In April 2014, the FDA warned physicians and the general public to avoid the use of power morcellators in uterine fibroid surgery, because of a risk of spreading a rare type of cancer.
Now, medical device manufacturer Boston Scientific has announced it will soon release a new system that will be a safer alternative to power morcellators, allowing doctors to perform minimally invasive uterine removal without risk of spreading cancerous tissues.
Morcellators Tied to Cancer Risk
Power morcellators are surgical tools used to cut up larger tissues for extraction through small incisions during a laparoscopic procedure, such as uterine fibroid removal or hysterectomy. These procedures have benefitted many women, because they leave smaller scars and allow for a faster recover than traditional, abdominal surgery.
Early this year, however, scientific studies revealed that for some women with undetected cancerous tissues in the fibroids or the uterus, these tools could spread such tissues around the abdomen, leaving them behind to seed other dangerous cancers in the body.
Since the FDA warning, doctors and hospitals have debated what to do about morcellators. Some hospitals have stopped using them, reverting to other treatment options. Some doctors argued that to ban them completely would be to remove a minimally invasive procedure from the market that has benefitted thousands of women. Still other doctors suggested using a surgical bag to capture the tissues for removal, but there remain some difficulties in implementing that option.
New System Evacuates Potentially Cancerous Tissue
According to the Boston Scientific press release, they’ve completed the first procedures with the “Symphion System,” and named them successful. The system is an all-in-one surgical tool that includes fluid management, pressure monitoring, and a bladeless tool to remove uterine tissue.
According to the company’s website on the new tool, it continuously evacuates resected tissue from the uterine cavity using a suction mechanism, thereby preventing it from escaping to infect another part of the body.
The Symphion System was actually developed by IoGyn, a California-based medical products company. Boston Scientific acquired the whole of the company in May of 2014, after the FDA had approved the new tool for use in the removal of uterine fibroids and other gynecological polyps.
The company introduced the new system during the American Association of Gynecologic Laparoscopists (AAGL) 43rd Global Congress, November 17-21, 2014.
Women Suffering Morcellator-Induced Cancer Eligible to File a Lawsuit
Some women who have gone through uterine fibroid removal with a power morcellator and then were diagnosed with an advanced stage cancer have filed lawsuits against the manufacturers of these tools, claiming the companies failed to provide adequate warnings concerning the risks. Most also claim that the companies failed to conduct sufficient safety tests on the tools before making them widely available.
The risk remains low—the FDA states that about one in 350 women going through a hysterectomy or myomectomy for the treatment of fibroids will have an undetected cancer. Current screening methods are not adequate when it comes to finding these cancers, however, leaving women in the dark as to whether they should take the chance. New technologies such as this one from Boston Scientific may allow more women to go through a minimally invasive procedure without the cancer worry.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.