Incidence of silicone breast implant rupture
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Incidence of silicone breast implant rupture. / Hölmich, Lisbet R; Friis, Søren; Fryzek, Jon P; Vejborg, Ilse M; Conrad, Carsten; Sletting, Susanne; Kjøller, Kim; McLaughlin, Joseph K; Olsen, Jørgen H.
I: J A M A Surgery, Bind 138, Nr. 7, 07.2003, s. 801-6.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Incidence of silicone breast implant rupture
AU - Hölmich, Lisbet R
AU - Friis, Søren
AU - Fryzek, Jon P
AU - Vejborg, Ilse M
AU - Conrad, Carsten
AU - Sletting, Susanne
AU - Kjøller, Kim
AU - McLaughlin, Joseph K
AU - Olsen, Jørgen H
PY - 2003/7
Y1 - 2003/7
N2 - 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.
AB - 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.
KW - Adult
KW - Breast Implants
KW - Female
KW - Humans
KW - Incidence
KW - Magnetic Resonance Imaging
KW - Prevalence
KW - Proportional Hazards Models
KW - Prosthesis Failure
KW - Risk Factors
KW - Rupture, Spontaneous
KW - Silicone Gels
U2 - 10.1001/archsurg.138.7.801
DO - 10.1001/archsurg.138.7.801
M3 - Journal article
C2 - 12860765
VL - 138
SP - 801
EP - 806
JO - JAMA Surgery
JF - JAMA Surgery
SN - 2168-6254
IS - 7
ER -
ID: 260665598