FDA UPDATE

SERIOUS COMPLICATIONS OF TRANSVAGINAL SURGICAL MESH

A Review of the Problem
Ralph Zipper, MD, Director Zipper Urogynecology Associates

Dr. Zipper has been practicing Urogynecology for over 15 years. He is an expert in vaginal surgery and has helped develop some of the most promising treatments for pelvic organ prolapse. He has treated thousands of women for pelvic organ prolapse and trained over 1,000 surgeons in the treatment of such disorders.

Pelvic organ prolapse is a group of disorders characterized by the loss of support to the pelvic organs. The bladder, rectum, and/or uterus may bulge down or even out of the vagina.  Some women who have had a hysterectomy may even experience vaginal vault eversion, the vagina turns inside out and hangs down between the legs. These disorders are embarrassing and disabling.  Conventional surgery involves pinching together the weakened pelvic tissues in order to reduce the bulge. Unfortunately, these tissues are weak and the repair often fails. Secondary to such, surgeons over the last several decades have looked to medical device companies for surgical “patches” that may be used to support the pelvic organs. These patches are know as “mesh”. Unfortunately, the ideal mesh has not yet been identified. The best of the worst is a material known as polypropylene. It is a soft plastic patch.

Below, I have provided a summary of the FDA recent cautions as well as my opinion and alternative treatment options.

FDA UPDATE:

In 2008, the FDA released the first public health notice about transvaginal surgical mesh. The second notice was just released in July of this year. Here are the highlights:

  • Serious complications are not rare
  • The most frequent complications are:
    • Erosion of the mesh (mesh exposed, causing bleeding and discharge)
    • Pelvic pain (which may be severe)
    • Pain with intercourse
    • Inability to have intercourse
  • Additional surgeries may be required to deal with complications
  • There is limited evidence to suggest that mesh surgery provides a superior result to traditional non mesh vaginal surgeries.
  • Mesh placed abdominally is associated with lower complication rates
  • Surgeons should receive special training in using mesh
  • Surgeons should inform patients;
    • Mesh is permanent
    • May cause complications requiring more surgery
    • Complications may not be correctable
    • Surgeons should recognize that most cases of prolapse can be treated successfully without mesh
    • The complications of surgical mesh have not been linked to a single product.
  • The full update may be found by searching “FDA Vaginal Mesh Update” on the internet.

MY OPINION:

My opinion is based on my review of the literature, my fifteen years of treating pelvic organ prolapse with and without mesh, and my interaction with other experienced surgeons across the country.

  • Most prolapse can be treated without mesh
  • Treatment of severe forms of prolapse may fail without mesh
  • When mesh is used, complications may be dramatically reduced by:
    • Robotic placement of mesh rather then vaginal mesh surgery
    • Meticulous surgical technique
  • The small amount of mesh used in Sling Surgery performed for stress urinary incontinence is not associated with the same complications as transvaginal mesh surgery performed for the treatment of pelvic organ prolapse.
    • Polypropylene slings remain the standard of care for treating stress incontinence
    • Complications of chronic pain and erosion are uncommon

Complications of vaginal mesh surgery reported in the literature range from 1% to over 50%.  The huge variation in complication rates seems to be related to surgical skill and not any specific product. Unfortunately, there is no public database of surgical complications by surgeon.  The best a patient can do to avoid complications is to ask lots of questions and avoid mesh surgery, if possible. Patients should keep in mind that the robotic placement of mesh appears to be associated with substantially lower complication rates. The two brands of mesh I use are NovaSilk and Alyte.

Although, I continue to use mesh to treat more severe forms of prolapse (bulge hanging out beyond the vaginal opening),  I now perform most of these surgeries using the DaVinci Robot. No complications have occurred. Furthermore, I have developed a method that allows me to treat less severe forms of prolapse without mesh.  I call this method Thermal Colporrhaphy.  Patients treated with Thermal Colporrhaphy have minimal discomfort and none of the complications associated with mesh surgery. Thermal Colporrhapy is a 30-minute outpatient surgery.