Report to the FDA
How to Report to the FDA
Where to find the manufacturer name and lot number. When I received my hospital medical records I immediately looked in the physicians Post Operative Report to find the product name and number. I found the surgeon’s hand written note that it was Boston Scientific Advantage Fit Sling, so I went to the FDA site to report the product.
The FDA site is confusing because if you are not a medical technician, some things don’t make sense. If you don’t give the right answer, the screen makes a noise and a box pops up. I persevered and almost finished but was stuck because scanning through all the pages, I couldn’t spot where the product number was. The FDA site will not let you continue without it. I fortunately had the email address of the woman who had her tape removed, who also happens to be an RN, so I sent Marianne an email last night asking for her help in this matter. This morning she told me to look in the PERIOPERATIVE NURSING NOTES under implants. Thank God for Marianne! There it was, name, mfg and lot number.
I made my report to the FDA this morning. Why report it yourself? My surgeon did not do it and if we, the victims don’t either, then more women will be injured. The moral of this story is GET THOSE NURSING NOTES WHEN YOU ORDER YOUR RECORDS. Fortunately I did thinking there may be something important in them. My lesson from all this is, order the hospital records first! Report the product yourself, that way you know the government knows what is happening. Doctors don’t care. Then get this information to a lawyer! Here is information on how to report from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm :
Reporting complications to the FDA
In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product. You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
More information can also be found online here:
- MedWatch Online Voluntary Reporting Form (3500)
- FDA NEWS RELEASE (July 2011)
Update on Marianne. She had her second tape removal surgery early October. She used a walker to get around and to protect her stomach as well. She is doing better but is still off work. The first time she had this surgery she was off work six months. This surgery was worse, she lost most of the blood in her body and almost died. She is not sure if this will fix her problems or if more surgery will be required. LET’S ALL STOP THIS MADNESS. REPORT YOUR MESH TO THE FDA. IF THEY DON’T KNOW ABOUT YOUR HEALTH, NOTHING CAN BE DONE ABOUT IT
The link I gave to report to the FDA no longer works, so Google it.