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Q&A: Dr. Anthony Visco, AUGS President

Dr. Anthony Visco, AUGS

Dr. Anthony Visco, AUGS

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?

A:  “No.”

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. #

 

 

22 Comments

  1. Tammy says:

    Geez, are you sure he’s not running for President?

  2. Donna says:

    I couldnt agree with you more Tammy…..How about the woman who were not informed, kept quiet for many years because of being too embarrassed to tell anyone. Then when you find out alot info on this defective product the drs act like its in your head and theres nothing wrong with this mesh…..how far from the TRUTH can you get? Ive been suffering for many years. They say it can be partially removed or fully removed BUT you will have more complications then when you first started and who the heck wants that !!!!! My life has changed DRASTICLY since this implant. IN MY OPINION IT IS NOT A SAFE PRODUCT !!!!!!

  3. Kathy says:

    It would never be possible for a doctor to describe what mesh erosion feels like. Or, how about how mesh has ended my sexual life. What are the long term studies on what this mesh will become in twenty five years inside of us? Since it implanted as a permanent device would it not be important to know this ?

    It will be up to the victims to protect other women with our voice as it is obvious it will not come from their doctor.

  4. Jane Akre says:

    Does anyone have any idea why is seems so uncomfortable for doctors and patients to speak to each other? Surely the doctors don’t believe that women are in pain because lawyers are filing lawsuits? I truly do not understand the disconnect between patients in pain who go to doctor and a doc who fails to recognize or even acknowledge her pain. Almost all of the docs say “you’re the only one.”

    Is it because they were not told by the sales rep? Is it not in the patient brochure? Is it because they fear being sued? Doctors chime in here… thank you!

  5. Suffering from Pudendal Neuralgia says:

    This is all about the money. It’s not about the rights of women to have access to options. AUGS is concerned their bread and butter could be taken away. AUGS had 20 years to “keep track, to train, to inform, etc.” but they didn’t do it until they were forced to. They didn’t think of doing that on their own. Patient safety? Thousands and thousands of lives taken away. Wasn’t there a random clinical trial that was stopped in 2010 because of high erosion rates and no difference in outcome with and without mesh? These women were implanted by reknown expert physicians specially trained in implanting the mesh.The point is that polypropylene mesh is a dangerous product period. Do doctors have their wives, their mothers, their sisters, their daughters implanted with a mesh kit? I’d be surprised if they did.

    • peg says:

      Suffering from, These doctors would lie to their mothers to get money, remember the vast majority do believe humans came from animals and that we can all be treated the same, but we know very well, and not stupid enough to believe their lies, that humans are all different, differnt allergies, meds and more, true it is all about money, greed, and lies, they should see our scarring, mesh cutting into our bodies causing infections, and pain from mesh. not knowing one day to another what will be next, nerve damage , other body parts damage. See the bigger picture lease, look at all that have investments in these chemical companies, the president got the most pay off as did mitt romney, no matter who went into be president these chemical companies had their lying evil, butts covered with especially those appointed in states and judges and some attorneys to keep it quite, so they do not lose money and favors for all. there pockets get heavy with blood money. liars have no place in medical those that we trust with our lives and health, murder is what they are, those that have licenses to murder in america and those that lie and cover it up and stop truth the whole truth in courts of law. they can treat us like animals and if we do not do what they say, we get red flags as they lie in their reports, what difference is there what hitler and saddam and bin laden do to humans so evil as the president and others in both parties that invested or got money for favors in leadership in america, As it is well known how he placed those most corrupt to answer phones and in courts , lying, as richard nixon did, political, yes it is, the roots of those in every state that covered for medical doctors and nurses lying to people here. crimes that the women as they kow will never see justice for what these so evil in medical and chemical companies and our state and washington leaders have done to humans here, god help us.

