Document Detail


Natrelle round silicone breast implants: Core Study results at 10 years.
MedLine Citation:
PMID:  24867717     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available.
METHODS: Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture.
RESULTS: Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched.
CONCLUSION: The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Authors:
Scott L Spear; Diane K Murphy;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Plastic and reconstructive surgery     Volume:  133     ISSN:  1529-4242     ISO Abbreviation:  Plast. Reconstr. Surg.     Publication Date:  2014 Jun 
Date Detail:
Created Date:  2014-05-28     Completed Date:  2014-08-12     Revised Date:  2014-10-13    
Medline Journal Info:
Nlm Unique ID:  1306050     Medline TA:  Plast Reconstr Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1354-61     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00689871
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MeSH Terms
Descriptor/Qualifier:
Breast Implantation / methods
Breast Implants*
Breast Neoplasms / epidemiology
Female
Follow-Up Studies
Humans
Implant Capsular Contracture / epidemiology*
Magnetic Resonance Imaging
Patient Satisfaction
Prosthesis Design*
Reoperation
Comments/Corrections
Comment In:
Plast Reconstr Surg. 2014 Jun;133(6):1362-3   [PMID:  24867718 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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