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AUGS Defends Polypropylene Mid-Urethral Mesh Slings

AUGS logoMESH NEWS DESK,  September 26, 2016 ~ This story originally ran last March but is is appropriate as the organization, the American Urogynecologic Society (AUGS) begins its annual conference this week in Denver.

Expect to see some discussion of litigation and what potential exposure implanting physicians might expect from the plaintiffs who have so far filed more than 100,000 product liability lawsuits against seven manufacturers.

Though there are divisions among the 1,900 members of AUGS about the use of polypropylene slings and tape for POP, as an organization its position papers still supports the use of mid-urethral slings (MUS).

Introduced in the late 90’s, for the next decade, about seven manufacturers were in competition to get their polypropylene (PP) mesh implants to the market. One, Prolift by J&J, even bypassed any Food and Drug Administration (FDA) approval before the agency caught on three years later.

In 2008, the FDA issued a safety communications after receiving thousands of complaints that mesh problems were “rare” but the agency reversed itself by 2011 saying those same complications were “not rare.”

Prolift POP mesh sold on eBay July 2013

Prolift on eBay July 2013

The FDA, noting a five-fold upswing in complications, ordered post-approval studies to determine how implanted women were faring.

This year, the FDA gave industry 30 months to reclassify mesh for pelvic organ prolapse (POP) to class III or high risk. Manufacturers, facing the challenge and expense of conducting clinical trials, have instead taken their POP mesh off the market- Ethicon removed Prolift, Boston Scientific removed Pinnacle.

Boston Scientific is fighting allegations it imported counterfeit mesh resin from China when its U.S. supplier cut off the company, and American Medical Systems, sold to Endo, decided in February to close its women’s health division that makes mesh – ASTORA Women’s Health – due to the cost of litigation.

Desara Sling by Caldera

Desara Sling by Caldera

On February 26, 2016, the FDA convened a special panel to consider whether the trocars or stainless steel instruments used in the blind passage of implanting pelvic mesh should be considered of “moderate risk” a move up from their present category they share with band-aids and wheelchairs.

Trocars are used internally in the blind procedure of implanting mesh and have caused organ perforation, bleed-outs and nerve damage.

TREATMENT WORTH PROTECTING

douglass hale md augs president elect

Considering the above, and the fact that many doctors have been sued by mesh-injured women, might give pause to a medical society and its members to reconsider how doctors fit into the mesh mess.

But it’s not.

In a statement to its members Friday, March 4, the incoming president of AUGS (American Urogynecologic Society) Douglass Hale, MD, writes mid-urethral slings are a “treatment worth protecting.”

Hale blamed unpredictable juries who have put mid-urethral slings in the “crosshairs” of our legal system.”  Dr. Hale says companies have paid out large settlements and he points to ASTORA (formerly AMS) shutting down as an example, calling it a purely business decision, he says for AMS. It was “no longer worth the fight.”

On the contrary, he says, the data is overwhelmingly in favor of slings and doctors and patients should still be able to choose this option.

“Despite what some of our own members are saying, denouncing these products as unsafe, the data tells a different story that does not support this stance.”  ~ Douglass Hale, MD 

He calls it a “misrepresentation by our legal system” that juries have not seen the realities of these cases.

Never mind that many doctors have also been sued, along with the mesh manufacturers, putting a chilling effect on the use of mid-urethral slings as well as mesh for pelvic organ prolapse (POP). Never mind that there are more defective product lawsuits filed over alleged injuries from mid-urethral slings than the larger POP mesh, and never mind that juries who have listened to the evidence have decided that the mesh still on the market is defective in its design and in its instructions to doctors.

CORPORATE SPONSORS

Ethicon logo from room keyAUGS will try to sort it all out during its annual convention in Denver, Colorado September 27 to October 1, 2016.

Corporate sponsors can support a program at the platinum level for $75,000 to the copper level at $5,000. One can even have a hotel room key imprinted with a corporate sponsor as this was from the American Hernia Society a few years ago.  See the program for sponsorship here.   

AUGS corporate sponsorship in 2014

AUGS PFD Corporate research sponsorship 2014

 

AUGS is collecting a patient registry of women undergoing treatment for POP to evaluate the effectiveness, quality of life and safety associated with transvaginal/ transabdominal native tissue repair, transvaginal mesh and sacrocolpopexy and a pessary.

It is supported by ACell, ASTORA, Boston Scientific and Coloplast.

In 2014, the PFD Research Foundation received 64% of its funding from corporations. #

 

 

LEARN MORE:

AUGS Position on Mid-Urethral Slings  – http://www.augs.org/p/bl/et/blogaid=252

AUGS Talking Points – Physician talking points

AUGS Informed Consent  – AUGS Mesh Toolkit – Prepared Responses to FDA questions formatted

FDA Considers Reclassifying Surgical Pelvic Mesh Instruments  

http://www.medscape.com/viewarticle/859561

 

55 Comments

  1. Hopefully the road ahead gets rougher for the mesh manufacturers and the AUGS. They can manipulate facts, but they can’t manipulate all women’s bodies to be biocompatible with their products! They seem to view a significant number of patients, in the subgroup who have chronic foreign body reaction to their products, as affordable collateral damage. Well I hope the continuing lawsuits make it un-affordable for manufacturers of synthetic mesh, and doctors to do business as usual. Many doctors indiscriminately implant mesh into women with no idea of how to stop the foreign body response and no idea who will have a transitory foreign body reaction to polypropylene mesh. to make matters they don’t have the skills to remove what was designed to permanently “welded” into human tissue. Once I felt sympathy for doctors being duped, but my patience has run out, for closed minded stubborn professionals, who have done less research than most mesh injured women about the pitfalls of mesh.

