by Jen Snowden
I shared a link in several mesh groups recently about reporting your injury to the FDA through the MedWatch program. It seems a couple of us meshies may have done it, but I’m sure it looked pretty intimidating to some, as well. I want to explain WHY it’s so important to do this and then help you with the HOW.
Please, read on.
The MedWatch program is part of the post-market surveillance of products that are regulated by the FDA, meaning that if there are enough real complaints submitted, it can significantly affect a product’s ability to stay on the market.
Currently, the only ones required to submit a report are manufacturers, device user facilities, and importers. The device user facilities (hospitals, surgery centers, etc.) are only required to submit reports to the manufacturer unless they don’t know who the manufacturer is. Our doctors aren’t even required to report when we’ve been injured, it’s only voluntary.
But patients, caregivers, and consumers can submit their own voluntary reports, as well, and that’s where we come in. According to their site, “The FDA takes seriously reports of illnesses or injury that appear likely to have been caused by an FDA-regulated product. As few as one or two complaints can make a difference.” If a report has been made by your doctor or medical facility or even the manufacturer, your consumer report will be added to supplement information and diagnoses since. This is SO important in the regulatory system and is actually the only means that the FDA can do something about getting this crap off the market.
If we don’t make the reports, the FDA may never really know the seriousness or incidence rate of issues with mesh. We know the manufacturers and doctors who make the big bucks from producing and implanting it aren’t going to report it if they can make some other excuse or if they don’t have to. That’s another reason why they may brush our problems off as ‘not related to mesh.’ It’s up to US to make this Happen!
Note: You have 3 days from start to complete your report. If you do start it and realize you need more information, click save and make sure to write down your Report ID and Report Date to be able to come back to complete it later. I also advise you to do this on a desktop or laptop. Doing it from a smartphone would likely prove to be tedious and difficult.
1) Your implant log with the product manufacturer name, type, product number and serial number. This can be obtained from your records at the hospital where your mesh was implanted. Make sure to ask for ALL records when requesting records from the hospital. Some hospitals destroy records after 7 years. If you don’t have/can’t obtain the implant log, you can still file a report with the information you know.
2) Paperwork of doctor’s visits and diagnoses/issues confirmed by your doctor and disability determinations by SSD/SSI. It’s best to take pictures of this paperwork and have it ready to upload from a file on your computer, as only certain kinds of files are accepted. If you have a smartphone, you can email the pictures to yourself, then download from your email onto your computer. I suggest attaching them to the email as ‘small’ if that’s an option on your phone. Choose only the most important ones that show diagnoses of issues directly related to your implant, as you’ll only be able to upload up to 8 MB to the file.
3) Documentation of subsequent surgeries related to the implant, also as pictures to upload.
4) Dates of implant and any removal surgeries.
5) Picture of your implant if it has been removed and photo evidence provided. If it’s been removed and photo evidence wasn’t provided, the pathology report from your explant surgery hospital records can work, as well. If your mesh has not been removed, or you don’t have a photo or pathology report, don’t worry about that. You can still file your report!
1) Go to Medical Device Reporting (MDR): How to Report Medical Device Problems | FDA.
2) Click the middle red button that reads Report a Medical Device/Problem (Consumer/Patient).
3) Click the Consumer/Patient (FDA Form 3500B) button under “Begin Online Report”.
4) Answer each question that you know how to answer. Only * sections are required, but the more detail you can provide, the better.
5) ‘Tell us what happened and how it happened’ – this is the important part to write your story.
6) The first page of the report is also where you will click that you ‘have a picture of the product’.
This will allow you to upload up to 8 MB of files, which can be pictures of your doctor’s notes as described above and if you have a picture of the removed mesh. The acceptable file formats are JPG, JPEG, GIF, and PNG. If you don’t have a picture of the actual product, that’s fine, click yes anyways and upload your doctor/diagnosis reports. We still want them to have to see the things our doctors have diagnosed us with due to/since mesh!
7) Continue through the form with as many details as possible. Some of the information on the Device page you may not have, but as much as you can find from your records, include it. The more specific we are about what injured us, the more likely that a specific product will be targeted for review/recall.
8) In the Known Medical Conditions area, make sure to note whether it started before mesh or after mesh for anything that you are diagnosed with. Same with allergies, medications, etc. Maybe one day the science will connect it all, but we can let them know our truth now.
9) On the personal information page, don’t be afraid to include your details, but I do suggest marking the box at the bottom to keep your identity from being disclosed to the manufacturer IF you are in or are considering any legal action. If you’ve already gone through and are finished with legal action, feel free to disclose away if you haven’t submitted a report before. Maybe they’ll see that settlements or case dismissals will not silence us.
I can research and rave and post about mesh awareness until I’m blue in the face, but if we’re talking about taking REAL action that can make a difference, this is possibly one of the MOST important yet simple things you can do to try to protect others from being harmed by mesh-like we have. They can’t ignore us all, but they can’t hear us all if we don’t do our part to speak up. We can make a difference!
Simply put, Congress has not allotted enough money for the Food and Drug Administration to do its job as a watchdog over the thousands of medical devices on the market, says a former FDA professional.
The Food and Drug Administration has an unreliable way of tracking implanted medical devices. The agency knows it has a problem so it may follow the lead of consumer products.
Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, a certain number of patients will have an adverse reaction to hernia mesh.