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Natrelle Round Silicone Breast Implants: Core Study Results at 10 Years

Spear, Scott L. M.D.; Murphy, Diane K. M.B.A.On behalf of the Allergan Silicone Breast Implant U.S. Core Clinical Study Group

Plastic and Reconstructive Surgery: June 2014 - Volume 133 - Issue 6 - p 1354–1361
doi: 10.1097/PRS.0000000000000021
Cosmetic: Original Articles
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Discussion

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.

Washington, D.C.; and Santa Barbara, Calif.

From the Department of Plastic Surgery, Georgetown University Hospital; and Allergan, Inc.

Received for publication September 6, 2013; accepted October 3, 2013.

This study is registered under the name “Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants,” ClinicalTrials.gov identification number NCT00689871 (http://www.clinicaltrials.gov/ct2/show/NCT00689871?term=NCT00689871&rank=1).

Disclosure: Allergan designed and funded the study, and statistical analysis of the data was performed by James Robinson, M.S., and Ramkumar Krish, M.S., of Allergan. Scott L. Spear, M.D., is an Allergan consultant and received research support for conducting this study. Diane K. Murphy, M.B.A., is an Allergan employee and stockholder.

Scott L. Spear, M.D., Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, D.C. 20007-2113, spears@gunet.georgetown.edu

©2014American Society of Plastic Surgeons