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FDA adds ‘black box’ warning to power morcellator labels

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FDA adds warnings to power morcellator labels

The FDA today put so-called "black box" warnings on the labels for laparoscopic power morcellators advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.

The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.

The FDA last April issued a warning about the devices and convened a special advisory panel over the summer to consider their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas including the deadly leiomyosarcoma.

"At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma," the FDA said today. "If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood [emphasis theirs]."

"Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids," according to the FDA [emphasis theirs].

The black box warning reads as follows:

"The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices."

The FDA’s April warning prompted Johnson & Johnson (NYSE:JNJ) and its Ethicon subsidiary to voluntarily suspend sales of its LPMs.

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