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FDA Alert - Using surgical mesh for prolapse surgery

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  • FDA Alert - Using surgical mesh for prolapse surgery

    FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse

    Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.


    Pelvic Organ Prolapse
    Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

    Stress Urinary Incontinence
    Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.


    On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
    Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

    The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
    The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

    For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

    Summary of Problem and Scope:

    In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
    From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

    In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

    In particular, the literature review revealed that:
    • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
    • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
    • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
    • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

    The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

    Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
    Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

    The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

    Recommendations for Health Care Providers:

    As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:
    • Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
    • 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 using surgical mesh.
    • Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.

    In addition, the FDA also recommends that health care providers:

    • Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
    • Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
    • Consider these factors before placing surgical mesh:
      • Surgical mesh is a permanent implant that may make future surgical repair more challenging.
      • A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
      • Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
      • Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
    • Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
    • Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
    • Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

    Recommendations for Patients:

    Before Surgery
    • Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
    • Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.

    In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:
    • Are you planning to use mesh in my surgery?
    • Why do you think I am a good candidate for surgical mesh?
    • Why is surgical mesh being chosen for my repair?
    • What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
    • What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
    • Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
    • If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
    • What can I expect to feel after surgery and for how long?
    • Which specific side effects should I report to you after the surgery?
    • What if the mesh surgery doesn’t correct my problem?
    • If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
    • If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
    • If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

    After Surgery

    Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.

    Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.

    Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
    Talk to your health care provider about any questions you may have.
    If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.

    FDA Activities:

    The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:
    Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.

    Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.

    Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.

    Reporting Problems to the FDA:

    Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

    To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:
    Manufacturer's name
    Product name (brand name)
    Catalog number
    Lot number
    Date of implant
    Date of explant (if mesh was removed)
    Details of the adverse event and medical and/or surgical interventions (if required)
    Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
    Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
    Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
    Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

    Contact Information:
    If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at [email protected], 800-638-2041 or 301-796-7100.
    This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality.

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    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.

  • #2
    Thanks for your very informative post, Jill! Although I have never had it, I am wondering if it is the same stuff they sometimes used with Endometriosis patients. I think I read, a long time ago, that they often used it when a patient had very severe Endo/adhesions, to wrap the mesh around each organ or area whenever the Dr. separated the adhesions, where the organs were stuck together. The mesh was used to keep them separated in some (very severe) cases.

    Like I said, I am not certain if this was the same type of stuff or not. So, if anyone has any ideas (or seems to remember this too), please post.

    Thanks again, Jill, for passing this on!

    Sending hugs,
    I am not a medical professional. I do not give medical advice. In all cases, I urge you to talk to your Dr. about your treatment options.

    D/Xed 2003 with IC. Also have the co-existing condtions of VV, Vulvadynia, Lupus, Fibro, GERD, CPP, Endo, & Adhesions, and Depression

    Meds: Estrogel (due to total Hyster)
    The meds r/xed by my Pain Dr. from the Pain Clinic are as follows: Morphine ER and IR, Baclofen, and Lyrica and Seroquel (used off-label as a sleeping pill, but it also helps with depression)

    (I listed my meds in case someone reading this has been told like so many ICers that Drs dont r/x pain meds for IC.) I want you to know that there ARE tons of us who are also dealing w/this disease and the pain and many of us ARE on pain meds.)

    John 3:16 For God so loved the world that he gave his only begotten son, that whoever believes in him shall not perish but have everlasting life.


    • #3
      I'm happy that my sling is not mesh.

      Stay safe

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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.

      Anyone who says something is foolproof hasn't met a determined fool


      • #4

        I had the mesh put in, in may 2008 and had to have it taken out in feb of 2010 due to the fact that it eroded into my bladder, my dr could not remove all the mesh and to this day i am having serious side effects. I also had 3 surgeries prior to the mesh removal to remove bits and pieces of the mesh and another surgery due to vaginal scarring, I was told by my uro on my last visit i will have these complication the rest of my life, which includes monthy bladder infections, which at times have required picc line to get rid of just to come back again, I recommed noone should have this mesh put in, because now i have to live like this the rest of my life which is very emotional to me.


        • #5
          Jill, I'm personally very confused about this issue. It seems to be such a huge issue including "lawsuits" advertised on TV.

