FDA Issues Notification Regarding Serious Complications with Transvaginal Surgical Mesh
The U.S. Food and Drug Administration (FDA) recently issued a health alert stating that transvaginal placement of surgical mesh has been linked to several serious side effects. Transvaginal placement of surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Many companies, including large medical device companies like Bard and Mentor, manufacture this type of surgical mesh.
Over the last three years, the FDA says it has received more than 1,000 reports from nine different surgical mesh manufacturers of complications associated with surgical mesh devices used to repair POP and SUI. The most frequently-reported side effects associated with transvaginal placement of surgical mesh include erosion through the vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.
Other side effects may be caused during insertion of the surgical mesh. These side effects may include bowel, bladder, and blood vessel perforation. In some cases, discomfort and pain (including dyspareunia) from vaginal scarring and surgical mesh erosion have led to a significant decrease in patient quality of life. Treatment of the various types of side effects associated with transvaginal placement of surgical mesh may require additional surgical procedures (some of them to remove the surgical mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
The FDA has not yet determined whether specific characteristics put some patients at an increased risk for side effects with transvaginal placement of surgical mesh. Factors contributing to side effects may include the patient’s overall health, the surgical mesh material, the size and shape of the surgical mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
In order to help the FDA learn more about possible side effects with transvaginal placement of surgical mesh, physicians and patients are strongly encouraged to report complications to its MedWatch Adverse Event Reporting Program.
Transvaginal Surgical Mesh Attorney
If you or a loved one has suffered serious complication as a result of a surgical mesh product, such as Bard Avaulta surgical mesh, you may be entitled to compensation for your injuries.
Contact transvaginal surgical mesh attorneys today for a free and confidential case evaluation.