TY - JOUR
T1 - Five-year safety data for more than 55,000 subjects following breast implantation
T2 - Comparison of rare adverse event rates with silicone implants versus national norms and saline implants
AU - Singh, Navin
AU - Picha, George J.
AU - Hardas, Bhushan
AU - Schumacher, Andrew
AU - Murphy, Diane K.
N1 - Funding Information:
This study was sponsored by Allergan plc (Dublin, Ireland). Writing and editorial assistance was provided to the authors by Lela Creutz, Ph.D., of Peloton Advantage (Parsippany, N.J.) and was funded by Allergan plc (Dublin, Ireland). All authors meet the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship.
Publisher Copyright:
© 2017 by the American Society of Plastic Surgeons.
PY - 2017
Y1 - 2017
N2 - Background: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. Methods: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision- augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. Results: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. Conclusions: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants.
AB - Background: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. Methods: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision- augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. Results: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. Conclusions: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants.
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U2 - 10.1097/PRS.0000000000003711
DO - 10.1097/PRS.0000000000003711
M3 - Article
C2 - 28953716
AN - SCOPUS:85030995008
SN - 0032-1052
VL - 140
SP - 666
EP - 679
JO - Plastic and Reconstructive Surgery
JF - Plastic and Reconstructive Surgery
IS - 4
ER -