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

Launched by MOTIVA USA LLC · Jul 4, 2022

Keywords

ClinConnect Summary

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 I...

Gender

FEMALE

Eligibility criteria

• 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.