March 23, 2012 ~ The SAFETY OF UNTESTED AND NEW DEVICES (SOUND DEVICES) ACT OF 2012 is a critical step to stop others from being harmed by untested, unsafe medical devices like synthetic surgical mesh, say patients harmed by synthetic surgical mesh.
The Sound Devices Act, introduced by Rep. Edward Markey (D-MA) will give the FDA the authority to deny the approval of a medical device when it names a dangerous re-called "predicate" device. See background story here.
H.R. 3847 (here) states:
“To amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety, and for other purposes.”
All current Pelvic Organ Prolapse (POP) mesh kits and Bladder Sling mesh kits are based on the now recalled Boston Scientific ProteGen Sling, which was approved by the U.S. Food and Drug Administration in 1999 but later recalled for being "misbranded and adulterated."
Dr. M. Tom Margolis, interviewed by MDND (here) believes there are many options before surgery to correct pelvic organ problems, and that transvaginal placement of mesh introduces bacteria because it is a “clean, contaminated field.”
Safety Of Untested and New Devices (SOUND Devices Act) of 2012
Background: The vast majority of medical devices, approximately 90 percent, are authorized for commercial sale through what is known as the “510(k) process.” These devices do not need to undergo clinical testing in patients to demonstrate that they are safe and effective. Instead, FDA clears them based on their proven similarity to a device that is already on the market, known as a “predicate.” Once a device has been cleared by showing “substantial equivalence” to another product, it can then be used as a “predicate” for future devices, and so on.
Problem: A major loophole exists in the current 510(k) process. Manufacturers submitting a device for clearance through 510(k) can still use a device that has been recalled as a predicate. In other words, FDA does not have clear authority to reject a 510(k) device application even in cases where the company is claiming that their product is similar to one that has fundamental design flaws.
Several instances have occurred in which a predicate (or a product further back in a device’s “lineage”) was recalled due to major safety concerns, calling into question the safety of later devices cleared by FDA based on their similarity to the faulty product.
FDA acknowledges this flaw in the 510(k) process and is “concerned that allowing a device to be used as a predicate after it has been removed from the market due to safety problems would place patients at risk” because the new device could repeat the exact same problems of the previous version. (FDA document here).
Solution: The Markey bill protects patients by closing this loophole in the current 510(k) process. Specifically the legislation: