From the Department of Surgery, Dartmouth-Hitchcock Medical Center; Department of Surgery, Lahey Hospital and Medical Center; and Department of Biomedical Sciences, Geisel School of Medicine.
Plast Reconstr Surg. 2022 Aug 1;150(2):272e-278e. doi: 10.1097/PRS.0000000000009317. Epub 2022 Jun 3.
The U.S. Food and Drug Administration recommends women with silicone breast implants undergo magnetic resonance imaging surveillance to detect asymptomatic rupture. Screening is costly and often not covered by insurance. The authors assessed awareness of and adherence to these recommendations among patients with silicone breast implants.
The authors searched electronic medical records for patients aged 18 years or older with silicone breast implants placed between 2011 and 2016. Consenting patients were surveyed by telephone using a standardized script to assess awareness of U.S. Food and Drug Administration recommendations, whether they had undergone magnetic resonance imaging screening, and barriers to testing. Patients who declined to participate or could not be contacted were excluded. Demographics and operative data were collected. Odds ratios were calculated with one-sample 95 percent confidence intervals, and Fisher exact tests of independence were conducted under assumptions of normality. Multivariable logistic regression analysis was performed to test for confounding.
Of 370 patients meeting inclusion criteria, 109 consented to participate. Adherence to U.S. Food and Drug Administration recommendations was 5.9 percent (95 percent CI, 0.15 to 28.7 percent). There was no difference in adherence between patients undergoing cosmetic versus reconstructive surgery ( p = 1.00; OR, 0.80; 95 percent CI, 1.17 to 2.93), having health insurance ( p = 0.58), or residing in a county with median annual household income greater than that of the state of residence ( p = 0.33).
A small proportion of respondents had undergone magnetic resonance imaging in accordance with U.S. Food and Drug Administration recommendations. Low adherence highlights a potential limitation of current federal surveillance recommendations. Additional research is needed to better characterize adherence to magnetic resonance imaging surveillance recommendations, identify barriers to implementation, and determine whether this recommendation remains valid.
美国食品和药物管理局建议接受过硅胶乳房植入物的女性进行磁共振成像监测，以检测无症状破裂。筛查费用昂贵，而且通常不在保险范围内。作者评估了有硅胶乳房植入物的患者对这些建议的认识和遵守情况。
作者搜索了电子病历，以寻找 2011 年至 2016 年间接受过硅胶乳房植入物的年龄在 18 岁或以上的患者。通过电话使用标准化脚本对同意参与的患者进行调查，以评估他们对美国食品和药物管理局建议的了解程度、是否接受过磁共振成像筛查以及测试的障碍。拒绝参与或无法联系到的患者被排除在外。收集了人口统计学和手术数据。使用单样本 95%置信区间计算了比值比，并根据正态性假设进行了独立性 Fisher 精确检验。进行了多变量逻辑回归分析以检验混杂因素。
在符合纳入标准的 370 名患者中，有 109 名同意参与。遵守美国食品和药物管理局建议的比例为 5.9%（95%置信区间，0.15%至 28.7%）。接受美容手术与重建手术的患者（p=1.00；比值比，0.80；95%置信区间，1.17 至 2.93）、有医疗保险（p=0.58）或居住在家庭年收入中位数高于所在州的县（p=0.33）的患者之间，遵守情况无差异。
只有一小部分受访者按照美国食品和药物管理局的建议进行了磁共振成像检查。低遵守率突显了当前联邦监测建议的一个潜在局限性。需要进一步研究以更好地描述磁共振成像监测建议的遵守情况、确定实施障碍，并确定这一建议是否仍然有效。
