Used primarily to treat organ prolapse, transvaginal mesh is inserted into a woman’s body when pelvic organs begin to sink downward into the vagina. Mesh provides support, lifting organs back up where they belong. Some women develop organ prolapse after giving birth, others after hysterectomy and some with age, as muscles become less supportive. While pelvic mesh initially seemed much safer than more invasive treatments for organ prolapse and incontinence, it quickly became problematic. Countless women suffered serious pain and injury after insertion, ultimately triggering thousands of transvaginal mesh lawsuits. Transvaginal mesh removal is a major concern, since it’s frequently unsuccessful and often further injures the patient.
A Fast-Tracked Approval
The FDA approved TVM using its 510(k) pathway. This means TVM didn’t get tested in clinical trials before approval. As a result, manufacturers sold TVM with little safety data. This pathway approves devices which are similar to others already approved and on the market. In this case, TVM was compared to the mesh used to treat hernias. Many doctors began using it due to manufacturer claims that it was safer and more reliable than the invasive procedures once used to treat the issue.
Eventually, the FDA issued a safety communication saying that TVM’s safety was unclear. An important part of the warning? That surgery might not fix any resulting issues. Between 2005 and 2010, the FDA received nearly 3,000 reports of TVM-related complications, which include (but are not limited to):
- Infections
- Bleeding
- Pain during sex
- Organ damage
- Incontinence
- Erosion
- Urinary tract infections
- Vaginal scarring
- Vaginal shrinkage
- Emotional damage
Though every complication related to TVM insertion is horrible, erosion is clearly the most troublesome.
TVM Erosion
Erosion occurs when the mesh device moves through the vaginal wall over time. This is ironically somewhat similar to the migration of a woman’s organs that TVM intended to treat—only this time, the results are far more worrisome. While erosion symptoms vary from woman to woman, they usually include development of a tunnel connecting the rectum and the vagina, pus-filled sores, bladder damage, bowel injury, and very intense pain. Sometimes transvaginal mesh perforates or dislodges other organs as it moves, creating even more problems. Erosion almost always requires surgical transvaginal mesh removal, which is often more painful than the initial insertion procedure itself.
Transvaginal Mesh Removal: Is It Possible?
A study conducted by the Department of Obstetrics and Gynecology at Duke University Medical Center examined 31 patients undergoing transvaginal mesh excisions. Seventeen were endoscopic-assisted transvaginal excisions and 14 were not, resulting in a 53% success rate (success is defined as having no symptoms at follow-up). Three subjects needed three surgical procedures each to rectify the matter. Another seven required abdominal excisions—six of which had serious complications.
Even after successful transvaginal mesh removal, lasting damage may exist. Infections, perforations, nerve and organ damage and chronic infections are all common after excision. Sadly, some transvaginal mesh complications result in death. The FDA has not yet recalled these devices.
What You Can Do
If you or someone you know had transvaginal mesh insertion or excision, you may be eligible for compensation. An attorney with transvaginal mesh lawsuit experience can best represent your claim. Get started today by completing you free claim review form.