Bladder Sling Safety and Effectiveness Next Topic for FDA PanelBy bladderslingrecall, 17:39
Two of the biggest bladder sling and transvaginal mesh manufacturers, Johnson & Johnson and C.R Bard Inc., are facing over 400 lawsuits that were filed by patients who state that they have had internal injuries caused by the medical devices of these two companies. The number of accusations has been the cause of concern for the other 75,000 women who have received similar devices in the past year alone.
As of right now both bladder sling and transvaginal mesh devices hold a classification of moderate-risk, a classification that the manufacturing companies would like to keep.Many of these products have been approved for consumer use byt the FDA’s 510(k) process.But with the increasing amount of complaints filed against these devices, the United States Food and Drug Administration (FDA) has considered re-classifying these products to high-risk.
The FDA will soon be holding a panel to discuss the safety and effectiveness of bladder slings and transvaginal mesh. If the FDA finds that these devices are no longer safe and effective, its position will significantly affect the manufacturing companies. One of the major effects of being placed in the high-risk classification is that these companies will now be required to provide more significant data on the safety and effectiveness studies that these companies did on their products. This may become difficult as many of the devices had minimal studies done under the 510(k) approval process. These companies will then be forced to do new safety studies done under FDA guidance.
The FDA is currently also having discussions about a July 2011 report filed by the United States Institute of Medicine urging the FDA to stop the 510(k) approval process for moderate-risk devices.The current process which the FDA follows allows certain devices to enter the market if their manufacturers can show that they are “substantially equivalent” to other devices currently on the market. The IOM is calling for a new process to be developed which can provide a reasonable amount of assurance of the safety and effectiveness of moderate-risk products.
Bladder sling and vaginal mesh companies continue to claim that their devices are safe and effective and that the percentage of side-effect cases are within the “acceptable” range. Their argument is that thousands of patients receive their products every year without any complications or side effects. The FDA states that “While data is still emerging from studies, the important thing is for these studies to have accurate and non-biased data.” If you would like more information about if bladder sling and mesh devices are right for your current condition, consult with a physician.
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