Last April, the Food and Drug Administration warned both health care practitioners and the general public that a medical device was spreading a rare type of cancer. Now, medical device manufacturer Boston Scientific has announced that it will be releasing a new, safer alternative.
Power morcellators are medical devices used to treat uterine fibroids, tumors that originate in the uterus. They cut up the fibroids for easier extraction through small incisions, which leaves only small scars and allows women to recover more quickly.
Though fibroids are typically benign, they can be cancerous in very rare — less than one in 1,000 — cases. When women who have undetected, cancerous tissues undergo morcellation surgery, the tools could wind up spreading such tissues around the abdomen, leaving them behind to seed cancer in other parts of the body, as revealed by studies from 2014.
Since the FDA’s warning, health care practitioners have not been sure what to do about morcellation. Some felt that the FDA did not go far enough, and should have banned their use outright. Others side with the FDA, believing that their use is still beneficial in some cases.
Now, Boston Scientific’s new “Symphion System” could potentially put the issue to bed. According to the manufacturer’s release, the first procedure using the system was a success. Being pegged as an all-in-one surgical tool, the Symphion System has fluid management capabilities, pressure monitoring functions, and a bladeless tool that will remove uterine tissues. In order to prevent the risk of cancerous tissues from spreading, it continuously evacuates excised tissues from the uterine cavity.
While the FDA’s approval of the system is certainly a good step forward, it doesn’t really help the women who have already undergone morcellation and developed cancer as a result. Many of these patients have filed lawsuits against morcellator manufacturers, claiming that they failed to provide proper warnings in regards to the risks, and that they failed to conduct sufficient safety tests before making them widely available.
While the risk of having such cancerous tissues is still low, current screening methods are not adequate enough to detect and find them, which means women don’t know whether or not morcellation is entirely safe. New technologies, such as the Symphion System, will allow women to undergo minimally invasive procedures without having to worry about whether or not their undetected cancers could spread.