Why the FDA Took 23 Years to Warn About Morcellators: GAO Report

February 10, 2017

A new government study sheds light on why the US Food and Drug Administration (FDA) took 23 years to warn physicians and patients about the potentially fatal risks of power morcellators used in gynecologic procedures after the first device  was approved in 1991.

A member of Congress who asked the Government Accountability Office (GAO) to investigate this time lag said that the study identified "serious gaps" in the FDA's system for detecting postmarket problems with medical devices.

Surgeons use power morcellators in minimally invasive hysterectomies and myomectomies for the removal of uterine fibroid tumors. A morcellator shreds uterine tissue so it can be extracted through laparoscopic incisions. From the beginning, the FDA knew there was a low risk that the tool could disperse unsuspected uterine cancer in the abdominal cavity and upstage it, but the agency did not receive an adverse-event report on such a mishap until December 2013, according to the GAO study, issued earlier this week.

That report was filed by anesthesiologist Amy Reed, MD, PhD. Dr Reed, a mother of six, underwent power morcellation during a hysterectomy for fibroid removal in October 2013. The procedure dispersed an occult leiomyosarcoma, advancing it to stage IV. While battling her cancer, Dr Reed and her husband, Hooman Noorchashm, MD, PhD, have campaigned to ban the use of power morcellators in gynecologic procedures and strengthen FDA oversight of all medical devices.

After the FDA received Dr Reed's adverse event report, others like it poured in — 284 more through September 2016. Many could have been flushed out by Dr Reed's well-publicized case. Stories of women who died after morcellation upstaged an occult uterine cancer made the news. The FDA investigated and in April 2014 warned against using power morcellators in most women undergoing hysterectomy or myomectomy for uterine fibroids.

In November 2014, the agency turned that recommendation into a boxed label warning. The FDA also said at that time the dispersal of uterine cancer represents a serious injury that hospitals and other healthcare facilities must report to the FDA.

That instruction was another way for the FDA to say, "Don't keep us in the dark."

The agency requires device manufacturers and so-called user facilities, such as hospitals, to report any time a device may have caused, or contributed to, a serious injury or death. That requirement doesn't extend to physicians, but the FDA encourages them, along with patients and their caregivers, to voluntarily report problems.

Before December 2013, the FDA hadn't received any adverse event reports on power morcellators dispersing occult cancer. Hospital executives and physicians interviewed by the GAO said that up until the FDA ordered the boxed warning in November 2014, they didn't feel obliged to report such incidents because the devices were not malfunctioning but rather performing as intended, shredding uterine tissue.

"That's a cop-out," Dr Reed's husband, Dr Noorchashm, told Medscape Medical News. Hospitals and physicians who interpreted the reporting requirement that way, Dr Noorchashm said, should have known better because reportable adverse events aren't limited to device malfunctions but encompass a worsening disease state.

"We're talking about corporations and hospitals with educated lawyers who can read the law," he said.

An FDA investigation found evidence of widespread violations of reporting requirements involving both power morcellators and duodenoscopes, the GAO noted. In December 2015, the FDA began inspecting 17 hospitals where patients had acquired infections from contaminated duodenoscopes or, in the case of 5 hospitals, power morcellation had dispersed occult uterine cancer in women. Contrary to the FDA's expectations, there was no information about these incidents in the agency's adverse event database for medical devices. The FDA faulted the 5 hospitals inspected on account of morcellator mishaps for "significant deviations" from reporting requirements, the GAO said.

The GAO quoted Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, as saying that some hospitals lacked adequate procedures for reporting device-related death or serious injury, and sometimes hospital staff had a sketchy understanding of FDA reporting.  Dr Shuren also said the FDA believes that the 17 hospitals were not outliers but instead represented the tip of the iceberg in terms of nonexistent or limited disclosure of device mishaps.

When the FDA began to receive a stream of adverse event reports about the morcellators, manufacturers supplied the lion's share. Of the 285 reports from December 2013 to September 2016, more than 88% came from manufacturers; 10% from patients, family members, and physicians; and less than 2% from hospitals and other healthcare facilities.

Only 5 of the 285 adverse event reports were submitted to the FDA after the agency ordered the boxed warning in November 2014. The nose-dive in reporting paralleled a significant decline  in the use of power morcellations in minimally invasive hysterectomies since December 2013. One manufacturer of the devices pulled them from the market, some hospitals dropped the procedure, and some insurers stopped paying for it.

Many gynecologic surgeons, however, contend that laparoscopic power morcellation should remain available to women who need a hysterectomy or myomectomy because they would face a higher risk for injury and death in a traditional, open-field surgery.