  2. Liz says:

    Are you kidding me???? you must live under a rock Douglas Hale! Your statements sends a message to all those injured and all those that will continue to be injured by these barbaric contraptions that they don’t matter!!! Haven’t you learned anything over the past 5 years??? Clearly dollar signs hinders your ability to make honest decisions and allows you to put on blinders! Just downright appalling!Women’s lives do matter and our voices are NOT silent. We live with the truths every single day of our lives and this sustains us. It will be enough someday to end the misery for future women and those lives ruined will continue the fight on!!!

  3. just me says:

    I find this bad news. I had the Sparc sling implanted, had 2 surgeries to remove it, have had multiple UTI, had terrible back and hip pain due to it attaching itself to my pelvis, am unable to have relations with my husband, and could barely tolerate a pelvic exam. Unbelievable that they think this product is worth saving. Was it just the wrong brand that was implanted or do others have the same issues?

    • Jane Akre says:

      It does not appear to matter what brand… polypropylene, small pore mesh causes complications in many women and men with hernia repair. Even larger pores are causing foreign body reaction and/or they do not hold up well. Biofilms seem to love to congregate around these implants. I hope you have competent medical help.

  4. stopmeshimplants says:

    I really cannot believe what have just read. How can anyone in a position like Dr. Douglass comment that these products are treatment options worth defending? And what data is he referring to when he mentions the safety of these products. Don’t get me started about the “misrepresentation” of our legal system. Verdicts are finally proving the devastation of these mesh products. Our legal system is finally honoring the word and genuine experiences of all suffering of mesh implanted people. He had an opportunity to set the records straight about all mesh issues and chose not to. Shame on him.

  5. kitty says:

    Thanks foe report Jane. It is much to ponder. Acell is getting in the game. Ladies be very careful with removal.

  6. Anon says:

    Douglass Hale, MD writes mid-urethral slings are a “treatment worth protecting.”

    Mr. Hale, in all respect sir, what are you saying exactly? Can you please interrelate to everyone with a little more clarity?

    Did we all just sniff glue, or did you say the brand needed to be protected more than women? I mean, that’s what you said..

    Well shut the front door. Please forgive all of the justices, lawyers, the FDA, and the United States Government for not consulting with you first, before they stated the devices are defective, do injure, and can cause death. What were they all thinking protecting women over “the brand”?

    IMHO through education and experience, you need to be an outgoing leader instead of incoming, since you are already spewing propaganda. Mesh hurts.

    The really sad part is: The doctors and members of the AUGS will believe every word you say as gospel, because you are the leader of the pack.

    “The people are so thirsty for leadership and direction they will drink the sand in the dessert believing it to be a mirage of water.”

    People want to feel justified for their actions and are always looking for “like-same” people to be on their side, even though they accept how their own decisions are strictly for financial gain, and have no real care or merit for a woman’s best interest and health. So, they implant the medical devices, believing you (their fierce leader) telling them they did the right thing, when the real experts are saying no, um no you didn’t do the right thing and are not doing the right thing, we need to re-evaluate this mesh situation.

    When the AMA or the AUGS refused to do the right thing, the FDA and the courts had to step in by force.

    Had you and your people cared years ago about your “brand”, there would have been no need for pain and suffering, and loss of life. And no need for court or lawsuits or justice. And judging by your own words, a law degree you do not have..

    With reverse appeals and tort reform, very little money is ever received by a victim of mesh from a lawsuit. It is not about the money as much is about justice. Or admitting the product was/is faulty.

    How can you blame women for something they had no control over? You and your people had the control. And because there are so many lawsuits filed, does that show, how you and “the brand” can’t be trusted to do the right thing? The more suits that were filed, the more surgeries were performed and continued to increase for mesh medical devices? It was a “we will show you” kinda of thang, a middle finger to women, the FDA, to the attorneys, to the judges and to the court.

    And that motto obviously continues on today, as seen through your own spoken words Mr. Hale.

    The women who read this forum and contribute everyday for years, and the owner of this educational forum, and owners of the other internet forums, all who are seriously dedicated to educating people on the adverse effects of mesh, along with the experts who come here to this forum, who support and sponsor this non-profit forum, who give countless hours of assistance for free, are ALL more knowledgeable than you, Mr. Hale, on the subject of mesh. And the most rewarding part is, they are not even victims of mesh. They have no horse in the race. And yet, you have a medical degree? Correct? Or is your degree more geared towards Wall Street or investments? Just asking.

    Those who are dedicated who speak on behalf of mesh victims are journalists, doctors, attorneys, their staff, educators, people who care, Judges, families, friends, co-workers, those who give expert testimony, and the list continues on, and thankfully so.

    Because Mr. Hale, without people like them, people like you might actually have a chance to succeed with speeches that invoke fear. But now, you can talk the talk, but you will never after that speech, walk the walk. And if I was a plaintiff attorney, I would call you to the stand the first chance it was available.

