The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal.
The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used on a patient with an undetected cancerous growth, it can enable the cancer to spread, according to the FDA.
The tools have been under the scrutiny of the FDA for over a year – last November, the agency released a security communication warning that women undergoing hysterectomies or myomectomies using power morcellators faced 1 in 350 odds of having an undetected cancer that could significantly worsen through the treatment.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the agency wrote in their warning letter.
The Wall Street Journal said the GAO has agreed to take up the torch, stating the agency was likely to have staff to investigate the devices, their regulatory approval and other issues within 5 months.
The investigation was prompted by a letter signed by 12 members of congress who wanted the group to probe the use and clearance of the devices. The letter requested an investigation into the FDA’s handling of the devices, how it’s ensuring their safety and what it is doing to ensure the still-commercially-available devices aren’t causing harm, according to the paper.
Last July, An FDA panel convened to consider the use of power morcellators in fibroid removal in hopes of coming to a clear decision on the cancer risk from the devices, despite outraged testimony from dozens of attendees.
The 15-member panel offered several suggestions for mitigating the risk of spreading uterine sarcomas in using the morcellators, including an outright ban, stricter product labeling and limiting use in some patient populations.
The panel urged surgeons to take precautions including MRI, radiologic imaging and biopsy and to take patient age and exam findings into account to ensure a fibroid is not cancerous prior to removal. Peri-menopausal and post-menpausal women should definitely not have morcellation, they said. The committee also called for enhanced warnings to surgeons and increased communication to ensure that patients know there is a small but grave risk associated with the use of laparoscopic surgery and the use of LPMs and that other options, such as more invasive abdominal surgery, are available.
