Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants

Completed

• Conditions: Breast Implantation
• Interventions: Device: BIOCELL™ Textured 410 Implant

• Registration Number: NCT02132572
• Lead Sponsor: Allergan

Brief Summary

Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-07
• Results First Submitted: 2016-07-26
• Results First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Results First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

Inclusion Criteria

• Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 & 3 only) has been implanted
• Primary breast augmentation 3 to 10 years prior to data collection
• Submuscular/dual plane or subglandular implant placement

Exclusion Criteria

• Breast augmentation for Poland Syndrome or amastia
• Breast reconstruction following mastectomy
• Revision or secondary breast reconstruction
• Non 410 device at initial breast augmentation
• Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
• Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
• Axillary or peri-areolar approach
• Glandular mastopexy augmentation (skin excision only)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natrelle BIOCELL™ Textured 410 Implant	BIOCELL™ Textured 410 Implant	Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant	3 to 10 years	Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.