A coalition of patient, consumer, and public health groups urged the federal Food and Drug Administration to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.
“This decision by FDA sets a bad precedent for approving new devices,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Medical devices intended to save lives should require the FDA’s most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands of patients at risk of serious harm, similar to what we have seen with recalled metal hips and surgical mesh.”
A news release from the Consumers Union, publisher of Consumer Reports, states that the FDA recently granted approval for the new device after a small study of only 10 women and 144 men, under a process that is not as rigorous as the process the law requires for devices that are life-saving or life-sustaining.
The Consumers Union joined organizations including the National Women’s Health Network, U.S. PIRG and Public Citizen in sending a letter dated Feb. 29 to FDA Commissioner Margaret Hamburg. It concerns the endovascular suturing system, which is intended for the repair of aortic endografts, used to seal off aneurysms.
In the letter, the organizations argue that the device should have been classified as high risk and subject to stricter testing because it is implantable and life sustaining, and would result in serious injury or death if it doesn’t work correctly.
By law, high-risk devices are supposed to be reviewed through the FDA’s premarket approval (PMA) process, which requires a comprehensive evaluation, including scientific clinical studies, to ensure the device’s safety and effectiveness. However, the FDA reviewed the device under the de novo process, which is intended for low and moderate risk medical devices and is not as rigorous as the process for devices that are life-saving or life-sustaining.
