Congress considers medical device approval process

Members of Congress are debating this week whether to speed up the approval process for moderate-risk medical devices to help patients in need even if it puts those patients’ lives at risk.

The hearing bring to light a highly debated topic, and one that is pitting medical device manufacturers against consumer groups. These consumer groups include people like Lena Keeton, who nearly died after contracting a flesh-eating bacteria following surgery in 2001 during which she received surgical mesh to treat occasional incontinence. Overcoming the bacterial infection was only part of Keeton’s ordeal. Over the next decade, she has undergone 17 surgeries and ongoing medical complications because of the defective transvaginal mesh.

The surgical mesh bladder sling Keeton received to treat her condition is considered a moderate-risk medical device. Like nearly 90 percent of medical devices in this class, the mesh was approved by the Food and Drug Administration (FDA) for use without clinical testing to determine its safety and effectiveness because similar products were already on the market.

This accelerated approval process has been the norm for years. Medical device manufacturers say the process allows medical technology to move forward and puts needed devices on the market for patients in need. But consumer advocacy groups argue that this process is flawed, allowing the general population to serve as guinea pigs.

“We’re becoming a nation of cripples with stuff that’s supposed to save our lives,” Keeton told the Austin American-Statesman.

The Congressional hearing this week will focus on fees paid to the FDA  by device makers. The federal agency is proposing an increase in fees to cover the cost of hiring 200 more employees to work closely with medical devices companies when they are seeking approval on new devices.

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