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

Breast Implantation Clinical Trial

— RANBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132572
• Other study ID #: MAF-AGN-MED-BRE-003
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: June 22, 2015
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Conseil National de l'Ordre des MédecinsIsrael: Ethics CommissionIsrael: Ministry of HealthSpain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeUnited Kingdom: National Institute for Health Research
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Implantation

Intervention

Device:
• NATRELLE® 410 Breast Implants
Surgical implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence (i.e., incidence proportion) of first reoperation following the use of a BIOCELL™ textured 410 cohesive device.		3 to 10 years	Yes