• Government Agency Cites Gaps in FDA’s Reporting System in Power Morcellator Report
  • May 16, 2017
  • Law Firm: Law Offices of Peter G. Angelos A Professional Corporation - Baltimore Office
  • In August 2015, The Government Accountability Office (GAO) received requests from 12 US Congress Representatives to investigate the FDA’s handling of adverse event reports regarding laparoscopic power morcellator devices. Such reports claimed that the use of laparoscopic power morcellators spread cancer in those being treated for uterine fibroids. Early this year, the GAO released a report of its findings from the investigation.

    The GAO’s report found that the FDA’s post-market surveillance systems had significant problems leading to a hindered ability, on the administration’s part, to identify safety problems with the device. Specifically, the report found that the setup of the surveillance system led to underreporting of negative events due to a reliance on other passive methods of discovering gaps.

    The FDA requires medical device manufactures and importers to disclose any adverse device-related events within 30 days of the occurrence. The current passive reporting system has severe limitations as it relies on individuals to notice harmful occurrences or risk rather than the FDA proactively testing and seeking out any issues. This can leave serious gaps in the reporting system and often leads to un-reported or misreported adverse events.

    In cases when a power morcellator is used during surgery and the patient has undiagnosed uterine sarcoma, both the benign and the cancerous cells are strewn throughout the patient’s abdominal region, unknowingly causing the spread of cancer. The GAO report found that while the FDA knew of this potential risk even during the original approval process, the risks was overlooked because device makers claimed it was about 1 in 10,000. Today, however, the FDA estimates that the odds of a women undergoing myomectomies or hysterectomies also having undetected cancer is about 1 in 350.

    Despite the surveillance process, the first report of an adverse event linking the power morcellator with the spread of cancer was not received until December 2013, more than 20 years after the original approval. Even though the FDA’s Center for Devices & Radiological Health received reports which were triggered by cancer incidences, it stated that they saw no corresponding event reports linking the two. This is, in part, attributed to doctors who failed to connect the cancers to the power morcellator device.

    While companies such as Johnson and Johnson have voluntarily pulled their power morcellator devices and the FDA has issued a “black box” label warning of the risk, there is still much to be done to address future use of this device, the provision of aid to the effected individuals and the FDA’s passive reporting system.

    “The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen and include a roadmap to address it.” said Representatives Louise Slaughter (D-N.Y.) and Brian Fitzpatrick (R-Pa.) in recent remarks. Slaughter and Fitzpatrick are part of the 12 members of congress who requested the investigation into this device in August 2015.