    And please, for the love of puppies and fields of sunflowers, please do go and testify for the defense. That would be amazing to see you tell the judges and the courts the brand was more important and the courts are frivolous and the FDA is senseless and useless..and is all a waste of time.

    It appears you have very limited knowledge on any part of mesh, the companies who make mesh, where it comes from. And know nothing about women who suffer from mesh. Yes sir, Mr. Hale, you are completely in the dark on the pros or cons of mesh medical devices.

    Perhaps you were put on the spot, threw some words out there to seem believable and to see what would stick, and instead, you came up looking like a fool, whose lack of education and knowledge on the subject of mesh is earth shattering, as you, the “leader”, know so little.

    How many court documents have you actually sat down and read on a mesh lawsuit? How many court trials involving mesh or medical devices have you observed?

    How many affidavits have you read? How many decisions have you experienced? How many of the very few doctors who remove mesh have you sat down and interviewed (on/off the record)?

    How many surgeries to implant or extraction of mesh have you observed, either in real time or by video?

    How many expert witnesses (for both sides) have you met with, interviewed, or had the pleasure of reading their opinions?

    I would say zero and zero and zero and zero to all, based on your own erroneous statements. Remember, you must own the very words you have spoken as time goes on. No wavering back and forth. If you believe it so strongly, then stand your ground like the country singer who stands by her man.

    Who have you spoken with at John Hopkins? Who have you had the pleasure of meeting from UCLA on the subject and treatment of mesh, and mesh removal, and treatment to the patient after mesh?

    Can you name five doctors by memory, without looking them up, who perform mesh removals? Do you know what states they are from?

    I guarantee you, that 50% of the women who come to this forum, and 70% of the experts who come here can name at least three of the doctors, and their states.

    How many articles have you read on this forum? Have you searched the comments to see how to better your brand you want to protect?

    How man people have you reached out too?

    Professors at the universities? Georgia Tech Research Labs?

    Where exactly did you get the limited knowledge you have of mesh? From the salesman from the mesh companies who teach your doctors how to install mesh like car parts, except these salesmen have no medical experience at all do they Mr. Hale? They have no idea about mesh other than what a 10 minute video taught them to turn around and teach your peers, is that correct?

    But, judging from your words and actions those salesman seem to have more knowledge about mesh than you ever did or do?

    Who have you spoken or met with from Emory Hospital, Northside Hospital, Florida Hospitals, Missouri Hospitals, or any of the Hospitals where actual caring doctors and nurses try to pick up the pieces from a reversed mesh surgery? And literally, mean..to pick up or shall we say “pick out the pieces” of mesh from a woman’s body?

    Have you seen the pictures up close and personal of the rotting flesh and mesh together?

    What did the experts at Columbia say to you about Mesh and Mesh medical Devices Mr. Hale?

    What is Harvard teaching their grads about mesh and product litigation?

    Do you know what the DUBI connection is to mesh that is a cause of great concern? I mean do you know before you google it or make blanket statements before knowing?

    Oh ye who know so little….

    Sir, you have nothing to validate your statements, They are all very broad and ill willed. You are very disingenuous. And these are the nice nouns to describe your flawed speech, and method of teaching on the subject of mesh.

    May I suggest knowing before speaking, that way you don’t look like a complete idiot. And everyone who is well versed on the subject of mesh, or who is experiencing the pain and suffering from mesh, and everyone in between all know you are not being fully honest with others or yourself.

    These people are actually living the mesh diet every day in such a way that you could never comprehend.

    They began their journey on finding the truth. They are experiencing the evilness of the brand you love and want to protect so well. They want to know why does it not work, why so much pain, so much infection, loss of teeth, hair, when it started, who could help, what can be done now, why did it have to happen? How much damage? How does it cause cancer? Long term damage from plastic and all of the chemicals, how did it affect the muscles, the pelvic, the back…So many questions..

    So yes Mr. Hale, by all means you keep protecting the brand. While everyone else is cleaning up your mess. And it is your mess now, and you are the leader telling your peers to rise up and protect.

    And please sir, I challenge you to provide a list of names of patients,who willingly wanted to participate, who have experienced mesh or any form of a mesh medical device implanted in their body, who is happy with the results after five to seven years later, then perhaps your brand protection would be better believed.

    We both know the “happy I got mesh” list is never going to appear, is it?

    How many women have you met, spoken to, or contacted to get their perspective on mesh? Not just women who have mesh inside their bodies, but the other women? You know, like family members, co-workers, friends, neighbors, and acquaintances of mesh patients? You know, the people who have no stake in a lawsuit at all, but can flat tell YOU the truth of what they see in mesh patients and the suffering when mesh patients do not even know they are being watched.

    A woman can certainly fake a lot of things in life, but pain from mesh. erosion from mesh, suffering from mesh, there is no faking.

    In your speech, are you saying the United States Justice system is incompetent but the AMA is not , and the AUGS is smarter, knows all, and is above the law, and beyond the US Justice System in deciding what is right and wrong with reported defective medical devices? And, are you saying the AMA & AUGS are above and beyond those pesky little people at the FDA?

