Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Textured Surface and Polyurethane Foam-coated Surface
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Unexpected Adverse Events
研究概览
简要总结
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.
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
- •provide written informed consent.
- •female at birth
- •be 18 years of age or older
- •have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
- •having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
- •ability to comply with the protocol throughout the follow-up period.
排除标准
- •mammary reconstruction in at least one breast or augmentation after previous reconstruction,
- •pregnancy informed or breastfeeding at the inclusion moment,
- •advanced fibrocystic disease at the time of implantation,
- •neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
- •reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
- •immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,
- •signs of inflammation of the breast or implant site at the time of implantation,
- •Increased risk of immediate postoperative complications due to use of illicit drugs or medications,
- •Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
- •have participated in another clinical study up to 6 months prior to the placement of the implant,
- •any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.
研究组 & 干预措施
Textured Group
Women undergoing primary and secondary breast augmentation with Silimed® Textured Silicone Gel-Filled Breast Implant.
干预措施: Silimed® Textured Silicone Gel-Filled Breast Implant (Device)
Polyurethane Group
Women undergoing primary and secondary breast augmentation with Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
干预措施: Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant (Device)
结局指标
主要结局
Unexpected Adverse Events
时间窗: Every three years through the 10 years length of the study.
Estimate the unknown short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
Expected Adverse Events
时间窗: Every three years through the 10 years length of the study.
Estimate the known short-term and long-term risk / adverse event rate for Silimed® silicone gel-filled breast implants with textured surface and Silimed® silicone gel-filled breast implants with polyurethane foam covered surface
次要结局
- Patient's Satisfaction in General(Every three years through the 10 years length of the study.)
- Patient's Quality of Life(Every three years through the 10 years length of the study.)
- Patient's Satisfaction in Relation to Aesthetic Result(Every three years through the 10 years length of the study.)
- Evaluator's Satisfaction in Relation to Aesthetic Result(Every three years through the 10 years length of the study.)