Surgical mesh has been around since the 1950's; doctors originally used it to repair hernias. The use of mesh gradually expanded to include abdominal repair of prolapse and then repair of urinary incontinence. Finally, surgeons began inserting the mesh vaginally instead of abdominally to repair prolapse. Many different manufacturers make surgical mesh, but the material all looks and works basically the same regardless of who makes it.
The transition to use surgical mesh transvaginally came because not every surgeon had been trained in using it abdominally. The trans vaginal insertion of surgical mesh meant nearly any surgeon could use it, since insertion of the mesh into the vagina is a fairly straightforward procedure. Doctors also considered the process to be the only alternative for women whose vaginal tissues were too weak to take the traditional suture-based prolapse surgery.
The FDA approved the sale of mesh kits for prolapse repair in 2004. These kits contained surgical tools, specialized instruments for the procedure, and the mesh, which can be cut to fit each individual woman.
Surgeons began to use the kits, as did general gynecologists who had not necessarily been trained in prolapse surgery. The kits’ ease of use allowed unqualified doctors to try their hand at this procedure.
Questions about FDA Approval
Things seemed to be going well for trans vaginal mesh at first. But after a few years of use, problems began appearing in some women. As the number of patients reporting problems with the mesh increased, questions about the FDA's approval process for the mesh kits began to arise. The mesh kits had been approved based on a prior approval of a similar product used for urinary incontinence – a product that had been taken off the market in 1999 due to a high percentage of complications after surgery. The FDA called this product "misbranded" and "adulterated," a fact widely publicized in a 2002 report in the New Jersey Star Ledger.
While surgical mesh had been used safely for abdominal hernia and prolapse repair for decades, no surgical mesh had been used in a human vagina prior to the FDA’s approval. Researchers had never done long term tests on the mesh’s safety or efficacy, so no information on its long-term effects was available.
Salvage Operations: Now Common on Trans Vaginal Mesh
Many doctors now perform salvage surgeries to remove trans vaginal mesh. The doctors who do these surgeries agree on one thing... the vagina is not a good place for mesh implantation. Its natural flora includes several types of bacteria. Salvage doctors say this flora cannot be cleaned from the vagina prior to implantation of the mesh, and this leads to surgical complications with the mesh, sometimes immediately and sometimes years down the road. Basically, surgical mesh cannot be inserted into the vagina in a sterile manner.
The pain, bleeding, and breakthrough of mesh into the vaginal wall and the organs beyond it are all caused by infection due to the non-sterile environment in which the trans vaginal mesh surgery is performed. Even when the mesh moves into the vaginal wall and organs beyond it, infection is the root cause; the vaginal bacteria causes the wound from the surgery to break down, which in turn can make the mesh move to places it does not belong.
Removing Mesh is Messy
Removing trans vaginal mesh is not always a straightforward or safe procedure. Pieces of the mesh can be left behind. When the mesh really gets embedded into the vagina, surgeons face the tough task of trying to extract the mesh without damaging the surrounding tissues. This task often proves complex, and women can be left with permanent vaginal injuries from the procedure itself.
These injuries can cause chronic pain, interfere with enjoyment of sex, make periods more painful, promote incontinence, and increase the incidence of vaginosis. Many women who have trans vaginal mesh complications require psychological counseling to help them cope with these diverse problems.
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