April 3, 2013 ~ Dr. Anthony Visco is Chief of Urogynecology at Duke Univ. Medical Center and President of AUGS. The American Urogynecologic Society (AUGS) was founded in 1979 and is a professional organization of 1,400 physicians and allied health professionals who care for women with pelvic floor disorders, specifically pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Last week AUGS issued its position statement that surgical mesh should be free of any restrictions on its sale and use. See the background story here.
Editor, Jane Akre asked Dr. Visco about the statement.
Q: What prompted this position statement? I know it’s been in the works for awhile but what specifically prompted it?
A: “Rather than what prompted it I’d rather talk about the overall purpose of the position statement and work back to what prompted it. There have been some recent restrictions on certain surgical options available to women. Partly in relation to some recent events and including vaginal mesh as well as potentially expanding beyond that. And we considered the climate, the FDA notifications and what’s available. And our concern is not really with any one particular procedure it’s solely that we felt we should come out with a position to oppose the restrictions of choices, surgical options and non-surgical options for women. It’s very simple. That sort of decision of what’s right for a patient ought to be left to the patient and her physician.”
Q: And it was coming from other entities like a medical malpractice insurer from what I read from your statement there.
A: “Yes there were a number who were considering it or had decided to ban some options for women. The point is we have an obligation to adequately inform women and I think in general the FDA has been very helpful providing information directly to the patient, to the public to include elements that ought to be discussed as part of the informed consent process.
Q: Is there any actual informed consent form that AUGS is working on so doctors can all be on the same page?
A: “We’re not working on it we created it over a year ago and have it available as part of an informed consent tool kit we call it. See it here.
“And we want to standardize, I should say we think it is the right thing to do to have as standard of a process as possible so there aren’t variations in the risks and benefits that are discussed with a patient when she’s faced with a decision of how to treat whatever pelvic floor disorder she has.’
Q: Has that been a problem in the past, the informed consent process?
A: “I’m not sure it’s been a problem we just identified that with FDA notifications listing certain things that ought to be discussed. I don’t know if it’s a problem I wouldn’t characterize it as that, I would say that based on what the FDA came out with, we took it proactively upon ourselves to say anyone who is discussing options with a patient include these things. And those will be updated based on what just came out two days ago from the FDA.’
Q: I noticed they refreshed their FDA web page. What’s different with that compared to what there was previously?
A: “One thing that I think would be very helpful, and why I thought this call would be important, is to try and do what we can to inform women of not only what their choices are, which we are trying very hard to protect, but also we often use a blanket term of ‘mesh’ and we really feel it’s different.
“ The FDA on its first webpage talks about three broad categories. Those three broad categories are vaginal mesh for prolapse, transabdominal mesh for prolapse repair and mesh for stress urinary incontinence. And those are three broad categories that I think help frame discussions of risks and benefits.”
Q: I understand the differences.
A: “I tell you we could do a better job of educating and informing patients about these three categories.’
Q: So you are making a distinction between POP mesh and SUI mesh? Are you making a distinction then between the numbers of complications that one could predict in those two different categories?
A: “Most, including the FDA, would make a distinction between those three categories. They’ve come out even in their earlier statements. The listing of the three bullet point categories is very helpful to frame the discussion. They have generally categorized those in three different categories including previous position statements.’
Q: Does AUGS distinguish among those three? And if so what might the complication rate be for the three different types of mesh?
A: “The complication, the size, the location and how it’s placed vary not just by those three broad categories but by several other factors, frankly beyond the limits of this telephone call. The FDA conducted a systematic evidence review that was presented during the September 2011 meeting that broke things down into generally those categories along with the systematic review that compared risks and benefits of the various procedures depending on those general categories.”
Q: You seem to be saying in this position statement that AUGS should be doing a better job training physicians, is that correct?
A: “No you keep using the term doing a better job, those are your terms they are not our terms so I want to be clear. I think we have issued credentialing guidelines to help credentialing bodies at the local level not at the state or national level. It’s usually at the hospital or health system level. Previously I think they were just informed locally with mechanisms to assess competency and things like that. So that these credentialing guidelines go through what should be considered when credentialing for these procedures.”
Q: Are those guidelines published somewhere?
A: “They are published in our journal and they are also available on our website. The thing that would be helpful would be for you and others to help publicize the fact we’ve spent a lot of time working on these guidelines and get the word out these guidelines exist. That would be a helpful thing that could be done for women.”
Q: Is that because they are not generally known now?
A: “The sacrocolpopexy guidelines just came out earlier this month (AUGS Sacrocolpopexy Guidelines) so some of these things are very recent. The vaginal guidelines were previous to that (AUGS Guidelines_for_Providing_Privileges) I think the position statement that just came out talks about the importance of credentialing guidelines to give people a framework and develop their own local guidelines. The credentialing bodies can choose to be more or less restrictive, these are just guidelines, however, I really think it will provide them with information they’re going to need to make a somewhat standard process.”
Q: I’ll be sure to highlight that in this story. I did a little research into the FDA October 2008 communication (here) and it said back in 2008 specialized training should be addressed and there should be more vigilant oversight. Has that not been taken into consideration by the physicians?
