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OpenTrials
Completed

NCT Number: NCT02132572

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

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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Key information

Conditions

Breast Implantation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BIOCELL™ Textured 410 Implant

Device

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

Primary outcomes

  1. Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

Acronym: RANBI

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 7, 2014
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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