Early Experience of the Use of Cohesive Silicone Implants for Breast Reconstruction

Abstract

Background: The silicone gel implants have been widely used for breast augmentation and reconstruction since 1960s. In 1992, the use of the silicone gel implants for breast reconstruction and augmentation was limited by United States Food and Drug Administration (FDA) because of a possible link to connective tissue diseases. Implant manufacturers began developing new generation silicone implants, so-called ”cohesive gel” implants, that had increased silicone cross-linking to create a more viscous gel. Several prospective, multicenter trials had been performed to ensure their safety and efficacy. The cohesive silicone implant was qualified for the use of breast reconstruction in Taiwan on Nov, 2008. As the silicone gel controversy has resolved, the reintroduction of gel devices as the preferred implant following two-stage or one stage breast reconstruction surgery was suggested with improved aesthetics Aim and Objectives: The purpose of this study was to examine the surgical outcomes of a single medical center in a consecutive series of breast reconstruction cases using the cohesive silicone implants. Materials and methods: A retrospective chart review was conducted to identify all patients who underwent breast reconstruction with cohesive silicone breast implant in a single medical center over 21 months period (Dec 2008 to Aug 2010). For each patient, demographic information, comorbidities, and surgical information (implant size, number, the type of excision, incision site and concomitant surgery) were recorded. In addition, outcomes were analyzed to identify complications and the need for surgical revision. The cosmetic result was evaluated with the self-assessment sheets. Results: A total of 28 smooth wall cohesive silicone gel implants were placed in 21 patients during the 21-month study period. The overall complication rate per implant was 10.7% (3/28). The most common complication was wound infection (7.1%; 2/28). No implant rupture or gel bleed was found. No significant difference of complication rate was found between the patients who had immediate or delayed breast reconstruction (1/13 vs. 2/15; p=1.00, Fisher's exact test). Two revisions were noted in our case series due to radiation ulcer with implant extrusion and implant intolerance. The self-assessment report revealed a good result of the overall satisfaction and improvement in self-confidence (each of the average scores was 8.5 and 8.3 in a 10-point scale). Eighty-eight percent of the patients (16/18), who returned the self-assessment sheets, would recommend other patient to do the breast reconstruction with cohesive silicone implants. No any connective tissue disease was found in our study. Conclusions: In our study, no causal relationship has been established between cohesive silicone breast implants and other disease. Our study illustrates a good preliminary result of the cosmetics, safety and efficacy of smooth wall cohesive silicone implants use for breast reconstruction in both immediate and delayed breast reconstruction groups with relative low complication and revision rate. This is the first preliminary result of breast reconstruction with cohesive silicone implants in Taiwan and long-term follow-up should be continued.