    You know what? You are so right. Let us shut down the FDA, and the courts and court cases involving medical devices, tape worm mesh, TV Mesh devices and let you and your friends just have it. Install all the mesh you can. Seven days a week, round the clock. No one watching, treat all women like the cadavers you think they are..And you and your AUGS friends/peers can just make all that money, dream of money, eat money, greed money, all made off the pain and suffering of women.

    What happened to doctors? How did it get to this point?

    Protect the brand over a woman.

    Who are you protecting Mr. Hale?

    The injustice is the butchering of females all around the world with a product that is not even a product but a science project gone way wrong.

    You think this is a game sir? Do you truly believe the law firms, judges, and plaintiffs do not have anything better to do than to pick on your “brand” ?

    Mr. Hale, please forgive me, I just remembered how, AUGS reminds all of the providers to make sure they tell all women who are hurting or worried about the side effects of mesh, “Ma’am. it is all in your head. It is not the mesh causing the problems, even though your insides are now hanging out, and you can’t sit down and your vagina is eroding, it is all in your head. ”

    One attorney who is handling many cases regarding mesh, and these are cases actually filed name by name, stated that every single woman interviewed stated the almost exact same thing verbatim when they started complaining to their doctors about the problems they were having after mesh surgery. He said every AUG doctor who performed the original mesh surgery told their patient to go see a psychiatrist, that everything they were experiencing was in their head. And the ones who needed more pain medication after the surgery were told they were drug seekers. Even though the majority had never taken narcotics before in their life, outside of a major surgery or dental visit.

    Doctors have a name for everything when they describe their patients. The days of doctors actually loving their jobs and patients appears to be over and now we have the new generation of Mr. Hale’s.

  7. anna says:

    Its all a society of monsters, who agreed to place meshes on women with no knowledge on how to remove them. You could say they probably made more money than the pharmaceutical companies. That’s why they are so quick to say what a wonderful product this is for women. except for the fact they forget to tell you the pain you would be suffering for the rest of your life. The fact is, almost all this implanting doctors had no idea how to remove it, and, still don’t . I must tell you the grass is not greener on the suffering women side, but it certainly has been for the doctors and pharmaceutical Co..

  8. Don't give up! says:

    Mr Hale just wondering are you seeing psychiatrist by any chance you have over a hundred thousand women ready to take the stand in a court of law to swear on the holy bible to tell the truth and nothing but the truth that mesh has ruined their lives – will you?
    It seems in your mind you’re also saying that the wrong juries were picked, so what now you want to hand pick them is that it? Let me tell you something, I live with a mesh-injured woman who has gone through hell since having this mesh put in and having two revisions so far.
    My wife has nerve damage, she is in constant pain on a daily bases she is constantly getting sick here autoimmune system seems to be getting weaker and weaker pain though her hips thighs,lower back,pain down her legs, sharp pains going up her back down her arms to her fingers tips so her fingers sure numb in which she had to have to other surgeries constant pain in her groin pelvis, pain having a bowl movement,high blood pressure,high cholesterol,to type two diabetes which she never had until the second revision and so on. Not to say it’s took everything from her maybe like her dignity self-worth even though I tell her how beautiful she is my wife is so scared what is going to happen next and so am I.
    Oh I forgot to mention the ridiculous amounts of medications my wife has to take on a daily basis and some four times a day in which she never took medications or even liked to take medications.
    My wife was a healthy vibrant young woman before having a simple short procedure done which was supposed to improve her life since then in the last five to six years her body has gone through so much and she is only fifty and she can barely walk some days all because of mesh and you are saying it’s worth fighting for, give your head a shake.

  9. tammy says:

    this is just nuts and criminal how are these fools getting by with this !!!!!

  10. Mary Pat says:

    Does anyone know how to start an internet petition to have Dr Hale removed from his post at AUGS? I say we do it.

  11. Mary Pat says:

    This paragraph was Cut and pasted from AUGS website. Board of directors for AUGs is meeting in 2weeks. I say we bombard the board of directors with letters demanding Hale be fired and they get a president who cares about women more than money.

    ” AUGS has been in contact with other industry partners who assure us, they are not going to abandon the sling market. Boston Scientific, Caldera, Coloplast and Gynecare remain committed to the midurethral sling market and are prepared to ensure physicians have access to these products. We stand along with SUFU by our position statement made concerning midurethral slings and are planning to release an updated version. AUGS leadership has mobilized quickly this week to speak with all involved parties to get the full story behind these recent events and the AUGS Board of Directors is meeting in 2 weeks. There we will be discussing a measured strategy to respond to this latest threat and to protect the midurethral sling as a treatment options for physicians and their patients. All of us will need to work together to protect this treatment option, so please be ready to participate and respond when the calls come for your help. Stay tuned….”

    As written by Dr Hale. He is appealing to his AUGs members to support his position. I say we, the mesh injured, must write to the board of directors at AUGS demanding that mesh injuries be acknowledged and prevented. STOP putting greed and money before safety. Heres their address:

    AUGS

    2025 M Street, NW, Suite 800

    Washington DC 20036

    Phone: 301-273-0570

    Fax: 301-273-0778

    Email: info@augs.org

    • Jane Akre says:

      Remember, some AUGS members do not agree with leadership,… they are members of a medical society. What AUGS represents and what defendant attorneys represent in court to juries is a solid agreement on these issues. I would like to hear from those who are not in standing with this AUGS position. You can post anonymously… your identity will be kept a secret. Thank you.

