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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.
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:
Henceforth, these devices will generally be referenced as "Motiva Implants®."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary /Revision Augmentation Cohort | Patients that underwent primary and/or revision augmentation from 3 years or more postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year to complete after study start |
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Inclusion Criteria:
Exclusion Criteria:
Genetic women as inclusion criteria.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Cirugia Plastica Peralta Mantilla | Pavas | Provincia de San José | 10109 | Costa Rica | ||
| Centro Europeo de Cirugia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29040370 | Background | 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. | |
| 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. | ||
| 21378658 |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C448039 | prolyl-proline |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| San José |
| 10108 |
| Costa Rica |
| 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. |
| 26960549 | 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. |
| 27599330 | 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. |