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Mentor MemoryGel Post-Approval Study — MGPAS  

Breast Reconstruction Clinical Trial

Official title:
MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00756652
Study type Observational
Source Mentor Worldwide, LLC
Contact
Status Completed
Phase
Start date November 1, 2006
Completion date July 31, 2019
View Details
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