Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants

Plast Reconstr Surg. 2014 Sep;134(3 Suppl):27S-37S. doi: 10.1097/PRS.0000000000000609.


Background: The availability of different styles of silicone gel implants-including traditional round devices and shaped, form-stable implants-offers a variety of choices for women undergoing breast augmentation and reconstruction. The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel (round) MemoryShape/Contour Profile Gel (shaped) devices through 9 years of use in women undergoing breast augmentation or reconstruction.

Methods: The Mentor Core studies are nonrandomized, open-label clinical trials designed to assess the long-term safety and efficacy of silicone gel breast implants. The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method. Patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again.

Results: Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants (3.4% vs 11.3%, respectively, in primary augmentation, P < 0.0001; 15.6% vs 24.4% in revision-augmentation, P < 0.05). Reoperation, explantation, and infection rates were comparable between devices across cohorts, except for lower incidence of infection with shaped than round implants in primary reconstruction (1.6% vs 6.2%, P < 0.05). Rupture rates were lower with shaped implants, with significance reached in primary augmentation patients at 8 years (3.1% vs 10.3%, P < 0.05). High levels of patient satisfaction (exceeding 94%) with both devices were reported at 9 years across cohorts.

Conclusion: Prospective data through 9 years support comparable safety of round and shaped breast implants, and high levels of patient satisfaction, in patients undergoing primary and revision breast augmentation and reconstruction.

Trial registration: NCT00753922 NCT00812097.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Breast Implantation / instrumentation*
  • Breast Implantation / methods
  • Breast Implants*
  • Female
  • Humans
  • Incidence
  • Kaplan-Meier Estimate
  • Middle Aged
  • Outcome Assessment, Health Care
  • Patient Satisfaction / statistics & numerical data
  • Postoperative Complications / epidemiology
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure
  • Reoperation / statistics & numerical data
  • Silicone Gels*


  • Silicone Gels

Associated data