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Overview of Stress Urinary Incontinence
Stress urinary incontinence, or SUI, is a condition involving loss of bladder control that can be due to a number of different factors that can include illness, injury or other conditions that can cause weakening of the pelvic muscles or supporting tissue. Treatments for SUI have been the subject of controversy and even legal action, as some of these have caused serious injury.
The medical definition of SUI is urine leakage during moments of physical stress involving pressure on the abdominal muscles according to the FDA. This can include laughing, hiccups, coughing or sneezing or certain types of exercise. SUI is most common among women, and may result from pregnancy, pelvic surgery, or as a consequence of the aging process. It may also be exacerbated by obesity and tobacco use.
SUI is caused by the weakening of pelvic muscles and tissues that support the bladder and urethra. This causes the bladder to literally fall out of place (this is known as Pelvic Organ Prolapse, or POP), which compromises the urethra’s ability to control urine flow. Another cause is weakening of the sphincter muscle, which normally controls urethra function.
Treatments
One common treatment for stress urinary incontinence has been to use surgical mesh, also known as a transvaginal mesh or pelvic sling. There are non-surgical options for women suffering from SUI, which include Kegel exercises, collagen injections into the affected area, or use of a prosthetic device known as a pessary, which helps in restoring pelvic organ support. However, more serious cases require surgery.
One surgical option is to use the patient’s own tissues to create a supportive sling to hold pelvic organs in place. The other is the use of surgical mesh. Surgeons who have advocated for the use of mesh for the treatment of stress urinary incontinence argue that the procedure is less invasive. However, there have been many serious issues with transvaginal mesh:
- mesh erosion, causing the material to break through the vaginal surface or organ tissue
- serious infections
- POP and stress urinary incontinence recurrence
- painful intercourse (dyspareunia)
In some cases, these complications have been attributed to surgeon error or lack of experience. However, evidence presented in lawsuits have revealed that many of these mesh devices were poorly designed, or have been made from materials that are incompatible with human tissues.
Lawsuits and Settlements
The first injury lawsuits against mesh manufacturers first came before judge and jury in 2012. Over the past seven years, juries have consistently sided with plaintiffs, awarding damages in the millions of dollars. The first corporate defendant to lose a pelvic mesh case was C.R. Bard, which was ordered to pay $3.6 million to a plaintiff who had experienced serious complications after being implanted with the company’s Avaulta Plus mesh device. Ironically, Bard had recalled the product only a few weeks prior to that verdict.
Other mesh manufacturers that have faced litigation include:
- Ethicon (a division of Johnson & Johnson)
- American Medical Systems (a division of Endo Pharmaceuticals)
- Boston Scientific
- Coloplast
- Cook Medical
Some of these companies have reached global settlements with plaintiffs; others are using delaying tactics or are attempting to have the cases against them dismissed.
