The U.S. Food and Drug Administration has issued a warning against using a common surgical instrument to remove the uterus or fibroids in women.
In a statement posted on the official website of the FDA on Monday, 24 November, the agency said that using the laparoscopic power morcellators for surgeries can pose a serious health risk if the patient suffers from undiagnosed cancer.
The FDA said that the surgical tool used during fibroid surgery can spread an unsuspected cancer to other parts of the body, including the abdomen and pelvis and thus affect a patient's long-term survival.
The device, according to drugwatch.com, uses its rotating blades to cut a small opening and break down large tissue masses, including fibroids, into small fragments. These devices have been widely used by doctors as they provide faster recovery; involve less pain and other complications after the surgery.
The latest warning comes after the agency found that one in 350 patients of hysterectomy (removal of uterus) or myomectomy (removal of fibroids) also suffered from an unsuspected uterine sarcoma, a malignant cancer formed in muscles or tissues of uterus.
The report warned against using the devices on two types of patients: women who are either around menopause or have already reached menopause, or patients whose tissues can be removed undamaged through vagina or a small opening.
"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," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news release.
FDA has also made it mandatory for manufacturers to include a box warning while labelling their product. "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," Dr. Maisel, said.
In an attempt to spread awareness among professional involved in this field, in July this year, the federal authorities had organized a meeting of Obstetrics and Gynecology Devices Panel.