    • Mamohio (sad & disappointed) says:

      I think that is a great idea to write to AUGS. ALL OF US GOT TO START STIRRING THE POT. We aren’t going down without a fight. Maybe Mr. HALE you got all your info from the cadavers? @Anon well said and I second all that! Why doesn’t he ask the women who have actually been injured before making asinine comments like that. I wish we could put some mesh in him. Maybe he would change his tune. Mr.Hale we invite you Apr 11 in Charleston, WV. You could get some real eye opening information. We would love to debate you and AUGS you should change your name to UGHS.

  12. Rhonda says:

    I am sure Mr. It Is Safe has not had to watch wife, sister, mother or friend that has had complications from mesh. This has ruined many lives and still have more that are just starting to have issues. One of my best friends mother who is 73 now has to have hers removed. It has caused things that can’t be fixed. Having had removal surgery 18 months ago I know only a fraction of what she is to endure. I was a lucky one with just one surgery and only small bit they could not remove. I find it so appalling that ANYONE can say these are safe. Not for everyone!!!! I am sure you do have some who have not had problems but how can you ignore the thousands that have so many complications and surgeries becass of it? Sometimes I wonder if we will ever get justice or if once again big money wins. God bless.

  13. Debi says:

    Omg, unbelievable! !!! But just like a political Dr Hale is going out of office this year, and her is in the corporate members pockets. I wonder which one he is going to work for. Deep pockets goes a long way. But we know the truth, and the day’s of ” the good old boys ” is over!!!!!!

    Dr Douglass S. Hale

    1-301-273-0570

    In fo@augs.org

    Maybe we could email and ask him.

  14. Anon says:

    Mr. Hale,

    Did you just open the door by finally announcing publicly that AUGS & OBGYN doctors have the blessings of the AMA and AUGS to continue to use mesh on a patient verses other alternatives? Then why should these same doctors who implant mesh medical devices not be held accountable in a court of law for purposely causing the pain and suffering for thousands of women and men, as you are encouraging these doctors to continue to use defective products and patients be damned?

    If they know, which they do now, how can they not be liable? Hiding behind pharma is no longer an option. The elephant in the room is too big too hide anymore.

    You are strongly standing by pharmaceutical companies and their products, regardless of what the evidence shows? I am asking you as I can’t determine from your speech.

    Doctors have been screaming for years it was not their fault and they didn’t know the results and were uninformed, how they were not medically trained, but you are saying it is business as usual, and the mesh surgeries continue.

    You can’t ride two butts with one saddle Mr. Hale.

    You can’t sit on the fence when it suits you. Either doctors are for mesh regardless of the effects, which can include death, or they are not for mesh. With your statements, how can doctors at this point not be held liable as much as the pharmaceutical companies? How can you personally guarantee the safety of another man’s self made Gold Standard of Care Product? You can’t honestly say that you know where these chemicals come from or how they are made or by who with every single medical device. You can buy them on ebay, you can buy them on Amazon, from the black market and online from numerous sources. You can even buy them from a world wide petroleum company that sells them to the pharmaceuticals company even though it was never intended for human use.

    How can you justify the safety of a product that you did not make or know of its real original origins? How can you stick your neck out like that to your peers?

    Can someone please explain why doctors should not be named in the lawsuits moving forward? Because if they continue down this road, the insanity will never stop. Women and men who are not well informed on the dangers of mesh, will basically keep agreeing to their own damnation, trusting in doctors who never had their best interest at hand. And these same doctors will dismiss them the minute trouble comes their way on the adverse effects. And trouble will come knocking, for some almost immediately and for others a little ways down the road. It depends on which defective product was implanted and how. G-d help those implanted with mesh and by the robot. That is truly the blind leading the blind leading the blind. Robotic Surgery another demon to tackle on a different day.

  15. Anon says:

    FYI

    Gag Order may not apply to doctors or Mr. Hale unless your doctor is named in your lawsuit.. This is one time women or a voice that can speak for them, may not want to stay silenced. Post at your own risk, but your voice needs to be heard regarding the AMA and the AUGS stance on mesh. Just stick to the facts and ask him questions he can’t or won’t ever answer.

    If not here, please voice some where else before 100,000 more women and men may be purposely injured by mesh or mesh medical devices.

  16. Carol says:

    This is from authors web site:

    This evidence indicates a probable performance gap/opportunity for improvement in establishing more consistent and detailed counseling of patients on the risks associated with mesh sling surgery for SUI.

    In one relevant study, Deng et al. performed a retrospective review of all cases of midurethral sling complications that presented to their institution (UCLA Medical Center from 2001-2005).52 Researchers also performed a literature review of complications due to midurethral slings and searched the FDA manufacturer and user facility device experience (MAUDE) database for corresponding self-reported complications. At the authors’ institution, a total of 26 patients with voiding dysfunction after sling surgery were found to have mesh in the urethra or bladder. Moreover, the MAUDE database contained significantly more major reported complications than incidence rates reported in published literature. Overall, the authors concluded that major complications of mesh sling surgery are more common than published literature suggests.

    So he knows problems are major. Now he chooses to lie on behest the medical world.

    I can assure you the reason for under reporting is that doctors everywhere are telling women the pain, UTI’s ect are not caused by the mesh. Well then Mr. Doctor just what is causing all the problems if not the mesh?

