New Bill Could Help Identify Potentially Dangerous Medical Devices

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New Bill Could Help Identify Potentially Dangerous Medical Devices
08.23.2016 News

Everyday millions of Americans rely on medical devices to live healthy lives, but when these devices turn out to be harmful, it can take months or years for the U.S. Food and Drug Administration (FDA) to take action. A new Bill introduced to Congress aims to shorten the time between reports of defective devices and FDA action.

Called the Medical Device Guardian’s Act, the Bill would require doctors to report adverse events to the FDA. Under current regulations, reporting is completely voluntary, and the side effects caused by dangerous devices often go unreported. The Bill is sponsored by Representative Mike Fitzpatrick and has been referred to the House Committee on Energy and Commerce.

The Dangers of Unreported Adverse Events

Fitzpatrick says he was inspired to sponsor legislation to change the reporting system after the delay in public awareness about the dangers of power morcellators. When the FDA approved power morcellators in the 1990s, there was clinical evidence suggesting the devices could inadvertently spread cancerous cells during laparoscopic hysterectomies and myomectomies. 

Despite clinical evidence and real-life experience, the FDA did not receive any reports of adverse events regarding morcellators until 2013. After the first report that the device spread cancer, hundreds of additional reports flooded the FDA. Finally in 2014, more than 20 years after its approval, the power morcellator was given a black box warning.

Growing Numbers of Defective Devices

Unfortunately for consumers, power morcellators are not the first instance of dangerous devices going unreported. A similar story can be told about the Essure contraceptive device. Approved in 2002, the birth control method became a popular method of permanent contraception because it did not require surgery or hospital stays. For nearly ten years, the Essure device was continually implanted in women, and many suffered from debilitating headaches, vomiting, nausea, device migration and organ perforation, and unexpected pregnancy, among other symptoms. For many women, the only way to get relief from their symptoms was to undergo a complete hysterectomy. 

The reports of dangerous side effects fell on deaf ears until 2015 when the FDA finally decided to investigate the device. In February 2016, the FDA issued a black box warning for the Essure device, but it was too late for thousands of women who had already suffered from the device.

Women’s gynecological and obstetrical devices aren’t the only defective medical devices that slip through the cracks under the current reporting system. Devices like IVC filters and hip implants were implanted into thousands of patients before the FDA released safety statements warning of the devices’ potential for failure. If passed, the Bill could help save thousands of Americans from the serious side effects caused by the use of defective medical devices.

Blizzard Law: Defective Medical Device Attorneys

If you or someone you love has been injured or killed by a defective medical device, you need a legal team that is not afraid to take on giant pharmaceutical companies. The experienced defective device lawyers at Blizzard Law PLLC have helped victims of dangerous devices for more than 30 years. Call us today for a free consultation to discuss your case.