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Home ► Blog ► Who is Monitoring the Safety of Vaginal Mesh Kits?
More than ten years ago, vaginal mesh kits were introduced to the market in an attempt to obtain the benefits of a more durable repair as well as to simplify and standardize the technique of mesh placement vaginally.
It now appears that a substantial number of women who underwent surgical procedures using mesh to repair pelvic organ prolapse or stress urinary incontinence are left with a whole new set of complications that may require further surgery. These women can’t help but question the system and the manufacturers that should have protected them from further injury.
When the FDA was given responsibility for medical devices (such as vaginal mesh kits) in 1976, Congress specified that those medical devices already on the market could continue to be sold without testing.
At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for the market if they were “substantially equivalent” to existing products, referred to as a “predicate device”. This was a way for device makers to obtain approval on an expedited basis.
Medical devices come into the marketplace 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 a 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.
As a result, thousands of medical devices have received FDA clearance based on older devices, neither of which was subjected to the kinds of rigorous pre-market testing required for pharmaceuticals.
In 2009, the Institute of Medicine (IOM) noted about 4,000 medical devices were cleared under the expedited 510(k) process – more than 90% of all devices subject to FDA clearance.
In response to concerns by policymakers and patients about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective, the FDA turned to the IOM for unbiased and authoritative advice.
At the request of the FDA, The IOM looked further into the medical device process. The IOM found that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old process, the IOM concluded that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. As of yet, the system has not been corrected.
Under this FDA approval system, vaginal mesh devices were cleared for use in treating incontinence in 1996, and for pelvic organ prolapse in 2002. And now, we are learning of the numerous injuries that these mesh kits are causing.
If medical device companies are going to use this expedited regulatory process, they should have a greater responsibility to make sure the product they take to market is safe since it did not go through normal safety channels. Medical device companies stand to make a substantial profit off of devices like vaginal mesh kits that went through the expedited approval process. It is not unfair to expect these same companies to be responsible for the monitoring of these devices as they make their way through the market and, subsequently, be held responsible if the device is later found to cause injury.
While we would all like to see a better FDA approval process, companies that stand to profit remain in the best position to monitor their own products and regulate themselves when it comes to the provision of adequate warnings and possible recalls.
The number of complications related to transvaginal mesh is staggering. There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA. Official reports of complications are made to the FDA’s Adverse Event Reports System (FAERS). Reports number in the thousands with at least 10 deaths being reported.
These reports are voluntarily made by physicians or patients who become aware of the complications by various means. Recent studies estimate that the actual rate of injury may be 1,000 times what is reported in the AER database. This rate of injury would not be surprising considering that more than 100,000 of these types of procedures are performed annually.
Reported complications are an important and helpful tool for the FDA. The FDA will use this in their post-approval surveillance. But, it is important to remember that the FDA is a regulatory body and a severely underfunded one at that. The manufacturers of these types of products are in the best position to know what is happening with their product. They have representatives that are in doctors offices daily and actually assist with surgery. It may surprise some to learn that these company representatives actually “scrub in” for surgery to help doctors with the placement of the mesh. It defies logic to think that these representatives, and in turn the manufacturer of the transvaginal mesh, did not know that so many women were getting hurt.
It was intriguing what Rebecca G. Rogers, MD had to say in 2008 about this trend in medical device surgery, and its practical implications:
“In the past, surgery was learned from mentors, typically senior surgeons, who either taught us directly as residents and fellows or indirectly as colleagues when discussing or observing cases. Surgical innovation was driven by expert opinion. Innovations are still introduced by surgeons, but are now marketed by companies whose primary allegiance is to their stockholders, not to our patients.”
Sadly, Dr. Roger’s insightful words appear to be even more relevant than ever, considering the number of injuries being reported to the FDA from transvaginal mesh, and the amount of money being made by this product.
Women injured by these vaginal mesh products need to find the courage to hold the manufacturers responsible for their misconduct.
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