Beverly Hills, Oxnard, and Santa Barbara, Calif.; and Tulsa, Okla. From the Department of Plastic Surgery, USC School of Medicine; Department of Plastic Surgery, OU College of Medicine; OSU College of Osteopathic Medicine; Integrated Breast Center at St. John's; and Sientra Inc.
Plast Reconstr Surg. 2014 Jul;134(1 Suppl):47S-56S. doi: 10.1097/PRS.0000000000000349.
Since the first generation of breast implants, major design innovations, including consistency of the gel, palpability and thickness of the shell, and barrier materials in the shell, have been introduced. Surgeons have not had metrics to assess and compare available implants.
Research at independent laboratories included 4 tests: gel elasticity (the gel's ability to retain its shape), gel compression fracture (the resistance to permanent gel deformation), gel-shell peel (the integration of the gel with shell as a cohesive unit), and morphological analysis.
Sientra's round High-Strength Cohesive (HSC) experienced the least gel elasticity (5.805 mm), whereas Allergan's round implants experienced the most (7.465 mm). Among shaped implants, Allergan 410 experienced the least gel elasticity (3.242 mm), whereas the Sientra HSC+ implant experienced the most (4.270 mm). Sientra's round (36.32 lbf) and shaped (44.16 lbf) implants demonstrated the highest resistance to gel fracture, with Allergan's implants demonstrating the least among round (23.06 lbf) implants and Mentor Contour Profile Gel (CPG) among shaped (30.45 lbf) implants. For the gel-shell peel test, Sientra's implant required over 26% greater force than Allergan's implant and over 35% greater force than Mentor's implant. Sientra's shaped implants required more than double the peel force than Allergan 410 (119% greater) and Mentor CPG (130% greater). Morphological results showed Sientra's implants preserved structural integrity (-1.10% change).
The initial findings show that these implant characteristics are individual factors to be considered separately and are not necessarily correlative. Further study of implants using these and other testing techniques will help clinicians choose between implants.
自第一代乳房植入物以来，已经引入了重大设计创新，包括凝胶的一致性、外壳的可触知性和厚度以及外壳中的阻隔材料。外科医生没有评估和比较可用植入物的指标。
独立实验室的研究包括 4 项测试：凝胶弹性（凝胶保持其形状的能力）、凝胶压缩断裂（凝胶抵抗永久变形的能力）、凝胶-外壳剥离（凝胶与外壳的集成作为一个有凝聚力的单元）和形态分析。
Sientra 的圆形高强度粘性（HSC）凝胶弹性最小（5.805 毫米），而 Allergan 的圆形植入物最大（7.465 毫米）。在成形植入物中，Allergan 410 的凝胶弹性最小（3.242 毫米），而 Sientra HSC+植入物最大（4.270 毫米）。Sientra 的圆形（36.32 lbf）和成形（44.16 lbf）植入物对凝胶断裂的阻力最大，而 Allergan 的植入物对圆形植入物的阻力最小（23.06 lbf），Mentor Contour Profile Gel（CPG）对成形植入物的阻力最小（30.45 lbf）。对于凝胶-外壳剥离测试，Sientra 植入物所需的力比 Allergan 植入物大 26%以上，比 Mentor 植入物大 35%以上。Sientra 的成形植入物所需的剥离力比 Allergan 410 高出一倍以上（增加 119%），比 Mentor CPG 高出 130%（增加 130%）。形态学结果表明，Sientra 植入物保持了结构完整性（变化-1.10%）。
初步结果表明，这些植入物特性是单独考虑的个体因素，不一定具有相关性。使用这些和其他测试技术对植入物进行进一步研究将有助于临床医生在植入物之间进行选择。
