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.
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!
American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling called RetroArc, used to treat incontinence.
Johnson & Johnson was supposed to be holding thousands of pages of documents in preparation for defective mesh trials, instead, the documents disappeared, destroyed by the company. Was it intentional?
Contributor, Aaron Leigh Horton profiles one mesh implanted woman to see how she is coping.