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Transvaginal mesh refers to a type of surgical mesh used in medical procedures to repair weakened or damaged tissue in treatments for transvaginal repair of pelvic organ prolapse. Pelvic organ prolapse, or “POP,” occurs when a person’s pelvic organs – including one or more of the bladder, uterus, rectum, and bowel – drop and bulge or “prolapse” into the vagina due to weak or otherwise damaged internal structures, which can occur following childbirth or surgery such as a hysterectomy. POP can cause discomfort and pain in those who suffer from it, and can include a disruption of sexual, urinary and defecatory functions. The FDA estimates that 30% to 50% of women may experience POP in their lifetimes, with 2% of women experiencing symptoms from POP. A transvaginal surgical mesh may also be used in medical procedures to treat Stress Urinary Incontinence (“SUI”). SUI is a type of incontinence caused by leakage of urine during physical stress. If you are experiencing pain related to a transvaginal mesh procedure, contact a transvaginal mesh lawyer to help you recover compensation.
Use of transvaginal surgical mesh has caused numerous complications in thousands of patients who have undergone procedures to treat POP or SUI. Patients have commonly experienced erosion through vaginal epithelium, infection, urinary problems, recurrence of prolapse and/or incontinence, perforation of the bowel or bladder, and pain causing significant reduction in the quality of life. Patients experiencing complications from transvaginal surgical mesh have undergone treatment for these complications, including additional surgery procedures (which can include removal of the mesh), IV therapy, blood transfusions, and drainage of hematomas and abscesses, although these treatments are not always effective in reversing the harmful side effects of the transvaginal mesh.
The FDA has released numerous warnings about these dangerous side effects of transvaginal surgical mesh since 2008. The FDA recommended that doctors obtain specialized training for use of the transvaginal mesh, and that they be vigilant in detecting for adverse complications in women who have undergone the treatment. The FDA further recommended that doctors provide patients with written copies of the patient labeling from mesh manufacturers and inform patients of complications associated with the transvaginal mesh complications which include “the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).” The FDA also recommended that doctors inform patients of the fact that some complications from use of transvaginal surgical mesh may require additional surgery and may ultimately not be correctable.
In 2011, the FDA updated its warnings about the use of transvaginal surgical mesh to indicate that use of such materials is “an area of continuing serious concern” and to inform health care providers that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” The FDA also indicated that there was not significant evidence to indicate that use of transvaginal surgical mesh was more effective than use of non-mesh products and that use of the mesh may expose patients to greater risk than non-mesh products.
Thousands of plaintiffs injured by the use of transvaginal mesh have been successful in bringing lawsuits against the manufacturers of transvaginal mesh, and Boston Scientific, one such manufacturer, recently paid $119 million to settle 3,000 lawsuits related to injuries caused by transvaginal mesh. In other cases, one individual received a $73 million award for her injuries in 2014, while another was awarded $25 million in compensatory damages and $75 million in punitive damages for her injuries in May 2015.
If you or someone in your family has undergone procedures involving the use of transvaginal surgical mesh (whether related to the treatment of POP, SUI, or some other condition) and has experienced the symptoms described here or other adverse health effects from the use of the transvaginal surgical mesh, please contact our office for a confidential consultation with a skilled and knowledgeable transvaginal mesh lawyer in the field of personal injury and pharmaceutical products liability.