Risk of spreading unsuspected cancers prompted new warnings, agency says
WebMD News from HealthDay
<h3/> By Dennis Thompson
HealthDay Reporter
<h3/> MONDAY, Nov. 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Monday announced that new "boxed warning" labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.
The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there's no way to guarantee surgical morcellation wouldn't increase the risk of spreading cancer to other parts of a woman's body.
The new warning will let surgeons and patients know that "uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients," the FDA said in a news release.
Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used "in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous," the FDA added.
That's because in about one in every 350 cases, women who undergo hysterectomy for fibroids may have an unsuspected uterine sarcoma, the FDA said, and morcellation might help spread that cancer.
"The FDA's primary concern is the safety and well-being of patients, and taking these steps will help the agency's safety recommendations to be implemented as quickly as possible," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the agency's news release.
"Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed," he added.
The FDA did not rule out the safe use of morcellating devices in some patients. The new warning label should help narrow the candidate patient population, however. "For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may [still] be candidates for this procedure," the agency said in the news release.
WebMD News from HealthDay
<h3/> By Dennis Thompson
HealthDay Reporter
<h3/> MONDAY, Nov. 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Monday announced that new "boxed warning" labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.
The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there's no way to guarantee surgical morcellation wouldn't increase the risk of spreading cancer to other parts of a woman's body.
The new warning will let surgeons and patients know that "uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients," the FDA said in a news release.
Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used "in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous," the FDA added.
That's because in about one in every 350 cases, women who undergo hysterectomy for fibroids may have an unsuspected uterine sarcoma, the FDA said, and morcellation might help spread that cancer.
"The FDA's primary concern is the safety and well-being of patients, and taking these steps will help the agency's safety recommendations to be implemented as quickly as possible," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the agency's news release.
"Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed," he added.
The FDA did not rule out the safe use of morcellating devices in some patients. The new warning label should help narrow the candidate patient population, however. "For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may [still] be candidates for this procedure," the agency said in the news release.
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