    My problems disappear after full removal by Dr. Raz.

    Carol

    • Jane Akre says:

      So good to hear your symptoms resolved after a mesh removal. Congratulations!

      • DIVA 64 says:

        I am thankful to hear your symptoms have disappeared after surgery with Dr Raz removal of the Mesh. I am in a waiting list I have an appointment in Feb 2017. It may be to late for me my Mesh was put in 2002. I have been seeking medical help since 2006, although shortly after surgery the Dr. That performed the surgery began noticing shorting of the vagina. By 2006 without hearing of any Mesh issues myself I started having pain that felt the same as the pain from endrometosis ,and pain going down the front of my legs. The doctor I saw just said it was sciatic, I have had more doctors stick their head in the sand that people I have dates. I was a very active lady enjoyed the beach swimming in a pool. I have Lupus an autoimmune disease since Mesh. I don’t know if getting the Mesh out will destroy the Lupus, make my life good again allow me to void like a normal person does get rid of all the pain have energy again,not have every organ of my body including brain heal. I truly have faith in God and Dr Raz and pray I get my life back. I worked hard all my life I believed I would someday retire and travel. Now it is not even good for me to live alone I fall to frequently say the words I can’t remember to often. No one in my family ever had dementia or alhimizer disease.
        I am hoping and praying that Dr Raz can help me get my life back. Mesh Polypropylene is a killer no doctor should use it for hernia repairs or bladder repairs ever again I have read that the bladder repair can be performed using the patients own skin folds. This would be the only acceptable bladder surgery that guarantees a woman would never be poisoned ,crippled,live life with chronic pain from plastic not compatible being placed inside their body. It is wrong it shows no regard for human life when a Dr ignores a patients complaints and does not diagnose them.Does not help them. And or still believes Mesh is an answer. I have so little faith in Doctors now because of the Mesh and Doctors failure to diagnose before I became so sick MRI performed 2008 showed problems I was never informed. I only learned this by getting copies of all my MRI’ s. My trust level of doctors these days is almost Zero yet I need about 5 specialist I can not afford. Thank you Mesh Manufactures. Ask yourself this would you accept this product placed in your body to poison and cripple you. To destroy your life. If so I hope the 100,000 plus ladies lives ruined can set in an observation room and watch this surgery be performed. It would be pleasure.

    • kitty says:

      How long did u have mesh in. You are one lucky cookie

    • Bonnie m says:

      Carol how much was the surgry with dr raz

  17. meshinjuredwoman/Cathy says:

    I just googled Douglass S. Hale and a malpractice lawsuit showed up. Is this the president of AUGS????? Just wondering

  18. Don't give up! says:

    Mr Hale sir I hope your sitting at home with your family with not a worry in the world,do you want to know what I did tonight I took my wife to a walk in as she couldn’t breath properly this has been going on for a while she just had a heart monitor on her a week ago as she wasn’t feeling right as she hasn’t felt right for a while because of revisions and mesh.

    Do you know what else I did tonight I had to take my wife to the emergency in town here to get some test done they came back the Dr admitted her I gave my wife a kiss good by tonight as I couldn’t stay at the hospital and it was twelve midnight and I had to get home so I could get the kids of to school in the morning as we live in the country and there’s no relatives close to look after them.

    I left my wife on a two foot wide cot as that’s all they had but she had to stay at the hospital so staff there could watch her all night and then most likely send her of in the morning to a major hospital in the city so I will be there bright and early if I can’t sleep which I most likely won’t as I’m worried sick about her I will go and see if I can check in on her through the night.

    What are you thinking Mr Hale My wife is one out of thousands this is real this is happening mesh is ruining families hurting families killing families mesh hurt my wife Drs took an oath not to hurt people.

    • stopmeshimplants says:

      Dear Don’t Give Up,
      I am so sorry to hear about your wife. You know all too well what many of us are living with and it is shameful that some doctors choose to ignore our concerns. Please tell your wife we hope she gets the care she deserves and how lucky she is to have you taking such good care of her and your family. My hope is that this Dr. Hale begins to research the real data that shows the thousands of us harmed by these mesh slings and begins to act as a true leader and do the work to help all of us. Choosing to ignore these issues may save Dr. Hale from work in the short run but in the long run he will be remembered as the President of AUGS that chose not to step up and do the right thing by acknowledging the life changing harm of these mesh products. Your wife is in my prayers.

  19. kitty says:

    Ok I said ladies—we go to AUGS convention– DC—room for 6

  20. kitty says:

    After a knee replacement ot hip replacement —a patient goes to physical therapy and followup

    There was no physical therapy. Thete was nothing. We were left to fend for ourseves.

  21. Disgusted says:

    This whole affair is so unbelievable. The more we learn the more disgusting it becomes. It is still unreal that they want to go forward with this. This is criminal. The civil law does nothing to show how criminal it is. It isn’t considered lawful evidence. AUGS is stacked with industry associates from the various pharmaceutical companies. So it behooves them to push this. Their livelihood hangs in the balance. They are basically shaking their fists at the court system and declaring juries are seeing a “misrepresentation of the legal system”. Either women are very damaged by mesh or they’re not. The problem lies in the fact that not enough is known (proven) about the ramifications of mesh damage. There is no standard of care. It is a permanent placement that doesn’t allow for any issues. It has become political instead of scientific. This is what happens when money is the bottom line. Statistics can be twisted. So we’re hearing opinions. Where are the “facts”? We know from experience how bad this product is. Unfortunately, that alone does not qualify as “fact”. Incontinence is not the pariah that it is made out to be. It is not worth what we’ve been through. But this spin continues, all the way to third world countries. Lord help us!!

