in patients with round implants included asymmetry (n=20), capsular contracture (n=18), and breast mass (n=14). The most common reasons for the 120 reoperations performed in patients with shaped implants included asymmetry (n=16), seroma (n=12), and capsular contracture (n=11). While surgical approach, placement, and incision did not significantly influence the risk of capsular contracture in either type of implant, the use of antibiotic irrigation solution was associated with significantly reduced risk of capsular contracture III/IV in women with round implants. At the 8-year follow-up, 101 of 104 (97.1%) patients with round implants and 79 of 80 (98.8%) of those with shaped implants indicated patient satisfaction.
Prospective data through 8 years support comparable safety of round and shaped breast implants, as well as high levels of patient satisfaction, in patients undergoing breast reconstruction. With the availability of softer-and-round or firmer-and-contoured silicone gel breast implants, continued analyses of specific differences in clinical outcomes will help surgeons to knowledgeably counsel patients about the most suitable implant for their desired aesthetic outcome.
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