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

Study Identifier
MAF-AGN-MED-BRE-003
CT.gov Identifier
NCT02132572
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Breast Augmentation
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion 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)

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    Bordeaux, France
    Status
    Not applicable
    Location
    Düsseldorf, Germany
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
    Location
    Madrid, Spain
    Status
    Not applicable
    Location
    East Grinstead, United Kingdom
    Status
    Not applicable