Hölmich Lisbet R, Friis Søren, Fryzek Jon P, Vejborg Ilse M, Conrad Carsten, Sletting Susanne, Kjøller Kim, McLaughlin Joseph K, Olsen Jørgen H
Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen, Denmark.
Arch Surg. 2003 Jul;138(7):801-6. doi: 10.1001/archsurg.138.7.801.
The incidence of silicone breast implant rupture varies with implantation time and type of implant.
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.
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.
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.
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.
硅胶乳房植入物破裂的发生率随植入时间和植入物类型而变化。
通过重复磁共振成像（MRI）测量硅胶乳房植入物女性中植入物破裂的发生率。
设计、地点和参与者：1999年，从一大群接受美容性乳房植入物的女性中随机挑选出271名至少在3年前接受过乳房植入的女性，进行了基线MRI检查。2001年进行了第二次MRI检查；将在基线MRI时完好无损（n = 280）或在基线时完好无损但在第二次MRI之前取出（n = 37）的317个硅胶植入物（在186名女性中）纳入破裂发生率分析。
植入物被诊断为明确或可能破裂。计算了粗略的和按植入物年龄调整的发病率，并根据观察到的破裂率估计植入物存活率。
在2年期间，我们发现33例明确破裂（10%）和23例可能破裂（7%）。明确破裂的总体破裂发生率为每年5.3次破裂/100个植入物（95%置信区间，4.0 - 7.0）。破裂率随植入物年龄的增加而显著增加。双腔植入物比单腔植入物的破裂风险低得多。对于植入后3年仍完好的现代植入物，我们估计5年时无破裂存活率为98%，10年时为83%至85%。
植入物破裂的风险随植入物年龄增加而增加。预计至少有15%的现代植入物在植入后的第三年至第十年会破裂。
