Introduced in the 1990s as a solution to treat pelvic organ prolapse and stress urinary incontinence, transvaginal mesh, also referred to as a “bladder sling,” has led to several complications – from long-term painful conditions for the patient to multiple dangerous revision surgeries. Although complaints began around the same time this product entered the market, the FDA has refused to remove it, instead requesting stricter testing from its manufacturers.
A synthetic mesh surgically added, the device has frequently been given to patients suffering from pelvic organ prolapse (POP), a condition causing the pelvic organs to drop down, or stress urinary incontinence (SUI), in which ordinary, mundane activities place an unusual amount of pressure on the bladder. Women who have experienced childbirth or weight gain or, through age, had a hysterectomy or are going through menopause are more prone to either condition.
However, patients have experienced difficulties after the procedure, even a couple of years after the surgery: organ perforation and erosion and, to a lesser extent, constipation and urinary incontinence. The mesh, as well, has been known to contract or shrink once inside, resulting in tightening and pain for the recipient. The U.S. Food and Drug Administration further received reports of recurrent prolapse, neuromuscular issues, scarring, and emotional distress.
Out of all potential complications, transvaginal mesh erosion, also known as mesh extrusion, is particularly dangerous to and painful. This occurs when the screen material’s edges cut through the vaginal lining and adjacent organs, resulting in organ perforation, infection, bleeding, pain during intercourse, and urinary problems.
Removal, unfortunately, requires multiple revision surgeries and, because the body’s tissue grows around the mesh, may be extremely painful for the patient. Particularly costly and dangerous, the revision results in a long recovery, with damage and infection significant risks.
Recalls and FDA Warning
Recalls date back to the 1990s, and in 2008, the FDA released a public health warning about the product, although claiming complications were rare. The organization revised this statement three years later, adding that serious conditions like transvaginal mesh erosion are more common than previously believed, and requested manufacturers perform post-market safety tests.
While transvaginal mesh devices have yet to be removed, manufacturers now must perform stricter testing and, as of January 2012, need to conduct a three-year study on their products, per the FDA. All have been reclassified as Class III, an indicator of pre-market approval for safety and effectiveness.
For patients already with these products, these changes offer minimal consolation. As of 2010, 10 percent of all such surgeries were found to result in failure, while the FDA’s research discovered mesh systems may not fix POP any more effectively than non-mesh devices, instead posing a greater risk to recipients.
As medical professionals were not made aware of the associated risks, lawsuits have targeted manufacturers American Medical Systems, Boston Scientific Corp., Ethicon, C.R. Bard, and Coloplast. Regardless of manufacturer, all transvaginal mesh devices have the same flaws, pose similar risks, and were not fully tested for safety and effectiveness.
All cases have a two-year statute of limitations: two years from the time the recipient begins to feel pain or have problems or from learning about the dangers associated.
If you were a recipient of a transvaginal mesh device or bladder sling to treat POP or SUI, and are now experiencing pain or going through risky revision surgeries, Trantolo & Trantolo’s attorneys take on cases concerning these products. To learn your rights and get the justice you deserve, contact one of our locations to speak with an attorney.