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Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel
- Source :
- Plastic and Reconstructive Surgery. 141:7S-19S
- Publication Year :
- 2018
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2018.
-
Abstract
- In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years.The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction.Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons.The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.
- Subjects :
- Adult
Reoperation
Breast implantation
Surface Properties
Breast Implants
Breast surgery
medicine.medical_treatment
Dentistry
030230 surgery
Prosthesis Design
law.invention
Silicone Gels
Food and drug administration
03 medical and health sciences
chemistry.chemical_compound
Postoperative Complications
0302 clinical medicine
Silicone
law
Implant Capsular Contracture
Premarket Approval
Humans
Medicine
Breast
Prospective Studies
Breast Implantation
United States Food and Drug Administration
business.industry
technology, industry, and agriculture
Middle Aged
United States
chemistry
Multicenter study
Patient Satisfaction
030220 oncology & carcinogenesis
Breast implant
Lymphoma, Large-Cell, Anaplastic
Female
Surgery
business
Subjects
Details
- ISSN :
- 00321052
- Volume :
- 141
- Database :
- OpenAIRE
- Journal :
- Plastic and Reconstructive Surgery
- Accession number :
- edsair.doi.dedup.....8f7970f0706abaf661b0be449153ade5