Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
NCT ID: NCT02438332
Last Updated: 2016-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
330 participants
OBSERVATIONAL
2014-12-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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NATRELLE® INSPIRA® TruForm® 1 (Smooth)
Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants
Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants
Surgical implant
NATRELLE® INSPIRA® TruForm® 1 (Textured)
Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants
Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
surgical implant
NATRELLE® INSPIRA® TruForm® 2 (Smooth)
Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants
Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
surgical implant
NATRELLE® INSPIRA® TruForm® 2 (Textured)
Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants
Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
surgical implant
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
22 Years
FEMALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Banff Plastic Surgery
Banff, Alberta, Canada
Macleod Trail Plastic Surgery
Calgary, 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
Ottawa Plastic Surgery: Dr. Howard Silverman
Ottawa, Ontario, Canada
Rice Cosmetic Surgery
Toronto, Ontario, Canada
Cosmedical Rejuvenation Clinic
Toronto, Ontario, Canada
Yorkville Institute of Plastic Surgery
Toronto, Ontario, Canada
SpaSurgica
Waterloo, Ontario, Canada
Centre de Medecine et de Chirurgie Ambulatoires Isomed
Boucherville, Quebec, Canada
CCPEM
Montreal, Quebec, Canada
Cosmedica
Pointe-Claire, Quebec, Canada
Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville
Québec, Quebec, Canada
Sebastien Nguyen MD Inc.
Québec, Quebec, Canada
Cosmetic Surgery Clinic
Waterloo, Quebec, Canada
Sandra McGill MD Inc.
Westmount, Quebec, Canada
Countries
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Other Identifiers
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GMA-CAN-PLS-0337
Identifier Type: -
Identifier Source: org_study_id
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