A coalition of patient, consumer and public health groups on Wednesday urged the Food and Drug Administration to require more rigorous medical testing before putting a device used to address complications from aneurysm treatments on the market.
The FDA recently approved the device, but the coalition, in a letter to Commissioner Margaret Hamburg, called for stricter testing, saying the machine carries high risks to patients since it is surgically implanted and potentially life-saving.
“Medical devices intended to save lives should require the FDA’s most rigorous safety testing,” Lisa McGiffert of Consumers Union, one of 12 groups to sign the letter, said in a statement. “Bypassing such testing up front can put hundreds of thousands of patients at risk of serious harm.” The letter asks Hamburg to rescind the approval and require more stringent testing.
The FDA had not commented on the letter by early Wednesday afternoon.
The device, called an endovascular suturing system, is used in patients with complications following an endovascular graft used to treat aneurysms. The safety groups say the device was reviewed under a process that did not require as comprehensive an evaluation and clinical study as other devices that carry low and moderate risks to patients.
The letter follows a congressional inquiry into concerns raised by FDA scientists about the approval system for other medical devices. The Washington Post reported in January that the agency for two years intercepted and stored the Gmail communications of a group of agency doctors who raised concerns with Congress about the agency approving cancer screening and other devices despite the doctors’ determinations that the devices were not safe or effective.
The employees, who accessed their Gmail from work computers, filed suit in U.S. District Court in Washington alleging the agency violated their Constitutional right to privacy. The FDA relied on the information it gleaned through secret surveillance to fire, harass or pass over for promotion at least six doctors and scientists who communicated with Congress, the suit alleged.
An FDA spokeswoman said the surveillance was done because the scientists went public with confidential company information, a charge they deny.
House and Senate lawmakers have demanded that the FDA explain the legal basis for targeting employees who were raising concerns about unsafe medical devices.