Posted by Bill Sandweg on 14 September 2015.
I wrote recently about power morcellators and the risk that they spread previously undetected uterine cancer when used in laparoscopic procedures to remove uterine fibroids. As I wrote then, the power morcellator is a tool which is inserted into the small incisions used for laparoscopic uterine surgery. After the surgeon has cut away the fibroids from the wall of the uterus, the morcellator is inserted and used to chew up the fibroids so they can be flushed out of the uterus. To remove them whole would require a larger incision and a somewhat longer operative time.
The problem is that 1 in 350 women are believed to have previously undetected uterine cancer. If any of the fibroids contains cancer cells, the use of the morcellator to chew up that fibroid will spread those cells throughout the uterus and increase the risk that the cancer will spread and become worse.
Power morcellators have been on the market since 1991 when the FDA cleared the first ones for sale in this country. In my earlier post I noted that the FBI was going to investigate whether and to what extent the manufacturers knew that there were risks associated with the use of the morcellator but kept the information under wraps so they could continue to sell them. In the most recent news, the U.S. Government Accountability Office (“GAO”) has confirmed that it is going to investigate the FDA itself in light of allegations that the FDA knew early on about the risks of the spread of cancer but did nothing. While the agency admits that it knew cancerous cells, if present, could be spread, it maintains that it did not appreciate the magnitude of the risk until recent events brought it to the attention of everyone. The FDA has defended its procedures for approving new devices as fairly balancing the need for innovation with patient safety.
Power morcellators remain on the market but now bear the strongest warning the FDA can give for an approved device. The FDA cautions health care providers and patients about the risks and discourages the use of the device. Many health care institutions no longer use the device or permit its use in their facilities. As always, be an informed consumer of medical services and you will have the best chance of avoiding a bad outcome.