The Center for Science in the Public Interest welcomes the announcement that the Centers for Disease Control and Prevention is considering conducting a review of the pre-operative evaluation of women scheduled for hysterectomy or myomectomy (removal of fibroids), procedures sometimes performed with a controversial device called a power morcellator. A recent article in the journal Obstetrics & Gynecology finds a surprisingly high risk of unsuspected uterine, cervical and ovarian cancer (1.44%, 0.60%, and 0.19%, respectively) in women undergoing hysterectomy but diagnosed after the surgery had already occurred.  In women 55 and older, the risk of unsuspected uterine cancer alone was almost 10%.

As an associate commissioner at the Food and Drug Administration, my office was responsible for estimating the prevalence of unsuspected sarcoma (a specific form of cancer). This ultimately led to warnings from the FDA in 2014 that sharply limited the practice of power morcellation, since the process runs the risk of spreading any undetected cancer cells from a growth thought to be a fibroid throughout the patient’s abdomen, significantly worsening her prognosis. This warning was recently reviewed and reiterated by FDA commissioner Gottlieb.

While our focus at FDA was on sarcoma, the new paper expands the analysis to other forms of malignancy and finds prevalences of undiagnosed cancer that raise even greater public health concerns.  The FDA warnings against morcellation were a necessary step, but the new research and the magnitude of risk it reveals suggest that more must be done: a complete reevaluation of preoperative screening for these patients. The CDC is to be commended for ensuring that this reevaluation takes place in an evidence-based manner that will ultimately promote the health of women considering these procedures.

It is our hope that the CDC leadership will move quickly to establish the necessary guidelines to ensure that all gynecologists utilize adequate risk stratification methods, including robust tissue biopsy methods, to identify women with gynecological cancer preoperatively.