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FDA Warns About Complications of Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

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The FDA issued a public health notification yesterday to warn about a number of serious problems that have been associated with transvaginal placement of surgical mesh that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

According to reports received by the FDA from nine different manufacturers, over 1,000 people have suffered severe complications from the surgical mesh, including reports of infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Women have also reported recurrences of the prolapse or incontinence, and the need for additional surgeries to remove mesh that had eroded into the vagina.

A pelvic organ prolapse occurs when organs such as the bladder, uterus, bowel or rectum drop and push against the wall of the vagina. This happens when the muscles holding the pelvic organ in place become weak or stretched, often due to childbirth or surgery. The surgical mesh is used to support the muscle.

Female stress urinary incontinence is a condition where urine is involuntarily released during moments of physical stress due to weakened of the muscles that support the bladder and urethra. In repair procedures, the surgical mesh is designed to act like a hammock to reinforce the muscle.

The FDA recommended that physicians obtain specialized training for various placement techniques and that they closely monitor patients for problems with the surgical mesh. They have also indicated that patients should be informed of the surgical mesh risks, so that they understand that complications could seriously impact their quality of life.

No specific groups of patients were identified as being at an increased risk of thee surgical mesh complications. In addition, the notification does not single out any particular manufacturers or types of mesh.

In 2006, a type of surgical mesh used for stress urinary incontinence, known as the ObTape Vaginal Sling, was removed from the market by Mentor Corporation just three years after it was introduced when a large number of women experienced severe problems.

The Mentor ObTape surgical mesh differed from most other mesh devices, since it contained a “non-woven” design. This blocked oxygen and nutrients, substantially increasing the risk of surgical mesh problems, and some estimates suggested that the complication rate could be as high as 17% to 18%.

There are currently 22 ObTape surgical mesh lawsuits pending throughout the United States, which have been filed by women who suffered severe infections, extrusions and urinary tract erosions.

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203 comments

  1. Melody Reply

    I had rectal prolapse surgery in 2010 with surgical mesh, I have been in HELL ever since. I have vaginal and anal pain, leg pain, thigh pain, and cannot fully empty my bowels. Some days I have not stop diarrhea and other times it takes all morning of running to bathroom before I can somewhat empty bowels. I cannot ride in car or truck for any length of time and I am in constant pain! I have been to numerous doctors, with no help in sight. I would rather be dead, than to live like this, but I have a teenage son to think about! I also cannot hold my urine anymore and haven’t even thought of having sex. I need help!!!

  2. Grace Reply

    I had surgery on August 2003, after I was told that it was a simply procedure. That I would be able to resume my regular routine within weeks. Right before surgery I was again told that I could workout and return to jogging, that never happen it’s been 11 years and I thank Hod for still being here but life has been in and out of hospitals.
    Right after surgery I asked the doctor to remove whatever he put in me. I was told no that it would be better. I hate myself for not pushing for that because I have Boston scientific repliform
    And no one seems to believe that it cause harsh damage to the body. I had UTI’s from the very beginning, I was 36 yrs old and never experienced a UTI before this, which beginning my night mare for the next 6yrs I had infections to the point that I became allergic or rejecting antibiotics. The pain was just awful. The medications I’ve been on has caused my teeth to crack and break off, due to no been able to take antibiotics dentist would not see me. Finally after three surgeries the infections were under control. But the pain has continued we went for the forth surgery not count all the nerve blocks I’ve had over ten years things are not better. I get swilling wrist, fingers and palm turn red, my my neck and face and tongue swelled up. Life is been hard for me and my children have stopped breathing I can’t work I can’t do anything I have to have the kids help me. Has to be a solution to this problem I cannot continue like this

  3. maureen Reply

    I had rectal surgery in 2011 had to go back in 2012 to have 2/3 of it cut away the pain I went through I thought it was in my head pain down my legs across lower abdomen and my back severe headaches loss of interest in sex and now I have developed a cyst in my ovaries bladder is more weaker sometimes no control and pain when making a bowel movement – really thought I was going mad

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