Natrelle Style 410 Form-Stable Silicone Breast Implants: Core Study Results at 6 Years
| Autor: | Diane K. Murphy, G. Patrick Maxwell, Bruce W. Van Natta, Araceli Slicton, Bradley P. Bengtson |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Reoperation medicine.medical_specialty Time Factors Breast Implants Kaplan-Meier Estimate Prosthesis Design Risk Assessment Silicone Gels Postoperative Complications Patient satisfaction Risk Factors Surveys and Questionnaires medicine Humans Prospective Studies Prospective cohort study Breast Implantation Core (anatomy) medicine.diagnostic_test business.industry Magnetic resonance imaging General Medicine Capsular contracture Middle Aged Magnetic Resonance Imaging United States Prosthesis Failure Surgery Treatment Outcome Patient Satisfaction Cohort Female Patient Safety Implant business Risk assessment |
| Zdroj: | Aesthetic Surgery Journal. 32:709-717 |
| ISSN: | 1527-330X 1090-820X |
| DOI: | 10.1177/1090820x12452423 |
| Popis: | Background: The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously. Objectives: The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. Methods: This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan–Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale. Results: As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. Conclusions: These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications. Level of Evidence: 2 ![Graphic][1] [1]: /embed/inline-graphic-1.gif |
| Databáze: | OpenAIRE |
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