Transvaginal meshes have helped thousands of women who suffer from pelvic organ prolapse and urinary stress incontinence. Unfortunately, in 2008 the FDA reported complications from vaginal mesh products and some 30,000 women have filed suits for their injuries.
Vaginal meshes are made by a variety of manufacturers. Currently six of those companies have been targeted for litigation. Claimants argue that these manufacturers have manufactured and marketed vaginal mesh implants which are “defective, dangerous, and not fit for use.” Furthermore, claimants argue that the dangerous products have put thousands of women at risk. Common types of vaginal mesh implants include Bards Avaulta, Mentor ObTape, Gynecare TVT, Tyco IVS, MiniArc single incision sling, and Bards Pelvisoft, Pelvilace and Pelvicol.
Transvaginal surgeries have been performed since the 1990s. Unfortunately, although the transvaginal mesh has helped thousands of women over the last twenty-five years, it has also caused complications and the need for additional surgeries for some women.
Removal of the mesh can also be difficult. Not only do women increase their chances of hemorrhaging, pulmonary embolism, infection, and pneumonia, women may also incur heavy expenses with hospital stays and medical care.
It is estimated that 30 to 50 percent of the total female population in the world suffer from minor to severe Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Unfortunately, many of these women suffer a decreased quality of life from their condition. Vaginal mesh surgeries have been popular since the 1990s, but in recent years an increasing number of vaginal mesh surgeries have caused complications. In fact, from 2005 to 2007, the FDA began to receive hundreds of transvaginal mesh complaints. Women are now twice as likely to suffer a risk urinary incontinence and 7 times more likely to experience bladder perforation with a transvaginal mesh.
In October 2008, the FDA issued a Public Health Notification (PHN) to patients and medical professional reporting the negative results related to urogynecologic use of surgical mesh. The FDA also provided recommendations to patients and doctors about how to reduce the chance of risks. Specifically, the FDA studied medical device reports from January 1, 2005, through December 31, 2010, and have identified 3,979 reports of injury, death, and malfunction associated with POP repairs and SUI repairs. The most common complications from the use of surgical mesh devices for POP repairs included vaginal mesh erosion which is also referred to as protrusion, extrusion, or exposure. Patients also reported increase in painful sexual intercourse, bleeding, organ perforation, recurrent issues with prolapsed organs, urinary issues, bleeding, and vaginal scarring/shrinkage. Although the FDA’s Obstetrics & Gynecology Devices Advisory Committee has reviewed the issues they have not removed TVM devices from the market.