Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix

Study Overview
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Brief Summary
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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
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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®.

Official Title
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Study of the Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix in Primary and Revision Breast Augmentation

Conditions
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Breast Augmentation

Intervention / Treatment
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* Other: MRI and PRO


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary /Revision Augmentation Cohort<br>Patients that underwent primary and/or revision augmentation from 3 years or more postoperatively. | Other: MRI and PRO<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Percentage of participants with silent implant rupture identified on MRI evaluation. | 1 year to complete after study start. | 
| To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery. | 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. | 1 year to complete after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision Breast Augmentation, Primary Breast Augmentation, Breast Augmentation, Motiva Breast Implant, Silent rupture, Patient-Reported Outcomes