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Defective Medical Device Issues: The Limited Adverse Event Reporting System for Implant Defects


Issues with defective medical devices are so common that the U.S. Food and Drug Administration (FDA) has implemented a system designed specifically to identify and address medical device defects. This system, known as Medical Device Reporting (MDR), requires device manufacturers and importers to report known product defect or safety issues, and the FDA utilizes various other “postmarket surveillance tools” to identify adverse events involving implantable medical devices as well.  Treating physicians and patients are also encouraged to report adverse events from the use of medical devices and can make these reports by completing a MedWatch report through the FDA’s web site.  

Unfortunately, the MDR system has proven to be woefully inadequate. As explained by Dr. William H. Maisel, “[b]ecause of incomplete adverse event descriptions, significant underreporting of device-related adverse events, and the absence of denominator data, [MDR] data have significant limitations.” In other words, many adverse events involving implantable medical devices do not get reported, and this increases the risk of patients suffering unnecessary injuries and health complications significantly.

The FDA Receives Hundreds of Thousands of Reports about Defective Medical Devices Each Year

According to the FDA, each year the agency receives, “several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions.” These reports come from three primary sources:

  • Implantable Medical Device Manufacturers – Device manufacturers are required to submit reports to MDR, “when they learn that any of their devices may have caused or contributed to a death or serious injury.” Depending on the nature of the adverse event, the manufacturer may be required to issue a recall as well.
  • Implantable Medical Device Importers – Importers have similar reporting obligations to manufacturers. They are also required to notify manufacturers, “if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
  • Hospitals and Other Medical Facilities – Hospitals and other medical facilities must report suspected device-related deaths to the FDA and the manufacturer, and they must report serious injuries to the manufacturer (or the FDA if the manufacturer is not known). Medical facilities also have the ability to report device malfunctions that do not result in serious injury or death, although such reporting is not required.

Patients and healthcare providers can access some of the FDA’s adverse event database (known as MAUDE) through the FDA’s web site.

Limitations of the Adverse Event Reporting System for Implanted Medical Devices

Despite the volume of reports submitted to the FDA, it is widely understood that medical device defects are vastly underreported, with estimates being that far less than 10% of adverse events are ever reported to the FDA for failed medical devices. The MDR is far from comprehensive in terms of what it requires; and, while this is a matter of practicality to an extent (the FDA has acknowledged that it lacks the capacity to fully monitor all device-related adverse events), it still presents significant risks for patients. For those who experience adverse events, it is important to speak up, and this starts with engaging legal counsel to take appropriate legal action on your behalf. Sadly, the filing of a lawsuit on behalf of an injured patient is often the first very time that a manufacturer makes an adverse event report to the FDA for a failed device due to a number of loopholes and lack of adherence to current FDA requirements regarding this critical safety data. 

Coming Up in Part Four…

In Part Four of our five-part series on implantable medical device issues, we will examine the pervasive and widely-acknowledged concern of medical device manufacturers prioritizing profits over safety.

Contact the Florida Product Liability Lawyers at Searcy Denney

Searcy Denney is a Florida product liability law firm that represents individuals and families in claims against implantable medical device manufacturers nationwide. If you or a loved one has experienced an adverse event, we encourage you to call us 24/7 at 800-220-7006 or contact us online to arrange a complimentary consultation.

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