The Mentor Study on Contour Profile Gel Silicone MemoryGel Breast Implants

Area of Science:

• Plastic Surgery
• Biomaterials Science

Background:

• Presented two-year safety and efficacy data for Mentor MemoryGel implants to the Canadian Therapeutic Products Directorate Scientific Advisory Panel.
• Data were collected from a 10-year, multicenter study involving 955 women undergoing breast augmentation or reconstruction procedures.

Purpose of the Study:

• To evaluate the safety and efficacy of Mentor MemoryGel implants over a two-year period.
• To assess complication and reoperation rates in different patient cohorts.
• To determine the impact of a surgeon educational program on clinical outcomes.

Main Methods:

• The study enrolled 955 women into four cohorts: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction.
• Surgeons received an intensive clinical educational program.
• Data collected included complication rates, reoperation rates, and implant removal reasons over two years.

Main Results:

• Two-year complication or reoperation risk was 24.5% for augmentation, 30.2% for revision-augmentation, 42.9% for reconstruction, and 41.8% for revision-reconstruction.
• Rupture rates were 0% across all groups based on MRI.
• Implant removal rates varied by cohort, with capsular contracture being a common reason.

Conclusions:

• The study data led to the approval of Mentor MemoryGel implants for general use in Canada on October 20, 2006.
• The surgeon educational program positively impacted clinical outcomes and is recommended for all users of these devices.