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.”
Here’s what the Petition Wants to Accomplish
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.
- Thousands of women have been seriously injured by defective bladder slings (used to treat urinary incontinence) that cut into their bladders causing nerve damage, bleeding, and pain. Though Boston Scientific Corp. recalled their sling (ProteGen) in 1999, FDA has continued approving implants that trace their origin back to ProteGen. Background story here.
- J&J is facing thousands of lawsuits claiming that their metal-on-metal hip implants, which were cleared through the 510(k) process, are failing prematurely and causing metal poisoning. Though J&J has recalled the DePuy ASR Hip Implants, FDA does not have clear authority to reject applications for new hip implant applications claiming “substantial equivalence” to DePuy’s product. FDA could order post-market studies, but that would not prevent the flawed device from being used as a predicate.
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:
- Provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems;
- Requires companies to inform FDA if any products in their new device’s “predicate lineage” have caused serious harm and to explain how theirs avoids past mistakes;
- Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate;
- Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred (information that is often missing in the case of voluntary recalls);
- Calls for FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems (as with bladder mesh implants). #