An instrument surgeons use to perform less invasive hysterectomies or to treat uterine fibroids can inadvertently spread cancer, Health Canada warns.
A morcellator is a device used to grind the uterus so it can be removed through small incisions instead of cutting across the abdomen.
"Health Canada is concerned about Canadian and international reports of inadvertent spread of unsuspected uterine malignancies associated with the use of these devices," the department said in a notice to hospitals this week.
When surgeons perform the procedures, they are operating with the intention of removing a benign fibroid or uterus.
In reality, in an estimated 1 in 352 times, an unsuspected cancer called a uterine sarcoma is present, according to the U.S. Food and Drug Administration.
As well, the FDA determined the risk of another type of cancer called uterine leiomyosarcoma is 1 in 498.
Health Canada gave several recommendations to doctors who treat uterine fibroids, such as:
- Consider treatment alternatives, such as ones that don’t involve electric morcellators.
- Review the options with patients.
- Use morcellators in a bag to reduce the risk of inadvertent spread of uterine tissue.
Health Canada said it continues to evaluate the medical device safety issue and will provide further updates as needed.
In April, Johnson & Johnson said it is stopping sales of the devices, known as laparoscopic power morcellators.