    • Still Standinravestyg says:

      Disgusted, I agree with what you stated. To date, scientific study of post mesh complications state that there are complications with about 6% of implanted women. I believe this is an under- represented occurrence, especially since most of the science is determined by doing a retrospective chart review of patients implanted. There are no random controlled trials, there wont be because proving the hypothesis null would put women in potential harm. That will not pass the required institutional review boards for scientific research in the US. I believe that Caldera’s partnership with IVUMed will just open new areas to sell their product to women in underdeveloped countries who have no way of understanding an informed consent. They will truly be experimental or practice subjects as well all a tidy tax write off for .Caldera. i will tell you that I have sent a plea to the United Nations to investigate this travesty. I know someone who is attending the Global H

      • Disgusted says:

        Hi Still Standing, I’m looking forward to report on the Global Health conference. Thank you for all you’re doing. This is so hard, it feels like we’ve been rendered powerless. There is a huge cog of a system that is given to political agendas for profit. The FDA is not dealing effectively with this. The court system is bogged down. We don’t get national media coverage. Our lawyers are keeping us quiet with gag orders, so it doesn’t affect our cases. The devastation this has caused is inhumane. Suffering on a very large scale. Mesh isn’t the only medical product that is hurting people. Our whole medical system needs to be overhauled. Obviously standard of care isn’t the only problem, but it is needed. No standard of care should go on when suffering is evidenced. As it has been. How many doctors have we collectively seen? They know we suffer. Yet silence is ruling. Thank you Jane for this corner of the internet that shouts out the truth!!

        • Jane Akre says:

          Yes I agree. Doctors tell women to be compliant patients, and lawyers want the same kind of client. Settlements come with nondisclosure clauses and meanwhile docs keep putting in mesh. It’s madness.

      • kitty says:

        How can they say 6%. Where is the research—where are the control groups? Who are the people?

        • Still Standing says:

          Kitty, I will post some links to the research and several have put the complication rates around 6-8% that would be six out of 100, which is a significant number as it is. As I said before, there are no “control” groups. The available research is retrospective, that is, they go back to one hospital or practice, or group of practices and pull the medical records of women who have had mesh implants ( researchers do not have access to individual’s names) then they look at complications, say 6months, then 1year then out how ever many years they set, usually five. When they do this they generally look at a few predefined complications, like erosion, UTIs, vulvodynia , just for example. They may also look for age, smoking, BMI, or anything else they are interested in teasing out . Some research may want to know if the patient had a previous hysterectomy or other abdominal surgery. In England, a study looked at complication rates comparing rural and urban doctors. It is interesting. i’ll try to find that one. There are no purely scientific random controlled studies because now,with the known complications, they would be subjecting the participants to serious potential harm. What woman would agree to that knowing what we know? As far as standards of care, they are coming. I know of some physicians who are working on this. Vagnal mesh has only been used in large numbers over the last 12 years or so, so we ARE what is being figured out for standards of care. We are teaching the medical community a great deal about this subject…no kidding. Will post some links to scientific studies over the next few days. However, some links require a subscription or password in order to read the entire study. You can, however, read the abstract, which may be enough information for you. If not, let me know and I will see what I can do. You can always get access through a university library if you have one handy. They are usually part of a library loaning system.

        • Still Standing says:

          Here youngo. The first link,,this is the study I was thinking about that was from England. Its from Canada. Got close–Same Queen, different flag. This study actually puts complication rates at 3 to 4%. You can only view the abstract on this one.

          http://archsurg.jamanetwork.com/article.aspx?articleid=2432613

        • Still Standing says:

          Here is another great article. It has a very good list of citations so you can go to many of those and read to your heart’s content. This article is one of the best I have seen that is trying to synthesize information that will lead to standards of care for post mesh care.

          http://www.sciencedirect.com/science/article/pii/S0716864013701548

  22. kitty says:

    Ahh—yes—–standard of care. That is wherein the issue lies.

  23. Still Standing says:

    I did not finish my post. This person is delivering a plea to the Global Health conference this week. She has agreed to e-introduce me to some folks who have the power to influence this travesty. I will keep you informed and will,provide updates when I have them as well as people you can write to strengthen the case. Stay tuned.

  24. Rose says:

    Disheartening!!! Scientific minds dismissing science right in front of them. And simple anatomy for that matter. What ever happened to Do No Harm or is that selective where greed is concerned?? The NIH states “all synthetic mesh is not inert” and it is also being linked to squamous cell carcinoma among other things. That information somehow does not make it to the consent form ?? Nor does the fact that there are no standards of care for any complications when they do arise. Polypropylene (plastic) has NO business being inside the human body. President Obama even banned microbeads made from similar to same materials from our waters BUT its …ok as an implant??? The foreign body reaction can be catastrophic. Dr Hale what do you have to say to the hundreds of thousands around the world that have disabled by this so called gold standard? Dr Hale and others like him: you really should listen to the patients and if you still do not see the problem and connect the dots…. implant it in yourself. Then you will fully understand. The patients are all having the same to similar devastating effects. Polypropylene is neuro toxic garbage and should (like the microbeads) be banned immediately!!!!

