Silicone Gel Breast Implants: What We Know About Safety After All These Years
Authors: Prabath W.B. Nanayakkara, Christel J.M. de Blok
Journal: Annals of Internal Medicine (2015)

Editorials2 February 2016Silicone Gel Breast Implants: What We Know About Safety After All These YearsPrabath W.B. Nanayakkara, MD, PhD and Christel J.M. de Blok, MDPrabath W.B. Nanayakkara, MD, PhDFrom VU University Medical Center, Amsterdam, the Netherlands. and Christel J.M. de Blok, MDFrom VU University Medical Center, Amsterdam, the Netherlands.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-2427 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Plato defined knowledge as justified, true belief. What knowledge do we have about the safety of silicone breast implants? Controversy over their safety has been raging for more than 60 years (1). To date, more than 400 case reports and series have been published about the possible association between silicone implants and various health conditions, including autoimmune disease. In addition, thousands of patients all over the world have ventilated their beliefs that their implants have made them sick, despite many studies that have failed to demonstrate a significant association between silicone implants and the conditions patients describe. Given the absence ...References1. Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med. 1992;326:1713-5. [PMID: 1309171] CrossrefMedlineGoogle Scholar2. 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 Scholar3. Vasey FB, Zarabadi SA, Seleznick M, Ricca L. Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined [Editorial]. J Rheumatol. 2003;30:2092-4. [PMID: 14528500] MedlineGoogle Scholar4. Lappe MA. Silicone-reactive disorder: a new autoimmune disease caused by immunostimulation and superantigens. Med Hypotheses. 1993;41:348-52. [PMID: 8289701] CrossrefMedlineGoogle Scholar5. Vermeulen RC, Scholte HR. Rupture of silicone gel breast implants and symptoms of pain and fatigue. J Rheumatol. 2003;30:2263-7. [PMID: 14528527] MedlineGoogle Scholar6. Prantl L, Angele P, Schreml S, Ulrich D, Pöppl N, Eisenmann-Klein M. Determination of serum fibrosis indexes in patients with capsular contracture after augmentation with smooth silicone gel implants. Plast Reconstr Surg. 2006;118:224-9. [PMID: 16816700] CrossrefMedlineGoogle Scholar7. Wolfram D, Oberreiter B, Mayerl C, Soelder E, Ulmer H, Piza-Katzer H, et al. Altered systemic serologic parameters in patients with silicone mammary implants. Immunol Lett. 2008;118:96-100. [PMID: 18462807] CrossrefMedlineGoogle Scholar8. Young VL, Nemecek JR, Schwartz BD, Phelan DL, Schorr MW. HLA typing in women with breast implants. Plast Reconstr Surg. 1995;96:1497-519. [PMID: 7480270] CrossrefMedlineGoogle Scholar9. Shoenfeld Y, Agmon-Levin N. 'ASIA'rsquo;–autoimmune/inflammatory syndrome induced by adjuvants. J Autoimmun. 2011;36:4-8. [PMID: 20708902] CrossrefMedlineGoogle Scholar10. Maijers MC, de Blok CJ, Niessen FB, van der Veldt AA, Ritt MJ, Winters HA, et al. Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study. Neth J Med. 2013;71:534-40. [PMID: 24394743] MedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From VU University Medical Center, Amsterdam, the Netherlands.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2427.Corresponding Author: Prabath W.B. Nanayakkara, MD, PhD, Head, Section Acute Medicine, Department of Internal Medicine, VU University Medical Center, Postbus 7057, Amsterdam 1007 MB, the Netherlands; e-mail, p.[email protected]nl.Current Author Addresses: Drs. Nanayakkara and de Blok: Department of Internal Medicine, VU University Medical Center, Postbus 7057, Amsterdam 1007 MB, the Netherlands.This article was published at www.annals.org on 10 November 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoWorking Toward a Solution: The Unanswered Questions About Silicone Gel Breast Implants Rod J. Rohrich and Dinah Wan Long-Term Health Outcomes in Women With Silicone Gel Breast Implants Ethan M. Balk , Amy Earley , Esther A. Avendano , and Gowri Raman Metrics Cited byBreast Implant Illness (BII): Real Syndrome or a Social Media Phenomenon? A Narrative Review of the LiteratureAssociation of Breast Implants with Nonspecific Symptoms, Connective Tissue Diseases, and Allergic Reactions: A Retrospective Cohort AnalysisUS Food and Drug Administration and Plastic SurgeonsSilicone Implant IllnessImmunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse ModelsLong-Term Health Outcomes in Women With Silicone Gel Breast ImplantsTim Brown, MChir 2 February 2016Volume 164, Issue 3Page: 199-200KeywordsAllergy and immunologyAutoimmune diseasesBreast cancerForecastingImmune systemSafetyStiffnessSurgerySystematic reviewsVaccines ePublished: 10 November 2015 Issue Published: 2 February 2016 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...