Consumer Reports (Photo credit: Wikipedia)As the Senate prepares to vote on a bill this week reauthorizing the statute governing medical device oversight, Consumers Union has placed a full-page print ad in Politico today to help make patients aware of problems arising in the dangerous medical device loophole which may put them at risk. The new law would back the present system and ratify an agreement between the FDA and the medical device industry which would get devices on the market at an even quicker rate.
Consumers Union is urging lawmakers to provide the FDA with the authority it believes to be necessary to protect patients. In its ad, Consumers Union calls attention to the fact that under the current law, the FDA does not have the authority to require device makers to demonstrate they have corrected any design flaws when they desire to sell a new device based on a device that has already been recalled by manufacturers for safety issues. Consumers Union along with the FDA and the public, according to a recent poll, advocate that makers of medical devices should be required prove that the safety flaws which were the central basis of previous devices being recalled, have been corrected in the new device.
Lisa McGiffert, director of Consumers Union's Safe Patient Project refers to requiring this of manufactures of medical devices as "common sense reform." McGiffert believes that it is the "politically powerful medical device lobby has blocked this common sense reform," and that it is time to "close this absurd loophole" by authorizing the FDA with the power necessary to protect patients. She asserts that the makers of such medical devices "should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients."
McGiffert stresses that "medical device makers have misled Congress that this reform isn't necessary, but the evidence is clear that the FDA doesn't have the power it needs to protect patients. It's time to use some common sense and close this indefensible loophole in the law."
Although the medical device industry argues to Congress that the FDA has the necessary authority to address this issue, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, disputes this argument. While he does admit that "the program has served American patients well," and that "it's a challenge to eliminate a program without having a better alternative," he has expressed in media that the agency does not in fact possess the necessary power to fix this problem and properly safeguard patients. Likewise, he has stated that this loophole allows device makers to repeat safety flaws in new devices being cleared based on their similarity to previous devices recalled by manufacturers.
According to McGiffert, the investigation of the Safe Patient Project has illustrated that several implanted medical devices are never clinically tested on humans before being put on the market. However, tens of millions of Americans have undergone surgery and now live with medical device implants. Do these patients assume that such devices have been tested for safety and effectiveness on someone, somewhere? Consumer Reports believes that it is a safe bet to assume so.
Consumers Union's Safe Patient Project has determined that the FDA clears medical devices through its fast track 510(k) process. This process is based on whether devices are "substantially equivalent" to devices previously placed on the market. Therefore, over 90% of these medical devices do not require clinical testing before the FDA clears them for sale.
For most medical device implants, manufacturers only have to file paperwork and submit a user fee of around $4,000 paid to the FDA in order to begin marketing a product. As a result, the safety "testing" that occurs is generally in the bodies of unsuspecting patients
Furthermore, the current law requires the FDA to clear a medical device for sale, despite the new device being centered around a similar device previously recalled due to safety issues, even if the agency is aware that it repeats the same design flaws.As a result, it has been express by many that patients could potentially suffer severe consequences from these later cleared medical devices.
One currently well known example of a risk facing patients due to this loophole involves vaginal mesh implants. These implants are used to treat urinary incontinence along with weak pelvic organs in women in order to keep women's internal organs in place after tissue has been weakened by childbirth or age. Two years after the first vaginal mesh implant was introduced by Boston Scientific, after getting clearance by the FDA in 1997, its ProteGen bladder sling recalled. The company issued the recall after several hundred women implanted with the device had claimed serious complications as a result of the surgery.
However, even after the recall, the FDA has been forced to approve several other vaginal mesh products due to their "substantial equivalence" to the recalled ProteGen bladder sling. Subsequently, the FDA has received thousands of complaints from injured women because, as predicted, the problems they have been expeirencing with vaginal mesh implants were not exclusive to the recalled ProteGen sling.
Despite its clearance of vaginal mesh slings after ProteGen was recalled, in 2011 the FDA warned doctors and their patients that in addition to the serious injuries associated with these implants, that such consequences were not uncommon. It provided specific dangers accompanying vaginal mesh implants including mesh erosion through the vagina, bleeding, infections, urinary problems, and organ perforation. As a result of such injuries, many require numerous surgeries to fix the injuries. Additionally, the FDA warned that the complications associated with the implants along with the follow up surgeries to attempt to repair such damages may even leave some patients permanently disabled.
Furthermore, Consumers Union called attention to another issue regarding the risk involved with this loophole. It made it clear that this loophole would permit makers of medical devices to market other versions of hip implants after clearance by the FDA due to the similarities in former models of hip implants which have been recently recalled for issues regarding the safety of the product. Just as it is with the vaginal mesh implants and other medical devices, currently law does not permit the FDA to require manufacturers to establish that their new device has addressed and corrected any safety flaws associated with the previously recalled device.
Not only does Consumers Union generally disagree with the current law, its director of its Safe Patient Project, Lisa McGiffert, and the director of the FDA's Center for Devices and Radiological Health, Dr. Jeffery Shuren, a recent poll conducted by Consumer Reports illustrates the overwhelming opposition of the public to the practice under the current law. The poll showed 71% of Americans being of the opinion that a newly manufactured device, based on its similarities to a previous device recalled for safety issues, should not be permitted to be cleared by the FDA and therefore marketed.
Consumers Union recommends to the FDA the following to fix this issue:
1. Require that implants and other "life sustaining" devices be tested as least as rigorously as drugs.
2. End the practice of "grandfathering" high-risk new implants and life-sustaining devices.
3. Create a "unique identifier system," or IDs for implants, so that patients can be quickly notified about recalls and safety prblems.
4. Create national registries so that problems can be spotted quickly and patients notified.
5. Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
Note: Consumers Union is the policy and advocacy arm of Consumer Reports.