N/A
Completed N=201
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Breast Implantation
Source: ClinicalTrials.gov NCT02132572 ↗
Enrolled (actual)
201
Serious AEs
14.9%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant — 28 Percentage of Subjects
Summary
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant |
28 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02132572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.