ArticleAesthetic surgery journal2024
The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data.
Article in Aesthetic surgery journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Breast Envelope Complications After Revision Breast Implant Surgery: A Systematic Review.Aesthetic plastic surgery · 2026Pooled it
- Mid- to Long-term Outcomes Following Primary Augmentation With B-Lite Lightweight Breast Implants: A Prospective Multicenter Postmarketing Clinical Follow-up Study.Aesthetic surgery journal · 2026Trial
- Retrospective Validation of a Tissue-Preserving Breast Augmentation Approach: From Native Tissue Geometry to Surgical Practice.Aesthetic surgery journal · 2026Article
- The Demonstration of the Net Effect of Tranexamic Acid on Capsule Contracture in a Rat Model.Plastic and reconstructive surgery. Global open · 2026Article
- Systematic biocompatibility assessment of 4-µm surface silicone implants.Biomaterials and biosystems · 2026Article
- Breast Augmentation with Inferior Muscular Support: The Indication, Technique Evolution, and Outcomes.Aesthetic plastic surgery · 2026Review
- Clinical Outcomes in Women with Breast Implant Illness After Removal Surgery: Experience from a Latin American Center.Aesthetic plastic surgery · 2026Observational
- Sequential Advancement Method: A Funnel-Based Technique for Safe Placement of Small Breast Implants.Aesthetic surgery journal. Open forum · 2026Article
- Article
- Review
- Innovative Micro- and Nano-Architectures in Biomedical Engineering for Therapeutic and Diagnostic Applications.Micromachines · 2025Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSilicone breast implant design has evolved over the last 50 years. Regulatory bodies including the FDA require data to support the modifications designed to improve the safety, efficacy, longevity, and biocompatibility of breast implants.
objectivesThe authors reviewed the 3-year data on the safety and effectiveness of Motiva (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) SmoothSilk silicone gel-filled breast implants submitted to the FDA. The current submitted data include the primary breast augmentation and revisional augmentation cohorts.
methodsThe Motiva IDE is a prospective, single-arm, multicenter, 10-year pivotal study in which data are collected on breast augmentation, reconstruction, and revisional surgery. Three-year data were submitted to the FDA on adverse events, reoperations, patient and physician satisfaction, connective tissue diseases, and quality of life validated instruments. A subset of the patients underwent annual magnetic resonance imaging (MRI) at years 1, 2, and 3 to screen for implant rupture.
resultsA total of 451 patients were implanted in the primary augmentation cohort and 109 patients in the revisional augmentation cohort. There were 218 patients enrolled in the MRI cohort. Reported rates for reoperation for any reason were 6.1% in the primary augmentation cohort (92.4% follow-up) and 25.8% in the revisional augmentation cohort (88.7% follow-up). DISCUSSION: Motiva implants were first introduced in 2010. The 3-year Motiva data suggests that the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change.
conclusionsThree-year data from the primary augmentation and revisional augmentation cohorts submitted to the FDA demonstrate the safety and efficacy of the Motiva implants. There were low complication rates for implant-related complications and high surgeon and patient satisfaction. LEVEL OF EVIDENCE: 2:
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