Working Toward a Solution: The Unanswered Questions About Silicone Gel Breast Implants

Editorials2 February 2016Working Toward a Solution: The Unanswered Questions About Silicone Gel Breast ImplantsRod J. Rohrich, MD and Dinah Wan, MDRod J. Rohrich, MDFrom University of Texas Southwestern Medical Center, Dallas, Texas.Search for more papers by this author and Dinah Wan, MDFrom University of Texas Southwestern Medical Center, Dallas, Texas.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-2307 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The popularity of silicone gel implants among women undergoing breast augmentation has soared since the U.S. Food and Drug Administration (FDA) lifted its moratorium almost a decade ago. Silicone implants are an attractive alternative to saline, largely because of their more natural feel and appearance. It is not surprising that the FDA's reapproval of silicone gel implants in 2006 coincided with an increase in the number of breast augmentations performed that year—2006 was the first year that breast augmentation became the dominant cosmetic surgical procedure since the 1992 moratorium (1). The percentage of silicone devices used for breast augmentation has ...References1. American Society of Plastic Surgeons. 2006 Quick Facts: Cosmetic and Reconstructive Plastic Surgery Trends. Arlington Heights, IL: American Society of Plastic Surgeons; 2007. Accessed at www.plasticsurgery.org/Documents/news-resources/statistics/2006-Plastic-Surgery-Statistics/Quick-Facts-on-Cosmetic-and-Reconstructive-Plastic-Surgery-Trends.pdf on 12 September 2015. Google Scholar2. American Society of Plastic Surgeons. 2008 Report of the 2007 Statistics: National Clearinghouse of Plastic Surgery Statistics. Arlington Heights, IL: American Society of Plastic Surgeons; 2008. Accessed at www.plasticsurgery.org/Documents/news-resources/statistics/2007-Plastic-Surgery-Statistics/full-statstics-report.pdf on 12 September 2015. Google Scholar3. American Society of Plastic Surgeons. 2014 Plastic Surgery Statistics Report. Arlington Heights, IL: American Society of Plastic Surgeons; 2015. Accessed at www.plasticsurgery.org/Documents/news-resources/statistics/2014-statistics/plastic-surgery-statsitics-full-report.pdf on 12 September 2015. Google Scholar4. Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007;120:8S-16S. [PMID: 18090808] CrossrefMedlineGoogle Scholar5. Cunningham B, McCue J. Safety and effectiveness of Mentor's MemoryGel implants at 6 years. Aesthetic Plast Surg. 2009;33:440-4. [PMID: 19437068] CrossrefMedlineGoogle Scholar6. U.S. Food and Drug Administration. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Silver Spring, MD: U.S. Food and Drug Administration; 2011. Accessed at www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf on 12 September 2015. Google Scholar7. 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;164:164-75. doi:10.7326/M15-1169 LinkGoogle Scholar8. Diamond BA, Hulka BS, Kerkvliet NI, Tugwell P. Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction. 1998. Accessed at www.fjc.gov/BREIMLIT/SCIENCE/summary.htm on 12 September 2015. Google Scholar9. Bondurant S, Ernster V, Herdman R. Safety of Silicone Breast Implants. Washington, DC: National Academies Pr; 1999. Google Scholar10. Spear S. The breast implant story [Editorial]. Ann Plast Surg. 2006;56:573-83. [PMID: 16641640] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From University of Texas Southwestern Medical Center, Dallas, Texas.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2307.Corresponding Author: Rod J. Rohrich, MD, Department of Plastic Surgery, University of Texas Southwestern Medical Center, 1801 Inwood Road, Dallas, TX 75390-9132; e-mail, Rod.[email protected]edu.Current Author Addresses: Drs. Rohrich and Wan: Department of Plastic Surgery, University of Texas Southwestern Medical Center, 1801 Inwood Road, Dallas, TX 75390-9132.This article was published at www.annals.org on 10 November 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoSilicone Gel Breast Implants: What We Know About Safety After All These Years Prabath W.B. Nanayakkara and Christel J.M. de Blok Long-Term Health Outcomes in Women With Silicone Gel Breast Implants Ethan M. Balk , Amy Earley , Esther A. Avendano , and Gowri Raman Metrics Cited by3D Direct Printing of Silicone Meniscus Implant Using a Novel Heat-Cured Extrusion-Based Printer 2 February 2016Volume 164, Issue 3Page: 201-202KeywordsFood and Drug AdministrationForecastingHealth information technologyPlastic surgeryResearch designResearch reporting guidelinesRisk managementSurgeonsSystematic reviewsSystemic diseases ePublished: 10 November 2015 Issue Published: 2 February 2016 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...