Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2017 Oct;140(4):666-679.
doi: 10.1097/PRS.0000000000003711.

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants

Navin Singh  1   2 , George J Picha  1   2 , Bhushan Hardas  1   2 , Andrew Schumacher  1   2 , Diane K Murphy  1   2
Affiliations
Observational Study

Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants

Navin Singh et al. Plast Reconstr Surg. 2017 Oct.

Abstract

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.

Clinical question/level of evidence: Therapeutic, II.

PubMed Disclaimer

References

    1. American Society for Aesthetic Plastic Surgery. Cosmetic surgery national data bank statistics 2014. Available at: http://www.surgery.org/sites/default/files/2014-Stats.pdf. Accessed May 11, 2016.
    1. International Society of Aesthetic Plastic Surgery. ISAPS International survey on aesthetic/cosmetic procedures performed in 2014. Available at: http://www.isaps.org/Media/Default/global-statistics/2015%20ISAPS%20Resu.... Accessed May 11, 2016.
    1. Jewell ML. Silicone gel breast implants at 50: The state of the science. Aesthet Surg J. 2012;32:10311034.
    1. Balk EM, Earley A, Avendano EA, Raman G. Long-term health outcomes in women with silicone gel breast implants: A systematic review. Ann Intern Med. 2016;164:164175.
    1. U.S. Food and Drug Administration. FDA update on the safety of silicone gel-filled breast implants. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures.... Accessed May 11, 2016.