Avaulta vaginal mesh is a surgical mesh used to repair pelvic organ prolapse (POP). The FDA recalled the device for this reason in 2010. This particular type of surgical mesh is also linked to many problems, including erosion and hospitalization. In 2010, at least 100,000 POP surgeries involved this type of mesh. Because of the risks associated with this type of mesh, the FDA reclassified the product as a Class III medical device and is currently reviewing safety concerns and potential side effects.
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In one study, three women experienced Avaulta complication after the original surgery. The reason for the failure was unclear. The patients were asked to rate whether their symptoms had improved. They were also asked to complete the Defecatory Distress Inventory (PDI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) to assess their symptoms. Some patients experienced postoperative hemorrhage while some had continued to experience pain. The researchers also found that five women underwent subsequent POP and MUS placement. Avaulta vaginal mesh complications may require repeated procedures and revision surgery.
While Avaulta is generally considered safe, it does carry risks. In addition to causing pain, it can cause dyspareunia and mesh exposure. A recent French review of transvaginal mesh procedures found that Avaulta can lead to the same risks as other types of transvaginal mesh. In addition, the FDA warned that transvaginal mesh can cause a similar complication, called Avaulta Prolapse Syndrome.
In response to the growing number of reported risks of transvaginal mesh, the FDA issued a Public Health Notification in 2008. Since then, the number of adverse events related to this type of medical device has continued to increase. According to the FDA, 10% of women experience a complication within 12 months. Symptoms can range from pain during sex to bowel or bladder perforations. While the FDA has not recalled Avaulta vaginal mesh, it does recommend that patients seek alternative treatment options before undergoing transvaginal mesh.