Over the past year, consumer advocacy groups and families of women who were diagnosed with cancer have pressured the FDA to recall the devices. Instead of banning the use of morcellators in hysterectomies and fibroid surgery, the FDA has decided to add a “Black Box” warning to the label.
The new warnings will inform healthcare providers and patients that uterine tissues may contain unsuspected cancer.
The FDA warns that morcellators should not be used for the vast majority of women, including the following surgeries:
- Removal of suspected fibroids in menopausal or post-menopausal women.
- Intact removal of fibroids through the vagina or mini-laparotomy incision.
- Gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
When a power morcellator is used in gynecological surgery, the spinning blades grind up tissues so they can be more easily sucked out of the body. However, they easily leave behind tiny bits of tissue inside a woman’s abdomen. If this tissue contains cancerous cells, the morcellator can “seed” cancer throughout a woman’s abdomen and greatly decrease her chances of long-term survival.
In April 2014, the FDA warned that 1 in 350 women who has a hysterectomy for the treatment of fibroids actually has undiagnosed uterine sarcoma, and 1 in 500 has highly-aggressive leiomyosarcoma. Unfortunately, there is no reliable way to know whether the tissue is cancerous until after it is removed from the body.
Although power morcellators have been on the market since the 1990s, their popularity did not boom until recently, when the popularity of robotic surgery for hysterectomies and fibroid surgeries skyrocketed from 0.5% in 2007 to 9.5% in 2010.
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