Cancer-spreading risks associated with laparoscopic power morcellators have prompted the U.S. Government Accountability Office (GAO) to investigate the device. According to The Wall Street Journal, the device was on the market for two decades before the U.S. Food and Drug Administration (FDA) warned that it can spread uterine cancer.
Power morcellators cut up tissue into smaller pieces so that they can be more easily removed through incisions during minimally invasive procedures, most commonly hysterectomies. The tools cut out growths known as uterine fibroids. The problem is that sometimes what appears to be fibroids are actually cancer, and morcellation worsens a patient’s condition by spreading the cancerous tissue. The odds of an undetected cancer occurring in women undergoing procedures with a morcellator are 1-in-350, the FDA said last year. In November, the FDA placed a black-box warning on morcellators to notify users about the cancer risks.
Last month, twelve lawmakers wrote a letter to the GAO asking the government watchdog to investigate morcellators. Katherine Siggerud, managing director for congressional relations at the GAO, said “We’ve agreed to do the work,” according to WSJ. The agency sent a letter to Rep. Mike Fitzpatrick (R., Pa.), who was at the forefront of the action, saying they accepted the requiest “as work that is within the scope”, Siggerud told WSJ. She said that the timeline for the probe was uncertain, but staff is likely to be available to start working on the issue in five months.
WSJ reports that the FDA will likely face heightened criticism due to the investigation, which will look closely at how the agency handled the devices since the first one hit the market in 1991. Records, including device applications, indicate the FDA was aware of cancer-spreading risks with morcellators early on. However, the agency said severity of these risks were not clear until 2013. “I am glad the GAO has agreed to take up this investigation,” said Mr. Fitzpatrick said in a statement., according to WSJ. “What happened with the power morcellator should never happen again.”
The letter lawmakers sent to the GAO asked the agency to probe the capabilities of a regulatory process used to approve morcellators. The process has been under scrutiny for having lax requirements. Additionally, the lawmakers want to know whether problems with morcellators were properly reported, how doctors were trained and what the FDA is doing to evaluate their safety on the market.
