Review ArticleThe Safety of Silicone Gel-Filled Breast Implants A Review of the Epidemiologic EvidenceMcLaughlin, Joseph K. PhD*†; Lipworth, Loren ScD*‡; Murphy, Diane K. MBA§; Walker, Patricia S. MD, PhD§ Author Information From the *International Epidemiology Institute, Rockville, MD; †Department of Medicine, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, Nashville, TN; ‡Department of Preventive Medicine, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, Nashville, TN; and §Allergan, Santa Barbara, CA. Reprints: Joseph K. McLaughlin, PhD, International Epidemiology Institute, 1455 Research Blvd, Suite 550, Rockville, MD 20850. E-mail: [email protected]. Annals of Plastic Surgery: November 2007 - Volume 59 - Issue 5 - p 569-580 doi: 10.1097/SAP.0b013e318066f0bd Buy Metrics Abstract Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort studies with long-term follow-up. The topics addressed in this report include cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery. We conclude that the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis. The only study to examine an actual incidence rate of breast implant rupture reported rupture-free survival of 98% at 5 years and 83%–85% at 10 years for newer “third-generation” implants. Future studies are needed to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors. © 2007 Lippincott Williams & Wilkins, Inc.