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FDA to Set Panel for Bladder Sling Review

Posted on December 7 2012 in Bladder Sling, Health, Mesh, Women, POP, SUI, pain, swelling, bleeding

C.R Bard Inc. and Johnson & Johnson, two of the largest bladder sling and transvaginal mesh companies, are presently looking at over 400 lawsuits which have been filed against them by former customers saying that they have been injured by products of these companies. The rising number of lawsuits has become a cause for concern for the roughly 75,000 other women who have received the same devices last year alone.

Currently bladder sling and transvaginal mesh products maintain a moderate-risk classification and many of the manufacturing companies would like to keep it that way. Many of these products have been approved for consumer use byt the FDA’s 510(k) process.However, as the number of complaints by patients using these devices increased in recent years, the United States Food and Drug Administration (FDA) has considered re-classifying these devices to high-risk.

The FDA is scheduled to hold a panel which will discuss the effectiveness and safety of both bladder slings and transvaginal mesh devices.If the FDA finds that these devices are no longer safe and effective, its position will significantly affect the manufacturing companies. One of the effects of receiving a high-risk classification is that manufacturing companies will be required to provide more data on safety and effectiveness studies done on their devices. This could prove to be difficult as many of these devices had little or no studies done because they where approved by the 510(k) approval process. Companies might have to do brand-new safety studies under FDA guidance.

Currently the FDA is also having discussions about an United States Institute of Medicine report in July 2011 urging it to stop the 510(k) process for moderate-risk devices. The process which the FDA follows currently allows companies to get their devices approved as long as they can prove that these devices are “substantially equivalent” to other devices which are on the market.The IOM said a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.

The manufactures of bladder sling and vaginal mesh products continue to claim that their devices are safe and effective and that the number of side effect cases are still within the acceptable percent.The biggest argument that these companies have made is that thousands of patients go through bladder sling and transvaginal mesh surgery with their products and do not show any ill effects from them.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.” Consult with a doctor for more information on if bladder sling and mesh products are right for your current condition.

URL References:

bloomberg.com/news/2011-09-07/j-j-s-vaginal-mesh-to-be-weighed-by-fda-advisory-panel-as-lawsuits-climb.html

 

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