Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Impl… (NCT02438332) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
Canada330 participantsStarted 2014-12
Plain-language 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.
Who can participate
Age range22 Years
SexFEMALE
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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
What they're measuring
1
Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants