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عمومی::
فیبروم رحم
In November 2014, the US Food and Drug Administration (FDA) issued a black box warning against the use of power morcellation for excision of uterine fibroids to decrease the risk of disseminating malignant cells and worsening survival outcomes of patients with unexpected malignant neoplasms.
In a cohort of 75 487 patients who underwent hysterectomy for benign gynecologic indications, statistically and clinically significant increases in major and minor complications were observed following the warning in a subset of 25 571 women with uterine fibroids.
issuing communications on minimally invasive hysterectomy and morcellation among women with uterine fibroids.
By contrast, among a subset of 25 571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; 95% CI, 1.04-1.47; P = .02), and minor complications significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; 95% CI, 1.04-1.40; P = .01).
Major and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement.
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