Clinical trial NCT02438332: Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Implantation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 330
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants
timeFrame: 4 Years
Secondary outcomes:
measure: Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants
timeFrame: 4 Years
measure: Reasons For Primary Augmentation
timeFrame: 4 Years
measure: Time From the Date of Implant Until First Reoperation
timeFrame: 4 Years
measure: Reasons For Reoperation Incidence
timeFrame: 4 Years
measure: Incidences of Implant Removal With Replacement
timeFrame: 4 Years
measure: Incidences of Implant Removal Without Replacement
timeFrame: 4 Years
Other outcomes:
Locations:
city: Banff
country: Canada
facility: Banff Plastic Surgery
state: Alberta
city: Calgary
country: Canada
facility: Macleod Trail Plastic Surgery
state: Alberta
city: Edmonton
country: Canada
facility: Jonathan Toy
state: Alberta
city: Langley
country: Canada
facility: Y.E.S MedSpa & Cosmetic Surgery Centre
state: British Columbia
city: Oakville
country: Canada
facility: Institute of Cosmetic and Laser Surgery
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Plastic Surgery: Dr. Howard Silverman
state: Ontario
city: Toronto
country: Canada
facility: Rice Cosmetic Surgery
state: Ontario
city: Toronto
country: Canada
facility: Cosmedical Rejuvenation Clinic
state: Ontario
city: Toronto
country: Canada
facility: Yorkville Institute of Plastic Surgery
state: Ontario
city: Waterloo
country: Canada
facility: SpaSurgica
state: Ontario
city: Boucherville
country: Canada
facility: Centre de Medecine et de Chirurgie Ambulatoires Isomed
state: Quebec
city: Montreal
country: Canada
facility: CCPEM
state: Quebec
city: Pointe-Claire
country: Canada
facility: Cosmedica
state: Quebec
city: Waterloo
country: Canada
facility: Cosmetic Surgery Clinic
state: Quebec
city: Westmount
country: Canada
facility: Sandra McGill MD Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique de Chirurgie Plastique et Esthétique de la Haute-Ville
city: Quebec
country: Canada
facility: Sebastien Nguyen MD Inc.
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: