Mentor MemoryGel 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.

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Key information

Conditions

Breast Reconstruction Breast Augmentation Breast Revision

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mentor Silicone Gel-Filled Breast Implants

Device

Other names: MemoryGel Breast Implants

Saline Breast Implants

Device

Primary outcomes

Kaplan Meier Estimated Cumulative Incidence of Reported Complications

Time frame: 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

Time frame: 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 outcomes

Reasons for Reoperations

Time frame: 10 Years

Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years

Sponsors and collaborators

Lead sponsor

Mentor Worldwide, LLC

Industry

Registry information

Official study title

MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

Acronym: MGPAS

Important dates

Study start: 2006
Primary completion: 2019
Study completion: 2019
First posted: Sep 22, 2008
Registry last updated: Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed