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Regulatory Focus™ > News Articles > GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators

GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators

Posted 08 February 2017 | By Michael Mezher 

GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators

The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids.

In August 2015, a bipartisan group of 12 US Representatives wrote to GAO calling on it to investigate the FDA's handling of the issue.

The report finds that FDA may have been hampered in its ability to identify safety issues with power morcellators, in part due to longstanding challenges with the agency's postmarket surveillance systems, including underreporting of adverse events and reliance on passive surveillance methods.

Background: Power Morcellators

In December 2013, The Wall Street Journal first reported on the potential risk for unsuspected uterine sarcoma to be spread by power morcellators. Shortly afterwards, FDA received the first adverse event reports describing the spread of cancerous tissue after procedures involving the devices.

By this time power morcellators had been on the market in the US for more than two decades.

In 1991, FDA cleared the first power morcellator via the agency's 510(k) pathway, finding the device substantially equivalent to another device used for cutting tissue during joint surgery.

Since then, the agency has cleared a total of 26 morcellator devices, the most recent of which was cleared in October 2016 for use in combination with a recently cleared tissue containment device.

While FDA knew of the risk of power morcellators to spread tissue—both cancerous and noncancerous—since first clearing the devices in 1991, the incidence of unsuspected uterine sarcoma in women with uterine fibroids was thought to be rare, between one in 1,000 and one in 10,000 patients.

Figure 1. Timeline of FDA Actions on Power Morcellators

Fig 1 - Power Morcellators

Prompted by the reports of cancer being spread by the devices, FDA took a number of actions, including convening a signal review team in 2013, and in 2014 issuing safety communications, convening an advisory committee to review safety issues related to power morcellators and issuing guidance requiring a boxed warning for the devices.

During the course of its review, FDA also revised its estimate of the incidence of unsuspected uterine sarcoma in women with uterine fibroids to one in 350, much higher than previously thought.

According to GAO, FDA officials also noted that there was "no consensus within the clinical community regarding the risk for [tissue dissemination], particularly cancerous tissue," for power morcellators.

During its investigation, GAO found 30 articles published between 1980 and 2012 that discuss the risk of tissue dissemination by power morcellators, though GAO says that many of these articles "were limited in scope."

Postmarket Surveillance

In the report, FDA officials point to limitations in current systems for medical device postmarket surveillance, which rely on spontaneous reports submitted by manufacturers, healthcare providers and patients.

So why did it take so long for FDA to receive reports linking power morcellators to the spread of unsuspected uterine sarcomas?

According to GAO's investigation, the answer may lie with how physicians approach adverse event reporting and FDA's ability to actively detect device safety issues.

"For power morcellators, officials from three health care providers (two hospitals and one physician group) that [GAO] spoke to stated that prior to November 2014, physicians would likely not have considered the spreading of unsuspected cancer following the use of a power morcellator as a reportable adverse event, because the device would have performed as intended (e.g., cutting and extracting tissue)," GAO says.

Between December 2013 and September 2016, FDA says it received nearly 300 adverse event reports citing unsuspected uterine sarcoma being spread following uterine fibroid treatment with a power morcellator.

However, prior to media reports on the issue in 2013, the agency hadn't received a single report making the connection. Additionally, FDA says it has only received five reports citing events that occurred after the agency issued its second safety communication for power morcellators in November 2014.

The report also cites issues with manufacturers failing to follow medical device reporting requirements.

According to GAO, FDA inspected 11 of the 12 manufacturers that marketed power morcellators in the five years leading up to its investigation, three of which were issued warning letters citing reporting violations.

Looking forward, FDA officials told GAO they hope to improve device surveillance by working more closely with hospitals to identify issues as they occur and by developing active surveillance systems such as the National Evaluation System for health Technology (NEST) that could provide actionable information on device safety more quickly.

GAO Report, Highlights


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