          I happen to be one of the few/many who experienced extreme pain and vaginal erosion from mesh implanted vaginally in 11/2007. I basically suffered until I found my wonderful Uro/Gyn who agreed to remove the mesh 2/2010. It was at this time he suspected IC as well which I totally believe began during my recovery from the 2007 surgery. In 5/2010, my uro/gyn did the abdominal robotic surgery to repair my prolapsed bladder and vagina by then, again with mesh, but it's my understanding a different type than used the first time.

          I don't know what to do when I hear about this reporting to the FDA and on TV "lawsuits". Are they against the material itself, the doctors who used it??? Will it interfere with my health care if I report this to the FDA as suggested so much that I may have to find different doctors??? Also, need I ask my current uro/gyn if he had to report the issue himself and this is already a "done deal".

          I do think this is a horrible experience, has possibly lead to the medical problems I experience daily now and needs to be "counted" along with others who have also gone through the same type of problems but I have never been involved "legally" with any complaints regarding my health. (Just an FYI....I am also one of those who's IUD perforated my uterus and had to be surgically removed because it was sitting up against my hip bone....again, did not report anything because of ignorance/innocence & I guess I'm just one to think that risks are risks and things happen).

          Any suggestions as to what this means in the simplest manner would be helpful. I do not expect legal advice, just a more clear understanding of what the intent of this reporting is and to what extent it may affect me personally with my future health care. Also, need I ask my current uro/gyn if he had to report the issue himself?

          Thanks for any help you or others knowledgeable with this issue may offer.
          Never heard of IC til suspected....Never knew so many suffer from it. Praying for a cure. I've found can you...keep the hope.

          11/2007 IC Symptoms began during recovery of surgery for bladder susp & hysto: painful/urge/freq urination up to 50 times a day, pain walking, even water hurts.
          8/2009 Susp IC; 1/2010 Treatment began; 2/2010 Diag PFD, PT, Surg remove mesh; 5/2010 Surg, 2nd bladder repair, vag vault/sm int prolapse repair, IC confirmed in surg; 7/2010 Diag Candida Esophagitis, Gastritis, Diviticulosis, Gallstones,
          8/2010 Surg gallbladder
          TREATMENTS (updated 4/15)
          IC Diet since 8/2009 (Able to vary 4/15)
          Heparin/Lidocaine/Bicarb/Kenalog Instills 1xDay
          Aloe Vera Capsules, (2) 2xDay, Loratadine 1xDay
          Pantoprazole, Prelief, Pyridium up to 3xDay, Premarin Cream 3xWeek
          *DISCONTINUED since feeling better: Celexa 10mg daily*, Fiber supp*,
          Gabapentin 12/2011 worked well *, Macrodantin 100mg after instill*, Probiotics*, PT-PFD*, Valium Vag Suppositories: Cyclo/diaz/lido, 10/5/62.5mg *
          PROB MEDS: Elavil, up to 50mg 1/2011 ret&hbp, Urelle ret, Vesicare ret


          • #6
            Surgical mesh problems

            I really appreciate you sharing this information. I consider that women facing surgery with the use of surgical mesh should be aware of these issues.
            Surgeons have a responsibility to communicate to their patients these risks and closely follow the outcome of the surgery and specifically be aware of the complications that have been signaled in this FDA report. Why is this so important? After surgery spotting a problem early might save countless women from unnecessary pain and suffering. Gathering data and sending reports to the FDA is the only way that the organization can assess the issues raised about the safety of the products and make the necessary announcements and actions to save others from a bad experience. Maybe bad is a very mild word to describe what some women had to go through.

            Since this thread is dedicated to this topic I'd like to share with you another disturbing news regarding these meshes. It is not enough that these meshes generally holds serious risks, it has been identified that some meshes were counterfeit products made in China, and were marketed and distributed under a trusted brand.
            Here is the FDA alert about these products:
            I really hope that surgeons are paying attention to this communication and alert their patients, who may have been affected by these poor quality meshes.
            Spreading awareness of vaginal mesh for stress urinary incontinence risks.


            • #7
              OMG... great catch about the meshes made in China. Yet more proof that we cannot trust ANY MEDICAL PRODUCT or CONSUMABLE coming from China.
              Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality.

              Looking for books, magazines & reports on IC? Please visit the ICN Shop at: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

              Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.