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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-12-31

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.

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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®."

Conditions

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Breast Augmentation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Primary /Revision Augmentation Cohort

Patients that underwent primary and/or revision augmentation from 3 years or more postoperatively.

MRI and PRO

Intervention Type OTHER

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

Interventions

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MRI 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

Intervention Type OTHER

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes