Sunday, January 29, 2012

Warning about surgical mesh for pelvic organ prolapse repair

Are you or is anyone you know planning to have surgery for the repair of pelvic organ prolapse? If so, then you must read this about the warning from the FDA and the American Congress of Ob/Gyn (ACOG) about the dangers and risks of surgical mesh used to help repair these conditions.
Pelvic organ prolapse includes disorders such as the bladder bulging into or outside the vagina (called a cystocele) or the rectum doing the same (called a rectocele). For more than 50 years gynecology surgeons have been repairing these problems without using anything more than surgical instruments and sutures.
However, in the past 5-10 years, the use of permanent surgically implanted mesh is growing, and this mesh is causing many serious and devastating complications such as infections that will not heal, severe and chronic pain and the mesh is even breaking through the vaginal wall (erosion) causing pain, bleeding and a malodorous vaginal discharge.
For every mesh complication, the patient is likely to need a risky surgery to attempt removal of the mesh. These operations are fraught with danger since the mesh scars down and attaches to the surrounding tissues. Attempted surgical removal of the mesh can also lead to damage to adjacent organs such as the bladder or the rectum and the patient might even end up with a colostomy.
How did we get into this situation?
This is because these mesh products are FDA approved for use in humans in many cases with absolutely no safety data on their use in people. Sometimes the mesh is only studied in animals. Since mesh has been safely used for years for hernia repairs, the manufacturers basically assumed that their products would be safe in the vaginal area. Well, they assumed wrong.
According to ACOG, in their December 2011, Committee Opinion, Number 513, [1]
“…There seems to be a small but significant group of patients who experience permanent and life-altering sequelae [consequences], including pain and dyspareunia [painful intercourse], from the use of vaginal mesh.”
The number of studies on patients who have had mesh placement are few. In one study, “there was a higher rate of complications associated with vaginal mesh compared with native tissue vaginal repairs, including a 10% mesh erosion rate.” Ten percent of patients developed mesh that eroded right through their vaginal wall. In other studies the rate was as high as 20%!
The FDA has sent a warning to Ob/Gyn offices
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP [pelvic organ prolapse] are not rare.”
In its 2011 Safety Communication[2], the FDA identified vaginal placement of surgical mesh for pelvic organ prolapse repair as an area of “continuing serious concern”. The FDA recommends that clinicians inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, vaginal scarring, and narrowing of the vaginal wall in pelvic organ prolapse repair using surgical mesh, and doctors should provide a copy of the patient labeling from the surgical mesh manufacturer if available.
Better yet, find an experienced Gyn surgeon who can perform this operation safely without the use of mesh at all.

[1]   December 2011, Number 513, Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse.