There has been much debate over whether a popular device used in surgeries spreads cancers. Now the government has found proof that it does, and an official warning has been sent out about using the device.
The New York Times reports on the Food and Drug Administration warning against the use of a tool commonly utilized in uterine surgeries. Many experts have been warning against use of the device for years but this is the first time that a governmental agency has issued an official warning.
This is a power device that is used in at least 50,000 women in the United States every year. Evidence shows that the device spreads cancerous tissue. The Food and Drug Administration said that the device should not be used in the ‘vast majority’ of women.
The tools are known as laparoscopic power morcellators, and they have been widely used in operations to remove fibroid tumors from the uterus. Sometimes they are also used to remove the entire uterus.
What do they exactly do?
Morcellators actually work to cut tissue into pieces that can be pulled out through the tiny incisions made during even minimally invasive surgery.
What are federal health experts particularly concerned about?
The safety concern is that women who are having these operations sometimes have undiagnosed cancer and morcellators have aggressively spinning blades that can fling malignant cells around inside the abdomen and ‘upstage’ the disease to a more advanced and fatal form. Fibroids themselves are actually benign but can hide uterine sarcomas, which is an aggressive form of cancer that can quickly be deadly once it disseminates.
“In one in 350 women having fibroid surgery, biopsies after the operation find previously undetected sarcomas, the F.D.A. estimates. The risk of this cancer increases with age. Morcellating a sarcoma, the agency said, ‘may spread cancer and decrease the long-term survival of patients’,” according to The Times.
How long have these devices been in play?
Surgeons began using the devices in the 1990s. However, until recently, when new data became available, gynecologists thought the dangers of hidden sarcomas were miniscule, from about one in 500 to one in 10,000.
The action on Monday does not take morcellators off the market or disqualify their use, but does strongly warn doctors against using them in hysterectomies or fibroid surgery in the majority women. The food and drug agency is also recommending that manufacturers issue labels warning of the cancer risk and of two ‘contraindications’, which are specific instances in which morcellators should not be utilized.
Which women should not have these devices used on them?
Experts say the first contraindication warns that power morcellators should not be used in women who have reached menopause or are about to start menopause. They also should be avoided in patients whose tissue can be taken out intact through the vagina or a small abdominal cut called a mini laparotomy incision. These two groups of women actually cover most of those who need surgery for fibroids. Experts say the second contraindication says that morcellators should not be utilized when the tissue to be morcellated is known or supposed to be cancerous.
The Times reports, “The recommendations do not address a technique that some gynecologists have recommended to make the procedure safer: enclosing the tissue to be morcellated inside a bag, to catch any stray cancer cells. The new warnings are the agency’s first use of a type of directive called ‘immediately in effect guidance’, which allows it to skip the usual procedure of issuing a draft and allowing time for public comments.”
Despite the fact that this warning is being issued as a recommendation and not an order, the FDA is requiring manufacturers to issue warnings on the devices that pertain to them causing cancer.
