Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

Phase 3

Completed

Conditions: Breast Reconstruction
Breast Augmentation
Breast Revision

Interventions: Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface

Registration Number: NCT00753922

Lead Sponsor: Mentor Worldwide, LLC

Brief 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.

Detailed Description: Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Premarket Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A premarket approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision patients. Every patient implanted had to be part of an adjunct study, and had to be offered participation in a registry of gel-filled breast implant patients. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in a core clinical study.

The objective of this study is to determine the safety and effectiveness of the smooth and textured surface Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction or revision.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1008

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Augmentation	Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface	The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
Primary Reconstruction	Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface	The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity. Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Revison Augmentation	Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface	Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
Revision Reconstruction	Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface	Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.

Primary Outcome Measures

Name	Time	Method
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation	10 years	Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Overall Mean Change in Circumferential Chest Size	Change from baseline to 10 years post-baseline	Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture	10 Years	Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection	10 Years	Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement	10 Years	Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.