Overview

This trial is active, not recruiting.

Conditions breast reconstruction, breast augmentation, breast revision
Treatments mentor silicone gel-filled breast implants, saline breast implants
Sponsor Mentor Worldwide, LLC
Start date November 2006
End date July 2018
Trial size 43046 participants
Trial identifier NCT00756652, NCT00495534, P030053

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
mentor silicone gel-filled breast implants MemoryGel Breast Implants
Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
saline breast implants

Primary Outcomes

Measure
Kaplan-Meier Estimated Cumulative Incidence Rate of Breast Surgery Repoperations
time frame: through 10 years
Kaplan-Meier Estimated Cumulative Incidence Rate of Breast Implant Explantations
time frame: through 10 years

Secondary Outcomes

Measure
Reasons for Breast Surgery Reoperations
time frame: through 10 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Mentor Worldwide, LLC.