  6. Nonie Wideman says:

    http://tvtno.org/the-facts/surgical-mesh-and-autoimmune-disease-connection/ Dr. Visco., please check out my research and you will see why I do not appreciate or agree with the position your group has taken …..the dangers of FBR to synthetic mesh need to be acknowledged not minimalized…and the minimum that should be done is to reclassify synthetic mesh , and any implant for that matter to class three …….this is the least that must be done to restore any confidence in the medical community………. synthetic meshes may have their place in emergency surgeries but none of them should be used in elective surgery without testing biocompatibility with the patient that it is intended to be implanted in. Your profession should know by now that a significant subgroup of people will have an exaggerated foreign body response that does not stop!!! You damn well know that mesh does not always remain inert and it can degrade exposing the patient to degradation products that trigger immunity reactions that lead to autoimmune disease. Your professional needs a good swift kick in the ass as a wake up call !. Your idea of informed consent is an insult to those who have researched more than their doctors regarding the disasters that start with ignorance from doctors who can not tell if a pateint’s body will accept or reject implant materials, doctors who don’t follow up and watch for signs of prolonged FBR, and doctors who are slow to help their patients get implant materials removed ASAP when exaggerated and chronic FBR is diagnosed. The other kick you deserve is for not reporting every complication related to implant materials! Reporting of implant adverse reactions or events should be mandatory. The scope of the problem gets swept under the carpet marginalizing women’s health care !

  7. DebC says:

    He talks about keeping options available…. all options… But how many doctors are actually offering any real options for SUI or POP? How many doctors offer traditional non-mesh surgical repairs anymore? How many doctors that routinely use mesh kits for POP & SUI even know how to do ”non-mesh”, traditional repairs? How many docs who only use mesh, know how to remove the mesh if/when there are complications??

    This desire to keep mesh on the market is not about patient rights to options. It is about doctors rights to options. It is about the mesh manufacturers options. It is about money, greed, & marketing disused as a safe, quick & easy option. Mesh is an option that is not for the patient, but at the expense of the patient. An option adversely affecting thousands of lives… women, young & old, who find they are left with years, if not a lifetime, of pain & health issues that are anything BUT quick OR easy!

    • Kathy says:

      When I think back on the innocence of my spirit as I went to the doctor for my urine leakage in 2007 I understand why the opinion of Dr. Visco is so very dangerous. I NEVER expected surgery for my problem. I was a young, healthy and vibrant woman. I wanted to make sure I was “ok” and didn’t have a serious bladder problem causing leakage, as I was a bit shocked by the entire issue. I wanted to solve it, but…. in looking back I never would have imagined. $15,000 dollar surgery that has ruined the future. My symptoms were new to me and to have a doctor tell me that ” only” surgery” would fix this, in my first visit to him is terrifying to me now.

      We trust doctors and we should never be in this position.

  8. George says:

    Disappointed but not surprised by the glad-handing statements made by this MD. Seems to be missing the point of the problem with Mesh related complications even though already this year over 300 peer reviewed journal articles present data on the subject. Yet another case of NRA style of money buying status-quo by the medical device industry and AMA/FDA. G

  9. Terri says:

    One more money grubbing dr. who could care less about women or their health. To say give women options, any women who had the slightest idea of the real harm that mesh has caused would never take that chance. It makes my heart sick to hear,anyone promoting mesh.Its all about the money.Ten/Fifteen years from now after all these women have chosen the wrong option!!!!! Times will be like that all mighty cigarette,that kills and maims thousands .If I had known thirty years ago,what the tobacco companies knew. I would have never ever lit the first one.An excellant example of being given options instead of warnings.

