Many women have filed bladder sling lawsuits against companies that make this type of medical device, and the similar transvaginal mesh, and many of those women have won settlements for their pain and suffering. A bladder sling is a type of surgical mesh used specifically for the treatment of stress urinary incontinence, or SUI, in women. The sling acts to support the neck of the bladder to provide relief from occasional urinary leakage.
Several sling products on the market have proven to cause serious complications in women who had them surgically implanted. Some women have developed serious infections, erosion of the mesh into surrounding tissue, and even perforation and damage to nearby organs. Many of these women have suffered pain and other symptoms and have had to have additional surgeries. Lawsuits against the makers of the slings claim the device was not adequately tested and the procedure using it for SUI was misrepresented as safe.
Surgical Mesh and Bladder Slings
Surgical mesh is a common tool used by surgeons. It is a loosely-woven fabric used to support tissues and organs in the body. They may be made from synthetic materials or biological materials, like tissues from animals. Mesh can be used temporarily, only during surgery, or may be implanted to permanently support an organ. Temporary mesh dissolves over time in the body, while permanent mesh is supposed to stay intact and in place indefinitely.
Bladder slings are simply mesh used specifically to treat SUI. Stress urinary incontinence is a condition, most common in women, that causes urine leakage during physical stresses. These can include coughing, lifting something heavy, sneezing, or running, among other situations and stresses. The condition can be embarrassing and prevents many women from being active.
The incontinence comes from a weakening in the muscles that control urine flow. This is often a consequence of childbirth, which is why the condition is much more common in women. Bladder slings can be implanted to support the tissues that the muscles can no longer adequately support: the bladder, the neck of the bladder, or the urethra.
Bladder Sling Surgery and Complications
The U.S. Food and Drug Administration (FDA) have approved two types of bladder slings or mesh devices for treating SUI surgically. One is called tension-free, which means that the sling is attached using the patient’s tissue and the scar tissue that naturally forms to hold it in place. A conventional sling uses stitches to hold the sling in place.
Any surgery comes with a risk for complications, but having a bladder sling installed has proven to be especially risky and has led to multiple lawsuits. A very serious complication that can occur in some women is called erosion. This occurs when the synthetic material of the mesh erodes into the surrounding tissues. This can be painful, can lead to infections and bleeding, and requires surgery to remove the mesh and correct the damage.
It is possible that erosion can happen without any initial symptoms. In these cases the erosion may go untreated long enough that the mesh moves through tissues and perforates other organs. Perforation is physical damage to organs like the bladder or intestines and can cause serious infections, pain, bleeding, and enough damage to require one or more surgeries to repair the affected organs.
OBTape Bladder Sling Lawsuits
Several different meshes used as bladder slings and made by different medical device manufacturers have caused problems like erosion and perforation, but some have had more severe consequences than others. One of these was OBTape, a product made by Mentor Corporation, a company eventually bought by Johnson & Johnson. OBTape is no longer available today.
Numerous women had OBTape implanted to treat SUI between 2003 and 2006. Many of the women experienced serious cases of erosion and even rejection of the sling material by the surrounding tissues. The problem was thought to be that the slings were made from a counterfeit material. They were made with the same material that had been previously found to be problematic in devices made by Boston Scientific. Because the FDA allows certain medical devices that are similar to those already on the market to be approved without rigorous testing, the OBTape sling was quickly approved without being tested for safety.
Lawsuits against Mentor and Johnson & Johnson over the OBTape issues number in the hundreds. Many of these were grouped together in a multidistrict legislation case in Georgia. The company agreed to settle about 100 of these cases in 2015. In early 2016, one plaintiff and her legal team won a major victory against Mentor and Johnson & Johnson. Teresa Taylor won a $4.4 million jury verdict. The jury decided that OBTape was defective because of the material of the mesh and that it caused Taylor serious harm as a result.
Other Bladder Sling Lawsuits
Johnson & Johnson also saw trouble with a sling made by its Ethicon brand. The Abbrevo sling caused serious erosion in a plaintiff. The erosion was so bad that surgeons were unable to remove the mesh and this woman won a $5.7 million settlement. Another plaintiff who had an Ethicon sling implanted described undergoing 18 additional surgeries to correct the damage it caused. Along with other settlements and lawsuits, Johnson & Johnson ended up paying $7.8 million in punitive damages over Ethicon slings. This was punishment for misleading patients and doctors about the safety and effectiveness of treating SUI with a sling.
Boston Scientific is yet another company that has faced bladder sling lawsuits and that has been forced to pay up to the women who suffered. In Texas, the company had to settle for $34.5 million in the case of a woman who had serious complications following the implanting of the sling. The suit alleged that the company falsely marketed the device as safe and that there were alternative sling designs that would have been safer. The court found that Boston Scientific was grossly negligent in the case.
The number of cases against companies who made and promoted bladder slings for SUI surgery may continue to grow as more women step forward. There is more compensation to be recovered from these negligent companies, so if you suffered because of a bladder sling or mesh, you have a right to be heard and to seek compensation. These devices have caused women no small amount of pain and suffering, some damage that has been shown to be permanent, and countless painful surgeries to try to correct the damage. Let a lawyer help you decide what your options are and how you may recover monetary damages for your bladder sling complications.