Federal Watchdog Agency Will Probe Power Morcellators

September 04, 2015

The US Government Accountability Office (GAO) is going to launch an investigation into controversial power morcellators.

The devices shred uterine fibroids for easy removal through laparoscopic incisions. Critics say the devices accomplish that at the cost of endangering women's lives and therefore should be banned.

In April 2014, the US Food and Drug Administration (FDA) warned against using power morcellators for hysterectomies or myomectomies in most women with uterine fibroids because of the risk of spreading occult uterine cancer, found in 1 in 350 women undergoing these procedures. Six months later the FDA added a boxed warning to product labels.

Twelve members of Congress asked the GAO  last month to find out why the FDA took so long to issue its warnings, given that the devices have been on the market since 1991, and studies have long established the high risk they pose for spreading occult uterine cancer. The lawmakers also want to know if an expedited FDA approval process called 510(k) missed the cancer risk of the devices before they were cleared for use. They blamed power morcellators for hundreds, if not thousands, of deaths.

Earlier this week, the GAO informed Rep. Mike Fitzpatrick (R-PA), one of the leaders of the congressional group, that it would go forward with the requested study in about 5 months.

A Device Falling Into Disfavor

The problem with power morcellators gained national attention nearly 2 years ago after anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy for fibroid removal in late 2013 and then found out that the procedure had upstaged an occult tumor. Dr Reed and her husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, have lobbied the FDA and Congress to ban power morcellators and tighten the FDA's 510(k) approval process. Under 510(k), a manufacturer only needs to demonstrate that its product is substantially the same as a device already on the market. The physician couple says this process can put patients in harm's way because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events.

Since the FDA issued its first warning about the devices in April 2014, power morcellators have fallen into disfavor.  One manufacturer, Johnson & Johnson, voluntarily pulled its morcellators from the market, and major insurers have dropped or restricted coverage of morcellation procedures.  As a result, fewer surgeons are using the devices.

In an interview with Medscape Medical News, Dr Noorchashm said the GAO's decision to look at the regulatory history of power morcellators was "a step in the right direction." He cautioned, however, that the GAO could be unduly influenced by morcellator manufacturers, unnamed FDA officials, and gynecologic surgeons "who are trying to sugarcoat this thing and create the illusion that there's no problem."

"We'll see if the GAO is a nonpartisan, objective third party," he said.

Dr  Noorchashm's wife Dr Reed has experienced two recurrences of her cancer since her initial surgery for it. Dr  Noorchashm said she is undergoing an experimental treatment that the two of them devised in lab work.


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