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Mentor Contour Profile Gel implants: clinical outcomes at 6 years
Dennis C Hammond1, Mark M Migliori, David A Caplin
1Grand Rapids, Mich.; Edina, Minn.; St. Louis, Mo.; and Santa Barbara, Calif. From Partners in Plastic Surgery, MMK Plastic Surgery, Parkcrest Plastic Surgery, and Mentor Worldwide LLC.
Plastic and Reconstructive Surgery
|February 14, 2012
Summary
MemoryShape (Contour Profile Gel) breast implants show a 6-year effectiveness and acceptable safety profile for augmentation and reconstruction. Patient satisfaction remains high, with 96.6% recommending the procedure.
Area of Science:
- Plastic Surgery
- Biomaterials Science
Background:
- MemoryShape (Contour Profile Gel) are textured, cohesive silicone gel breast implants used in aesthetic and reconstructive surgery.
- A 10-year prospective clinical trial evaluated their long-term outcomes.
Purpose of the Study:
- To present a 6-year summary of clinical outcomes and patient satisfaction rates for MemoryShape (Contour Profile Gel) breast implants.
- To assess the safety and efficacy of these implants in various breast surgery procedures.
Main Methods:
- A prospective, open-label, multicenter clinical trial enrolled 955 women following FDA guidelines.
- Kaplan-Meier method was used to estimate cumulative incidence of complications over 6 years.
Main Results:
- Six-year cumulative incidence rates for key complications varied by procedure type, with capsular contracture ranging from 2.4% to 16.4% and explantation from 7.0% to 34.2%.
- Rupture rates at 6 years were low, ranging from 0% to 2.9%.
- Significant chest size increase (mean 1.5 inches) and high patient satisfaction (96.6%) were reported.
Conclusions:
- MemoryShape (Contour Profile Gel) breast implants demonstrate effectiveness and an acceptable safety profile at 6 years postoperatively.
- The implants are suitable for breast augmentation, reconstruction, and revision surgeries.