Ethan M. Balk, MD, MPH; Amy Earley, BS; Esther A. Avendano, BA; Gowri Raman, MD, MS
Disclaimer: This review was commissioned and supported by the Plastic Surgery Foundation, through financial contributions provided by Allergan Inc., Mentor Worldwide LLC, and Sientra Inc.
Acknowledgment: The authors thank the members of the Advisory Panel and staff at the American Society of Plastic Surgeons/Plastic Surgery Foundation, Arlington Heights, Illinois, for their clinical expertise and administrative support. We also thank our colleagues Daniel Driscoll, MD (plastic surgery) and Senada Arabelovic, MD (rheumatology), at Tufts Medical Center, Boston, Massachusetts, for their clinical input.
Disclosures: Dr. Balk, Ms. Earley, Ms. Avendano, and Dr. Raman report grants from The Plastic Surgery Foundation during the conduct of the study. Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1169.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Corresponding Author: Ethan M. Balk, MD, MPH, Center for Evidence-Based Medicine, Brown University School of Public Health, Box G-S121-8, Providence, RI 02912; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Balk: Center for Evidence-Based Medicine, Brown University School of Public Health, Box G-S121-8, Providence, RI 02912.
Ms. Earley: Mapi USA, 180 Canal Street, Suite 503, Boston, MA 02114.
Ms. Avendano and Dr Raman: Center for Clinical Evidence Synthesis, Tufts Medical Center, Box 063, 800 Washington Street, Boston, MA 02111.
Author Contributions: Conception and design: E.M. Balk, A. Earley, G. Raman.
Analysis and interpretation of the data: E.M. Balk, A. Earley, G. Raman.
Drafting of the article: E.M. Balk, A. Earley, G. Raman.
Critical revision of the article for important intellectual content: E.M. Balk, A. Earley, G. Raman.
Final approval of the article: E.M. Balk, A. Earley, G. Raman.
Provision of study materials or patients: E.A. Avendano, G. Raman.
Statistical expertise: E.M. Balk, G. Raman.
Obtaining of funding: E.M. Balk, G. Raman.
Administrative, technical, or logistic support: A. Earley, E.A. Avendano, G. Raman.
Collection and assembly of data: E.M. Balk, A. Earley, E.A. Avendano, G. Raman.
Silicone gel breast implants were removed from the U.S. market for cosmetic use in 1992 owing to safety concerns. They were reintroduced in 2006, with a call for improved surveillance of clinical outcomes.
To systematically review the literature regarding specific long-term health outcomes in women with silicone gel breast implants, including cancer; connective tissue, rheumatologic, and autoimmune diseases; neurologic diseases; reproductive issues, including lactation; offspring issues; and mental health issues (depression and suicide).
MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), and the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the first quarter of 2015).
4 researchers double-screened articles for longitudinal studies that compared women with and without breast implants and reported long-term health outcomes of interest.
4 researchers extracted data on participant and implant characteristics, analytic methods, and results.
32 studies (in 58 publications) met eligibility criteria. Random-effects model meta-analyses of effect sizes were conducted when feasible. For most outcomes, there was at most only a single adequately adjusted study, which usually found no significant associations. There were possible associations with decreased risk for primary breast and endometrial cancers and increased risks for lung cancer, rheumatoid arthritis, Sjögren syndrome, and Raynaud syndrome. Evidence on breast implants and other outcomes either was limited or did not exist.
The evidence was most frequently not specific to silicone gel implants, and studies were rarely adequately adjusted for potential confounders.
The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes.
The Plastic Surgery Foundation.
Ethan M. Balk, Amy Earley, Esther A. Avendano, Gowri Raman. Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016;164:164–175. doi: 10.7326/M15-1169
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Published: Ann Intern Med. 2016;164(3):164-175.
Published at www.annals.org on 10 November 2015
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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