FDA Adds “Black Box” Warning to Power Morcellators Over Cancer Risk

Power Morcellator Black Box Warning

Written by Faith Anderson on November 25, 2014

FDA Adds “Black Box” Warning to Power Morcellators Over Cancer Risk

Seven months after issuing an initial power morcellator warning in April, the FDA has announced a “black box” warning regarding the risk of power morcellation spreading cancerous tissue.

U.S. drug regulators issued a warning this week that popular surgical devices called power morcellators should not be used on most women undergoing hysterectomies, a decision that comes nearly one year after concerns first emerged about the risk of power morcellation possibly spreading undetected cancer. The FDA on November 24 called for an immediate “black box” warning for laparoscopic power morcellators, the strongest warning the agency can attach to potentially dangerous pharmaceutical drugs or medical devices. If you or a loved one has been harmed by side effects of power morcellation, our consumer advocates at the Consumer Justice Foundation can help put you in touch with an experienced power morcellator cancer attorney today.

Potential Side Effects of Power Morcellation

Power morcellators are controversial medical devices commonly used by surgeons during hysterectomy and uterine fibroid removal surgeries, to reduce the patient’s recovery time and limit the risk of surgical complications. The surgical devices work by allowing doctors to cut up the uterus or tumors and remove the tissue through a small incision in the abdomen, allowing for a less invasive surgery. However, serious concerns have been raised recently about the safety of power morcellators, after it was discovered that the devices may cause the spread of undetected cancer throughout the body, thereby lowering patients’ long-term survival rates.

Power Morcellators May Spread Cancer

While uterine fibroids are benign, they can be hard to distinguish from a deadly type of cancer known as uterine sarcoma, which doctors are unable to reliably detect prior to uterine fibroid surgery. This new power morcellation warning strengthens guidance the FDA issued in April, which indicated that power morcellators should not be used during uterine fibroid surgery, due to a risk of the devices spreading the uterine sarcoma throughout the body and worsening the outcome. According to the FDA in its latest warning, about one in 350 women undergoing uterine fibroid surgery have an unsuspected sarcoma that could be spread during the procedure.

FDA Recommends Strict Limits on Morcellator Use

“We believe that in the vast majority of women, the procedure should not be performed,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. And while the agency’s new warning falls short of an all-out ban on power morcellators, it does recommend strict limits on the device’s use. According to Boston physician and morcellator opponent Dr. Amy Reed, whose cancer was worsened during a hysterectomy with power morcellation, “I think the wording is such that no sound practitioner would use [the devices]. But there are still people who won’t know who will be at the mercy of their physicians.”

Contact a Power Morcellation Cancer Attorney Today

Although the largest morcellator maker in the U.S., Johnson & Johnson, pulled its device from the market after the FDA’s initial warning in April, there are still plenty of other morcellators that remain on sale in the United States. As part of the FDA’s new morcellation warning, the agency is calling on the manufacturers of power morcellators to update their product labels, and is also urging doctors to tell patients that uterine tissue may contain unsuspected cancer, which could be spread with the use of power morcellation during hysterectomy procedures or uterine fibroid surgery. If you believe you have been affected by a spread of cancer from power morcellation, contact a knowledgeable power morcellator cancer lawyer today for legal help.

[box type=”note” align=”aligncenter” ]Source: http://online.wsj.com/articles/fda-adds-new-warning-to-labels-for-laparoscopic-power-morcellator-1416842439?mod=WSJ_hpp_LEFTTopStories[/box]

Posted Under: FDA - Food and Drug Administration, Medical Products, Morcellation Cancer, Morcellator, News
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