A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 355
- 试验地点
- 29
- 主要终点
- Percentage of Participants According to Investigator Satisfaction With Implants
研究概览
简要总结
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
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
- 是
入选标准
- •For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants
- •Female, age 18 or older
- •Present with 1 or more of the following conditions:
- •Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
- •Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)
- •Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
- •Has adequate tissue available to cover implants
- •Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)
排除标准
- •For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery
- •Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- •Does not have existing carcinoma of the breast, without mastectomy
- •Does not have abscess or infection in the body at the time of enrollment
- •Is not pregnant or nursing
- •Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability
- •Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration
- •Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
- •Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
- •Is not willing to undergo further surgery for revision, if medically required
研究组 & 干预措施
Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
干预措施: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection (Device)
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
干预措施: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection (Device)
Revision-Augmentation
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
干预措施: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection (Device)
Revision-Reconstruction
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
干预措施: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection (Device)
结局指标
主要结局
Percentage of Participants According to Investigator Satisfaction With Implants
时间窗: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Percentage of Participants According to Participant Satisfaction With Implants
时间窗: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
次要结局
- Percentage of Participants With Local Complications(5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012))
- Percentage of Participants With Reoperations(5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012))
- Percentage of Participants With Implant Removal With or Without Replacement(5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012))