Transvaginal mesh (TVM) was introduced in 1996 to help women with stress urinary incontinence (SUI). A different mesh came a few years later to help treat pelvic organ prolapse (POP). POP is typically the result of weakened muscles from pregnancy and childbirth. A woman’s organs are able to slide down and out of place by those weakened muscle groups.
The Risks Of Transvaginal Mesh Surgery
TVM did not face much scrutiny or testing when first introduced in California and across the country. Manufacturers used the 510 (k) clause in the FDA’s code to bypass clinical trials and human testing. The clause allows manufacturers to skip trials and testing if they can demonstrate that their product is essentially just a variation on an already existing product. Transvaginal mesh was very similar to traditional mesh so it was approved.
However, manufacturers reportedly did not account for the location of the installation. Transvaginal mesh surgery implanted the product in a more sensitive location. The soft vaginal tissue would have very bad reactions to its presence. The mesh could become displaced, tear or cut, meld into the soft tissue, cause hemorrhaging or severe pain. Scarring and scar tissue were another serious problem.
Removing the product via a second transvaginal mesh surgery turned out to be extremely inefficient. Doctors often have to make multiple attempts to remove the mesh. Even still, they weren’t always able to remove all of it.
Alternatives To Transvaginal Mesh Surgery
The alternatives range from periodic fixes to the installation of a different kind of mesh. A mesh that is installed through incisions made in the abdomen of the woman reportedly has a much better rate of success than those made through transvaginal mesh surgery.
Other treatments can include Botox shots to relax the muscles and relieve pain. Electrical stimulation and exercises can be used to strengthen the muscles and help combat prolapse.
Legal Action And Compensation
Lawsuits have been filed in California and around the country in regard to transvaginal mesh surgery. The suits alleged product defect and negligence committed by the manufacturers. Many of these suits have been joined in a Multidistrict Litigation (MDL). MDLs allow for coordinated pretrial proceedings and discovery and often are more efficient for litigants.
If you or someone you love has been injured after receiving a TVM implant, contact Attorney Group for California today. We can help answer your questions and connect you with an experienced attorney, all at no cost or obligation to you. Contact us today.