Everyone now agrees that power morcellators as used now are not safe because they increase the risk of cancer in women. Experts at the FDA disagree as to whether or not they should be banned or continue to be used, but with stronger warnings.
The question is simple: should we ban morcellators and pull them off the market? An FDA panel of independent advisers met last week in Bethesda, Maryland to discuss exactly this. The experts were split as to whether the medical devices should be banned outright, or whether the option should still be made available, with informed consent.
Let’s back up. What’s all the concern about?
The history here is stunning. In December of last year, the FDA and, let’s me honest, most of the world has been sleeping on the issue of whether these morecellators can spread cancer that otherwise might have laid dormant. Five months later, in April, 2014, the FDA issued a statement urging doctors to stop using power morcellators for uterine fibroid removal and hysterectomies.
As someone who follow the history of how the science unfolds in mass tort medical device cases, the speed of this discovery of what has always been there to be seen was breakneck. Yet is was in front of the FDA and morcellator manufacturers’ faces all along: these morcellators are cancer spreaders.
How so? Doctors have no way to know whether the fibroids they are breaking up with a morecellator have cancerous cells. It is estimated that one in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma contained within the uterus, while another one in 400 have the even deadlier, leiomyosarcoma (LMS). These cancer cells can be hidden inside of the uterine fibroids. If a fibroid contains cancer cells, the cutting of the uterus with the power morcellator will cause cancer cells to spread throughout the peritoneal cavity, posing an extremely serious risk to a woman’s health. The spreading of these cells can quickly ignite the spread of the cancer.