N/A
N=42,491
Mentor MemoryGel Post-Approval Study
Breast Reconstruction · Breast Augmentation · Breast Revision
Bottom Line
View on ClinicalTrials.gov: NCT00756652 ↗Enrolled (actual)
42,491
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Kaplan Meier Estimated Cumulative Incidence of Reported Complications — 0.0; 6.7; 10.8; 11.2 Cumulative Reoperation Events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Mentor Silicone Gel-Filled Breast Implants (Device); Saline Breast Implants (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mentor Worldwide, LLC
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimated Cumulative Incidence of Reported Complications |
0.0; 6.7; 10.8; 11.2; 11.7; 12.5 | — |
| PRIMARY Kaplan Meier Estimated Cumulative Incidence of Explantation |
0; 3.0; 5.0; 5.2; 5.5; 6.0 | — |
| SECONDARY Reasons for Reoperations |
465; 17; 2; 26; 1; 238 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00756652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.