A: “Again I wouldn’t say it has not been. I think there have been a lot of changes. In the credentialing guidelines is the ability to address that statement to try and increase that awareness. The AUGS is developing a registry to try to allow the tracking of outcomes for providers so that’s another things we have done in response to the need to track these outcomes related to all pelvic floor disorders beyond vaginal mesh. There are a couple things to consider, we, first of all, want to protect the choices women have. I think that is the crux of the position statement. And the thing to remember is that complications can occur with or without mesh, with mesh and non-mesh repairs. We do not want to scare patients away from seeking care but we do want to have a framework where they are well informed and they can choose which option is right for them.
“We don’t feel it’s our job to either 1)- make the choice for the patient or 2) -remove choices that are available to that patient.”
Q: Yet we still have more than 10,000 lawsuits that have filed so the word is getting out… and when you consider litigation, so far it’s been product liability litigation. The Bard case did name the doctor and he has to pay $500k. I’m surprised a little by the position statement in it seems to open the door to more medical malpractice lawsuits, does it not?
A: “I wouldn’t believe that’s the case. The intention of the position statement I think I made pretty clear. I’m not sure what you mean by that.”
Q: Let me explain. If in here there are more suggestions for credentialing, additional training and specialization for implant surgeons, does that imply that the training has not been adequate?
A: “That is not the intention. We are solely saying it is important for surgeons to be adequately trained. That would be a big leap to say that any complication from a procedure, mesh or non-mesh related, would be due to poor training.”
Q: Okay so you are not squarely putting it on the shoulders of poor training for the mesh complications we are seeing.
A: “That is not the intention of the position statement.”
Q: Do you think there are some inherent problems with polypropylene implanted in the body?
A: “I and many others frequently implant polypropylene in well-informed patients.”
Q: Does AUGS not support the proposal by the expert panel convened in 2011 to reclassify POP mesh to Class III?
A: “AUGS has not come out with a position on whether mesh placed vaginally for POP should be reclassified. I think the FDA is a very able body and is considering that, they’ve made it public they are considering that and I would trust they’d make the right decision.”
Q: So there is no policy statement or position by AUGS one way or the other on that?
A: “No, that is correct. That could change but right now there is no position statement on that particular statement.”
Q: I looked at the SUI update page on the FDA website and they’ve continued to track the number of SUI mesh-related injures – it’s up to 1,876 up 36%. Does that surprise you?
A: “Well you recognize the difficulty with that is what we don’t have in there is what resulted in that increase. That increase could be real increases or it could be attention placed on that to create a higher rate of reporting rather than a higher rate of actual complications. And what we also don’t have in there is the denominator of how many procedures were done at that period of time. So were just more procedures done during that period of time but the rate was the same or was there better reporting or did the rate really increase? Understanding which of those factors explain the increase is really important when you’re trying to decide how things change over time.
“That’s where having a national registry has the ability to answer those sorts of questions. If you’re able to track both a pretty good sense of the total denominator, (the total procedures being done) as well as the total complications.”
Q: Isn’t that already what we have with the MAUDE database?
Q: How would that be different?
A: “This is an important point. If you have a voluntary mechanism for reporting of complications, it may just be that someone chose to report a complication, but that may also mean there are other complications that did not get reported. Were they motivated to report it because they heard about it because there is more public discussion about it. Let’s just say that were the cause, you might see an increase in the number of complications reported, but it wouldn’t really be an overall increase in rate of complications it’s just an increase in reporting.
“Part of this is that you want to know not just the number of complications that are reported, which is an important real number, but you also want to know the number divided by the total number of procedures done so you know what the percentage of complications really is. Until we have an ability to capture the total number of procedures, the denominator, we won’t know whether or not the rate is actually going up or down. So that’s really important when you’re trying to make a determination of whether a procedure’s rate of either harm or benefit is changing over time. You need to have the reporting, as accurate as possible, to get a full assessment of benefit and harm divided by a full assessment of everybody who underwent that procedure.”
Q: So we don’t have that with MAUDE because it’s sort of casual reporting…
A: “Yes, I don’t know if I’d call it casual. It is a voluntary reporting system.”
Q: And this new database, surgeons would enter the information, manufactures would enter, who would be responsible for putting information into this?
A: “Some of the studies are responding to 522 orders and individual surgeons could also report and track their outcomes. Informed patients, could also choose to also enter their information. At the end of the day I think we have a shared goal of healthy, happy patients with as low a complication rate as possible and as high an efficacy rate as possible. Some complications will occur no matter what you do, unfortunately. We try very hard to minimize them as much as possible. Unless we have full reporting we’re never going to be able to answer these questions as well as we’d like to. And I think this holds the promise to be able to do that.”
Q: Are you concerned at all that manufacturers may decide this doesn’t qualify as a legitimate mesh-related injury so ‘we’re not going to report it’?
A: “I think that it depends on what you’re asking; I’d frame it differently. There will be clear definitions and depending on, for instance the 522 orders, those studies will be closely monitored and we hope that once those outcomes are clearly defined, people will continue to follow those. We’re going to have, the ability for patients to enter data directly and they will be able to enter their experience and their symptoms over time.”
Q: Anything else you want to emphasize?
A: “I enjoyed the conversation very much and hope some of the points about credentialing guidelines are shared and that we advocates for women to have choices and to not have surgical options and non-surgical options removed. #