The Mentor Core Study on Silicone MemoryGel Breast Implants.

[BACKGROUND] In 2005, convincing safety and efficacy data were presented, resulting in the approval of Mentor MemoryGel Implants, with conditions.

[METHODS] The 1007 women enrolled in the 10-year, multicenter, Mentor Core MemoryGel Study were distributed into four cohorts: 551 primary augmentation patients, 146 revision-augmentation patients, 251 primary reconstruction patients, and 59 revision-reconstruction patients. Preoperatively and postoperatively, study instruments and physical examinations were administered to assess medical history, patient satisfaction, quality of life and body image, connective tissue disease diagnosis, rheumatology symptoms, and chest size change to determine the efficacy of surgery.

[RESULTS] Safety assessments included complication rates and rates of reoperation. Results at 3 years were reported at the U.S. Food and Drug Administration panel. Results indicate that the risk of any complication (including reoperation) at some point through 3 years after implant surgery is 36.6 percent for primary patients, 50.1 percent for revision-augmentation patients, 49.4 percent for primary reconstruction patients, and 47.5 percent for revision-reconstruction patients. Suspected rupture rates reported from the magnetic resonance imaging cohort were 0.5 percent for primary augmentation, 7.7 percent for revision-augmentation, 0.9 percent for primary reconstruction, and 0 percent for revision-reconstruction. Only two implants, in a single patient, were found surgically to be ruptured. There were 4.7 percent primary and 12.3 percent revision-augmentation patients who had their implants removed, with patient choice and severe capsular contracture being the most common reasons.

[CONCLUSION] The data demonstrated safety and efficacy of the devices, but also indicate that a focus must be placed on better education and technique to improve clinical outcomes in the future.