Biostatisticians Discuss Rare Fibroid Removal Complication


A professional knowledgable of biostatistics and FDA regulation was needed in a lawsuit concerning a female patient who underwent a myomectomy and contracted an unexpected malignant leiomyosarcoma. The virulent sarcoma tumor appeared after the patient had recovered from her operation, which had initially only been meant to remove benign fibroids from her uterus using morcellation. Allegedly, the morcellation instead catalyzed the carcinoma in the patient’s tissue. The rarity of this outcome was striking; the FDA had estimated that only 1 in 498 woman would ever contract an un unexpected leiomyosarcoma in this way, and that only 1 in 532 of those tumors would be malignant. Faced with the conclusion that the procedure might have facilitated this incredibly rare outcome to occur, the woman’s gynecologist was sued for malpractice.

Question(s) For Expert Witness

  • 1. Are you able to examine and opine on the FDA prevalence rates for unexpected uterine leiomyosarcoma and uterine sarcoma in a woman with presumed benign fibroids?

Expert Witness Response E-035862

I am very experienced in the biostatistics field, and am a former member of an FDA Special Advisory panel. Having 1 individual in 350 or 1 in 500 is quite common, at least by epidemiology standards. I would need to know the number of similar women at risk before saying that her case is unusual.

Expert Witness Response E-053725

I know how to calculate and analyze prevalence rates, and can certainly review the FDA reported prevalence rates; however, the extent to which they can be examined depends upon how much background material they provide to support their calculations. I am a clinical trialist and statistician with a good understanding of oncology. Additionally, I lecture on disease prevalence rates as they specifically relate to FDA orphan drug applications. I have attained several orphan drug designations from FDA and Emergency Medical Associates, which rely upon incidence and prevalence rates.

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