Transvaginal mesh devices have been approved to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). The device was approved to treat SUI in 1996 by the FDA. In 2002, the same device was approved for use in patients suffering from POP. The mesh devices have been used as an alternative method of treatment to surgical options which would treat the medical conditions by using existing tissue and/or sutures. To make implantation of the mesh easier, the medical device would be packaged in surgical “kits” giving the medical practitioner an “all in one” method for implanting these devices in female patients.
Women who’ve received the transvaginal mesh have experienced some or all of the following serious complications: mesh erosion and/or protrusion, abdominal or vaginal pain, infection, bleeding, dyspareunia (pain during intercourse), and vaginal scarring or vaginal shrinkage. These complications are both physically and psychologically painful requiring multiple subsequent treatments and surgeries to repair the problem created by the insertion of the vaginal mesh.
On July 13, 2011, the FDA issued an important and much more extensive Update to its prior Public Health Notification (October 20, 2008). This most recent announcement cautioned both healthcare providers and patients, stating that serious complications associated with the use of surgical mesh were not rare. This is a much stronger warning than the FDA’s 2008 position where the agency described these mesh complications as “rare”. This Update was supported by the fact that the FDA had received 2,874 adverse event reports since 2008. The FDA continues to monitor the safety and efficacy of these products that are causing painful and debilitating complications, and states that it will convene a special panel in early September 2011 to further evaluate these products.
There are different models and manufacturers of these vaginal mesh medical devices. Some of the companies that produce and market these products include Bard Medical, Johnson & Johnson, American Medical Solutions, and Boston Scientific.