Consumer Reports, one of the nation’s oldest and most trusted authorities on consumer product quality, has launched an offensive against the U.S. Food and Drug Administration’s (FDA) 510(k) medical device approval process, saying it has created “a nightmare scenario” for millions of Americans.
The FDA’s 510(k) process, used to push transvaginal mesh, bladder slings, and other medical devices to market, is often referred to as the “fast-track” process or fast-tracking because it does just that; the process speeds many medical devices to market by forgoing clinical safety testing. Medical devices that are granted a ride on the 510(k) speedway must demonstrate significant similarities to medical devices that have already been approved for use.
But as we have seen more and more in recent years, that criterion is woefully inadequate. Millions of Americans have been implanted with medical devices that are failing for unforeseen reasons, causing serious and injury and in some cases death.
The FDA approved certain transvaginal mesh products based on their similarities to a product made and subsequently recalled by Boston Scientific Corp. Current rules mandate the agency approve medical devices if their designs are based on products that have already been approved. The FDA may only reject devices if their designs are based on products that have been recalled by the FDA or a court.
However, there is a loophole in these rules that allows potentially harmful devices to stay on the market. This happens when the device’s design was based on a product that has been voluntarily recalled by the manufacturer before a forced government recall. Surgical mesh products based on Boston Scientific Corp.’s voluntarily recalled device fit into this category.
A recent report published in the American Journal of Obstetrics and Gynecology found that one in six women who received mesh implants to repair vaginal prolapse (a condition that occurs when the internal structures supporting the pelvic organs weaken, causing the them to drop from their normal positions and bulge, or prolapse, into the vagina) experienced complications months after surgery, including the device becoming exposed or protruding out of the vaginal tissue, pain, infection, organ perforation, and urinary problems.
But transvaginal mesh is just one small part of a problem that is fast becoming an epidemic of bad medical devices. In an email blast sent to one million subscribers, Consumer Reports President Jim Guest said “The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.”
He continued: “This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled – 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.”
A new bill recently introduced to the House Energy and Commerce committee for review aims to close the FDA’s 501(k) loophole and thus prevent potentially dangerous devices such transvaginal mesh from going to market without the appropriate safety trials. The Safety of Untested and New Devices Act would enable the FDA to refuse approval for devices that are based on the designs of products that have been voluntarily recalled by manufacturers.