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

Completed

• Conditions: Breast Implantation
• Interventions: Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants; Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants; Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants

• Registration Number: NCT02438332
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NATRELLE® INSPIRA® TruForm® 1 (Textured)	Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants	Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants
NATRELLE® INSPIRA® TruForm® 2 (Smooth)	Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants	Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants
NATRELLE® INSPIRA® TruForm® 2 (Textured)	Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants	Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants
NATRELLE® INSPIRA® TruForm® 1 (Smooth)	Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants	Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidences of Implant Removal With Replacement	4 Years
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
Reasons For Reoperation Incidence	4 Years
Time From the Date of Implant Until First Reoperation	4 Years
Incidences of Implant Removal Without Replacement	4 Years

Trial Locations

Locations (17)

Macleod Trail Plastic Surgery; 🇨🇦 Calgary, Alberta, Canada

Rice Cosmetic Surgery; 🇨🇦 Toronto, Ontario, Canada

Ottawa Plastic Surgery: Dr. Howard Silverman; 🇨🇦 Ottawa, Ontario, Canada

Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville; 🇨🇦 Quebec, Canada

Cosmetic Surgery Clinic; 🇨🇦 Waterloo, Quebec, Canada

Centre de Medecine et de Chirurgie Ambulatoires Isomed; 🇨🇦 Boucherville, Quebec, Canada

Sandra McGill MD Inc.; 🇨🇦 Westmount, Quebec, Canada

Cosmedica; 🇨🇦 Pointe-Claire, Quebec, Canada

CCPEM; 🇨🇦 Montreal, Quebec, Canada

Banff Plastic Surgery; 🇨🇦 Banff, Alberta, Canada

Jonathan Toy; 🇨🇦 Edmonton, Alberta, Canada

Y.E.S MedSpa & Cosmetic Surgery Centre; 🇨🇦 Langley, British Columbia, Canada

Institute of Cosmetic and Laser Surgery; 🇨🇦 Oakville, Ontario, Canada

Cosmedical Rejuvenation Clinic; 🇨🇦 Toronto, Ontario, Canada

Sebastien Nguyen MD Inc.; 🇨🇦 Quebec, Canada

Yorkville Institute of Plastic Surgery; 🇨🇦 Toronto, Ontario, Canada

SpaSurgica; 🇨🇦 Waterloo, Ontario, Canada