FDA warning on uterine device draws opposition from doctors

Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.

The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy. A power morcellator has tiny, high-speed blades that mince tissue into infinitesimal pieces, allowing doctors to perform the entire procedure minimally invasively, removing unwanted tissue through small incisions.

Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.

But in the unusual letter to the FDA — and a commentary published online Tuesday in the journal Obstetrics and Gynecology — the 48 gynecologists, gynecologic oncologists and surgical oncologists took issue with the agency’s decision, arguing that FDA officials got their numbers wrong about morcellation risks. Moreover, these doctors said the device should still be widely used in hospitals. Most institutions dramatically cut back or banned power morcellation altogether.

“No one is looking at the other side of the argument, and this is how many women will be harmed by being denied minimally invasive surgery,” said Dr. Eva Chalas, chief of gynecologic oncology and vice chair of obstetrics and gynecology at Winthrop-University Hospital in Mineola. Chalas is one of the letter’s signatories as well as a member of the Leiomyoma Study Group. Leiomyoma is another term for a fibroid.

The FDA required morcellator maker Karl Storz GmbH & Co. to add a so-called “black box” warning to its product label, the agency’s highest level of caution on medical devices and prescription drugs. The warning underscores a product’s potential for serious risks to patients that can include death.

In a statement, the FDA Monday night said, “The Agency’s recommendations have not changed. We continue to believe that inclusion of a boxed warning and contraindications to the use of power morcellation for uterine fibroid remajority of oval in the mwomen is both appropriate and necessary.”

Following its ruling in November 2014, Dr. William Maisel, chief scientist at the agency’s Center for Devices and Radiological Health, said the black box warning provides clinicians and patients with critical information about risks associated with spreading cancerous tissue when morcellation is performed.

“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,” Maisel said in a statement.

The FDA estimates the risk that morcellation can spread cancer to be 1 in 350. Before its research on morcellation links to cancer, the estimate was 1 in 1,000.

Chalas on Monday accused the agency of conducting little more than a Google search to obtain its risk ratio. She is supported by physicians from dozens of prestigious teaching institutions nationwide, including the University of California, Los Angeles, Vanderbilt University, Stanford University, University of Washington in Seattle, Yale University and Johns Hopkins. Chalas on Monday said her aim is to offer women a safe option and spare them from more invasive procedures that carry risks of blood clots, excessive bleeding and infection.

Signers of the letter said they have no affiliation with the power morcellation device maker and note in their journal commentary that they have no conflicts of interest of any kind. They said patients need to be properly selected for morcellation.

“We believe the FDA failed to identify important information, leading to inaccurate results,” said Dr. William Parker, lead author of the journal commentary and another signer of the letter to the FDA.

“We hope the agency will take a second look so that women will continue to have effective, minimally invasive treatment options for fibroids,” added Parker, director of minimally invasive gynecologic surgery at UCLA Medical Center.

Medical centers on Long Island and throughout the greater metropolitan area dramatically reduced their use of power morcellation or eliminated it altogether following the FDA’s ruling last year. Chalas said even her own hospital moved away from the device.

The North Shore-Long Island Jewish Health System, the largest hospital system in the region, is not using power morcellation at all.

“We decided even before the FDA decision — once the initial reports came out — to put a ban on it at all of our hospitals while we worked out what our appropriate action would be,” said Dr. Michael Nimaroff, vice chair and director of minimally invasive surgery.

Nimaroff said he and his North Shore colleagues conducted a study that was presented at a national meeting this year that showed alternative procedures produced excellent results without the risk. He underscored not being against morcellation and there are “containment” methods that improve the procedure’s safety.

Power morcellation has been awash in controversy following the 2013 case of Dr. Amy Reed, a Boston anesthesiologist who developed the dangerous cancer after power morcellation. The malignancy had lurked undetected in her fibroids. Her case helped open the FDA review of the medical device.

Hundreds of lawsuits have been filed against power morcellation nationwide. MoveOn.org has an ongoing petition to ban the procedure.

The recommendations

The doctors’ letter recommends:

* Greater caution should be exercised before recommending morcellation procedures for post-menopausal women, who are most at risk.

* Women 35 or older with irregular bleeding and presumed fibroids should have a biopsy of the lining of the uterus and normal Pap smear results.

* Although no test is available for leiomyosarcoma, certain ultrasound or MRI findings can raise suspicion of the cancer.

* Women considering procedures involving morcellation for fibroids should be informed of the potential risk of the cancer.

* Following morcellation, doctors should carefully inspect for retained tissue fragments and irrigate the pelvic and abdominal cavities thoroughly.

* Research projects should be initiated to find ways to noninvasively and preoperatively identify leiomyosarcoma and to discover how tissue fragments and cells are able to spread, implant and grow.