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Mentor MemoryGel Post-Approval Study (MGPAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00756652
First received: September 18, 2008
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

The U.S. Food and Drug Administration (FDA) recently 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. The postapproval study described in this protocol is intended to satisfy one element of FDA's postapproval monitoring requirements.


Condition
Breast Reconstruction
Breast Augmentation
Breast Revision

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • Long-term experience in U.S. women with MemoryGel implants [ Time Frame: through 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 42900
Study Start Date: November 2006
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Silicone Participants
2
Saline Participants

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants
  2. Active infection anywhere in her body
  3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
  4. Currently pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756652

Locations
United States, California
Mentor Worldwide LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: Sue Schwefel Mentor Worldwide, LLC
  More Information

No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00756652     History of Changes
Obsolete Identifiers: NCT00495534
Other Study ID Numbers: P030053
Study First Received: September 18, 2008
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013