At a glance
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MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
In Brief
An observational study evaluating Mentor Silicone Gel-Filled Breast Implants and Saline Breast Implants for Breast Reconstruction and 2 related conditions. Completed, enrolled 42,491 participants.
Detailed Summary
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.