The History of Transvaginal Mesh Implantation

By November 24, 2014 December 25th, 2017 Product Liability Lawyer

There has been a great deal of publicity regarding “transvaginal mesh” implantation in the past few years. However, the reference is somewhat of a misnomer, in that the product is actually surgical mesh that is used in a transvaginal placement to correct pelvic organ prolapse (or POP) and stress urinary incontinence (or SUI).

What is POP?

Pelvic organ prolapse is often caused by a weakening or stretching of the tissues holding the bladder and other abdominal organs in place. This results in the organs sagging and often bulging into the vagina. It is attributed to the stress of childbirth or to aging. The pressure on the organs can lead to a number of problems with uncomfortable and often painful symptoms.

POP Symptoms

Symptomatology in cases of pelvic organ prolapse generally centers around a feeling of pressure in the pelvic area, with the feeling that something is actually going to fall out of the vagina. Other symptoms may include:

  • Low backache
  • A stretching or pulling sensation in the groin area
  • Vaginal spotting or bleeding
  • Pain during intercourse
  • Frequent or urgent urination
  • Involuntary release of urine
  • Constipation

Actions such as jumping or lifting can often trigger these symptoms, and in more extreme cases, coughing or sneezing will cause involuntary release of urine from the bladder. The resulting difficulties from these problems range from embarrassing to painful. Clearly, the medical community was hard pressed to find a means for relieving women of these symptoms.

Early Use of Transvaginal Mesh

Surgical Mesh had been used since the 1950s to repair abdominal hernias, but it wasn’t’t until the 1970’s that surgeons began to employ it for POP. It proved a viable remedy and was in wider use by the 1980s. By 2004, physicians could obtain ready-to-use kits for implantation in their prolapse patients. Women who were not candidates for “native” prolapse repair, or use of their own tissue as a remedy for pelvic organ prolapse, could have surgical mesh implanted as an alternative.

There are a number of different types of mesh utilized as a medium for implantation. These include:

  • Synthetic Surgical Mesh – available in polypropylene and polyester knitted fabric for use in hernia repair, urinary incontinence slings, and prolapse replacement.
  • Native Tissue – use of the patient’s own tissue for reconstruction of defective tissue.
  • Biocompatible Material – a synthetic mesh of polypropylene and polyglactin fibers.
  • Cadaveric Fascia Lata – tissue recovered from the thigh of a cadaver.
  • Animal-Derived Mesh – tissue derived from the skin or intestines of animals; primarily harvested from cows (bovine tissue) or pigs (porcine tissue).

Some tests have shown that synthetic surgical mesh is more durable than other meshes comprised of human or animal tissue. However, there have been complications with a number of these materials.

Complications

Many women have experienced serious complications due to the vaginal implantation of mesh to relieve POP symptoms. Some of the complications have occurred years after surgery, and some have occurred at the time of surgery. These may include:

  • Erosion of the mesh and penetration of the vaginal epithelium
  • Pain and/or infection,
  • Urinary problems
  • A recurrence of the original prolapse problem
  • Perforation of bladder, bowel, or blood vessels during the surgical procedure

The Food & Drug Administration (FDA) has issued warnings on the implantation of surgical mesh, most notably in 2008, and again in an update in 2011. At the time of its first notification, the FDA indicated that there were over 1,000 reports of complications from the use of surgical mesh. By the time of its 2011 report, the FDA noted that it had received an additional 2,874 reports of problems with surgically implanted mesh as a result of its use to repair pelvic organ prolapse and stress urinary incontinence. The reports continue to mount and multiple litigations have resulted. When contemplating POP or SUI surgery, consumers must be fully advised of these issues in order to make an informed decision.