MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42,491
- 主要终点
- Kaplan Meier Estimated Cumulative Incidence of Reported Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, age 18 years or older (22 or older for breast augmentation patients)
- •U.S. resident
排除标准
- •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
结局指标
主要结局
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
时间窗: 10 years
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
Kaplan Meier Estimated Cumulative Incidence of Explantation
时间窗: 10 years
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
次要结局
- Reasons for Reoperations(10 Years)