The FDA has allowed the manufacturers of polypropelene transvaginal mesh and other devices to enter the US marketplace with very few safety checks. Congress is taking some important steps toward changing this system, but, it is important to remember that the manufacturers of these devices are in the best position to warn the public of known dangers and they should be held accountable when their silence leads to people being injured.
The 510(k) Process
Medical Devices come into the market place through one of two premarket processes. One method is to undergo the Premarket Approval process, including clinical trials in humans and demonstrations of safety and efficacy. This process typically only applies to “risky” devices and is not used very often.
The more common path a device will take is through the Premarket Notification process, more informally known as 510(k) clearance. Most devices are cleared through 510(k) because the FDA is required to review devices through the least burdensome means.
The FDA does not require 510(k) devices to undergo clinical testing to demonstrate safety or effectiveness prior to clearing the devices for sale. Instead the device manufacturer must only show that the device is “substantially equivalent” in safety and efficacy to another previously approved device or standard recognized by the FDA, also known as a “predicate device”.
In order to be eligible for clearance, the new device must exhibit roughly the same safety and effectiveness characteristics as the predicate device. That means the device must have the same intended use and technological characteristics as the cited predicate, and that the device poses no new safety or efficacy concerns.
Critics of the 510(k) clearance process point out that it doesn’t require devices to be shown effective in human populations and such devices can pose great danger to the unsuspecting American public as a result.
What is striking about the “substantially equivalent” standard is that a device can be found “substantially equivalent” to a device that is no longer on the market as well as a device that has been recalled from the market for its adverse effects in patients. So long as the FDA has not issued a mandatory recall of the device, it remains eligible to qualify as a “substantially equivalent” predicate device. It should be noted that mandatory recalls occur very rarely – a manufacturer must fail to voluntarily remove a dangerous product from the market.
It is not uncommon for a recalled and dangerous device to serve as the predicate devices for hundreds of other new devices. The FDA is required by law to clear all devices found to be “substantially equivalent” to their predicates, regardless of safety and efficacy concerns.
Transvaginal Mesh – The CopyCat Killer
The scope and severity of injuries caused by transvaginal mesh implants have made this device a prominent example of the dangers of 510(k) premarket clearance.
In his report, Defective Devices, Destroyed Lives, Congressman Edward Markey points to the “predicate lineage” of many vaginal mesh products currently on the market as the cause for their dangerous characteristics. A number of mesh products produced by both Boston Scientific and Ethicon (a subsidiary of Johnson and Johnson) are currently marketing mesh products found to be “substantially equivalent” to Boston Scientific’s ProteGen.
ProteGen was recalled in 1999 after hundreds of women reported experiencing severe pain, infections, and complications. Many of the women suffering today as a result of vaginal mesh could have been saved the pain and discomfort they are experiencing if the FDA clearance procedure was more stringent regarding substantial equivalency or if the manufacturers had warned of the dangers.
Congressman Markey and his fellow supporters seek to make the FDA device clearance process more stringent, and thereby make the devices on the market safer for the public. At the end of this month Congress will vote on the Safety of Untested and New Devices (SOUND) Act, H. R. 3847. SOUND seeks to improve the safety and efficacy of medical devices by giving the FDA the ability to reject a device based on a predicate that has been recalled. It further requires companies to inform the FDA if products in a device’s lineage have caused harm and instructs the FDA to create a database of dangerous devices so that manufacturers can determine what an acceptable predicate device is. And lastly the bill calls for the FDA to review high-risk devices if a product in their lineages has been recalled. So far, the bill has yet to gain any Republican support and seems unlikely to pass.
Whether the SOUND Act passes or not, it is imperative that the FDA revamp is clearance processes for medical devices as people are loosing their lives everyday. There have been more than 7 confirmed deaths related to vaginal mesh alone. Congressman Markey points out that the “FDA must have the flexibility to reject devices like mesh that are based on recalled products. These deadly devices are copycat killers.”
We completely agree with the SOUND Act and commend the work of Congressman Mackey. However, we believe that the safety of the American public requires that the manufacturers also be held accountable for placing dangerous devices on the market.
It is important to remember that the manufacturers of the mesh kits are in the best position to warn the public of complications on a timely basis. The FDA estimates that 300,000 women undergo surgeries using vaginal mesh on an annual basis – timely warnings are necessary so that women facing surgery are given all information necessary to make important decisions about their health and safety.