The Fight to Save Lives

The Fight to Save Lives

Douglass S Hale MD
is the president of AUGS and you can read the articles he has recently written concerning mesh implants and unpredictable juries. I believe we all need a ‘face’ to see when we read what a doctor has to say that concerns our future.

Ladies if your life became Hell after a mesh implant you need to know that there is an organization who is trying to make sure these injuries continue. That organization is called AUGS and it stand for The American Urogynecologic Society (AUGS).

This organization was founded in 1979 and it now has 1,900 members. It states in the write-up n their site that ‘AUGS promotes the highest quality patient care through excellence in education, research and advocacy‘ however they are not listening to their patients who live a disabling life because of mesh slings.

My day is often about helping a woman deal with the devastation of her mesh injuries. Many women try to get through life without doing anything for a long time about their complications until they are so bad off, they no longer have a choice. Why? The answers are simple. They have to raise children. They have to support themselves and their families. They will lose their hard earned way up a corporate ladder, if they take weeks or months off work. They are sometimes caring for aging family members or very young children. The list of things women have to do and take care of goes on and on.

Just yesterday I was trying to help a woman who has so many family responsibilities and doesn’t know where to turn. I can’t tell you too much but she just saw Dr. Raz and she was shocked at the bad news he broke to her. The complications are very bad after thirteen years of mesh and her surgery will not be easy, nor will her life go back to the way it once was. She like many of us have been, was devastated to learn how bad things are and she will have to be hospitalized for the removal procedure and it will be a long, long time of recovery. I truly felt deeply sorrow for her.

She like many women has been hanging onto her life by a tiny thread born from all her responsibilities, but she can no longer do that. So while researching her mesh type, I came across some articles written by the President of AUGS and I want to share with you how much they believe in these mesh products and why we have to fight harder to stop this from happening to many more women.

Midurethral Slings: A Treatment Worth Protecting

By: Douglass S. Hale, M.D. on Mar 04, 2016

Dear AUGS Members,

The FDA had readied us for issues with vaginal mesh in their 2008 and 2011 Safety Statements. However, what we didn’t anticipate was how unpredictable juries would respond to trials involving sling law suits.  In the face of overwhelming evidence supporting the most studied procedure in the history of incontinence treatments, polypropylene midurethral slings now find themselves caught in the crosshairs of our legal system.  Here is my answer to this man.

You obviously do not believe these products can cause such serious injuries to women, but I can assure you that they DO. I am now disabled because of Boston Scientific’s Advantage Fit sling. I am now on my seventh year of pain that never goes away.

The recent settlements doled out have caused companies producing slings to take a hard business look at whether the bad publicity and large sums of money involved with these cases are worth their time, investment, and energy.

The recent settlements were for a tiny minority of women and the rest of the injured women will be given a pittance for a lifetime of injury without any future care.
These manufacturers have been getting away with the slow killing of women all over the world and I for one will not stay silent. I will continue to fight until the FDA listens and does something so that no more women will have to live like we do.

As we are all now aware, ASTORA (formerly AMS) has answered this question for themselves with their announcement in the Wall Street Journal earlier this week.  They are shutting down production of all mesh products, slings and vaginal prolapse kits.  From a liability standpoint, their parent company Endo made a purely business decision that it was no longer worth the fight.  From a business standpoint, companies doing billions of dollars of business do not need the $50 million dollars that slings bring to their companies.

Endo barely announced that they were closing out these implants, before BOSTON SCIENTIFIC sent their sales people to pick up their business. If companies do NOT NEED the $50 million dollars that slings and mesh products bring to them, why are they not listening to the injured women who are left to deal with their complications? Why are they not all dropping these implants? We the women of the world have a right to be heard by the very people who continue to put these implants in women.

From a patient and physician standpoint, this is a completely different and disturbing matter. We need to protect the rights of our patients to make these decisions with their physicians. Acknowledging that there have been complications with slings (what medical treatments do not have complications?) we have to make data driven decisions when it comes to patient care.  The data is overwhelmingly in favor of slings for the appropriate patient.

