Mentor MemoryGel Post-Approval Study (MGPAS)

MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Augmentation; Breast Reconstruction; Breast Revision
• Intervention / Treatment: Device: Mentor Silicone Gel-Filled Breast Implants; Device: Saline Breast Implants

• Study Type: Observational
• Enrollment (Actual): 42491

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan Meier Estimated Cumulative Incidence of Reported Complications	The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.	10 years
Kaplan Meier Estimated Cumulative Incidence of Explantation	The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for Reoperations	Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years	10 Years

Collaborators and Investigators

• Sponsor: Mentor Worldwide, LLC
• Investigators: Study Director: John Canady, M.D., Mentor Worldwide, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 19, 2008
• First Posted (Estimate): September 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: P030053