We have written previously on the cancer risks associated with the use of laparoscopic power morcellators. Now the FDA, in a guidance update, says that this surgical device may spread cancer and shouldn’t be used in gynecological surgery that involves cancer or fibroids. The communique is a sharp warning against the use of morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal. The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival. Dr. William Maisel, FDA’s deputy director for science, in a statement, said:
The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options.
The FDA warned against the use of such tools earlier this year, but its latest warning was more urgent. The controversy over the tool’s danger prompted Johnson & Johnson unit Ethicon Endo-Surgery Inc. to execute a worldwide recall of its Morcelex brand devices in July. Ethicon had suspended sales of the devices in April.
As we wrote previously, laparoscopic power morcellation, one technique used to treat non-cancerous fibroids as well as in some hysterectomy procedures, uses a device to break targeted tissue into fragments that can be removed through an incision in the stomach. Of the 500,000 hysterectomies performed every year, about 11 percent are done using this method, according to the FDA. Although uterine fibroids are common and usually benign, about 1 in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer, according to the agency said. If you need more information on this subject, contact Melissa Prickett at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
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