© 2013 Bladder Sling | Last Modification Sep 10, 2013 | Disclaimer The information provided by Bladder Sling is not a substitute for professional medical advice, diagnosis or treatment.
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If you or somebody you know is suffering from bladder sling complications, you may be entitled to compensation. Fill out our form below for a Free Bladder Sling Case Evaluation.
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Bladder Sling Complications
Once touted as a sure-fire fix to stress urinary incontinence (SUI) problems for women of all ages, bladder slings are now considered increasingly dangerous. Made from flexible plastic materials and surgically implanted under the urethra, these devices are known to erode into nearby tissue, perforate organs and cause internal injuries.
Today, at least two major companies have pulled their bladder sling devices off the market. Johnson & Johnson’s Ethicon division and C.R. Bard both recalled their bladder slings following a growing number of lawsuits. While the companies have not linked their products to injuries, women nationwide are outraged that the companies sold bladder slings with little or no evidence that they work. In fact, many women feel duped by device manufacturers who used them as guinea pigs.
Problems with the slings started coming to light years ago. Often, within days or weeks of having bladder sling surgery, women started having problems. These devices are commonly made from a flexible plastic that is now known to erode once inside the body. The eroded plastic leaves sharp edges that cut into nearby organs, causing hemorrhage-like bleeding and infections. The plastic sling also contracts, causing intense pelvic pain.
Bladder Sling FDA Warning
Originally, the U.S. Food and Drug Administration (FDA) dismissed patient concerns regarding the device. But in 2011, the agency did a rare reversal of opinion, saying problems with the device were “not rare”. After receiving more than 4,000 complaints between 2005 and 2010, the agency said bladder slings, along with other transvaginal mesh products, do not fix the intended problem. Instead, they create additional problems.
Even more alarming is that surgery to correct the problem, called revision surgery, is rarely successful the first time. Because the mesh erodes into small shards and tissue grows and intertwines with the mesh, it is difficult for even the most skilled surgeon to remove.
Many patients are outraged that bladder sling sales began under the FDA’s 510(k) application process, which allows devices that are “substantially similar” to others already on the market to be sold without premarket testing or trials. They say the device manufacturers used them as test subjects instead of undertaking the proper medical study.
Bladder Sling Recall
While an FDA panel has said it would not support a nationwide bladder-sling recall – merely a reclassification that calls for more stringent premarket testing – several manufacturers have pulled their devices from the shelves.
In early 2012, the FDA told 33 manufacturers, including Johnson & Johnson and C.R. Bard, to study the rate of complications associated with bladder slings and other transvaginal mesh products. By June 2012, Johnson & Johnson’s Ethicon division announced it would discontinue several of its bladder sling devices, including the Gynecare Prolift and TVT Secur. The company said it was not ending sales because the product was defective. About the same time, C.R. Bard discontinued sales of its Avaulta line of slings.
The Bard recall came shortly after a jury awarded a California couple $5.5 million for injuries sustained as a result of Avaulta injuries. The plaintiff had undergone at least eight surgeries to correct mesh damage.
Financial Compensation for Victioms of Bladder Sling Complications
If you or a loved one has suffered as a result of bladder sling or transvaginal mesh surgery, contact our patient advocates for assistance. We will help you with the physical, emotional and financial toll that results from such a serious injury.