Do Your Part! ~ How to Report to the FDA

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Mesh Medical Device News Desk, October 13, 2021,
by Jen Snowden

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FDA Reporting - How to do Your Part!

Do you know if your doctor reported your adverse mesh event to the FDA? It’s likely they didn’t, and if they did, they likely didn’t include all the details of what you know and have experienced.

But YOU can report it yourself, and it’s SO important that you do! Each one of us may not make a big difference individually, but if the FDA is flooded with reports of nerve injury, chronic pain, reconstruction surgeries, pain management, chronic inflammation, fistulas, continuing incontinence/retention, infections, and everything that we’ve been through from mesh, it can’t be ignored! The ‘low incident’ rate that the manufacturers like to report could be changed drastically if we flood the FDA with reports of what we’ve been through, and maybe eventually the FDA will listen and pull this crap from the market.

How to do your part:

Go to https://www.accessdata.fda.gov/scripts/medwatch/

1. Click ‘Begin online report’ for Consumer/Patient.
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2. Fill out your information in the blanks. Some of this you may not have, and that is ok, as long as you make the report. In the ‘Tell us what happened and how it happened’ section, you have 4000 characters. That’s a lot. Use it to describe what happened and all diagnoses, surgeries, how it’s affected your life…include as much as you can.
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3. If you have your implant log, that is super important. TAKE A PICTURE of it to upload after you enter the information in the form. There is an upload link at the end of the form that you can provide pictures, not pdf or other files. This is not only proof of your implant that helps validate your report, but it also connects dots with other reports of the same mesh type, and will help the FDA connect the dots among the worst/most reported meshes, as well.
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4. You can also take pictures of diagnoses from other doctor reports - nerve damage, muscle spasm, chronic pelvic pain, extra surgeries, etc. The more we show that the injuries we’ve experienced are/have been diagnosed by a professional and are widespread among consumers/patients, the more they HAVE to listen!
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5. If you’ve submitted a report in the past, but you’ve had more issues or additional surgeries or diagnoses since then, you can file another report. They will connect your information to your first report and note the additional/ongoing issues.
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6. It doesn’t matter how long ago your mesh was implanted, if you’ve had any issue, even if you still only suspect it’s from the mesh and doctors haven’t necessarily confirmed it (because we know how they like to ignore our pain or blame it on something else), still report it.
   

Shortly after you submit your completed report (could be a couple/few weeks), the FDA will send you an email with an official acknowledgment letter and an Access Number for your individual report. If you are adding onto a previous report, or may want to in the future, this is the number you will use.

It may be too late to help change what happened to us, but you could make a difference in preventing mesh from being implanted in others. Let’s work together and save some lives…submit your report today!

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