  10. Betty says:

    Great questions Jane. I felt his responses tried to “put the ball back in your court – by insinuating that your questions were the issue:. It is still denial, based on the premise of full disclosure. Between the Dr. and the patient indeed.Of course, they need to put this into laymen’s language because we wouldn’t understand the medical terminologogy used. I just went through this with a friend. The Dr. covered 3 different procedures, and of course all three had the same risks. I just cannot see it. The previous procedures may not have been permanent, and they did have some issues. However, loss of completel life was not one of them! The largest issue I’ve heard from the pro-mesh Dr.’s that I’ve seen is that it is cruel to have their take 3 months to heal from the procedure. If I knew then, what I know now, I’d have easily gone for the 3 month healing process – I still haven’t healed and it’s over 4 years. Who are they kidding??? All this is the name of open discussions. I’d like to know who hasn’t received a phone call trying to say that microsoft, or another company has identified a problem on their computer – a well known scam, or Rachel a voice from the credit card industry. It is the same thing. They’re selling us a product, in hopes we’ll buy and they’ll make a profit. They will emphasize the one they like best. I have another friend who wasn’t even told she was getting mesh put into her body. Just that she needed a fix. So easy, only 1/2 hour surgery. It does blow one’s mind that I went in for 1/2 hour surgery outpatient procedure and came out, maimed for life. GIVE US A BREAK! IF WOULD BE GREAT IF IT COULD BE BETWEEN THE DR. AND THE PATIENT, IF THEY WERE TRUTHFUL TO BEGIN WITH. TRUST HAS ERODED AWAY ON ALL LAYERS. THE MANUFACTURERS, THE DRUG REPS, THE DR.’S – WHO ISN’T SUSPICOUS?? SORRY, IT IS WAY TOO LATE FOR THE DR.’S TO AUDIT THEIR OWN AGENCIES. OPTIONS ALSO WOULD BE SLANTED TO WHAT IS EASIEST FOR THE DR. I’VE SEEN THIS FIRST HAND. WE NEED REGULATIONS ON THE ELECTRICAL INDUSTRY, THE POWER INDUSTRIES – HOW ABOUT TRYING SOME OF THESE REGULATING BODIES ON THE MEDICAL INDUSTRY. THIS WOULD BE THE BEST IDEA.

    • Kathy says:

      I feel each patient should be given a copy of the video of surgery. If I had any idea the Trocars would be plunged into my groin area , if I saw what a Polypropelene mesh sling looked like or a anchor looked like or where it would be put I would have never agreed to surgery. Let alone that I would have known from the video without any input from my doctor that Poise pads were a much better option for me. Today, my groin is hurting so much that I can’t get up the steps without each step hurting so much I scream out in pain. Trocar injury ? I have pieces of mesh that come out of my vagina because of Erosion.

  11. MarieAnn says:

    Mr Augs Pres, I am a nurse who can’t work because I was not offered another option, just mesh! If I’d seen a picture of the trochars and prolift, I’d said is that something Dr Mengele used? If this keeps up the nursing shortage is going to skyrocket. I’ve lost count with all the nurses who can no longer work because they’ve been raped by this wonderful mesh for POP and SUI. Also, almost everyone I know, knows of some poor woman harmed by this torture device. Would you implant this crap in your mom, wife, or daughter, would you take a chance on their being a successful recipient of this device? We are the ongoing clinical trial, I didn’t sign up to be part of your clinical trial. This is Criminal behavior from device companies and their accomplices, You! Also, all women go through vaginal changes with menopause, vaginal atrophy is a catastrophe when you have mesh under your vaginal lining.! Not good science!! Not all women can take HRT! What is wrong with you people? How would you like plastic dug out of your penis?

  12. Kathy says:

    It is 4:00 am. I awoke with such Groin pain that is worse laying down that I am now standing. I’m so tired and yet laying down is so painful. Today, as I lifted my beautiful Grandchild the pulling in my Groin was so painful and yet I hide it from my family. So tired of hiding the pain and at the same time, so tired of complaining.

    I need a Mesh specialist. I know in a few years they will exist, yet, I need one now. I would tell them that nothing feels like it use to in my vagina. I miss sex. My husband misses sex. I miss speed walking and exercise. Both are now painful, before mesh these two human instincts were such a part of me.

    I am confused. I do not know how to solve doctor, insurance or removal issues with mesh. It has been six years.

    I want help and am too sick fight harder in the confusion.It has been a long six years.

    I just had a small amount of leakage. Nothing that called for something being permanently implanted into me.

