Pharmaceutical

FDA review confirms cancer risks with power morcellator tool

morcellator FDA review confirms cancer risks with power morcellator toolA two-day review of a controversial surgical instrument used to remove uterine growths less invasively than surgery confirmed the Food and Drug Administration (FDA) concerns that the device could unintentionally spread cancer throughout a woman’s body. The FDA says women should be made aware of the risks before undergoing procedures in which the instrument will be used.

The surgical tool is known as a power morcellator, and is typically used with a tube-shaped blade that grinds up and removes uterine fibroids or, in some cases, the entire uterus. The devices were introduced in the 1990s and have been used in about 50,000 procedures annually since then. Morcellator procedures were favored over traditional open surgeries because they are less invasive and less scarring.

In April, the FDA urged doctors to stop using power morcellators to remove fibroids or hysterectomies because doing so increases the risk of spreading cancer. An estimated 1 in 350 women develops a type of uterine cancer, known as uterine sarcoma, after undergoing a morcellator procedure, which can lessen their odds of long-term survival.

“If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA warned in a statement.

The FDA says there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, thus the instruments should not be used to remove fibroids. If doctors wish to use them, the agency advised, they should make sure their patients are aware of the risks before the procedure is performed.

The warning comes too late for Debra Valverde, who said her cancer worsened after she underwent the procedure. She says she cries every day knowing her children and her elderly father will be without her soon. “I am waiting to die. I am counting the days,” she testified. “I beg you, please stop morcellation.”

The FDA recommends that doctors follow up with patients on whom they have performed laparoscopic power morcellation procedures during hysterectomy or myomectomy (removal of fibroids only), even if these patients do not have symptoms and were told following their surgery that tests were normal. Women who have undergone one of these procedures who have persistent or recurrent symptoms should consult with their doctors. Symptoms of uterine sarcoma include abnormal non-menstrual bleeding or bleeding after menopause, abnormal vaginal discharge, pelvic pain and/or mass.

Sources:
Tech Times
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