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  1. #1
    ICN Founder icnmgrjill's Avatar
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    Serious Complications with Surgical Mesh For Bladder Suspension surgery

    Folks... this caught my attention today. Ironically, I spent some time with a woman just the other day who had this complication. The mesh used to suspend her bladder had eroded through her vaginal wall and was actually hurting her husband during sexual intercourse. Now the FDA has revealed that this has been seen hundreds of times and is a VERY SERIOUS complication to this procedure. FYI - Jill


    FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

    Issued: October 20, 2008

    Dear Healthcare Practitioner:

    This is to alert you to 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. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

    Nature of the Problem

    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. 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.

    Recommendations

    Physicians 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.

    Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/sur...sh-popsui.html.

    Reporting Adverse Events to FDA

    FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility.

    We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, or obtain the fillable form online at www.fda.gov/MedWatch/getforms.htm, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

    Getting More Information

    If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

    FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/servi...?code=USFDA_39 .

    Sincerely,

    Daniel G. Schultz, MD
    Director
    Center for Devices and Radiological Health
    Food and Drug Administration
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  2. #2
    ICN Member aleet7's Avatar
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    OMG Jill!!!! One of the uro's that I went to warned me of this! The Uro after that one promised me that he would fix my cystocele with no problems until he found out that my husband was a Lawyer! He changed his mind when my husband came to the appointment to talk about the procedure. I was totally shocked to see the doc squirm and tell my husband that he wouldn't think of performing this procedure on me and making things worse!!! He made me feel psycho especially since he assured me that he could make my cystocele go away and then changed his mind in front of my husband. I went home and cried because I couldn't understand why he would tell me that and change his mind. Wow now I'm glad that I didn't have it done now!
    Best Wishes,
    Teela
    DX'd with IC 5/08
    other Dx's~SVT: had Catheter
    Catheter Ablation Aug 19,2010
    Migraines, PFD, Hypertension,
    Prolapsed Pelvic
    Organs and Degenerative Disc
    Disease, Kidney stones, Insomnia
    Two bulging discs w/tears and osteo
    arthritis in multiple joints in the spine



    Current Meds:Elmiron 400 mg per day
    Benicar Hct 40-25mg for Hypertension
    Norvasc 2.5
    Vicoden as needed for pain
    Cymbalta 30 mg
    Prelief
    CystaQ
    Prosed
    Lidoderm Patch


    Psalm 121
    I will lift up my eyes to the hills from whence comes my help? My help comes from the Lord, Who made heaven and earth.


    "Be Kinder than necessary because everyone you meet is fighting some kind of battle"

  3. #3
    ICN Member aleet7's Avatar
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    I forgot to add that I'm going to Pelvic floor therapy to help with my cystocele and PFD.
    Thanks for sharing this important information!

    Teela
    DX'd with IC 5/08
    other Dx's~SVT: had Catheter
    Catheter Ablation Aug 19,2010
    Migraines, PFD, Hypertension,
    Prolapsed Pelvic
    Organs and Degenerative Disc
    Disease, Kidney stones, Insomnia
    Two bulging discs w/tears and osteo
    arthritis in multiple joints in the spine



    Current Meds:Elmiron 400 mg per day
    Benicar Hct 40-25mg for Hypertension
    Norvasc 2.5
    Vicoden as needed for pain
    Cymbalta 30 mg
    Prelief
    CystaQ
    Prosed
    Lidoderm Patch


    Psalm 121
    I will lift up my eyes to the hills from whence comes my help? My help comes from the Lord, Who made heaven and earth.


    "Be Kinder than necessary because everyone you meet is fighting some kind of battle"

  4. #4
    ICN Member dg2901's Avatar
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    I heard stories of this happening 5 years ago when I had a tvh/a&p repairs. I guess with all procedures there are risks, and until they happen one doesnt know. Fortunately (in hindsight) my Dr didnt use any type of mesh material for my repair so I didnt have this concern.
    Hopefully by now the manufacturers have figured out whats causing such a high complication rate and have come up with a new material to use.

    Diana

  5. #5
    Forum Manager ICNDonna's Avatar
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    I have a sling, but it's not mesh.

    Donna
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    I am not a medical authority nor do I offer medical advice. In all cases, I strongly encourage you to discuss your medical treatment with your personal medical care provider. Only they can, and should, give medical recommendations to you.

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  6. #6
    ICN Member
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    Sling

    Hi

    I just got this sling done on November 9th, 2008. I suffered from stress urinary incontinence. Before i got it done I had found a website and some info on the complications.
    I talked with the surgeon at length about what i found and we even looked at the information together on the internet. I also took my aunt with me when i had the appointment to speak with the surgeon as she is a nurse.

    This was a outpatient procedure for me. And so far it seems to be going well for me. I had the TVT sling done.

    erosion through vaginal epithelium, my dr said this could happen if there was not enough muscles and tendons for the sling to attach to.

    infection, would or could happen if you did not follow the post -op instructions for personal hi genie.

    pain, like the dr said some may have pain some may not --Now i did have some pain as i have 2 abdominal incisions but the pain is almost gone now.

    urinary problems, dr said this could happen if the mesh tape was pulled to tight during the procedure.

    . There were also reports of bowel, bladder, and blood vessel perforation during insertion. Dr said this goes back to the skill of the dr doing the surgery.

    As far as having sexual intercourse i was told no sex with my husband for 4 weeks and then when we do have sex the surgeon suggested that we make sure that we are totally relaxed and to take it easy.

    So only time will tell. Since I've had the surgery done I've talked with 10 other people that had a sling done and only one had problems but as far as i'm concerned those problems happened because she did not listen to the dr.
    She told me that she had sex 4 days after the surgery and that it was very painful for her and her husband.

    I will keep you all updated on my progress.

  7. #7
    ICN Member snowgirl's Avatar
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    When my mother had her tvt done I wanted a uro who had done many. I picked her urologist. She had some urinary retention afterwards and we had to cath for 10 days. IT was not an easy surgery with the cathing. vicky

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