    It just makes no sense to me. But, I had a huge amount of trust in medicine.

    I was very trusting.

    Now, I just want an apology, better help, getting to UCLA and my health back.

  13. Obviously, Dr. Visco has not cared enough to read about the plethora of problems related to the degradation of polypropylene mesh in the body. I was also a healthy, vibrant woman ten years ago who simply went to the Ob/Gyn for fibroids/ uterine prolapse…not SUI. I had a laparoscopic procedure to remove my uterus, AND the doctor had implanted a mesh bladder sling that I did not really need at 45 years old. Now, I have urethral erosion, chronic

    UTI ‘s, and Sjogrens Syndrome, nephritis, skin disease, and much more! I have NO chance for even partial recovery without having the ” offending” agent totally extracted! I hate the flippant attitude of these doctors who have NO IDEA of the potential risks, ( including death), that these mesh slings pose. There ARE alternatives in treating SUI without the use of mesh!

  14. Mary Pat says:

    Jane, your questions for dr visco were spot on. Thank you for being the voice of mesh victims. His position is heartbreaking. Too bad all mesh victims can’t converge on him at once to recant their suffering. I think if he had to face us and listen to the reality of our lives the sorrow alone would do him in. We can only hope and pray that his wife will be implanted with mesh so he will face the truth the hard way. He is a cold hearted, greedy monster and he is the head of AUGs. That only confirms what mesh victims have already learned, we cannot trust doctors. I think that answers your question about the “disconnect between doctors and mesh victims”. We are living proof of what’s wrong with medicine and they can’t bear to see it. They choose to “see no evil, hear no evil…..and report no evil…”. They are in denial. Because I have been mistreated by so many doctors at appointments, when I schedule appointments I honestly tell the practitioner that I have mesh to find out first if the doctor is willing to see a mesh patient. In most cases, they are not. Doctors don’t know what to do with us, they don’t know how to help us and we are a sad reminder of how corrupt medicine is. When you add that to their fear of the mesh lawsuits, they just want us to go away…..

    • Jane Akre says:

      Mary Pat- You express yourself very well and your words are heartbreaking. I’m sorry this has happened to you. There are caring doctors and patient advocates who might help send you in a better direction. Many women have improved after some help. If you want, I can send you to some patient advocates, but I need your permission to send your email. They are not lawyers or a lawyer referral service, they are women who have been there. There is nothing in it for them except sharing their experience since they’ve been through it and possibly helping your find a doctor and telling you what to ask. Please contact me privately (see the about us page) and let me know if I can share your email… thank you!

  15. Terri says:

    Shouldn’t all this credentialing taken place “before” allowing the Mesh on the market? It seems like they are back tracking. The doctor was very adamant about giving women choices or options to choose from. However, all this should have been worked out PRIOR to the FDA’s approval or endorsement. Many lives have been adversely affected by this backwards attempt to give women the choice. This should have been taken care of from the beginning.

  16. carol says:

    What a CAD

  17. Fibroids says:

    Thank.

    fibroids uterine

    http://fibroids-uterine.com

  18. Lisa says:

    I believe I read there are over 50,000 lawsuits now…
    All this doctor is trying to do is protect the doctors from being sued by making sure the woman signs a statement about risks/benefits…do they tell women about the Burch procedure,,,my uro gyno said, “we were trained to do that”, but that was 10 yrs ago. The doctors only know mesh, they were told it was permanent and not meant to come out, and doctors deny their patients pain and a mesh failure diagnosis, because they do not want to be sued, they do not know how to take it out, and their insurance does not allow them to refer out. Maybe they will do a partial and “clip” a piece out and call it a paitial removal. Why the fda is not including sui in their new warning is beyond me.
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm

    Mesh is mesh is mesh…I had a tvt sling, had a foreign body response, and almost died, because my Dr. Could not find the mesh and initially refused to refer me to ucla, until I picketed the hospital with MESH KILLS signs.
    I had to save my own life.

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