Status:

COMPLETED

Mentor MemoryGel Post-Approval Study

Lead Sponsor:

Mentor Worldwide, LLC

Conditions:

Breast Reconstruction

Breast Augmentation

Eligibility:

FEMALE

18+ years

Brief 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 ...

Eligibility Criteria

Inclusion

  • Female, age 18 years or older (22 or older for breast augmentation patients)
  • U.S. resident

Exclusion

  • If a saline participant, current or past, unilateral or bilateral, silicone breast implants
  • Active infection anywhere in her body
  • Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
  • Currently pregnant or nursing

Key Trial Info

Start Date :

November 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 31 2019

Estimated Enrollment :

42491 Patients enrolled

Trial Details

Trial ID

NCT00756652

Start Date

November 1 2006

End Date

July 31 2019

Last Update

June 4 2020

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