Report to the FDA

How to Report to the FDA

Where to find the manufacturer name  and lot number. When I received my hospital medical records I immediately looked in the physicians Post Operative Report to find the product name and number.  I found the surgeon’s hand written note that it was Boston Scientific Advantage Fit Sling, so I went to the FDA site to report the product.

The FDA site is confusing because if you are not a medical technician, some things don’t make sense.  If you don’t give the right answer, the screen makes a noise and a box pops up.  I persevered and almost finished but was stuck because scanning through all the pages, I couldn’t spot where the product number was.  The FDA site will not let you continue without it.  I fortunately had the email address of the woman who had her tape removed, who also happens to be an RN, so I sent Marianne an email last night asking for her help in this matter. This morning she told me to look in the PERIOPERATIVE NURSING NOTES under implants.  Thank God for Marianne!  There it was, name, mfg and lot number.

I made my report to the FDA this morning. Why report it yourself?  My surgeon did not do it and if we, the victims don’t either, then more women will be injured. The moral of this story is GET THOSE NURSING NOTES WHEN YOU ORDER YOUR RECORDS.  Fortunately I did thinking there may be something important in them.  My lesson from all this is, order the hospital records first!  Report the product yourself, that way you know the government knows what is happening.  Doctors don’t care.  Then get this information to a lawyer!  Here is information on how to report from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm :

Reporting complications to the FDA

In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product. You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

More information can also be found online here:

Update on Marianne.  She had her second tape removal surgery early October.  She used a walker to get around and to protect her stomach as well.  She is doing better but is still off work.  The first time she had this surgery she was off work six months.  This surgery was worse, she lost most of the blood in her body and almost died.  She is not sure if this will fix her problems or if more surgery will be required. LET’S ALL STOP THIS MADNESS.  REPORT YOUR MESH TO THE FDA.  IF THEY DON’T KNOW ABOUT YOUR HEALTH, NOTHING CAN BE DONE ABOUT IT

The link I gave to report to the FDA no longer works, so Google it.

4 Comments

  1. Virgie Schowalter

    After reading these articles, I have decided I need to have BOTH of my TVTs removed. Less than a month after the first TVT was implanted (July 2009) my bladder quit and had to have a catheter inserted. I went to a Urologist who was suppose to remove the first one and input another one correctly. Said the first one was too far back. He did not remove the first because it would entail too much cutting so just put in another. (September 2009) I still am incontinent most of the time. However, there are times I just have to sit and wait for it to trickle out. I have stabbing lower abdominal pain from time to time. Also,intercourse is too painful and it feels like there is an obstruction. My OBGYN said it was constipation. I’ve fought constipation all my life and never had problems with intercourse. I have been having difficulty walking and it kept getting worse. Plus I couldn’t sleep at night because of the pain in my right hip and down my right leg. I went to an orthopedic doctor who thought maybe it was bursitis so gave me a steroid injection in my hip and 6 weeks of physical therapy. I’m doing better but still can’t walk very far before my hips have lots of pain. Also my inner thigh and groin area spasm from time to time. Therapist couldn’t understand why my muscles had large knots in them. Could this be from the implant?

    I’ve had two surgeries without success and am scared of another surgery. I might end up worse.

    I need hope and a doctor who can show me successful results from removing the TVTs and reconstructing so I am not incontinent and out of pain.

    Reply
    1. lavalinda

      Virgie having more than one sling is very common because when women complain these doctors take them back to surgery and put a second one over the first one. Sadly this is very common. Please get your records and first know what has been put into you. By the things you have mentioned you have serious side effects that will only worsen in time. You can join me and learn so much more through facebook and twitter and keep up with the blogs and changes. What you are asking for is a guarantee, but there is none. Damage has already been done to you and I can tell you in time things will only worsen. The mesh needs to come out.

      Reply
  2. Kimberly Ryan

    I had complete hysterectomy and repaired prolapse bladder and sling put in about 3 1/2 yrs ago.

    I keep getting swollen lower stomach and deep burning pain in side my lower stomach (belly button area and pain radiating all around). Leaking urine and pain is paralyzing.

    NOTE: I have Fibro, CFID, and IBS and host of other health problems can I still report FDA?

    Reply
    1. lavalinda

      Kimberly you are in danger and need to have a culture test done, not a dipstick urine test done in the office. A culture will take about 4 days to grow to show the bacteria. If is is not taken care of this could happen. http://meshangelnetwork.com/2014/06/understanding-sepsis/

      Reply

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