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

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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Key information

Conditions

Breast Augmentation

Sex eligibility

Female

Study type

Observational

Primary location

Clinica de Cirugia Plastica Peralta Mantilla, Pavas, Provincia de San José, Costa Rica

About this study

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®."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI and PRO

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

Primary outcomes

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.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Motiva USA LLC

Industry

Registry information

Official study title

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

Acronym: MIRO

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 8, 2022
Registry last updated: Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed