Twelve members of Congress asked a federal watchdog agency last week to investigate why the US Food and Drug Administration (FDA) took so long to warn that power morcellators may spread unseen cancers in the course of removing uterine fibroids.
"Hundreds, if not thousands, of women in America are dead" because of these devices, the bipartisan group of lawmakers wrote in an August 7 letter to the US Government Accountability Office (GAO).
The lawmakers also want the GAO to determine whether an expedited FDA process for approving medical devices "sufficiently identified" the cancer risk before power morcellators entered the marketplace.
The 12 members of Congress include Rep. Michael Fitzpatrick (R-PA), Rep. Louise Slaughter (D-NY), and Rep. Ralph Abraham, MD (R-LA).
First approved in 1991, morcellators shred uterine tissue for easy removal through laparoscopic incisions. The FDA recommended in April 2014 that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids. It estimated that 1 in 350 women undergoing these procedures for fibroid removal have an unsuspected uterine cancer. Six months later, the agency added a boxed warning to the devices saying that they may spread occult cancer and "decrease the long-term survival of patients."
The healthcare industry has been retreating from the use of power morcellators ever since. One manufacturer, Johnson & Johnson, has voluntarily withdrawn its morcellators from the market, and several major insurers have dropped or restricted coverage of the procedure. As a result, fewer surgeons are morcellating uterine tissue, according to America's Health Insurance Plans.
Courting of Congress Pays Off
The recent scrutiny of power morcellators began in early 2014 after anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy for fibroid removal in late 2013 and later discovered that the procedure led to the upstaging of an occult tumor. Dr Reed and her husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, have vigorously campaigned for the ban of power morcellators and reform of the FDA approval process, called 510(k), that brought the devices to market. Under 510(k), a manufacturer need only establish that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm say this expedited process endangers patients because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events.
The physician couple has courted various members of Congress to join their cause. With the request for a GAO investigation, their efforts have apparently paid off.
The 12 lawmakers who petitioned the GAO noted that studies going back to 1990 have reported that the risk for women having occult uterine cancer was anywhere from 1 in 200 to 1 in 462.
"Despite these studies, as late as last year, the FDA, the medical device industry and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-ten thousand," the lawmakers wrote. "How did they get it so wrong for so long?"
Besides requesting a study of the FDA's delayed response to the risk associated with power morcellators and the possible failings of its 510(k) process, the 12 members of Congress asked the GAO to determine the following:
Whether power morcellator manufacturers, importers, user facilities, and the FDA followed adverse-event reporting regulations to safeguard patients;
What activities or training the morcellator manufacturers provided to clinicians, and what medical society standards apply to learning how to use the devices;
What steps the FDA is taking to decide whether power morcellators should remain on the market.
The GAO does not automatically undertake every investigation requested by Congress. "We typically look at such things as whether data needed would be available, whether there are any legal obstacles, whether an Inspector General's Office already has work under way, as well as several other factors," said GAO spokesperson Chuck Young. It usually takes a few weeks for the agency to decide whether to launch a study, according to Young.
In an interview with Medscape Medical News, Dr Noorchashm acknowledged that a GAO inquiry is not guaranteed. "They probably will investigate," he said. "But there's no guarantee that the Congress will act on a GAO investigation."
"A lot of people have died," said Dr Noorchashm. "The legislation [that established the FDA approval process] is broken. We're asking for a root-cause analysis."
His wife, Dr Reed, underwent cytoreduction and hyperthermic intraperitoneal therapy followed by six rounds of systemic chemotherapy after her upstaged uterine cancer was discovered in 2013. Subsequent MRI and CT scans could not find any cancer, and she returned to work. In February, she had a second operation along with radiation therapy after the cancer resurfaced behind her left kidney, impinging on her spine and the second lumbar nerve.
Dr Noorchashm said his wife experienced a second reoccurrence of the cancer in June, this time near her thoracic spine, leading to more radiation therapy.
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Cite this: Lawmakers Ask GAO to Investigate Power Morcellators - Medscape - Aug 11, 2015.