Morcellation Tool to Remove Uterine Fibroids and Cancer Comes Under FDA Scrutiny
A power laparoscopic morcellation tool is commonly used to remove uterine fibroids or perform hysterectomies. Doctors use the tool to remove uterine fibroids, which can cause heavy and prolonged periods, pain, and infertility. However, the FDA is now urging women to know the risks of undergoing surgery with the morcellation tool because of preliminary evidence that it can cause the spread of undetected cancerous cells in the uterus to other parts of the body. In fact, doctors will now be required to have women undergoing surgery with the tool to sign a waiver acknowledging that they understand the risks of the procedure in possibly spreading cancer.
Procedure Grinds Fibrous Tissue, Removes it Through the Abdomen
During a procedure using the laparoscopic morcellation tool, doctors grind fibrous tissue in the uterus and then remove it through a small incision in the abdomen. Women may decide to undergo the risky surgery to bypass the pain and annoyance of menstrual problems related to their uterine fibroids. Uterine fibroids are noncancerous growths or tumors that can occur inside the uterus, within the muscle walls, or on the surface of the uterus. However, some women may have undetected uterine cancer known as uterine sarcoma, which could be spread to other parts of the body when uterine fibroids are being removed. Previously, the FDA estimated that 1 in 7,000 women may have undetected uterine cancer that could be spread during the procedure to other parts of the body. Now, the agency is revising those estimates and determined that the number is as high as 1 in 350 women.
FDA Stops Short of Banning Morcellation Tool in Uterine Surgeries
The FDA has not banned the use of morcellation tools during fibroid removal or hysterectomies, but the maker of the device, Johnson & Johnson has ceased production in response to the recent findings. The FDA is urging doctors to consider the risks of using the morcellation tool, particularly when it is difficult to detect all forms of uterine cancer even with testing prior to the procedure. Because the tool can spread cancer cells, it can drastically diminish the likelihood of survival for women who do have uterine cancer, but don’t know it until the morcellation tool spreads it. This has left doctors in a particular lurch of whether to continue to offer the procedure, which many claim is successful and helpful for those suffering from uterine fibroids, or decide it is too dangerous to continue offering the procedure because of the small number who will be affected by the spread of uterine cancer cells to other parts of the body. Some say that it is up to the patient to decide for themselves with the proper information, while others say that there is no acceptable rate of injury or death to patients from the use of a medical device.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.
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