  25. kitty says:

    They may be used to their lavish life style. I noticed they didn’t say transvaginal. I guess they will do sacroplexy (spelling)? That way they can put the wire hanger in and not hit a blind nerve

  26. kitty says:

    NO MORE WIRE HANGERS!

  27. anon says:

    It has been one year and six months since Dr’s M&M removed the J&J Prolift Mesh from my torn to piece body.

    I am sicker now than before the removal. I have so much scar tissue and so much pain.

    I don’t know what the final answer will be on mesh, but if it is all not pulled off the market, then this would be a true ethic cleansing against women.

    The facts don’t lie. The women have ALL stated the exact same issues and problems.

    And to this day, none of us have a real doctor for follow up care.

    I am so confused on why the AMA has gone silent on the issue.

    And to this day, no doctor knows what to do with us.

    The settlements offered to some women seem very low and one sided, according to the articles on this site.

    Victims are in and under so many CA’s that we can’t really support each other. It is hard to heal or comprehend it all without help.

  28. Linda says:

    Remember the doctors support the product and everybody turns a great profit. Even hospitals are making money for putting it in and taking it out. There is lots of money changing hands!

  29. Kitty says:

    Good morning Anon…WIshing u well. M& M are supposed to be the best…for the rich and famous. It may take time…. as we all know. This is a highly vascular and nervous place. Another problem spinniing out of this mess might be
    Diverticulosis\lysis. JANE has had some posts on her site from several years back from women that have suffered this affliction. The nutritional tips that SS has offered recently is salient advice for good Gut health. Be well my friend.

  30. Kitty says:

    Diverticulytis…big difference between lysis and lytis..sorry

  31. Alicia W says:

    In June of 2014, after several years of pelvicand leg pain, mygynecologist referred me to Dr Sarah Hammil of NW OBGYN of Spokane, WA She s also on the junior advisory panel for Society of Gynecological Surgeons and her pro mesh research has been funded by grants from AUGS and generous donations from various manufacturers. Her research thus far is pro mesh in every way Unfortunately, I was unaware of any of this. I presented with a prolapsed bladder, easily palpable mesh, extensive scarring, and symptomatic of recto vaginal fistula, My husband had also been lacerated by exposed mesh when we attempted to have sexual intercourse Before I was even examined, Dr Hammil made it clear that she would not do surgery and that i needed physical therapy. Then she attempted to examine me but could not fully assess my condition due to severe pain. She offered nothing to help with my pain and said it was due to anxiety I went to physical therapy twice but it caused so much more pain that I could not continue. I went to my next appointment with Dr Hammiland she said ” it looks like we’re going to surgery for mesh removal,” I consented to what I believed would be an attempt at a full removal. After surgery, she informed us that she was able to get it all out except for a “tiny piece behind a bone”. At my 6 week follow up I was still in severe pain, it was actually worse, and I could feel mesh in my vagina. She told me that was impossible and that she had no idea why my leg hurt, she said “the mesh isnt anywhere near your leg”and refused to refer me for a second opinion. I requested my records to find she had documented that nothing was wrong with my Perigee mesh and Monarc slingbut that she removed Perigee mesh at my request. I went to another gynecologist and he said “mesh is clearly palpable” on exam and I had extensive scarring, I went through several testsand he diagnosed me with an obturator neuropathy and pudundal neuralgia. He referred me to a urogynecologist in Seattle. I showed up for my appointment and before she examined me, she informed me there would be no surgery, her words were verbatim of Dr Hammil. I asked her if they knew each other and she said no,she also said my pain was caused by anxiety. I left her office immediately. I did a little investigating to find that both doctors were affiliated with AUGS and were Facebook friends it took me another 8 months to find a Doctor willing to see me. It was 600 miles from my home. He performed surgery and removed mesh that had eroded on both sides of my urethra and removed “dense” scarring on top of eroded mesh, I had a post operative hematoma that required a return to the O R. I had to have 2.blood transfusionsnd was in hospital for a week. He confirmed that Dr Hammil had only removed a small section underneath my bladderand left me with eroded sling, scarring, and fistula. I reported Dr Hammil to state medical board and the investigation consisted of a letter with some questions to Dr Hammiland that’s it. She claimed there was no evidence of scarring, erosion, or fistulaand the medical board said she followed standard of care and closed the complaint. I appealed the decision and provided them with the records of other doctors who referred me for mesh removal and the surgeon who helped me. They accepted my appeal and it looks like she may be disciplined but I’m not holdig my breath. Both of the doctors who are affiliated with AUGS lied to me, falsified my records, and caused significant delays for me to get proper treatment. They left me in severe pain and caused more issues then they solved getting tbeMedical Board to listen has been a year and a half long nightmare and I still don’t know what will become of my complaint. Why is nobody doing anything to regulate these greedy horrible women who turned a blind eye to my suffering and minimized my complications for benefit of manufacturer?

    • Jane Akre says:

      Alicia- You are an excellent writer…. Congrats for reporting the doctor… You are amazing. Can anyone answer the question she asks?

  32. Sea says:

    Lost for words as the moment after reading all above … while living in pain …

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