NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

Not Applicable

Terminated

• Conditions: Breast Reconstruction; Breast Implant Revision; Breast Augmentation
• Interventions: Device: Anatomically shaped silicone gel-filled breast implants

• Registration Number: NCT01853605
• Lead Sponsor: Allergan

Brief Summary

Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-07
• Results First Submitted: 2015-07-16
• Results First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Results First Posted: 2015-08-11
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3811

Inclusion Criteria

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.

• Female, age 18 or older
• Present with one 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 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 MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Read More

Exclusion Criteria

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants

• Does not have advanced 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., 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reconstruction	Anatomically shaped silicone gel-filled breast implants	Women undergoing breast reconstruction.
Augmentation	Anatomically shaped silicone gel-filled breast implants	Women undergoing breast augmentation.
Revision-Augmentation	Anatomically shaped silicone gel-filled breast implants	Women undergoing revision of previous breast augmentation.
Revision-Reconstruction	Anatomically shaped silicone gel-filled breast implants	Women undergoing revision of previous breast reconstruction.

Primary Outcome Measures

Name	Time	Method
Subject Satisfaction With Breast Implants on a 5-Point Scale	5 years	Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Investigator Satisfaction With Breast Implants on a 5-Point Scale	5 years	Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
Local Complications	5 years	Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.