Faculty Collaboration Database

Comparison of Allergan, Mentor, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon's 10-Year Experience. Plast Reconstr Surg 2015 Nov;136(5):957-966

Date

10/28/2015

Pubmed ID

26505700

DOI

10.1097/PRS.0000000000001675

Scopus ID

2-s2.0-84945923807 (requires institutional sign-in at Scopus site)   21 Citations

Abstract

BACKGROUND: Contoured cohesive gel breast implants have been recently approved in the United States. These implants have been available for premarket approval studies for selected surgeons. The purpose of this study was to assess a single surgeon's outcomes in three specific clinical situations-breast augmentation, secondary augmentation, and breast reconstruction-using implants of all three contoured cohesive gel implant manufacturers (Allergan, Mentor, and Sientra) over a 10-year period.

METHODS: The authors performed a prospective study of contoured cohesive silicone gel breast implants. Demographic and outcomes data were recorded. Complication rates were compared among the three implant manufacturers.

RESULTS: From 2001 to 2013, 695 patients were included from U.S. Food and Drug Administration clinical trials. Mean age at implantation was 42.7 years (range, 18 to 82 years), and mean time enrolled was 5.3 years (range, <1 to 10 years). One hundred sixty-four patients (24 percent) received Allergan implants, 245 (35 percent) received Mentor implants, and 286 (41 percent) received Sientra implants. Three hundred eighty-four patients (55 percent) underwent primary augmentation, 198 (29 percent) underwent secondary augmentation, and 113 (16 percent) underwent breast reconstruction. The total complication rate was the lowest for primary augmentation of the Mentor group compared with the Allergan and Sientra groups (p < 0.05). There were no significant differences in complication rates when used for secondary augmentation and reconstruction. There was no statistically significant difference between implant group reoperation, explantation, or capsular contracture rates. Overall implant rupture and rotation rates were low (0.7 percent and 1.3 percent, respectively). Patient and surgeon satisfaction was high.

CONCLUSIONS: Contoured cohesive gel breast implants overall have low complication rates and high patient and surgeon satisfaction. The authors believe these implants to be safe and effective in breast augmentation and reconstruction.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Author List

Doren EL, Pierpont YN, Shivers SC, Berger LH

Author

Erin L. Doren MD Associate Professor in the Plastic Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Breast Implantation
Breast Implants
Cohort Studies
Device Approval
Esthetics
Female
Follow-Up Studies
Humans
Implant Capsular Contracture
Middle Aged
Postoperative Complications
Prosthesis Design
Prosthesis Failure
Reoperation
Retrospective Studies
Risk Assessment
Silicone Gels
Time Factors
United States
United States Food and Drug Administration