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To Whom Have You Reported Your 'Adverse Event' ?

Jane Akre, Editor

I have a question –

Assuming you’ve had a problem with synthetic surgical mesh, who have you reported your complications to?   The manufacturer, the FDA? 

Did you enter a report into the MAUDE database of the FDA, the only way the agency is able to track  “Adverse Events” ? MAUDE is the only tool the FDA has to measure the complications and is thought to represent just a fraction of the actual injuries.

See earlier story on how to report to the FDA’s MAUDE database (here).

 

15 Comments

  1. Linda Dodson says:

    Once I found out that I had a medical device of surgical mesh material in me, I asked my Dr for the name of the product and the name of the manufacturer. My mesh was made by Ethicon, Inc. I called their 1-800 number and spoke to a nurse. She referred me to three different Gynecologists in Georgia that were familiar with their products. I chose one of the Dr’s that she referred me to, and he took out the cystocele mesh, during two separate surgeries and overnight hospitals.

    My first call to Ethicon did not, to my knowledge, result in them filing an adverse event report. A second call to Ethicon resulted in them filing a false and inaccurate adverse event report to the FDA. After learning this, I knew there was a cover-up with manufacturer’s. At the time, in 2006, I was unaware that the FDA had an adverse event reporting system. It was by pure accident that I went to the FDA website and found the adverse event reporting system. After reading hundreds of adverse event reports, I was outraged that the FDA allowed these medical devices to be placed in a woman’s pelvic floor area. Also, it was during this time that I found my own adverse event report that I was able to identify due to the date and events.

    After numerous calls to the FDA Atlanta office and being ignored, I finally set down and wrote a letter to the FDA, complaining about synthetic mesh materials. I had spent hundreds of hours on the internet trying to research and learn everything that I could about synthetic mesh material and it being placed in a woman’s pelvic floor area. I also read the FDA’s policies on approval of these products under the 510-(K) process and their own enforcement policies. My letter turned into a very detailed letter consisting of 28-pages. I personally met with the FDA in Atlanta in February 2007. They took my complaint very seriously.

    The FDA forwarded my complaint letter to their New Jersey office where Ethicon, Inc. operates. The FDA spent five or six days conducting an on-site investigation and cited Ethicon for violations and issued a FDA form 483.

    • Jane Akre says:

      Thank you Linda-

      You are a real hero! Your letter to the FDA was awesome… they simply couldn’t argue because you are using their own lingo which you clearly understand. I’d like to publish all 28 pages of it, maybe an Oped?

      Anyhow how to call the FDA- Their Hotline 1-800-FDA-1088 ( Let me know what they say, how seriously they take you)

      Here are instructions from a previous story:
      How to Report an Adverse Event

      You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:
      By phone- 1-800-FDA-1088
      • By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
      • By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

      MedWatch Online Voluntary Reporting Form (3500) is here.

      Look up Adverse Events:
      Manufacturer and User Facility Device Experience (MAUDE) data
      As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

      For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:
      1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
      2.) Brand Name: Tension Free
      3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
      4.) Records Per Report Page: Change to 500 and click Search.

  2. Susan says:

    Jane, I got your name from a blog, by Linda@teacupmilliner. I had surgery in Greenwood S.C. in March of 2010. I had both a prolapse bladder and rectal repair. The Dr. told me this was the newest technique, and so much less evasive then the bladder repair I had 20 yrs. earlier at 27, when stitches where used. I thought ok, I won’t have to go home with a cath this time, sounds good. From day one, This has been a nightmare. I had no idea the hell that I would go through, on a daily basis, because of my decision. I work at a Co. where I am on my feet 9 hrs. a day. I now work part-time because the pain in my pelvic area, becomes too much. The man that I have been married to for 28 wonderful years, and I can not in anyway be intimate. It kills me just a little more everyday. This product is so wrong, and these surgeries are an ibomination! My husband is kind and loving and, thank god, understanding. But what if he weren’t. I want my life back, and I damn sure want these companies to have to STOP manufacturing these products. Lives depend on it!

    • Jane Akre says:

      Susan-

      I’m so sorry to hear about the situation you have been put in from a “minimally invasive” product. Unfortunately your story is so similar to others. I’ll contact you separately . If we can do a profile, others can jump in and offer you some direction and help. Thanks so much for contacting us.

