Transvaginal mesh dangers have been steadily rising in the past few years as more and women face serious, debilitating injuries. It’s an epidemic that’s sparked concern from the FDA, countless physicians and the entire scientific community — but it’s left many patients feeling baffled. The transvaginal mesh product is similar to another surgical mesh used to treat hernias and other serious conditions, but with serious repercussions. Why is transvaginal mesh so dangerous, and what can we do about it?
Surgical Mesh For Hernia Treatment vs. Vaginal Vault and Organ Prolapse
Doctors used the first surgical mesh products to repair hernias. Hernia mesh keeps organs and intestines from protruding through the abdominal wall. It’s been largely effective and is still used by many doctors today. As a result, many manufacturers began developed mesh for other uses, such as vaginal vault and organ prolapse. While the initial mesh uses were tested in clinical trials, transvaginal mesh bypassed this rigorous approval process. Called the 510(k) pathway, it judges a product based on its “substantial equivalence” to another on the market — in this case, the surgical mesh used to treat hernias.
The 510(k) Pathway’s Role in Exposing Women to Transvaginal Mesh Dangers
While this pathway exists to promote the swift, efficient move of medical devices and drugs onto the market (and offers patients cutting-edge products in the process), it’s essentially a loophole. Though the product itself — surgical mesh — is the same, the area of the body it’s implanted into is different.
Infection, Erosion Among Serious Transvaginal Mesh Dangers
In order for a surgical procedure to go well, the area needs to be immaculately clean and sterilized. According to WBUR’s Common Health, the vagina naturally contains a flora of bacteria, among which you’ll find E. coli and Staph. This bacteria stays in the vagina during surgery, which makes women’s wounds incredibly susceptible to infections. This is significant in terms of mesh erosion, one of the most troublesome transvaginal mesh dangers. It’s not quite erosion so much as a infection with subsequent wound break down, but nonetheless, it is incredibly dangerous and painful. For many women, it necessitates multiple surgeries to rectify the problem— if it can at all.
Yet another problem: Vaginas expand and contract on an as-needed basis (like in pregnancy and childbirth). As a result, they don’t always stay the same size. As the mesh erodes through the vaginal wall, it causes the woman a significant amount of pain and can make sex incredibly uncomfortable for both parties. The mesh itself can contract with the vagina as well, causing even more injury to a woman’s body.
Needless to say, TVM has not been as safe as surgical mesh used for other procedures, and many people have questioned the validity of the 510(k) process as a result. The FDA issued several warnings about transvaginal mesh dangers, illustrating that serious injuries are not at all uncommon. Some doctors argue that though transvaginal mesh has largely been proved to be too dangerous and risky to be used on most women, there are still a few cases where it’s a good option, while others say that different kinds of abdominal and vaginal surgeries are always better.
What You Can Do
If either you or someone you know had debilitating pelvic mesh injuries, you may be eligible for compensation. It’s a good idea to speak with an attorney before you file a transvaginal mesh injury claim.
1. Zimmerman, Rachel. “Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh.” CommonHealth. November 4, 2011. Accessed May 20, 2015.
2. “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.” Accessed May 20, 2015.
3. “U.S. Food and Drug Administration.” UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication. July 13, 2013. Accessed May 20, 2015.
4. “Women’s Health Care Physicians.” Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse. December 1, 2011. Accessed May 20, 2015.
5. Lazarou, George. “Pelvic Organ Prolapse.” Pelvic Organ Prolapse. Accessed May 20, 2015.