"Transvaginal Mesh Is Life-Threatening"

Miami, FLMedical consultant and analyst Lana Keeton believes that transvaginal mesh, like other synthetic surgical mesh (e.g., Kugel mesh), should never have been put on the market. "Synthetic Surgical Mesh is a life-threatening device," Keeton says. "It is toxic, over-engineered and degrades during manufacture, shelf life and in the human body following surgical implantation."

LawyersandSettlements (LAS): Why do you believe that transvaginal mesh, or any surgical mesh is life-threatening?

Lana Keeton (LK): Synthetic mesh is a misuse of the body's inflammatory process. The tension-free concept is for human tissue to scar into the interstices of the mesh to hold it in place following surgical implantation. The concept is flawed as the final result of implantation is never known as there is no clinical data to support this. And despite processes used during manufacturing process, polypropylene leaches nonylphenol.


(LAS): What is nonylphenol and why is it dangerous?

(LK): Nonylphenol is an endocrine disruptor and has an estrogen effect. It causes thymocyte apoptosis, which can result in auto-immune disease. It is an endocrine disruptor showing estrogenic activity.

According to the EPA, nonylphenol is toxic to aquatic organisms. EPA also intends to propose a new regulation in 2011 that would require any company that wants to use NPEs or nonylphenol in new applications to notify the agency before doing so. Plus, federal regulators will consider adding nonylphenol and NPEs to the list of chemicals of concern that might present an unreasonable risk to human health or the environment.

(LAS): How is surgical mesh physically dangerous?

(LK): Synthetic mesh degrades continually, starting with the thermal knitting during manufacture, in the package on the shelf and inside the human body. Dr. Bruce Ramshaw presented his findings on hernia mesh explants to the CDRH/FDA, demonstrating how mesh hardens, shrinks and deforms while implanted. This is in addition to scar contracture caused by the actual surgical procedures to implant the mesh. Mesh/tissue integration is ill- defined in the literature and in clinical trials.

(LAS): Are you saying that this tape and the medical device "Transvaginal Mesh Sling" or TVT is defective?

(LK): Yes, without a doubt. The Gynecare TVT System and its TVT Device (Prolene mesh tape) are inherently defective for more than one reason. The tape itself has abrasive edges that cut human tissue to sensitive organs like the bladder, the vagina, the urethra. It is a process that will not stop unless your doctor surgically intervenes in some manner. I have reports from an expert witness that the edges of the tape are defective.

The plastic sheaths that cover the tape for the purpose of implanting it in your body have to be pulled out after the tape is put inside you. Any movement of that tape after implantation is undesirable based on a patent that Ethicon filed in 2004.

(LAS): What happened with the Ethicon patent?

(LK): This patent shows that the first tape implantation didn't work. Ethicon edges caused the problem so the company tried to change the edges; they were stabbing in the dark to try and make it work but nothing can make it work because it's a bad product, just like Kugel mesh. Whether this synthetic mesh is used for hernia repair or POP and bladder suspension, it's all the same product and all bad.


(LAS): If transvaginal mesh is life-threatening, why are doctors routinely implanting it in patients with Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI)?

(LK): It is frequently described as the "new gold standard" because it is popular, not because it has been proven safe and effective.

Doctors are misled by rosy medical marketing by the manufacturers showing high cure rates and very low complications. (There are no randomized controlled trials to support these numbers, just press releases from the makers of the mesh.) Patients are told nothing. Frequently they do not even know mesh has been implanted in them. If they do know the doctor has used mesh, there is no readily available information telling them exactly what kind of mesh has been permanently surgically implanted. Patients are left in the dark.

(LAS): What kinds of problems with this mesh are being reported?

(LK): Short-term complications include infection and urinary retention, while long-term complications are de novo urgency and urethral and vaginal erosions. As I said (above), it can result in auto-immune disease.

(LAS): If problems do develop, what is the prognosis?

(LK): Future medical treatment for the serious complications of mesh becomes a mine field. The body's own natural inflammation process, by which the surgical mesh adheres to internal tissues, never reaches the healing phase. A cascade of complications follow as chronic inflammation sets in. Auto-immune diseases multiply as the body fights the chemical leaching of nonylphenol from the polypropylene meshes. Other synthetic meshes, all petroleum based, create havoc in the body as they leach their own proprietary blend of chemicals.

(LAS): What kind of procedure was in place to treat POP before TVT was introduced?

(LK): Skin grafts were implanted but they didn't have a great success rate—what can you expect when you are trying to sew weakened tissue?

Let me explain it this way: You have holes in a threadbare bed sheet. You place a patch over the hole and sew it to the threadbare material. That patch will pull away from the sheet because it is too strong for the sheet. If that is the problem, doctors will just get a bigger patch. Instead of a 4" x 4" piece of mesh, they will use a 10" x 10" piece, and that is literally torture.

All problems that require mesh, such as POP, are symptoms of weakened tissues, not diseases. So doctors are trying to treat the symptoms. Instead, they need to strengthen the tissue—not fix the hole. They need to use biologic mesh that functions with the tissue and is not cross-linked; it is constructive remodeling that promotes your own tissue.

(LAS): Why would doctors use synthetic mesh rather than biologic mesh?

(LK): Biologic mesh is more expensive and the doctor needs greater surgical skills and training in order to constructively remodel with biologic mesh. (But there have been problems with biologic mesh.)

This question goes back to promotion and marketing by the drug industry: Doctors who would have never considered this procedure are now emboldened by these mesh kits and do procedures they wouldn't have thought of doing in the past.

The bottom line is that TVT should never have been put on market. It is the same design of mesh that is being used in the abdomen. The premise is that mesh doesn't move in the abdomen because it is flat. But pelvises are used to walk, sit, have sex—a pelvis moves, and having this TVT implanted is a very bad move.