FDA-What Are We Waiting For?
It's been months since the FDA said a word about mesh, and years since it's known stronger action was needed. Meanwhile, more and more people are getting hurt. Sign our letter below to let them know how you feel.
FDA-What Are We Waiting For?
Prolift mesh kit, Ethicon, J&J
At the end of July, the Food and Drug Administration (FDA) closed its comment period for the public to weigh in on reclassifying pelvic mesh as Class III, meaning high-risk. As most readers of Mesh News Desk understand, that is the classification where it should always have been. To make a permanently implanted medical device anything less (moderate risk) does nothing to assure the safety of the public! As you may also know this proposal to reclassify did not include the same polypropylene mesh used to treat incontinence (SUI stress urinary incontinence) or hernia repair.
This leaves the thousands who are suffering from these implants with no options and business as usual for mesh manufacturers and the doctors who continue to promote mesh as a treatment for those two conditions.
Increasingly, doctors who are being identified as the experts in mesh removal, are weighing in that there are inherent problems with polypropylene mesh that need to be addressed before its continued widespread use.
In other words, the red flags are waving.
Reclassification means that the mesh will have to be proven safe before it is marketed. It is a higher bar to reach and involves clinical trials. The leading theory is that mesh will never be able to reach those benchmarks for safety. And mesh manufacturers will not want to invest the millions necessary for the testing.
In essence, innovation will be stifled. That is the cry manufacturers put in the ear of the FDA, which seems to be leaning toward the concerns of the industry over the injuries of Americans.
Here’s What You Can Do
Add your name and comment to this letter:
By mid-November we’d like to have this petition sent to the FDA to insist it do its job putting people first. The next two weeks will be our gathering time for signatures.
First- Please sign this petition which will be forwarded to the FDA.
Then – Whether you can share on Facebook and tell 20 friends to sign on; Post on your FB group and make it an effort; Include your picture or a sharable graphic to bring attention to the issue – You all are very adept at making things happen.
Lastly- If you have a list of friends, send it to them as well. I will be putting it on the Mesh News Desk newsletter, going out today, to add another thousand or so to the effort.
Next on the Horizon- Doctors and Lawmakers!!
The FDA is apparently in no hurry to make things happen. The first mesh warning went out in 2008, the second, more serious warning in 2011! It said mesh complications were “not rare.” What are we waiting for?
Will your doctor or lawyer sign on as well?
In fact: FDA-What Are We Waiting For? Might be a very good campaign theme. Hurry up FDA, make things happen and do so now!
As always, thank you for everything you do! Warm regards, Jane A., Editor MND
Tell the FDA is a PDF version if you want to send one yourself!!!!