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.
Video Discussion by Matthew M. Hanasono, M.D., is available Online for this article.
Tampa, Fla.
From the Division of Plastic Surgery, Department of Surgery, and the Breast Health Program, University of South Florida; and the Cosmetic and Reconstructive Surgery Center.
Received for publication February 4, 2015; accepted May 21, 2015.
Presented in part at the 57th Annual Meeting of the Southeastern Society of Plastic and Reconstructive Surgeons, in Nassau, Bahamas, June 8 through 12, 2014.
A Video Discussion by Matthew M. Hanasono, M.D., accompanies this article. Go to PRSJournal.com and click on “Video Discussions” in the “Videos” tab to watch.
Disclosure: The authors did not receive any financial support for this research study. Sponsors (Allergan, Mentor, and Sientra) supplied a small stipend to cover the administrative costs of paperwork and submission for the FDA clinical trials. All patients paid for their procedures with all implants priced at cost but received stipends from the breast implant manufacturers to return for follow-up visits and MRIs during the 10-year duration of the studies.
Lewis H. Berger, M.D., 2901 West St. Isabel Street, Suite 2C, Tampa, Fla. 33607, lberger@tampabay.rr.com
