Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

Breast Implantation Clinical Trial

— RANBI-I  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438332
• Other study ID #: GMA-CAN-PLS-0337
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: July 22, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device

• Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection

• Subfascial, 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 NATRELLE® INSPIRA® device implanted at initial breast augmentation

• Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation

• Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator

• Axillary or peri-areolar approach

• Mastopexy augmentation

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Implantation

Intervention

Device:
• Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants
Surgical implant
• Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
surgical implant
• Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
surgical implant
• Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
surgical implant

Locations

Country	Name	City	State
Canada	Banff Plastic Surgery	Banff	Alberta
Canada	Centre de Medecine et de Chirurgie Ambulatoires Isomed	Boucherville	Quebec
Canada	Macleod Trail Plastic Surgery	Calgary	Alberta
Canada	Jonathan Toy	Edmonton	Alberta
Canada	Y.E.S MedSpa & Cosmetic Surgery Centre	Langley	British Columbia
Canada	CCPEM	Montreal	Quebec
Canada	Institute of Cosmetic and Laser Surgery	Oakville	Ontario
Canada	Ottawa Plastic Surgery: Dr. Howard Silverman	Ottawa	Ontario
Canada	Cosmedica	Pointe-Claire	Quebec
Canada	Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville	Quebec
Canada	Sebastien Nguyen MD Inc.	Quebec
Canada	Cosmedical Rejuvenation Clinic	Toronto	Ontario
Canada	Rice Cosmetic Surgery	Toronto	Ontario
Canada	Yorkville Institute of Plastic Surgery	Toronto	Ontario
Canada	Cosmetic Surgery Clinic	Waterloo	Quebec
Canada	SpaSurgica	Waterloo	Ontario
Canada	Sandra McGill MD Inc.	Westmount	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants		4 Years	No
Secondary	Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants		4 Years	No
Secondary	Reasons For Primary Augmentation		4 Years	No
Secondary	Time From the Date of Implant Until First Reoperation		4 Years	No
Secondary	Reasons For Reoperation Incidence		4 Years	No
Secondary	Incidences of Implant Removal With Replacement		4 Years	No
Secondary	Incidences of Implant Removal Without Replacement		4 Years	No