FDA Warning: Some Uterine Fibroid Removal Procedures Tied to Increased Cancer RisksApr 18, 2014
The U.S. Food and Drug Administration (FDA) just issued a caution to physicians to cease using power morcellators during laparoscopic surgeries to remove uterine fibroids, a fairly common surgical technique.
The agency indicated that this surgical technique might unexpectedly spread cancerous tissue into patients’ abdomens, according to Law360. Some two-dozen power morcellators remain on the market; however, the FDA warned physicians to consider use of other treatment methods for women diagnosed with symptomatic fibroids instead of using the power morcellators to remove fibroids (myomectomy) or a woman's uterus (hysterectomy) laparoscopically.
Power morcellators are generally used to cut the fibroid or uterine tissue into pieces, which is then pulled out through abdominal incisions. According to FDA data, however, some one in every 350 women who are diagnosed with fibroids may also have a uterine sarcoma. The slicing of that cancerous tissue may allow it to spread, reducing a patient's long-term survival rate, wrote Law360.
"The FDA's primary concern as we consider the continued use of these devices is the safety and well-being of patients," said William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals," Maisel added.
Some 500,000 hysterectomies are performed annually and about 11 percent are conducted using power morcellators via laparoscopic surgery, the FDA indicated, according to Law360. Maisel pointed out that physicians should be aware of the clinical risks tied to power morcellators because of the way in which they were approved in 1995. Power morcellators received FDA clearance through a process known as the 510(k), wrote Law360.
Under the 510(k) process, a medical device may bypass human clinical trials if it is found to be similar to an already approved device. Maisel indicated that he did not believe that the risk would have been discovered during traditional clinical trials and that this issue highlights the need for FDA post-market surveillance of medical devices to be conducted, according to Law360.
The FDA indicated that uterine fibroids are non-cancerous growths originating from the smooth muscle tissue in the wall of the uterus. The National Institutes of Health (NIH) indicate that most women will develop uterine fibroids at some point in their lives and, while most uterine fibroids never lead to significant issues, they may cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, which may sometimes require medical or surgical treatment. Treatment options, including traditional surgical hysterectomy, performed vaginally or abdominally, as well as myomectomy, laparoscopic hysterectomy, and myomectomy without morcellation, are among some of the treatment options.
The FDA also indicated that it will be convening a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.
Following the FDA’s advisory, health care giant, Johnson & Johnson, announced that it was stopping the sale of its power morcellators pending a better understanding of the devices’ risks tied to the spread of hidden cancers during fibroid removal, as well as a re-definition of the devices by the medical community, The Wall Street Journal reported. Although Johnson & Johnson announced that it would be suspending morcellator sales, it noted that this suspension is not a product removal. The suspension affects all of the firm’s morcellator products, which are the "Gynecare Morcellex," "Morcellex Sigma," and "Gynecare X-Tract." Although no morcellator device recall has been put in place, in response to the FDA advisory, the Cleveland Clinic and Brigham and Women’s hospitals indicated that they have suspended morcellator procedures in their facilities.
Johnson & Johnson’s Ethicon division began selling the devices in 1998 and indicated that the devices were sold with cautions to physicians concerning the spread of cancerous or suspicious tissue. The device maker did acknowledge that the diagnosis of some cancer prior to surgery might be challenging, according to The Wall Street Journal.
Other morcellator device makers are Karl Storz GmbH, Olympus Corp., and Richard Wolf GmbH, The Wall Street Journal indicated.