Transvaginal mesh is a synthetic or biologic material that is permanently implanted in women to repair pelvic organ prolapse (POP) or to support the urethra to treat urinary incontinence. However, recent research shows serious transvaginal mesh side effects and complications associated with the mesh products such as infection, organ perforation, bleeding and pain during intercourse may be outweighing the good.
Other painful side effects and symptoms of transvaginal mesh injuries include:
- Blood vessel perforations
- Recurrence of pelvic organ prolapse (POP)
- Mesh protrusion through the vaginal wall
- Vaginal erosion
- Vaginal mesh shrinkage
In July of 2011, the FDA released on update in which they stated that the “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” This was in response to the FDA receiving an additional 1,503 reports of complications from 2008 through 2010 stemming from transvaginal mesh POP repairs. The negative reports have perhaps made the FDA sit up take a closer look.
The FDA Considers More Review Scrutiny for Transvaginal Products
A medical malpractice article titled, “TRANSVAGINAL MESH CONSIDERED HIGH RISK BY FEDERAL ADVISORY PANEL” written by Babbitt & Johnson, P.A. sheds additional light on the fact that currently, transvaginal mesh products are typically eligible to obtain FDA approval without clinical trials as long as the product is “substantially equivalent” to a product already on the market. However, given the recent problems reported with transvaginal mesh devices, this expedited approval process with this product has been called into question.
Reclassifying transvaginal mesh products would most likely add costs to manufacturers. However, the end result would be that the products were much safer for patients in the future.
Doctors and Specialists Heed the Warnings of Mesh Usage for POP procedures
It appears that doctors and specialists are heeding the FDA warnings for use of mesh as the usage has dropped among specialists. Our article titled, “TRANSVAGINAL MESH BEING USED LESS IN POP REPAIR” cites a surgical mesh survey of 281 physicians. Of the 281, 23% claimed they intended to reduce their use of surgical mesh in recurrent vaginal POP repair.
Thousands of Federal Lawsuits Pending over Transvaginal Mesh Products
The Associated Press reports that there are more than 6,000 federal transvaginal mesh injury lawsuits pending against the manufacturers of pelvic and transvaginal mesh products. The importance of these cases cannot be overstated at this point.
Unfortunately, much of this information comes too late for the thousands of women who have already been injured by transvaginal mesh.
If you or a loved one has been injured as a result of transvaginal mesh use, it is important to speak with a knowledgeable transvaginal mesh injury attorney as soon as possible in order to learn what your rights are given your circumstances.