FDA Report Exposes Flaws With Post Marketing Reports of Medical Devices

Defective Medical Devices
FDA Reporting

By Zac Pingle, Staff Writer

On Wednesday, the Government Accountability Office (GAO) released a report regarding the investigation of the federal Food and Drug Administration (FDA) and its handling of adverse event reports of laparoscopic power morcellator devices.

Since 2013, reports of power morcellator devices spreading cancerous and noncancerous tissues in patients treated for uterine fibroids. Specifically, The Wall Street Journal first questioned the health risks associated with power morcellators, as several doctors pointed to the connection of cancerous tissue being released into a patient’s body during the minimally invasive procedure of removing growths from the uterus. In the 20 years previous to this article, the FDA did not receive any reports making such a connection to power morcellator devices, according to the GOA report.

However, the FDA did estimate that a risk of cancer from this procedure may exist at a rate of between one in 1,000 to one in 10,000. It was later found the actual risk of releasing cancerous tissue into a patient was about one in 350. Since the article from The Wall Street Journal was published, the FDA received almost 300 reports of adverse events involving morcellator devices between December 2013 and September 2016.

In response to the reports, the FDA created a Safety Communication team in 2014 to make reporting such events a priority. Additionally, in 2015 a bipartisan group of 12 US Representatives wrote to the GAO, calling for an investigation into the FDA’s procedures in handling the matter.

The Problem With FDA Reporting

The system currently in place at the FDA relies almost solely on manufacturers, healthcare providers and patients reporting adverse events of medical products to the FDA. Furthermore, it is relatively rare for medical devices to be tested by an outside party once they have hit the market. This, as speculated by the GAO, plays a large part in why medical products are not reported and recalled until many people have already suffered from adverse effects.

In this case, there was simply very little coverage in the medical community that made the connection between power morcellator devices and the risk of spreading cancer. The GAO points to the fact that there were only 30 articles regarding the risk of power morcellators between 1980 and 2012, and that these articles were “limited in scope.” The GAO report also states that “no consensus within the clinical community [existed] regarding the risk for [tissue dissemination], particularly cancerous tissue,” from the use of power morcellators. The GAO also elaborated that physicians did not report unsuspected cancer following a uterine growth removal procedure because “the device would have performed as intended (e.g., cutting and extracting tissue).”

The fact that very few agencies exist for the purpose of testing and analysing on-market medical devices means that reports critical of medical device safety do not make it to the FDA until it is too late for many patients. The GAO also believes that failure of manufacturers to report adverse events to the FDA may have also played a part. The point is, the FDA can only be notified of a potentially dangerous product if it is informed by the manufacturer or physician, both of which derive income from selling such products. The FDA can also be notified by patients themselves. Unfortunately, patients usually have little or no knowledge regarding the medical science behind medical devices and no way to associate their conditions with a defect in those products.

To report an adverse event to the FDA, click here.

Add new comment