Power Morcellator Cancer Risk Raises Questions about FDA Oversight

Regulators_Warn_of_Cancer_Risk Associated_with_MorcellatorsSkepticism is being raised about how the U.S. Food and Drug Administration (FDA) oversees certain issues in light of recent issues with power morcellators. The agency has a database that catalogs problems with medical devices, including power morcellators, which have been used since the 1990s. However, it was not until December that any of these reports showed that the tool could spread a rare and hidden uterine cancer.

According to the Wall Street Journal, medical studies have been discussing this risk of spreading hidden uterine cancer with power morcellators since the tools have been on the market. The FDA, however, did not look into the issue until a Boston doctor made her case public in The Wall Street Journal.

Morcellators are often used in minimally invasive uterine fibroid surgeries. They help separate the tissue into smaller pieces so they can be more easily removed. However, these tools may also lead to deadly complications by spreading unknown cancerous tissue throughout the body.

Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization that advocates for product safety, said to WSJ “Why is it that even when we know numerous women have already had this happen to them, it’s not in the database?”

In April, the FDA discouraged surgeons from using morcellators in minimally invasive procedures due to the risk of spreading hidden cancers. The agency said that an estimated one in 350 women have a concealed cancer that can be spread by the tools.

The Wall Street Journal reports that it has identified at least two dozen cases where morcellators worsened a cancer prognosis using medical records and interviews with doctors. Cases have also been identified in medical journal articles and researchers.

On Thursday and Friday, the FDA will hold a hearing to discuss the tools.

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