- Legislators Request Power Morcellator Investigation
- September 10, 2015
- Law Firm: Waters Kraus LLP - Dallas Office
- Twelve congressional members have asked the U.S. Government Accountability Office to conduct an investigation concerning the laparoscopic power morcellator - a device used in gynecologic surgeries that can spread undetected cancer cells throughout the body. A bipartisan group of lawmakers sent a letter to the GAO, criticizing the Food & Drug Administration for being lax in its decision to authorize use of the power morcellator. The letter noted that manufacturers had known for decades about studies suggesting the potential for serious harm.
Bipartisan Congressional Group Sends Letter to GAO Seeking an Investigation of Dangers Associated with Power Morcellators
Surgeons have used power morcellators in tens of thousands of hysterectomies to dice up fibroid cysts in the uterus with a whirling blade and then remove the bulky masses with a slender vacuum inserted through tiny incisions in the abdomen. The problem with this medical device is that it can also slice up hidden cancerous tumors and send the malignant cells spiraling into other areas of the body. Morcellator manufacturers had claimed that the risk of undetected cancer is just 1-in-10,000. But in truth that number is 1-in-350.
In 2014, the FDA issued a warning about the risk and required that manufacturers include a black box warning with the devices. This is the FDA’s strongest caution. In response to the FDA’s warnings, Johnson & Johnson withdrew its power morcellator from sale. But not all makers have followed suit and many power morcellators remain on the market.
What the Congressional members reportedly want to know about the FDA is “how did they get it wrong for so long?” According to lawmakers who signed the letter, “hundreds, if not thousands” of American women are dead because of the power morcellator.
Specifically, the letter asks the GAO to look into the following:
- Did the FDA’s approval process adequately uncover morcellator risks before the device was sold?
- Did device makers adequately monitor morcellator dangers?
- Did manufacturers adequately train physicians?
- What is the FDA doing now to assess whether the power morcellator should remain for sale?