  3. Jane Akre says:

    Hello All-

    Some phone numbers here- however- if you are represented by a law firm PLEASE check with them BEFORE you contact the manufacturer! ****

    Ethicon- 1-877-384-4266- Ethicon Customer Support Center/ then ask for the Complaint Department #5 or to speak to a nurse #6. They are the front line and they will want to know what procedure you had done, the complications you are experiencing, the dates, hospital, the lot number, etc. The company has a complaint department that looks at the information and analyzes it to see if it’s related to the product therefore ‘reportable’ to the FDA.

  4. Jane Akre says:

    Boston Scientific – 1-508-683-4000. Complaints Department. The complaints go directly to the complaints department in Marlboro, Mass. Call the urology complaints department at 1-866-868-4004. You should probably have the lot number and model number in advance of the call if you can.

    **If you are represented by an attorney Please Check with them before calling the manufacturer**

  5. Jane Akre says:

    American Medical Systems – 1-800-328-3881, choose Option #1 to reach Patient Liason. You may have to leave a callback number.

    **If you are represented by an attorney- Please Check with the firm before contacting the manufacturer***

  6. Jane Akre says:

    **Please check with your Law Firm BEFORE you contact the manufacturer**

    Davol Bard -1-800-562-0027, they will forward you onto the field Assurance Department which is 1-800-556-6756, ext. 2335. You need to know the patch lot number (8 digits) and the reference number (7 digits). The manufacturer is obligated to pass the complication complaint onto the FDA while the hospital and surgeon is not required to, though they are encouraged to do just that.

  7. Teri Mathison says:

    Thank you for your encouragement tonight Jane! This gave me hope that there will be a light at the end of the tunnel. Thank you for all you do to help women like myself who are suffering, not knowing where to turn for help.

    • Jane Akre says:

      Teri-
      I’m so sorry this happened to you. There is an amazing and growing group of very vocal and smart women who are not suffering in silence anymore!! They are getting their device numbers, filing complaints with the FDA, contacting their legislators, finding doctors and lawyers to address what has happened AND supporting one another! You are definitely NOT alone, in fact your story is remarkably similar to everyone else. Again- I’m so sorry though….

  8. Denise says:

    I have been suffering ever since Oct 22, when the doctor put this ethicon mesh in, instead of just sewing very small hernias from prior aortic surgery, Nov 3 had to go to er because you could feel heat from my surgery, even though the doctor that did the hernia surgery was at er he didn’t come see me, evidently told the er doctor to give me some antibiotics and send me home on some stronger pain killers. Well the next day I had appointment with doctor that did surgery, guess he just wanted to get office visit too, he put me into hospital. The stuff that was in my drain, looked like pond scum and fish scales, but no one in er would take sample of fluid. On Nov 5 2011 I woke up from surgery with a football size hole in my chest, the doctor had to take all muscles and everything else that was touching the mesh out, I was put on a vac unit with sponge material to get the infection out. Well same doctor was playing with my life because instead of getting infectious disease doctors involved he decided he would handle the infection too. Well throwing up with no muscles that connected wasn’t fun, the doctor wouldn’t even give me anything to calm my stomach, wouldn’t let me eat anything but liquids, no saltines that always made ya feel better with throwin up, omg. I got out of hospital and had to travel back and forth in ambulance every other day to get these sponges changed, I smelled like a dead deer on side of road that got hit a week ago, the pain was unbearable!!!!!!!! I took at least 2 vicodins before the ride and one more before the nurses started pulling the tape and sponges that grew to my insides everyday. It did eventually heal together, looked like I was bout 8 months pregnant, went to plastic surgeon and he couldn’t believe it, he has known me for at least 17 years and I have never been that big, I couldn’t see my feet, and even having 2 kids I was never that big. I have been tall and thin like a rail all my life, well I have talked to lawyer she hasn’t been in hurry to get back with me, haven’t been able to have sex with my husband of now 23 years, this is now almost 3 years cause I feel like I am gonna blow wide open with someone else’s muscles holding me together since the other doctor took all the other muscles out of me cause of infection. It is almost as bad as my screwed up back surgeries that I didn’t need but must have been lab rat for those too. Tell me what I can do???? I have figure back, but missing belly button, now have 3 different ones from plastic surgery, don’t feel like I have any strength anymore at all, worse after this surgery……….

  9. Regina says:

    Research presented towards APPG will, doubtless, be filtered back to Parliament all together – interesting times.

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