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

NCT05449587 | Completed

• 1 other identifier: CLINP- 001010
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Augmentation

Keywords

Revision Breast Augmentation; Primary Breast Augmentation; Breast Augmentation; Motiva Breast Implant; Silent rupture; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Primary /Revision Augmentation Cohort

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

Other: MRI and PRO

Interventions

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 /Revision Augmentation Cohort

Eligibility Criteria

• Gender Eligibility Details: Genetic women as inclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have undergone Primary/Revision Breast Augmentation with the Motiva Implants from 3 years or more postoperatively completed a breast MRI and the postoperative BREAST-Q Questionnaires.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Motiva USA LLC: lead

Study Sites (2)

Clinica de Cirugia Plastica Peralta Mantilla

Pavas, Provincia de San José, 10109, Costa Rica

Location

Centro Europeo de Cirugia

San José, 10108, Costa Rica

Location

Related Publications (5)

• Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-Term Safety of Textured and Smooth Breast Implants. Aesthet Surg J. 2017 Dec 13;38(1):38-48. doi: 10.1093/asj/sjx157.

  PMID: 29040370 BACKGROUND

• Zingaretti, Nicola & Fasano, Daniele & Preis, Franz & Moreschi, Carlo & Ricci, Silvia & Massarut, Samuele & De Francesco, Francesco & Parodi, Pier. (2020). Suspected breast implant rupture: our experience, recommendations on its management, and a proposal for a model of informed consent. European Journal of Plastic Surgery. 43. 10.1007/s00238-019-01610-1.

  BACKGROUND

• Meadows KA. Patient-reported outcome measures: an overview. Br J Community Nurs. 2011 Mar;16(3):146-51. doi: 10.12968/bjcn.2011.16.3.146.

  PMID: 21378658 BACKGROUND

• Wong T, Lo LW, Fung PY, Lai HY, She HL, Ng WK, Kwok KM, Lee CM. Magnetic resonance imaging of breast augmentation: a pictorial review. Insights Imaging. 2016 Jun;7(3):399-410. doi: 10.1007/s13244-016-0482-9. Epub 2016 Mar 9.

  PMID: 26960549 BACKGROUND

• Ray JG, Vermeulen MJ, Bharatha A, Montanera WJ, Park AL. Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes. JAMA. 2016 Sep 6;316(9):952-61. doi: 10.1001/jama.2016.12126.

  PMID: 27599330 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; prolyl-proline

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: July 8, 2022
• Study Start: November 22, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

CO (2)