A Murky, Misunderstood Risk

The GAO also explored what the FDA thought the risks of power morcellators were before it received the December 2013 report from Dr Reed.

The study looked at 25 power morcellators, nearly all of them indicated for gynecologic surgery, that the agency approved from 1991 through 2014. There were no clinical trials to assess their safety or efficacy because they were all greenlighted through the FDA's 510(k) approval process. Under 510(k), a manufacturer need only demonstrate that its product is substantially the same as one already on the market. In the case of the first power morcellator approved in 1991, the predicate product was an electromechanical device for cutting tissue in orthopedic procedures. The 24 morcellators that followed piggy-backed on a previously approved morcellator.

Despite having no clinical trial data in hand, FDA regulators told the GAO they had known that power morcellators could spread occult uterine cancers since 1991. This awareness explained why labels for 12 of the 25 morcellators recommended that surgeons use a containment bag when they cut tissue that is diagnosed as or suspected to be cancerous, or any other tissue that could prove harmful if dispersed.

Research published before Dr Reed's case also identified the risk of power morcellation spreading tissue, but FDA officials told the GAO that consensus was lacking about the exact nature of the risk, particularly when it came to cancer tissue. The GAO dug up 30 articles published between 1980 and 2012 that "mentioned or concluded a risk of tissue dissemination" with power morcellation or the need to remove all tissue fragments following a surgery.

However, the GAO said most of these papers were case studies or otherwise limited in scope. And none of the studies estimated the risk of spreading tissue — cancerous or not — during power morcellation, according to the GAO.

The FDA came up with a risk estimate by proxy, however. Before December 2013, the prevalence of occult uterine cancer in women with a presumed uterine fibroid was thought to range from 1 in 1000 women to 1 in 10,000, the GAO said. FDA officials reasoned the risk of power morcellation dispersing such cancerous tissue would be just as low.

After Dr Reed filed her report, the FDA reviewed the scientific literature to reassess the risk of morcellation spreading occult cancer and announced startling lower numbers in April 2014. It estimated that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids would have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.

Reactions to the GAO Study

In a statement issued to Medscape Medical News, the FDA said that it agreed with the findings of the GAO report and continued to warn against using power morcellators in hysterectomies and myomectomies for most women.

The agency also said that it was well aware of the shortcomings of the "passive" system now in place to monitor medical devices after they reach the marketplace.  It is passive because it depends on institutions and individuals to identify a harmful mishap, or the risk for it; link it to a particular medical device; and take the time and trouble to report it. The FDA said it was building an improved, more active surveillance system called the National Evaluation System for Health Technology. It's designed to glean performance data on medical devices from electronic health records, billing claims, clinical registries, and other data sources.

The American College of Obstetricians and Gynecologists (ACOG) issued a statement both applauding the thoroughness of the GAO investigation and reaffirming its support of power morcellation as an "important option" for removing fibroid tumors, provided that clinicians obtain informed consent and evaluate risk factors for uterine cancer.

"Morcellation is a minimally invasive technique that spares women from increased morbidity and mortality associated with abdominal surgery," said ACOG CEO Hal Lawrence, MD, in a statement released to Medscape Medical News. "All medical procedures carry risk and that risk can never be completely eliminated. Moving forward, ACOG welcomes the collection of meaningful data that will help provide for the safe and effective use of power morcellators."

In contrast, Dr Noorchashm told Medscape Medical News that the GAO study confirmed the severity of the risk posed by power morcellators. Extrapolating the 285 adverse events reported to the FDA from December 2013 to September 2016 to the previous 2 decades of morcellator use suggests that "hundreds if not thousands of women have been harmed, or have died," said Dr Noorchashm.

The study, he said, also underscores the need to tighten the FDA's 510(k) approval process for medical devices so that they are subject to safety vetting beforehand and active surveillance afterward. Another needed reform, Dr Noorchashm said, is passage of the Medical Device Guardians Act, which would require physicians to report deaths or serious injuries caused by a device to the FDA.

Rep. Louise Slaughter (D-NY), a cosponsor of the bipartisan measure,  said the GAO study established "what we have long expected: there are serious gaps in the FDA's device reporting system, and that immediate Congressional action is needed to reform the process and save lives."

"After the initial report from Dr Reed, hundreds of other safety reports began to flow into the FDA," Slaughter said in a news release. "But it should not have fallen upon the patients to bring this to the FDA's attention."

As for Dr Reed, her husband said that she continues to fight a very aggressive leiomyosarcoma with chemotherapy, immunotherapy, radiation therapy, cryoablation, and repeated surgeries, the last one in early February.

"She's recovering well," said Dr Noorchashm. "We're hoping to achieve a cure at some point."

Follow Robert Lowes on Twitter @LowesRobert

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