Study: FDA Morcellation Warning Leads to Increase of Invasive Procedures

Posted On November 3rd, 2017 By CSSFIRM.COM

An FDA warning against power morcellation during laparoscopic surgeries has led to a shift toward more invasive gynecological procedures for women with uterine fibroid tumors, according to a study published recently in Obstetrics and Gynecology. As many as 70 percent of all women develop non-cancerous uterine fibroids prior to menopause.

According to researchers at the University of California San Francisco, who conducted the study, this shift could have a negative effect for women who want the most minimally invasive approach used to remove uterine fibroids. The study found that the FDA safety communication concerning the risks of morcellation was directly associated with a reduction in the use of laparoscopy.

What are Power Morcellators?

Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. They allow the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small abdominal incision. Most uterine fibroids, or growths in the uterus, are benign. However, according to the FDA, approximately one in 350 women who undergo surgery for uterine fibroids actually have undetected uterine cancer.

Pre-Surgical Testing Is Ineffective in Diagnosing Some Uterine Cancers

When a woman undergoes pre-surgical testing, doctors are not able to determine if the uterine fibroids contain a deadly type of uterine cancer known as leiomyosarcoma (LMS). Power morcellators are used to chop up benign uterine tissue intended for removal, but if the blades of the device come into contact with cancer cells, the risk of metastasis is increased because the cells are distributed throughout the abdominal cavity.

As a result, most health experts and government regulators now agree that laparoscopic morcellation of uterine fibroids puts women at risk, often unnecessarily. Therefore, most, but not all, gynecologists no longer use power morcellators during uterine fibroid surgery.

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