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Q & A

Jane Akre

I’m Jane Akre, the News Editor at Mesh / Medical Device News Desk and I’m here to help and to put a face on the devastating injuries that women and men report to the FDA. Really.  I have found this to be an extraordinary story ever since I did the Suffering in Silence series more than two years ago for InjuryBoard.com

See it here:

Suffering in Silence- Part One;    Part Two;    Part Three;    Part Four 

Here’s my background from another website I run, Journalism Juice. I have more than 30 years in the news business and find the lack of regulation over these devices often used by the targeted baby boomer generation to be a major story especially since they are intended to be permanently implanted!

There is more followup on defective automobiles than medical devices which do not undergo premarket approval.

I am not a lawyer or a medical professional so the information contained in this site is not intended to substitute for information from your lawyer or doctor, however I can access the professionals who can answer your questions!

I understand if you don’t want to use your name. I do need to verify you are a real person so let me know how I can contact you. Let’s continue the conversation.

9 Comments

  1. Jane Akre says:

    Okay Okay- don’t all jump in at once… I will ask myself a question here. Q: Why haven’t you talked to Johnson and Johnson Ethicon’s division and gotten their point of view.

    Good question!!

    I have called Matthew Johnson, hear PR guy at Ethicon Women’s Health no fewer than 15 times and always left a polite message with absolutely NO response. I asked Piet Hinoul of Ethicon who testified at the the FDA hearings in September who I could address about whatever followup studies Ethicon is doing on its mesh products. he told me as well to contact Matthew Johnson. Here is his number 732-516-8439. Maybe you’ll have better luck than I did. Thanks and stay connected!

    ja

  2. Amy Gezon says:

    Have any phone contacts for Boston Scientific——I’d like to thank them for the long and enduring memories!

  3. Amy G says:

    Every woman who has received mesh without being notified of the FDA warnings or the limited long term follow up for safety should file a complaint with the Joint Commission and inform them of the facility you received the mesh from. Perhaps facilities hospitals and outpatient surgical centers will comply with appropriate consent if they risk losing their accreditation by JACHO.

    complaint@jointcommission.org

    • Jane Akre says:

      Excellent suggestion Amy- I’ve always wondered why Medicare doesn’t get involved since we have many million dollar bladders out there. Although many mesh patients are not Medicare age…

  4. George says:

    Hello Ms. Akre,

    My dilemma – Heading in for my 8th abdominal surgery since 2006 on the 15th – will be 4th in past 16 months.

    Had incisional hernia “fixed” with recalled medical device – Large Kugal mesh with ring – ring came out this past August, explant mesh in December – no mesh was implanted. Incisional hernia has returned along with umbilical hernia from lap port. Both are expanding and are very painful.

    So no mesh-suture repair does not work for me.

    But what alternative to mesh is there?

    My surgeon is one of the few that tries to repair complicated cases, so I doubt it is him or his group from a skill standpoint.

    Not easy to think that I will get another patch that will probably cause problems down the road, but I need to stay alive to find out.

    Thanks George

    • Jane Akre says:

      George- I’m so sorry you’ve been through this… fortunate you got the Kugel mesh and ring removed considering what so many others are living with. There are quite a few folks here who are experienced in hernia mesh alternatives. Hal Samples had surgery (see his profile) and Bruce Rosenberg (see Resources) is very knowledgeable..Those are good starting points. Let me know if you need contacts!

  5. Rebecca says:

    Hi Jane

    I am 31 years old. I had a Miniarc urethral sling (made by american medical systems) implanted in 2009. I have had back problems ever since. Also leg numbness and abdominal swelling, I now pee about every 20 to 30 min and it never feels like I empty my bladder completly. I talked with my doctor and he said ” that little tiny piece of mesh that i used will not cause any of these problems. My GYN put in my mesh. I also contacted AMS to see if anyone has reported any of these side-effects. The patient liason told me NO she has not heard of any of these side effects. But looking online a lot of women have these side effects… WHAT SCHOULD I DO????????????

  6. Tammy says:

    I had the SPARC sling implanted in 2006 when I had my hysterectomy. My doctor asked me if I ever had trouble urinating when I coughed, sneezed, ran, etc. I replied, “absolutely, even laugh!” I can’t do too much without that happening! Well he encouraged me to get the bladder sling at the time of the hysterectomy, therefore, I did. (We trust our gynecologists, right? I mean their doctors, eight to ten years of school). DUH! Well, I had to catheter myself for 2 weeks directly after. This should have been my SIGN! However, they told me this was normal as they did supply the catheters. Well around 2008, I started this “up all night to urinate every couple of hours,” it made it so difficult to concentrate at work the next day. I went to a doctor and “nope, no UTI,” but it came back later my thyroid was low. Well placing me on meds for that didn’t help! I was having mood swings and believed I was starting peri or full menopause, placed on medication for that, nope that didn’t work! Have lived with this problem as it would come and go months at a time, pass or maybe I would learn to “ignore” it as docs did, then when it got bad enough was forced to deal with it again, began to! Well after the surgery, Monday, March 12th, yes over a week ago, the urogynecologist (specialist) told my spouse she did not remove it, because she could not find it??? I have encountered pain after pain over the last few years, only getting less tolerable, just to have an unnecessary surgery? Well, she reported she did end up removing “scar tissue,” but as I said did not locate the medical device to remove, but said she would refer me to a pain management physician!!!!! ARE U SERIOUS! Just give me a death sentence doc and medicate me in the mean time! Do you think I can get some kind of help? I am frightened and scared reading all of these stories! I have received the operative report from her procedure and am still awaiting the original surgical procedure from 2006. As a recovering addict for over thirteen years, I will absolutely NOT take narcotic medication for pain to tolerate medical negligence! More important, who pays for this mesh mess? Do we just suffer and die? WoW, I would have liked to know what I was getting into in 2006!

    • Jane Akre says:

      Tammy- Do you have insurance? A partial removal can be worse than doing nothing. I’ll put you in touch with some patient advocates who can walk you through the steps that they encountered. no medical or legal advice, just sharing their experience.

      Most people find it oddly comforting that they are not alone in this. Unfortunately there are thousands of women just like you, going through the same thing.

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