Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants (RANBI-I)

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.

Study Overview

• Status: Completed
• Conditions: Breast Implantation
• Intervention / Treatment: Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants; Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants; Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 1R4
    • Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville
  • Quebec, Canada, G1V 4M6
    • Sebastien Nguyen MD Inc.
  • Alberta
    • Banff, Alberta, Canada, T1L 1B7
      • Banff Plastic Surgery
    • Calgary, Alberta, Canada, T2H 0L8
      • Macleod Trail Plastic Surgery
    • Edmonton, Alberta, Canada, T5M 327
      • Jonathan Toy
  • British Columbia
    • Langley, British Columbia, Canada, V2Y 0C8
      • Y.E.S MedSpa & Cosmetic Surgery Centre
  • Ontario
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic and Laser Surgery
    • Ottawa, Ontario, Canada, K1Z 8R9
      • Ottawa Plastic Surgery: Dr. Howard Silverman
    • Toronto, Ontario, Canada, M2J 1V1
      • Rice Cosmetic Surgery
    • Toronto, Ontario, Canada, M2P 2C2
      • Cosmedical Rejuvenation Clinic
    • Toronto, Ontario, Canada, M5R 2J3
      • Yorkville Institute of Plastic Surgery
    • Waterloo, Ontario, Canada, N2J 1M3
      • SpaSurgica
  • Quebec
    • Boucherville, Quebec, Canada, J4B 7M6
      • Centre de Medecine et de Chirurgie Ambulatoires Isomed
    • Montreal, Quebec, Canada, H3G 1B9
      • CCPEM
    • Pointe-Claire, Quebec, Canada, H9R 5N3
      • Cosmedica
    • Waterloo, Quebec, Canada, N2L 3S2
      • Cosmetic Surgery Clinic
    • Westmount, Quebec, Canada, H3Z 1S3
      • Sandra McGill MD Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects that have undergone a primary breast augmentation for aesthetic reasons with NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 implant.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NATRELLE® INSPIRA® TruForm® 1 (Smooth); Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants	Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants; Surgical implant; Other Names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 1 (Textured); Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants	Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants; surgical implant; Other Names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 2 (Smooth); Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants	Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants; surgical implant; Other Names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)
NATRELLE® INSPIRA® TruForm® 2 (Textured); Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants	Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants; surgical implant; Other Names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants	4 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Reasons For Primary Augmentation	4 Years
Time From the Date of Implant Until First Reoperation	4 Years
Reasons For Reoperation Incidence	4 Years
Incidences of Implant Removal With Replacement	4 Years
Incidences of Implant Removal Without Replacement	4 Years

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GMA-CAN-PLS-0337