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Incidence of Silicone Breast Implant Rupture
Lisbet R. Hölmich, MD;
Søren Friis, MD;
Jon P. Fryzek, PhD;
Ilse M. Vejborg, MD;
Carsten Conrad, MD;
Susanne Sletting, MD;
Kim Kjøller, MD;
Joseph K. McLaughlin, PhD;
Jørgen H. Olsen, MD, DSc
Arch Surg. 2003;138:801-806.
Hypothesis The incidence of silicone breast implant rupture varies with implantation time and type of implant.
Objective To measure the incidence of implant rupture by repeated magnetic resonance imaging (MRI) among women with silicone breast implants.
Design, Setting, and Participants In 1999, 271 women who had received breast implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic breast implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 silicone implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses.
Main Outcome Measures Implants were diagnosed with definite or possible rupture. Crude and implant age–adjusted incidence rates were calculated, and implant survival was estimated based on the observed rupture rates.
Results We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing implant age. Double-lumen implants were associated with substantially lower rupture risk than single-lumen implants. For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years.
Conclusions The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.
From the Institute of Cancer Epidemiology, Danish Cancer Society (Drs Hölmich, Friis, Kjøller, and Olsen), and the Department of Radiology, Rigshospitalet (Dr Vejborg), Copenhagen, Denmark; the Departments of Plastic and Reconstructive Surgery (Dr Hölmich) and Radiology (Dr Sletting), Herlev University Hospital, Herlev, Denmark; the International Epidemiology Institute, Rockville, Md (Drs Fryzek and McLaughlin); the Department of Medicine and Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tenn (Drs Fryzek, McLaughlin, and Olsen); and the Department of Radiology, Hjørring Hospital, Hjørring, Denmark (Dr Conrad).
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