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Laparoscopic Power Morcellator Pulled From the Market

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Los Angeles, CAThe controversial power morcellation tool made by Ethicon, a subsidiary of Johnson & Johnson (J&J), is being withdrawn from global markets. J&J announced its decision this week, because of reports that suggest the device can inadvertently spread cancer in women undergoing hysterectomies.

The withdrawal of the power morcellators follows on just weeks after the US Food and Drug Administration (FDA) held hearings on the risk for cancer associated with the surgical device. A spokesperson for Ethicon said this is not a recall. In a corporate statement, Ethicon noted that its morcellators are not inherently defective; they functioned as designed. However, hospitals are being asked to return the devices.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy. During this process, some tissue, cancerous and non-cancerous, can be spread throughout the abdominal cavity. If there is undetectable cancer embedded in the fibroid, that cancer could instantly become Stage 4, or metastatic, cancer.

In April, the FDA issued a safety communication discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, the FDA determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. 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.

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It will be a better idea if the FDA can widen their scope more. This is a very good move.

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