I have a serious question. It’s regarding the FDA warnings for mesh, and I would really like some input from ANY doctors out there still promoting/using mesh, or the people marketing it, or just anyone familiar with the whole “mesh mess”.
It is not a real hard question. No opinions are necessary. I’m just looking for some cold hard facts. A website link would be perfect. Ready?
QUESTION: WHERE in the FDA warnings does it mention mesh for SUI is safe, and that:
“any reduction or restriction of the use of the MUS (midurethral slings) would be a DISSERVICE to patients.” ??
I’m asking, because I keep finding articles and websites where AUGs and doctors are making it sound like the FDA is telling them mesh for SUI (Stress Urinary Incontinence) is perfectly safe, and that it is just the mesh for POP that is causing all the problems. Not only that, but they are making it sound like the FDA is saying that they SHOULD KEEP using mesh for SUI, or they are actually NOT being a good doctor. ??
Now, I admit, that even if the FDA DID say mesh for SUI is safe, I wholeheartedly WOULD not and DO NOT AGREE, for many VALID reasons. But, the question is does the FDA state this? Do they? Anywhere? And, if not – then why do doctors and researchers keep making it sound like they do?
Take for an example, this article: “Management of Complications After Tension-Free Midurethral Slings“(http://synapse.koreamed.org/DOIx.php?id=10.4111/kju.2013.54.10.651#B7), from Oct 2013. The article has MANY things I personally would question, but for now, let’s stick to this part, where it says:
“But in the Public Health Notification the FDA issued in 2011, there was a warning about the use of transvaginal mesh for pelvic organ prolapse surgery only and not for SUI surgery. The FDA also noted that any reduction or restriction of the use of the MUS would be a disservice to patients .“
That reference #7 is a link to the July 2011 FDA warning (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm), which I’m quite familiar with. And, unless I am missing something, it does NOT state anything in it about how it would be a “disservice” to reduce the amount of mesh slings for SUI used. ?! It does, in fact, say that the warning is geared towards POP mesh. However, it ALSO mentions a lot of statistics about problems from mesh for SUI – such as almost as many reported complications for SUI (1371) as there were for POP complications (1503). That is a far cry from promoting mesh for SUI, is it not?
I wrote about this a few times, like here: “Why is it Okay to Use Mesh For SUI, but Too Risky for POP?“, and I have not received any real answers on this yet. I mean, it’s bad enough the FDA has NOT publicly come down on mesh for SUI, as hard as they have for POP. But, where does it show that they are actually RECOMMENDING the mesh slings be marketed and used as the best option?? Let alone state that if they (the doctors) are NOT using mesh slings/tape, then, they are “doing their patients a disservice”?
A disservice? ?! How so? By saving them a real live “Not rare” risk of having severe complications? Yeah, right. I WISH my doctor had done me such a “disservice”.
Now, I admit that I have not had much time to read the FDA website lately, so maybe I missed something. But these articles are from a few years back, and they are referencing FDA warnings from even further back. Which does lead me to another question….
Is that even legal? Can they (doctors, AUGs, researchers) make blanket statements and references to the FDA, making it sound like the FDA said something, if they have not?
Before I go calling Dr. Tufan Tarcan in Turkey to try to get to the bottom of this, I will first give someone the chance to prove me wrong. Did the FDA say these things? I seriously want to know. So, please feel free to share and post this question elsewhere. I would like input from anyone who knows, and can link to the FDA warning or update to show this? Not to an article, probably written by paid consultants for the mesh manufacturer companies, but to the FDA website that they keep using as an excuse. If the FDA has indeed said this, I will politely thank you for pointing it out to me, and admit I was wrong. I will still disagree. But, at least I will quit blaming the doctors and researchers making these statements for misquoting and for what appears to be actually twisting the FDA warnings around to service their own agendas.