Pharmaceutical

Reported transvaginal mesh injuries lead to creation of non-profit support group

2012 TVM serious complications Reported transvaginal mesh injuries lead to creation of non profit support groupOn October 20, 2008, the Food and Drug Administration (FDA) released a public health notification concerning the serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The FDA’s notification informed the public of the possible health risks associated with the treatment, recommended steps for physicians, and how to report an issue that has occurred because of surgical mesh.

Despite the warnings released in 2008, the FDA reported in 2010 that around 300,000 women underwent surgeries to repair POP using the controversial product. Around 80 percent of 260,000 surgeries done the same year to repair SUI used transvaginal mesh as well.

Common complications from transvaginal mesh include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of POP or SUI. The mesh can also tear the bowel, bladder, or blood vessels during insertion.

The mesh is soft when implanted, but hardens once inside the body. This may allow for tears and punctures to nearby organs and tissue. Certain types of transvaginal mesh are made of polypropylene, which can be toxic to humans. Some cases report that vaginal scaring and mesh erosion significantly decreased the patient’s quality of life because of the high amounts of discomfort and pain.

Earlier this month in Texas, a transvaginal mesh lawsuit resulted in the award of $73.5 million to a victim who suffered nerve damage, pain and infections linked to the transvaginal mesh. Boston Scientific, the company that designed and marketed the mesh, was found guilty of gross negligence. Numerous lawsuits have been filed across the nation against a variety of device makers.

In the midst of legal battles and physical recovery, victims are seeking to connect with each other across the country.

Victims of transvaginal mesh surgeries are finding support through the TVT-NO! Mesh Survivor Foundation, the only international 501(c)3 nonprofit organization that educates and supports those suffering the aftereffects of the surgery and offers referral services. TVT-NO! aims to be a safe haven for women injured by surgical mesh.

President of the Board of Directors, Teresa Sawyer, established the TVT-NO! Mesh Survivor Foundation with her husband to help stabilize women’s lives financially and aid women in finding the treatments they need to begin regaining their quality of life. Through the Foundation, Sawyer shares the story about how her own life was altered when a “non-invasive” treatment involving surgical mesh led to a year of life-threatening complications.

Teresa Sawyer and the TVT-NO! Mesh Survivor Foundation extend an invitation to anyone impacted by the surgical use of mesh. A message on the website reads, “If you or a loved one is facing a major illness caused by the use of Vaginal Mesh, you don’t have to go it alone. Healing from this surgical procedure is long and painful—we can help. Join us as we warn women of the risks posed by TVT and support woman as they rebuild their lives.”

Sources:
Claiborne Progress
TVT-NO!
Lawyers and Settlements
FDA