FDA Warns Healthcare Workers About Transvaginal Surgical Mesh

Bard Mesh ProductThe FDA has released a warning to medical professionals about serious complications with transvaginal surgical mesh repair of pelvic organ prolapse (POP). Although patients have been complaining by the hundreds about their surgical mesh complications, the FDA had previously reported these problems as “rare”. That stance has changed as the FDA has now received thousands of reports of “adverse events” associated with surgical mesh procedures.

The FDA has told the medical world in a recent statement that “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.”

The agency says they will continue to evaluate the effects of using surgical mesh, and will notify the healthcare community of their findings. In the meantime, you can read what other patients have to say here in the comments of our post from 2008.

Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse – (FDA PDF: 07/13/2011)

There are 10 comments. Add yours.

  1. Laura

    Lana, Hello, This is really good information. Thank you and I was wondering if you would email me so I can talk to you about some of your opinions. Blessings to you.

    Reply
  2. Lisa White

    I am very impressed with Dr Zimmern and his staff. I am scheduled for removal in December. It has been a nightmare, horrible electrical like pains and I am so grateful to understand what has caused all my symptoms and am grateful to be getting it out!

    Reply
  3. Norma

    I had the mesh put in in June of 2010. It caused an erosion so that was corrected in Oct 2010. The first surgery helped some, but the second reversed it. So July 2011 I had yet a third surgery to attach my urethra to the walls of my abdomen. It is working great, but the mesh was supposed to be removed at the time of the third surgery, but wasn’t . Now I still have the mesh in my body, and it is very painful……….I am trying to find a OBGYN in or near Tacoma , Wa. who is experienced in finding and removing this foreign object from my body.
    Any help there would be greatly appreciated.

    Reply
  4. Kathy

    Lana, could you possibly email me? I have appointment with Dr. Zimmern in April to discuss mesh removal. I would really feel less stressed if I could actually communicate with a patient of his that has already gone through the surgery. I live in Texas but I am apx 6 hours away from Dallas.

    I have considered Dr. Raz but I don’t know about insurance coverage and if it is even possible for me to afford to travel there. Thank you

    Reply
    • Myra

      I have an apt. next week with Dr. Zimmern. Do you have more information on him since your post?

      Reply
      • Kim

        Myra, I was wondering if you have had your appt with Dr. Zimmern and how it went. I am trying to get my mom to go see him for mesh removal. Thank you!

  5. cindy

    I had a total hysterectomy 2 years ago, I am now starting to feel some pain. I had the bladder prolapse and they used mesh to pull it back up into place. I’m having shooting pains, and I swear I’ve felt the pain go down to where my leg and body meet. The doc made a small incision in both my legs at this point, I forget what for.. but the pain is on my left side. I have an appt at the end of Feb. I am very concerned after hearing about the recall, and lawsuits out there!

    Reply
  6. jennifer

    i had the mesh screen put in dec 6th, 2011 . been having problems ever since i know its been so soon since i had it done , but i also had my ovaries taken out at same time. i just started reading on all this and it really scares me. i live in pennsylvania. all i was told it was obcare ( the mesh screen ) i feel the pain should be gone by now and the infection, had to go to e.r once already . dont know what to do , go back to dr. on jan 4th 2012..

    Reply
  7. Pat Suba

    I am scheduled to have this procedure done on 9/6/11 but after researching the use of synthethic mesh, I am calling it off. I have questioned my ob-gyn surgeon about the long term results , pros and cons of using the mesh and complication rates. She has been vague, to say the least, telling me there hasn’t been alot of follow up studies . I would rather live with what I have now, I am 70, than risk complications which appear to be severe, and have to endure additional surgeries, pain, infections for the remainder of my life.

