MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up

Abstract

Background: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years.

Methods: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure.

Results: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent.

Conclusion: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction.

Clinical question/level of evidence: Therapeutic, IV.

Trial registration: ClinicalTrials.gov NCT00753922.

Conflict of interest statement

Disclosure: Dr. Caplin is a consultant and clinical investigator for Mentor Worldwide, LLC, and Establishment Labs. Dr. Calobrace has no financial disclosures to report. Dr. Wixtrom is a consultant for Mentor Worldwide, LLC. Drs. Estes and Canady are employees of Mentor Worldwide, LLC. This study was sponsored by Mentor Worldwide, LLC.

Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc., on behalf of the American Society of Plastic Surgeons. All rights reserved.

Figures

Fig. 1.

Kaplan-Meier estimated cumulative incidence rates of (above, left) reoperation, (above, right) capsular contracture Baker grade III and IV, (below, left) explantation with or without replacement, and (below, right) infection.

Fig. 2.

Primary reason for reoperation through 10 years (frequency ≥10 percent in at least one cohort).

Fig. 3.

Primary reason for explantation through 10 years (frequency ≥10 percent in at least one cohort).

Fig. 4.

Patients in magnetic resonance imaging (MRI) cohorts A and B who completed magnetic resonance imaging evaluation by year.

Fig. 5.

Kaplan-Meier estimated cumulative incidence of rupture by patient.