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Mentor MemoryGel Post-Approval Study

NCT00756652 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42491

Last updated 2020-06-04

Study results available
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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.

Conditions

  • Breast Reconstruction
  • Breast Augmentation
  • Breast Revision

Interventions

DEVICE

Mentor Silicone Gel-Filled Breast Implants

DEVICE

Saline Breast Implants

Sponsors & Collaborators

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • John Canady, M.D. · Mentor Worldwide, LLC

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-01
Primary Completion
2019-07-31
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756652 on ClinicalTrials.gov