乳房再建における大容量シリコーン乳房インプラントの安全性：400人の患者を対象としたAthena多施設共同前向き研究

For women in the United States desiring implant-based breast reconstruction, the maximum volume of commercially available silicone breast implants has, to date, been 800cc. We evaluated the safety of MENTOR® larger-size MemoryGel® Ultra-High Profile breast implants (≥930cc) in women undergoing postmastectomy breast reconstruction.

This 10-year, multicenter, open-label, prospective, investigational study assessed the safety and effectiveness of larger-volume implants in women undergoing postmastectomy 2-stage primary or revision reconstruction. Three-year Kaplan-Meier curves and multivariable Cox regression analyzed the association between patient and treatment characteristics and surgical outcomes. Breast-Q was used to assess effectiveness at 3 years.

Four hundred women were enrolled (225 primary, 175 revision reconstruction). Mean body mass index (BMI) was 35.8 kg/m2; 81% had a BMI ≥30 kg/m2. At 3 years, the cumulative incidence of postoperative complications (excluding rupture) was 63.0% (95% confidence interval [CI], 58.1-67.9). The reoperation rate was 24.5% (95% CI, 20.4-29.1), and the explantation rate was 15.8% (95% CI, 23.5-19.9). Independent predictors of complications included radiation and a history of smoking. There were no significant associations between postoperative complications and implant volume ≥1135cc or <1135cc. Breast-Q scores at Year 3 showed significant improvements from baseline in satisfaction with breasts, psychosocial well-being, sexual well-being, and physical well-being (all P<0.0001). The mean score for satisfaction with outcome was 79.9.

These 3-year results demonstrate that larger-volume silicone breast implants represent a safe and effective option for patients with larger breasts who are requesting postmastectomy implant-based reconstruction.ClinicalTrials.gov Identifier: NCT02724371.