Public overwhelmingly supports stronger medical device oversight

A Consumer Reports poll shows the public overwhelmingly supports more government oversight of medical devices. The poll was released just as House and Senate Committees released draft legislation to change the way medical devices are approved by the Food and Drug Administration (FDA).

Currently, the vast majority of medical devices are approved by the FDA through an accelerated program that allows devices to be approved with clinical trials to evaluate safety and efficacy if there are similar devices already on the market. This process was established several years ago to help move a backlog of devices through the system and deliver them quickly to consumers who need them. It soon became apparent that the expedited process was making the public serve as guinea pigs for medical devices with unproven safety records.

Reports of problems with the process began surfacing. One example is transvaginal mesh, a type of surgical mesh used in the repair of pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. Complaints to the FDA show that the devices have caused serious and often lifelong problems when the mesh erodes into the vaginal wall.

Consumer groups called for a ban of the products, but an FDA advisory panel recommended keeping the products on the market but putting stronger warnings on its labels. Most transvaginal mesh devices were approved through the FDA’s expedited approval process.

The problem with the FDA’s medical device approval process came to a head in recent months, forcing the agency to consider other approval methods. It proposed to the committees raising fees medical device companies pay to have their devices approved. This extra money would be used to hire 200 new federal employees over the next five years who would work closely with device manufacturers to not only speed up the approval process, but also better vet them before approval is granted.

But the Consumers Union, the policy and advocacy arm of Consumer Reports, is fighting that plan. The group says Congress should reject the committee’s draft bill because it would significantly weaken device safety oversight rather than strengthen it.

“Our poll shows that Americans support common sense reforms that would help improve medical device oversight and keep patients safe,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “The vast majority of the public wants strict requirements that ensure new implants are safe and effective.”

Source: InfoZone