Study of the Safety and Effectiveness of Mentor Siltex® Contour Profile Gel Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction or Revision
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 955
- 试验地点
- 2
- 主要终点
- 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
研究概览
简要总结
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's 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 approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be 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.
详细描述
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.
In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of the Core Gel implant or Memory Gel breast implant.
The objective of the Contour Profile Gel Study, which started in 2002 is to determine the safety and effectiveness of the Silicone Contour Profile Gel Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction, or revision. In the duration of this study patients are required to have follow-up visits 10 weeks post-surgery and every year after surgery through the 10th year of completion. Additionally, out of the approximately 1000 patients enrolled in the CPG study, 400 have been randomly selected to have MRI scans at their 1,2,4,6,8,and 10 year post-surgery visits. Protocol changes now require all patients in this study to have MRI scans at years 6, 8, and 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is genetic female, 18 years of age or older
- •A candidate for:
- •Primary breast augmentation (general breast enlargement)
- •Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry)
- •Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
- •Signs the Informed Consent
- •Agrees to return device to Mentor if explant necessary
- •Agrees to comply with follow-up procedures, including returning for all follow-up visits
排除标准
- •Subject 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, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
- •Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
- •Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
- •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
- •Are HIV positive
- •Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor
- •Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
结局指标
主要结局
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
时间窗: 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
时间窗: 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 Any Reoperation
时间窗: 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 Baker III, IV Capsular Contracture
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点