Phase 3
N=1,008
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
Breast Reconstruction · Breast Augmentation · Breast Revision
Bottom Line
View on ClinicalTrials.gov: NCT00753922 ↗Enrolled (actual)
1,008
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation — 25.5; 49.0; 43.6; 50.7 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mentor Worldwide, LLC
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation |
25.5; 49.0; 43.6; 50.7 | — |
| PRIMARY Overall Mean Change in Circumferential Chest Size |
7.45; 4.88; 2.89; 4.18 | — |
| PRIMARY 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture |
12.1; 20.5; 24.4; 36.9 | — |
| PRIMARY 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection |
1.6; 6.2; 1.4; 0.0 | — |
| PRIMARY 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement |
11.6; 33.4; 24.1; 37.8 | — |
Summary
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety.
Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Eligibility Criteria
Inclusion Criteria
- Subject is Genetic female and at least 18 years old
- A candidate for:
- Primary breast augmentation (for post-lactational mammary involution or general breast enlargement)
- Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity)
- Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
- Signs the Informed Consent
- Agrees to follow the procedures for explant analysis
- Agrees to comply with follow-up procedures, including returning for all follow-up visits
Exclusion Criteria
- Patient is pregnant
- Has nursed a child within three months of study enrollment
- Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
- Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome
- Currently has a condition that could compromise or complicate wound healing (except reconstruction patients)
- Patient in Augmentation cohort and has diagnosis of active cancer of any type
- Infection or abscess anywhere in the body
- Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
- Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
- Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Premalignant breast disease without a subcutaneous mastectomy
- Untreated or inappropriately treated breast malignancy, without mastectomy
- Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
Data sourced from ClinicalTrials.gov (NCT00753922). 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.