Stress Urinary Incontinence
Stress Urinary Incontinence (SUI) is a debilitating bladder condition that results in a leakage of urine during physical activity. There are several available treatments, ranging from lifestyle changes to surgery. One surgical method is transvaginal mesh surgery, which has been found to have painful, long-term complications in a large number of patients.
The Food and Drug Administration (FDA) began reviewing the safety of the procedure in 2011.
SUI occurs when a woman’s pelvic tissues and the muscles which support the bladder are weakened. Abdominal contractions during physical activity such as exercise can trigger a leakage. Laughing, coughing, sneezing and other movements can have the same result.
About 20 to 40 percent of women suffer from SUI. It is caused by physical changes that stretch the body, such as pregnancy, childbirth, weight gain, sports injuries and menopause.
Women with SUI may be able to treat the problem through exercises and lifestyle changes, such as limiting intake of water and caffeine. Other options include implantation of a pessary device, collagen shots and transvaginal mesh surgery.
During transvaginal mesh surgery, surgical mesh is permanently implanted inside a woman's body in the form of a sling. When used to treat SUI, the surgical mesh is intended to provide support for the urethra.
Surgical mesh is regulated by the Food and Drug Administration as a Class II medical device. The FDA issued its first public health notification concerning transvaginal mesh complications in October 2008. The FDA upgraded the warning on July 13, 2011, after receiving reports of more than 3,800 complications since 2005. The agency is currently reviewing the safety of surgical mesh, but in its July 13, 2011 warning, the agency asked health care providers and patients to only choose transvaginal mesh surgery after carefully assessing all other options.
The FDA reports 10 percent of women who have undergone transvaginal mesh surgery suffered from mesh erosion within a year of surgery. Other possible complications include infection, bleeding, pain during intercourse, organ perforation, urinary problems, vaginal scarring and neurovascular muscular problems.
These conditions may be corrected through surgery and medical treatment. In some cases, multiple procedures and hospitalization may be required. Some conditions cannot be corrected.
Transvaginal surgical mesh has not been recalled, but lawsuits have been filed across the country by women who have suffered injury.
The Boston product liability lawyers at Breakstone, White & Gluck specialize in handling cases involving defective medical devices. If you have experienced injuries as a result of transvaginal mesh surgery, it is critical to preserve your rights. For a free legal consultation, contact us today at 617-723-7676 or use our contact form.
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