We the patients have rights to change what happened to us and YOU ARE NOT LISTENING TO US when we go to your offices and explain why we are in so much pain. You do not want to know!

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. The misrepresentation by our legal system of the facts makes it hard for juries to see the realities of these cases.  What have been silenced are patients that have been successfully treated with these products and would repeat their operations without hesitation.

The Data is outdated and none of these products were properly tested EXCEPT in women.

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….

Sincerely,

Douglass Hale, MD
AUGS President

So what does their position statement say? It begins with a standard paragraph.
Introduction The purpose of this position statement by the American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) is to support the use of the midurethral sling in the surgical management of stress urinary incontinence, the type of urine leakage generally associated with coughing, laughing and sneezing.

It concludes with this paragraph.
Conclusion The polypropylene midurethral sling has helped millions of women with SUI regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly. With its acknowledged safety and efficacy it has created an environment for a much larger number of women to have access to treatment. In the past, concerns over failure and invasiveness of surgery caused a substantial percent of incontinent women to live without treatment. One of the unintended consequences of this polypropylene mesh controversy has been to keep women from receiving any treatment for SUI. This procedure is probably the most important advancement in the treatment of stress urinary incontinence in the last 50 years and has the full support of our organizations which are dedicated to improving the lives of women with urinary incontinence.

Dr. Hale you are WRONG. You could care less about what happens to the thousands of women who will live with the lifelong injuries your doctors create without any help by the very factions that designed and made these implants. You are a doctor who does not know what it is like to live in pain because of an implant and I can tell that you have no wish to learn.

Ladies, the War on MESH has not ended nor will it end while organizations like this one refuse to believe those of us who are injured. These people have a ONE TRACK MIND and it is to protect what they want to do to us regardless of the consequences to our health and well-being.

Now read the second article this doctor wrote.

Organizations Lend their Support to Mid-urethral Slings

By: Douglass S. Hale, M.D. on Jun 23, 2016

Over the past six months, I have received numerous emails from members inquiring about what AUGS is doing to protect the mid-urethral sling as a treatment option for their patients. During this time, the AUGS Board has been implementing various short- and long-term strategies that will support all of our members and their patients in ensuring the appropriate treatment options for treating SUI are available. Apparently he is only open to healing from the members of this site. However let me give you more information so that you can contact him. He practices in Indiana.

Dr. Douglass Hale is currently the Medical Director for Female Pelvic Medicine and Reconstructive Surgery at the Indiana University Academic Health Center and serves as Co-director of the Female Pelvic Medicine and Reconstructive Surgery Fellowship at Indiana University/Methodist Hospital.  He is a   clinical professor at Indiana University in the department of Obstetrics and Gynecology. He joined Urogynecology Associates in 1993 and has served as senior partner since 2006.

Dr. Hale is Board Certified by the American Board of Obstetrics and Gynecology and American Board of Urology in Female Pelvic Medicine and Reconstructive Surgery; a subspecialty first recognized in 2013 by the American Board of Medical Specialties.

He has edited text books, written chapters, published over 60 scientific studies in peer-reviewed journals, as well as presenting regularly at national and international scientific meetings. Most notable are his three trips (2009, 2011, 2013) to China as an invited surgeon and lecturer. He is enjoying his life and travelling while many of us can no longer do so.

He is most known for his innovative surgical approaches to pelvic floor disorders.  In 2003 he became the first urogynecologist in the country to perform a DaVinci assisted laparoscopic sacral colpopexy for pelvic organ prolapse and has since become a leader in minimally invasive surgical techniques for prolapse repair.  This spares the patient a major abdominal incision, is less painful, and allows for a quicker return to normal activities of daily living.

