Medical Device Regulations Need Tightening, Owing to Morcellator Dangers

Amid increasing complaints that power morcellators—surgical tools used in gynecological procedures—have been linked to the spread of cancer, the U.S. healthcare industry is calling for a crack-down on medical device approval regulations. The tool has been used for over two decades to remove uterine fibroids by grinding up tissue through a small incision in the abdomen, yet after the FDA issued a warning in November 2014 that the device could disseminate unknown, hidden cancer, insurers of 93 million Americans have curtailed or are considering limiting morcellator use. Karen Ignagni, president and chief executive of trade group America’s Health Insurance Plans said in a letter to Senator Bob Casey that chief medical officers have reported “a major reduction in the use of laparoscopic power morcellators in today’s market,” though the dangerous devices still remain on the market.

Real Time Analytics