Patient Safety Coalition Protests FDA Approval of Aneurysm Device

A coalition of consumer and medical groups is protesting the FDA's recent approval of an aneurysm device that it says requires more rigorous testing, according to a Consumers Union news release.

The medical device is used for addressing complications from aneurysm treatments, and the FDA announced its approval following a small study of 10 women and 144 men. In a letter to FDA Commissioner Margaret Hamburg, the groups maintain that the device should have been classified as high risk and subject to stricter testing because it is implantable and life sustaining. Failure to function correctly could lead to serious injury or death.

 



The group also argued the clinical testing of the endovascular suturing system was insufficient since it only included 10 women, no comparison control group and only one year of follow-up. Based on these reasons, the coalition has called on the FDA to rescind its approval and require more rigorous clinical testing before entry into the market.

The letter is signed by the American Medical Women's Association, the Consumers Union, Public Citizen and several other groups. To view their letter to Commissioner Hamburg in full, click here.

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