At a glance
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Study of the Safety and Effectiveness of Mentor Siltex® Contour Profile Gel Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction or Revision
In Brief
A Phase 3 clinical trial evaluating Mentor Siltex® Contour Profile Gel Mammary Prosthesis for Breast Augmentation and 2 related conditions. Completed, enrolled 955 participants across 1 site.
Detailed Summary
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Study Details
Timeline
Interventions
The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.