Companies that make ultrasonic surgical aspirators should label them as contraindicated for removing uterine fibroids because they could inadvertently disseminate occult cancer, the US Food and Drug Administration (FDA) said yesterday.
The nonbinding guidance from the FDA reprises the agency's warnings about power morcellators and rekindles the debate in medicine over the risks and benefits of laparoscopic fibroid surgery.
Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.
Some devices are explicitly indicated for removing uterine fibroids, while other devices have more general indications — that is, for laparoscopic, open, and gynecologic surgery — that can be interpreted to include fibroid removal, according to the FDA.
In its guidance document, the FDA said the device's oscillating tip can disperse the tissue that it fragments with ultrasonic waves despite its suction action. In the case of cytoreduction, the risk of disseminating occult cancer is outweighed by the device's benefits, which include more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection, according to the agency.
However, when it comes to removing uterine fibroids, the risk of spreading occult cancer is not outweighed by the benefits, "particularly since there are alternative treatment options available," the FDA stated. The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."
Accordingly, the FDA said it was recommending the following addition to labels for ultrasonic aspirators indicated for laparoscopic, open, or gynecologic surgery: "Contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."
Power Morcellator Redux
It's not clear what triggered yesterday's guidance statement, which was proposed in November 2016. The FDA said it didn't know of any instances of surgeons using ultrasonic aspirators to remove uterine fibroids and that it was "generally not aware" of reports of the devices disseminating or upstaging occult uterine cancer. Such adverse-event reports frequently prompt the FDA to take regulatory action. Medscape Medical News asked the FDA whether some individual or group had requested the guidance, but the agency's response skirted that question.
One medical society is on record opposing the new FDA recommendation. Commenting on the draft version of the guidance last year, the American College of Obstetricians and Gynecologists (ACOG) said the contraindication for using ultrasonic aspirators to remove fibroids was "too rigid and eliminates patient choice." The society weighed in on the issue even though it didn't know of any surgeons using the device in hysterectomies and myomectomies. ACOG agreed that the device can disseminate occult cancer but disagreed with the FDA's claim that there are safer alternatives, noting that abdominal hysterectomies come with greater health risks. "The College recommends minimally-invasive approaches to hysterectomy," ACOG said. It pointed to a draft study by the Agency for Healthcare Research and Quality stating that "the risk of encountering a sarcoma at the time of fibroid surgery is low and the method of fibroid tissue removal does not appear to determine survival."
ACOG makes the same argument about the need to preserve laparoscopic power morcellation as an option for women with fibroid tumors. The use of power morcellators to shred uterine tissue has declined sharply since 2014, when the FDA added a boxed warning to their labels stating that they should not be used in most women undergoing a hysterectomy or myomectomy for fibroid removal lest occult cancer be dispersed. One in every 350 women who has such a procedure will develop an occult uterine cancer, according to the agency.
Power morcellators came on the market in 1991, but it wasn't until December 2013 that the FDA received its first report of the device upstaging an unsuspected uterine cancer. The patient was anesthesiologist Amy Reed, MD, PhD, MD, PhD, a mother of six who underwent a laparoscopic hysterectomy 2 months before and then discovered that she had a uterine leiomyosarcoma, which morcellation had advanced to stage IV. Dr Reed died at 44 years of age on May 24.
In February, the Government Accountability Office reported that before the boxed warning in 2014, hospital executives and physicians didn't feel obliged to report instances of power morcellators upstaging occult cancer because the devices were not malfunctioning but rather performing as intended.
Before her death, Dr Reed and her husband, Hooman Noorchashm, MD, PhD, waged a high-profile campaign to ban the use of power morcellators in gynecologic surgery. Dr Reed lived to see one manufacturer of power morcellators withdraw its product from the market, some hospitals drop the procedure, and some insurers stop paying for it. Dr Noorchashm continues to carry on the fight.
Violation of a Core Surgical Principle?
In an interview with Medscape Medical News, Dr Noorchashm called the FDA's guidance on ultrasonic aspirators "appropriate" but asked why the FDA hadn't recommended the same kind of absolute contraindication for power morcellators (the agency spokesperson declined to answer that question). Dr Noorchashm, a heart surgeon, surmises that the FDA caved in to industry pressure to keep power morcellators in the hands of gynecologic surgeons.
Any number of medical devices, ranging from manual morcellators to robotic surgery systems to ultrasonic aspirators, can be used to remove uterine fibroids laparoscopically, he said. All of them have the potential to disperse occult cancer. The core problem, he argued, is not the devices but the willingness of gynecologic surgeons to use them, despite the risk of disrupting a possible cancer.
"That's a core surgical principle being violated," said Dr Noorchashm. He said that gynecologic surgeons would know better if they were cross-trained in other surgical disciplines. "It's not malice, but cognitive corruption."
Medscape Medical News requested an interview with a physician leader of the Society of Gynecologic Surgeons, but the group did not make anyone available.
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Cite this: FDA: Don't Remove Uterine Fibroids With Ultrasonic Aspirators - Medscape - Oct 31, 2017.