Cancer Risk Associated with Surgical Tool Raises Questions About FDA Oversight

In hearings this week, a Food and Drug Administration (FDA) panel is considering the risk of spreading hidden uterine cancer through the use of a power morcellator, a surgical tool used in the removal of fibroids.

The FDA began to closely examine the risk of spreading cancer only late last year, when a Boston doctor took her case public in The Wall Street Journal, Fox News reports. Older reports about the power morcellator documented such things as malfunctions and injuries to patients, but medical literature has highlighted the risk since the tool made its debut.

Morcellators slice up generally benign uterine fibroids so they can be removed through small incisions in minimally invasive procedures. In April, the FDA issued an alert to doctors, discouraging the use of the morcellator for these procedures because an estimated one in 350 patients could have a concealed cancer that the device may spread, according to Fox News.

The FDA has not removed power morcellators from the market, but has discouraged their use in fibroid surgery and hysterectomies because there is “no reliable way to determine if a uterine fibroid is cancerous prior to removal,” according to William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

The FDA is holding hearings this week about the device and will consider whether they should carry a black box warning about the risk of spreading cancer. Critics say the power morcellator case demonstrates weaknesses in FDA oversight of medical tools after they reach the market. The Journal identified at least two dozen cases before December 2013 where morcellators likely worsened cancer, according to Fox News. “Why is it that even when we know numerous women have already had this happen to them, it’s not in the database?” asked Diana Zuckerman, president of the National Center for Health Research.