Dr. Hale is the President Elect of the American Urogynecologic Society and will assume the Presidency of this organization in 2016.  He is also a member of the Society of Gynecologic Surgeons where he has served in numerous capacities including program director, Society of Laparoendoscopic Surgeons, American Medical Association, and a Fellow in American College of Obstetrics and Gynecology and the American College of Surgeons.  As Co-director of the fellowship training program Dr. Hale and Dr. Heit continue to attract top national candidates for these positions.  Dr. Hale’s mission remains to improve the care and quality of life for women with pelvic floor disorders.

Read more about him here. http://myurogyn.com/douglass-s.-hale,-md,-facog.html

Watch his video here so that you know who he is and what he has to say that concerns all women. http://myurogyn.com/what-is-urogynecology.html

 So now let’s read more he has written.

As you know, in 2014 AUGS and SUFU published a position statement concerning the mid-urethral sling, the most studied procedure for SUI in the medical literature.  In March of this year, AUGS reached out to numerous medical societies to solicit their support of this document.  I am happy to announce that the societies contacted undertook their own thorough review of this document and responded with overwhelming support.  Today, we can now say that in addition to AUGS and SUFU other organizations supporting our position statement include ACOG, SGS, AAGL, and AUA.

They have been very busy gathering those who wish to continue doing this to women, which is why we much share our stories to the WORLD.

Likewise, patient advocacy groups including NAFC and WHF also added their support of the document.  This consensus was initiated by AUGS, with support from SUFU, to include every major medical society working in this space. It is our hope that the addition of these medical societies and patient advocacy groups will help physicians when they counsel their patients regarding treatment options for SUI, as well as present a powerful message within the medical community. The new statement is available on the AUGS website.

We too can present a POWERFUL MESSAGE to them. SAY NO TO MESH IMPLANTS!

While this statement is important to help educate our patients and the broader medical community, more will be needed to ensure a balanced discussion occurs in our community, as well as in the media. The mid-urethral sling is the most studied procedure for SUI in the medical literature, however the majority of that data is from outside the United States and there remains gaps in the literature around longer-term outcomes. The Board has approved the development of an SUI Surgery Registry to track physician reported process and outcome measures, as well as patient-reported outcomes. It is our hope that this US-based registry will be used by AUGS members as a way to track their outcomes which will contribute to the medical literature on the value of all SUI surgical options so that we can ensure women have the most effective treatment option available to them.

ANYTHING these people do to track the outcome on mesh implants will be BIASED because they want to continue using these products REGARDLESS of the injury cost to women!

To those patients that have had complications with their treatment for SUI, we acknowledge them and empathize with them. BULLSHIT.  All our procedures for SUI come with risks. Risks you have chosen to ignore and not give women all the true facts.  No physician ever does a procedure with the hope that there will be an untoward outcome. There is no medical treatment that is free of complications and it is up to us as physicians to obtain proper informed consent
Informed consent can only come when a doctor is open minded and you people are
NOT
and choose the correct procedure for the particular patient after discussing the risks and benefits.  That being said, as physicians, we need to make decisions based on scientific data. Scientific date is NOT BASED ON LIVES AUGS is committed to advocating for patients and physicians being able to make the best decisions concerning their care.  In addition to the above measures, an application has been placed with AHRQ to obtain an authoritative, non-biased review on treatments for SUI.  A PR firm has been retained to help provide a balanced discussion on treatment options for SUI as well.   As our strategies evolve, we will continue to update the membership on our progress.  So now you know that they are using a PR firm to sway your vote.

It is time for women to speak out and share your horrible story. Your loss of income. You loss of marital status because sex is so difficult and painful after mesh complications.

So what else did I find on the Internet about this doctor? Remember his views on informed consent? Read this.

This was on October 8, 2009 It states it is not for publication but you can download this and read it all for yourself Douglass S. Hale, M.D. v. Melissa Phelps

This gist of this is on January 22, 2002, Dr. Hale performed a total abdominal hysterectomy with bilateral salpingo-oophorectomy, Burch retropubic urethropexy, abdominal sacral colopopexy, abdominal paravaginal defect repair, and an abdominal vaginal rectocele repair on a woman by the name of Melissa Phelps.

