Clinical trial NCT05449587: Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Official title: Study of the Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix in Primary and Revision Breast Augmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Augmentation
Keywords: Revision Breast Augmentation
Primary Breast Augmentation
Breast Augmentation
Motiva Breast Implant
Silent rupture
Patient-Reported Outcomes
Lead sponsor: Motiva USA LLC
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 111
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

Detailed description: 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®."

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.

Primary outcomes:
measure: 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.
timeFrame: 1 year to complete after study start.
measure: To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery.
timeFrame: 1 year to complete after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Pavas
country: Costa Rica
facility: Clinica de Cirugia Plastica Peralta Mantilla
state: San Jose
city: San Jose
country: Costa Rica
facility: Centro Europeo de Cirugia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.