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: October 21, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Breast Reconstruction
Breast Augmentation
Breast Revision
Device: Mentor Silicone Gel-Filled Breast Implants
Device: Saline Breast Implants

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:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • Kaplan-Meier Estimated Cumulative Incidence Rate of Breast Surgery Reoperations [ Time Frame: through 10 years ] [ Designated as safety issue: Yes ]
    The cumulative incidences of reoperations through 10 years for women with MemoryGel breast implants will be estimated based on surgeon reporting using Kaplan-Meier methodology

  • Kaplan-Meier Estimated Cumulative Incidence Rate of Breast Implant Explantations [ Time Frame: through 10 years ] [ Designated as safety issue: Yes ]
    The cumulative incidences of explantations through 10 years for women with MemoryGel breast implants will be estimated based on surgeon reporting using Kaplan-Meier methodology


Secondary Outcome Measures:
  • Reasons for Breast Surgery Reoperations [ Time Frame: through 10 years ] [ Designated as safety issue: Yes ]
    Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years


Enrollment: 43046
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 Assigned Interventions
MemoryGel Breast Implant Participants
MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
Device: Mentor Silicone Gel-Filled Breast Implants
Other Name: MemoryGel Breast Implants
Saline Breast Implant Control Participants
Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
Device: Saline Breast Implants

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756652

Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: John Canady, M.D. Mentor Worldwide, LLC
  More Information

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: October 21, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 26, 2016