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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Breast Implantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Natrelle BIOCELL™ Textured 410 Implant

Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

BIOCELL™ Textured 410 Implant

Intervention Type DEVICE

Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

Interventions

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BIOCELL™ Textured 410 Implant

Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No