The laparoscopic power morcellator, in wide use for years, should not be used in the “vast majority” of women undergoing a hysterectomy or myomectomy, the Food and Drug Administration announced.
The updated safety communication regarding the use of laparoscopic power morcellators to treat uterine fibroids includes an Immediately in Effect guidance to manufacturers of the devices that the labels should include “specific safety statements” in the form of a boxed warning and two contraindications on proper usage.
“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 a statement. “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.”
According to the FDA announcement, the boxed warning on future labels should say, “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
The first of the two contraindications, both of which also would be included on all future laparoscopic power morcellator labels, warns against using the devices for removal of uterine tissue that possibly contains fibroids in patients who are perimenopausal or postmenopausal, and candidates for en bloc tissue removal through the vagina or minilaparotomy incision, as these groups of women “represent the majority of women with fibroids who undergo hysterectomy and myomectomy.” The second contraindication cautions against using laparoscopic power morcellators “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”
“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. Maisel said in a statement.
This announcement appears to be stronger than the previous statement, “perhaps geared to those select few who have not ceased using the laparoscopic power morcellator,” Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Gynecologic surgeons must collaborate with medical engineers to create equipment that will enable women to once again enjoy the advantages of minimally invasive techniques that we have worked so hard to develop,” he added. “We have seen an increased number of laparotomies, and thus increased women’s risk for postoperative morbidity. I am hopeful that novel approaches will soon be made available for our patients.”
This latest set of warnings is an update of guidelines originally issued by the FDA in April 2014, in which the federal agency stated that use of laparoscopic power morcellators for hysterectomy or myomectomy can significantly increase the risk of spreading “unsuspected” cancer found in the tissue of the uterine wall. A quantitative analysis released by the FDA estimated that 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.
The agency announced that its Immediately in Effect (IIE) guidance applies to all new and currently marketed laparoscopic power morcellators used for “general and specific gynecological indications.”
The campaign to highlight the risks of morcellators has been led by Dr. Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 leiomyosarcoma after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids. Dr. Noorchashm and Dr. Reed have called for a ban on the use of laparoscopic power morcellators.
Asked to comment on the FDA announcement, Dr. Noorchashm said the decision represents “ a massive and historic regulatory failure on the part of FDA Center for Devices and Radiological Health.”
In an interview, he added, “The evidence of avoidable deadly harm was beyond doubt in this case. But the FDA CDRH could not bring itself to fully protect those at risk. This demonstrates that the FDA is a ‘captured agency’ with more loyalty to corporate and industry interests than to patient safety. I think the United States Congress needs to conduct a hearing and overhaul and clarify the FDA’s overall mission. And in particular medical device safety legislation. Corporations have power, people don’t. And without cogent federal government, lives are left exposed.”