Mentor MemoryGel Post-Approval Study

Completed

• Conditions: Breast Augmentation; Breast Reconstruction; Breast Revision
• Interventions: Device: Saline Breast Implants; Device: Mentor Silicone Gel-Filled Breast Implants

• Registration Number: NCT00756652
• Lead Sponsor: Mentor Worldwide, LLC

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-01
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Results First Submitted: 2020-03-27
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Results First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42491

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Saline Breast Implant Control Participants	Saline Breast Implants	Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
MemoryGel Breast Implant Participants	Mentor Silicone Gel-Filled Breast Implants	MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery

Primary Outcome Measures

Name	Time	Method
Kaplan Meier Estimated Cumulative Incidence of Reported Complications	10 years	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.
Kaplan Meier Estimated Cumulative Incidence of Explantation	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Reasons for Reoperations	10 Years	Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years