Breast Augmentation
Conditions
Keywords
Revision Breast Augmentation, Primary Breast Augmentation, Breast Augmentation, Motiva Breast Implant, Silent rupture, Patient-Reported Outcomes
Brief summary
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
Detailed description
Single-arm, multicenter study with a minimum of 160 subjects who underwent Breast Implant surgery from 3-10 years postoperatively. Following IRB / EC approval - and if applicable Competent Authority approval - Magnetic Resonance Imaging (MRI) and Patient-Reported Outcome (PRO) with the validated BREAST-Q will be collected at a single time point for all enrolled subjects. MRI data will be used for the analysis of silent rupture, and BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction. Two styles of Motiva Implants® will be used for this study: * Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round (referred to as Motiva Implants® Round ProgressiveGel® Plus, or Round) * Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round Ergonomix® (referred to as Motiva Implants® Ergonomix® Round ProgressiveGel® Ultima®, or Round Ergonomix). Henceforth, these devices will generally be referenced as Motiva Implants®.
Interventions
OTHERMRI and PRO
MRI as a standard of care for the analysis of silent rupture. BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction: Satisfaction with breasts; Satisfaction with outcome; Psychosocial well-being; Physical well-being
Sponsors
Motiva USA LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Cisgender women. * The subject has undergone primary or revision augmentation surgery with Motiva Implants® Round or Round Ergonomix®, which are still implanted before enrolling in the study. * The subject underwent breast implant surgery at least three (3) years or more before enrolling in the study. * The subject has undergone an MRI to evaluate implant rupture in the last 3 years before enrolling in the study or is willing to undergo an MRI evaluation. * The subject is willing to follow all study requirements (signing informed consent, completing questionnaires, attending a baseline visit, and allowing access to previous MRI images or having new MRI images for the study).
Exclusion criteria
* The subject had undergone fat grafting, needle biopsy, or any procedures that might have caused an iatrogenic rupture. * The Subject or Investigator are aware of a possible ruptured device that has not been removed. * The subject is pregnant or nursing. * The subject has any condition that impedes the use of Magnetic Resonance Imaging (MRI), including implanted metal devices, claustrophobia, or other conditions that would prohibit MRI scans.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe the rate of silent rupture in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery. | 1 year to complete after study start. | Percentage of participants with silent implant rupture identified on MRI evaluation. |
| To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery. | 1 year to complete after study start | Mean scores of the BBREAST-QTM - AUGMENTATION MODULE (POSTOPERATIVE) VERSION 2.0, scales: * PSYCHOSOCIAL WELL-BEING. Values 1-5. A higher score means a better outcome. * SATISFACTION WITH BREASTS. Values 1-4. A higher score means a better outcome. * PHYSICAL WELL-BEING: CHEST. Values 1-3. A higher score means a worse outcome. * SATISFACTION WITH OUTCOME. Values 1-3. A higher score means a better outcome. |
Countries
Costa Rica
Outcome results
None listed