    I have questioned the need for synthetic mesh for many months. This is an elective surgery for me but my symptoms can be lived with. The FDA needs to recall the entire line of synthetic mesh and we, as women, must refuse to be guinea pigs for the medical equipment companies that continue to test their products on us , finding the products cause death and sufferring, and THEN take them off the market. We are their test dummies!
    Induring the pain and additional surgeries that many women have had is obscene. The physicians seem to be just as clueless or maybe they act that way to avoid lawsuits. WE must be able to sue . Tort reform must never take place in the US . Everyone needs to be held accountable for the health and well being of persons who are in need of treatment.

    Reply
  8. Lana Keeton

    Even when synthetic surgical mesh is not recalled, it causes serious harm, and even death.

    ALL SYNTHETIC SURGICAL MESH CAUSES SERIOUS COMPLICATIONS, SOME WORSE THAN OTHERS. And, NO, the “new ones” are not better.

    Surgical mesh is like a window screen that has raw edges. Your tissue scars into the interstices of the mesh. Removing it from your body is like removing gum from your hair. You have to remove some healthy human tissue in order to surgically remove mesh.

    But it is worth it to get it removed. Think about having a splinter in your finger. You would never consider doing physical therapy or trigger point injections. You would remove the splinter and then allow it to heal. But so many doctors further torture injured mesh patients by recommending physical therapy and/or trigger point injections before mesh removal.

    Search for a highly skilled surgeon with a lot of experience with mesh removals before you have a second surgery. A bad second surgery frequently is worse than the original mesh surgery.

    I had surgery with Dr. Philippe Zimmern in Dallas, Texas last June. I am so happy with the results. After going to Cleveland Clinic Weston for 7 years and having multiple partial mesh removals, by Dr. G. Willy Davila, I finally went to Dr. Zimmern. Dr. Zimmern did an MRI to find the mesh, did a 3 hour surgery and took out 4? of mesh. Finally I was set free from 8 1/2 years of chronic pain.
    (I DO NOT recommend Cleveland Clinic Weston, Florida. They continue to promote surgical mesh knowing all the harm it causes.)

    I had consulted with Dr. Raz when I lived in Los Angeles in 2008 but did not have health insurance coverage for UCLA at the time. I would have treated with he and Dr. Larissa Rodriguez if I had had the coverage.

    Both of these doctors are amazing. I know many women who have had surgery with each one of them and all of them are better, some with better results than others, depending on who did the original surgery and what mesh product was used.

    CONTACT INFO:
    Philippe E. Zimmern, M.D.
    Department of Urology, J8.122
    University of Texas Southwestern Medical Center at Dallas
    Aston Ambulatory Care Center
    5323 Harry Hines Blvd. #8882
    Dallas, Texas 75390-9164

    214-645-8765, Press #1 and then #2 (for new patients)
    214-645-8769 fax

    http://www.utsouthwestern.org

    Patrice Lynn Manley is Dr. Zimmern’s Nurse.
    She goes by Lynn but her e-mail is Patrice.
    Call and leave a message for her. She will always get back to you the same day.
    Patrice.Manley@utsouthwestern.edu

    – – AND – –

    Shlomo Raz M.D. Professor of Urology
    Chief Division of Pelvic Medicine and Reconstructive Surgery
    Director Fellowship Program
    Department of Urology UCLA School of Medicine
    200 UCLA Medical Plaza, Suite 140
    Los Angeles, California 90095

    Phone 310-794-0208 Fax 310-794-0211

    Elizabeth Vasquez, patient coordinator, in Dr Raz’s office.
    She handles the financial and insurance stuff.
    The phone is (310) 794-0206 and her email is elvasquez@mednet.ucla.edu.

    AN IMPORTANT WORD OF CAUTION:
    Be careful of any surgeon who holds himself out to be an “expert” at mesh removal. Especially those with the websites targeting mesh patients. The really good ones are not advertising. They are too busy taking care of all the injured mesh patients they already have.

    I sincerely hope everyone posting on this site finds help to remove this human torture device. No human should ever do this to another human, especially a doctor to a patient.

    Blessings to all, Lana Keeton
    Founder & President
    Truth in Medicine Incorporated

    Reply

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