I have no doubt many of you will recognize her pain. Because following the surgery, Melissa Phelps said she suffered from chronic pelvic floor pain that affects her pelvic floor, her hips, and her lower back down to her legs. She also had has spasms in her pelvic floor that require her to lie down until the spasms subsides. She maintained that she is not able to work and is permanently and totally disabled.

On January 22, 2004, Melissa Phelps filed her proposed complaint with the Indiana Department of Insurance alleging that Dr. Hale failed to properly disclose the risks associated with the surgery so that she could make an informed consent to the operation.

The trial court held a hearing on Dr. Hale’s motion for summary judgment on December 5, 2008.

On December 15, 2008, the trial court issued a written order denying Dr. Hale’s motion for summary judgment. The underlying principle is that in order to make an informed decision about their health, the patient must have the relevant facts. Id. If the physician has possession of those facts, the physician has a duty to disclose them.

So does this doctor really believe in informed consent? You will have to read for yourself and decided. I personally believe that many doctors do not believe that we should be told the true facts BEFORE they perform any surgery on women.

6 Responses

  1. Judy K.
    | Reply

    Thank you for sharing this article, Linda.
    Dr. Hale is apparently a liar! I would be willing to wager that he would NEVER agree to have this horrible, toxic mesh implanted in his wife, mother, daughter, or ANY woman he cares about.

    How sad that each injured woman won’t get her day in court to tell her own personal story of the hell she has gone through because of the mesh. We suffer, our families suffer, and many women lose everything in the end…. while others cannot afford to have the much needed mesh removal surgery at all.

    Once the mesh problems start in your body, they only continue to worsen greatly. Every woman must do everything in her power to get to UCLA for mesh removal. It isn’t easy and many sacrifices are made to get there for most women. The companies who make the mesh and the doctors who use it are doing everything in their power to stop us from getting the help we so desperately need. Sadly, mesh placement continues on a daily basis by unscrupulous doctors who simply do not give a damn about what it does to so many women, and our own FDA has chosen to look the other way.

  2. Sugar Sue
    | Reply

    Thank u Linda for this fine post
    Too bad so may of us cannot have complete removal. 13 years of mesh for POP could leave the bladder like cottage cheese
    . I guess I’ll continue to walk with “wooden hips”…foot parathesia.. bowel seepage and constipation… did I mention pain? We should meet at AUGS during convention

  3. Michelle Hedgcoth
    | Reply

    thank u, i didn’t know about ams, i am happy that they are shut down. So many side effects, then with the medications we are taking on top of the pain, which is overwhelming. One thing I haven’t seen alot of is the mental stress patients go through and that support medically that is available for patients. As a patient of the Pop,with all it’s complications, it has changed my life completely. I have sought help for this because coping and dealing with all the issues that come with the aftercare from a revisional surgery is overwhelming and getting every doctor, which is hard to do, on board for your own healthcare. Alot of women have lost faith in the medical and legal system that was supposed to be set up to help patients, victims, especially ones who had careers and a normal life prior to the mesh hell as we call it. I am happy to see that the fight for patients and victims of this horrific life is being advocated for. As I continue my research, I am hoping to find more help out there for victimes/patients like the ones mentioned here and the ones that suffer in slience or that I havent found yet. I am knew to speaking out, but I can’t stay silent anymore. We need help. Thank You Mhedgcoth, Mesh/Chronic Pain Warrior and Survivor.

    • Linda
      | Reply

      Michelle I have written about this and stated that dealing with it often means getting help by talking to someone. I do understand how it is and writing about it has helped me so much. Sometimes it is good to keep a diary and I have written about that too.

  4. Dont wana
    | Reply

    Dr Hale did my surgery this year and now will not help me with all the issues i am having from the TVT sling! Keeps telling me I will get better. He has actually not even seen me since surgery but sends one of his “team” in!!

    • Linda
      | Reply

      Don’t wana. I am afraid your story is very, very common and all you can do now, is go somewhere where they will help. UCLA.

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