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Background: Two-year safety and efficacy data were presented to the Canadian Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario, Canada. Methods: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel study were distributed into four cohorts: 572 augmentation patients, 123 revision-augmentation patients, 191 reconstruction patients, and 69 revision-reconstruction patients. The surgeons in the study received an intensive clinical educational program in addition to the protocol. Results: Mentor’s 2-year study results indicate that the risk of any complication or reoperation at some point through 2 years after implant surgery is 24.5 percent for primary augmentation patients, 30.2 percent for revision-augmentation patients, 42.9 percent for primary reconstruction patients, and 41.8 percent for revision-reconstruction patients. The rupture rates reported from the magnetic resonance imaging cohort were 0 percent for all groups. Patients reoperated on at least one time were as follows: 9.4 percent for primary augmentation, 12.8 percent for revision-augmentation, 27.3 percent for primary reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent of primary augmentation patients, 7.3 percent of revision-augmentation patients, 8.9 percent of primary, and 11.6 percent of reconstruction patients had their implants removed, with patient choice and capsular contracture being the most common reasons. Conclusions: The data from the Mentor CPG Gel Study resulted in approval of these implants for general use on October 20, 2006. The educational program resulted in improved clinical outcomes and probably should be required for all surgeons using the devices.

An experimental study is recorded that compares the use of soft gel silicone implants with, and without, a silicone sheet Dacron felt spacer, using the scalp of the guinea pig as a test site. Capsular contractures were produced in 45 percent of the control animals without the spacer. This was documented histologically to be related to a migration of muscle fibroblasts and could be prevented by the fixation of the Dacron felt to the pocket floor peripheral to the implant.