Bladder slings and the similar transvaginal mesh products were supposed to provide women and their doctors with a less-invasive, less-risky way to treat common gynecological and urinary conditions. What happened instead is that thousands of women suffered from serious and severe complications with lasting health consequences.
Because of the damage caused by bladder slings and the fact that many women feel they were never warned about the risks before undergoing procedures, lawsuits have plagued the makers of this device. Bladder sling settlements have been won by many injured women, but many others have failed to get compensation even though companies misrepresented their devices as safe and low-risk.
What is a Bladder Sling?
A bladder sling is a specially-sized piece of surgical mesh used to treat stress urinary incontinence (SUI) in women. SUI occurs when the muscles and other tissues that support the bladder, bladder neck, or urethra become weak. The result is that a woman cannot always control the flow of urine. During mild physical stress, like when laughing, coughing, or lifting something, a small amount of urine leaks out.
SUI is not uncommon and often happens with women as a result of childbirth. The solution to treat it is to insert a piece of mesh, a bladder sling, under the part of the urinary tract that needs support. There are two types of bladder sling recognized and approved by the U.S. Food and Drug Administration (FDA). A tension-free sling is attached to tissues by allowing scar tissue to form and hold it in place. Conventional bladder slings are held in place with stitches.
Complications that Led to Lawsuits and Settlements
As with any type of surgery, the insertion of a bladder sling comes with risks of complications. Any surgery may lead to bleeding, blood clots, or infections, but some of the complications associated with bladder sling surgery are much more serious and have been the subjects of major lawsuits and the resulting settlements for the plaintiffs.
One of these serious complications is called erosion and occurs when the mesh of the bladder sling erodes or wears through the surrounding tissue inside the body. This can be very painful, but it also may not cause any symptoms until the mesh is so embedded in the tissue, surgery to remove it becomes nearly impossible.
If erosion is not detected and corrected quickly, the mesh can migrate out of place and perforate other tissues and organs. The organs most affected by this are the bladder and urethra, colon, and rectum. The consequences of both erosion and perforation can include severe pain, swelling and infection, bleeding, and damage to tissues and organs that requires surgery, often multiple surgeries. In extreme cases, perforation of the colon or rectum can cause sepsis as bacteria spread through the body.
The Special Case of OBTape
Any type of bladder sling may cause complications that could lead to lawsuits and settlements, but a brand called OBTape has caused more problems than others. Mentor Corporation, which eventually became a division of Johnson & Johnson, developed and manufactured OBTape, a product that is no longer available because of the severe complications.
The problem with OBTape was thought to be the material from which it was made. While any mesh could cause the serious erosion and perforation seen in the women who had been implanted with OBTape, the number of cases caused by this product was higher than normal. Thousands of women with OBTape suffered from erosion, perforation, and rejection of the sling itself.
OBTape was made with a material that may have been counterfeit. It was the same material used in several Boston Scientific devices previously, which were found to be faulty. OBTape was approved by the FDA through its 510(k) process. This is an expedited approval process that allows medical devices to be approved without rigorous testing because they are similar to other approved devices. This process may have let OBTape slip through the cracks. Testing of the device would probably have uncovered the issue and saved thousands of women the pain and suffering of complications.
OBTape Bladder Sling Settlements
Mentor and Johnson & Johnson faced hundreds of lawsuits over the complications caused by OBTape and ended up paying a lot in settlements. In 2015 around 100 cases consolidated into a multidistrict litigation in Georgia ended in a settlement and pay out for the plaintiffs. In other cases individuals won settlements in jury awards.
One of these was the case of Teresa Taylor, who was awarded $4.4 million by a jury. Evidence presented in the case demonstrated that there was something inherently wrong with the material of the OBTape slings. It was too dense and did not allow the surrounding tissue to get nutrients. This led to a lot of instances of rejection of the mesh. The jury agreed that the evidence was strong enough to show negligence and warrant a settlement.
Other Settlements
OBTape was not the only product to be taken to court over complications. Johnson & Johnson’s Ethicon division made a product called the Abbrevo sling that led to severe complications in some women. One sued over the fact that the erosion she experienced was so severe that surgeons were never able to remove it all. She was awarded a $5.7 million settlement. Other women won settlements over Ethicon’s slings and the company was ultimately forced to pay punitive damages for promoting a device as safe when it actually was not.
Boston Scientific also faced lawsuits and paid settlements for bladder slings. In a Texas case a woman made the case that the company marketed their devices as safer than they really were. She also made the case that other bladder slings would have been less risky and that Boston Scientific’s product had a faulty design. Her arguments were successful and she won a $34.5 million settlement after the court decided that the company was seriously negligent in her pain and suffering.
Cases against makers of bladder slings are still ongoing and there may still be time to win settlement money. If you suffered the complications of a bladder sling made by any manufacturer, you may have a case and a lawyer can guide your next steps as you seek compensation.