Eight-Year Follow-Up Data from the U.S. Clinical Trial for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel
| Autor: | Kamakshi R. Zeidler, Kaveh Alizadeh, Tess B. Godinez, Jennifer L. Harrington, David Broadway, W. Grant Stevens |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Reoperation medicine.medical_specialty Adolescent Breast Implants Prosthesis Design law.invention Silicone Gels Food and drug administration Young Adult chemistry.chemical_compound Patient satisfaction Silicone law Implant Capsular Contracture Humans Medicine Adverse effect Breast Implantation Aged Rupture business.industry General Medicine Capsular contracture Middle Aged United States Prosthesis Failure Surgery Clinical trial chemistry Patient Satisfaction Premarket Approval Application Breast implant Female business Follow-Up Studies |
| Zdroj: | Aesthetic Surgery Journal. 35:S3-S10 |
| ISSN: | 1527-330X 1090-820X |
| Popis: | Background On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. Objectives The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. Methods The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant–related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. Results Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. Conclusions Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. Level of Evidence 3![Graphic][1] Therapeutic [1]: /embed/inline-graphic-1.gif |
| Databáze: | OpenAIRE |
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