A bladder sling is a medical device used to treat a condition called stress urinary incontinence, or SUI, which is the leakage of urine when physical stress is placed on the bladder or urethra. SUI can be embarrassing and uncomfortable and can have a serious impact on daily activities and a person’s ability to enjoy life. Treating SUI with a surgically inserted bladder sling can be life changing in a positive way.
Some people who have had bladder sling surgery, though, have experienced serious negative consequences and complications from the surgery or from the sling itself. These have included infections, organ perforation, and erosion of the sling into neighboring tissue, just to name a few. Many patients have suffered pain and other symptoms from these complications and have had to have additional surgeries. Lawsuits have been filed against certain makers of bladder slings because of this.
Stress Urinary Incontinence
SUI is a condition characterized by uncontrollable leakages of urine, due not to mental stress, but physical stress or movement. Someone with SUI loses urine when coughing, running, laughing, sneezing, or lifting something heavy. Any kind of physical activity has the potential to cause leakage for someone with SUI. Having this condition and being unable to always control urination is embarrassing and can cause a person to become isolated, afraid to go out or be around other people.
SUI is more common in women than in men because childbirth contributes to the causes of the condition. SUI occurs when the muscles that are used to hold urine in weaken. This may happen in the sphincter muscles, those that control the flow of urine through the urethra, or in the pelvic floor muscles, which support the bladder and urethra. In addition to giving birth, other factors that can lead to this muscle weakness include injuries or surgery, but sometimes the causes are unknown.
Bladder Sling Surgery
There are ways to treat SUI before resorting to surgery, but for many people these treatments just aren’t enough. Medicines, pelvic exercises designed to strengthen the muscles, and behavioral changes like losing weight or urinating regularly may help, but often surgery is the only way to stop leakage entirely. The surgical treatment for SUI involves inserting some type of sling to support the urethra or bladder when the muscles can no longer do so adequately.
Types of Bladder Sling Surgery
There are two main types of bladder sling surgeries and several different devices that can be used for support that are approved by the U.S. Food and Drug Administration (FDA): tension-free and conventional. The difference is that tension-free procedures use the patient’s own tissue to secure a sling. Scar tissue forms over the device to hold it in place. In the conventional style of surgery, stitches are used to hold the sling in place.
To perform the procedure, depending on the type of surgery and sling, the surgeon may need to make vaginal or abdominal incisions or both. For a tension-free procedure the sling is a strip of synthetic mesh tape that goes underneath the neck of the bladder or the urethra. The sling may also be made of tissue from the patient’s own body.
For conventional bladder sling surgery, again the surgeon uses either a synthetic mesh sling or tissue, inserts it under the neck of the bladder or the urethra, pulls it tight, and then attaches each end to the pelvic tissue using stitches. This type of surgery requires larger incisions and may require a longer hospital stay and greater recovery time.
Most patients find that urinary leakage decreases after recovering from bladder sling surgery, but others will still experience leakage and some will see improvements only to find the condition gets worse again. There are also risks associated with any type of serious surgery like this and they include the formation of blood clots, excessive and dangerous bleeding, and infections.
Bladder sling surgery also comes with the risk of specific and serious complications. The synthetic material of the sling may break down over time. The sling or the surgery can cause damage to the surrounding tissues of the bladder, vagina, or urethra. Some patients experience difficulty urinating after surgery and may have to rely on a catheter, a thin tube inserted into the urethra, to empty the bladder. Irritable bladder, which causes the urge to urinate frequently, may also occur.
One of the most serious complications of bladder sling surgery is the erosion of the synthetic material into surrounding tissues. This can cause pain, bleeding, and infections, and often requires surgery to correct. A sling may even cause perforation of other organs, which can have serious and painful consequences. If the sling contracts, it can cause severe pain and pain along with intercourse.
Even when the overall outcome of bladder sling surgery is successful, patients must be prepared for a painful and tricky recovery. They need to be able to insert a catheter for several weeks instead of urinating. They must avoid lifting and having baths, using pools, and having intercourse for a couple of months to prevent infections.
One particular type of bladder sling caused a number of cases of erosion in women having this surgery. The synthetic tape used as a sling was made by Mentor Corporation and was called ObTape and was used in women between 2003 and 2006 when it was pulled from the market. ObTape was connected to a bladder sling material that had previously been recalled by the FDA, made by Boston Scientific. The sling was found to have been made from counterfeit material.
Another problem with ObTape was that it was made from a material that was denser than that in other types of ladder slings. This thicker material led to more complications including rejection by the surrounding tissues and erosion. ObTape was approved without testing, through the FDA’s 510(k) expedited process. The FDA allows products to be approved without testing in this way when they are similar to other approved medical devices.
While thousands of women received bladder slings made with Mentor’s ObTape, only a few hundred have filed lawsuits against the company. Those suits have been consolidated in multidistrict litigation in Georgia and Johnson & Johnson, which bought Mentor Corporation, recently agreed to settle about 100 cases. If you were affected by ObTape bladder slings, you can still step forward and become a part of the potential settlement. If you experienced complications from any type of bladder sling, speak with a lawyer to see what recourse you have to seek compensation.