Transvaginal Placement of Surgical Mesh Can Cause Serious Complications in Prolapse and Incontinence Surgeries

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Transvaginal Placement of Surgical Mesh Can Cause Serious Complications in Prolapse and Incontinence Surgeries

October 22nd, 2008 laurie

The FDA on October 20 sent a letter to healthcare practitioners warning about complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences.

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI, the warning letter stated. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

The FDA’s letter to physicians said doctors should:

Obtain specialized training for each mesh placement technique, and be aware of its risks.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

The FDA urges patients, before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene. Questions patients should ask the surgeon before agreeing to surgery in which mesh will be used:

What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
What’s been your experience in dealing with the complications that might occur?
What can I expect to feel after surgery and for how long?
Are there any specific side effects I should let you know about after the surgery?
What if the mesh doesn’t correct my problem?
If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?