Symptom Spotlight – “Ascites”*

Today’s Spotlight Symptom is:  “Ascites”

Many mesh-injured women and men suffer from this condition, yet it seems to be one of those symptoms that many doctors write off as “idiopathic” when seen in mesh-injured patients. Please refer to yesterday’s blog post to understand how doctors use the term “idiopathic” in a clinical setting.

Click here to learn how to Pronounce Ascites

Definition of Ascites: Ascites is the accumulation of fluid (usually serous fluid which is a pale yellow and clear fluid) that accumulates in the abdominal (peritoneal) cavity. The abdominal cavity is located below the chest cavity, separated from it by the diaphragm. Ascitic fluid can have many sources such as liver disease, cancers, congestive heart failure, or kidney failure. (SOURCE: http://www.medicinenet.com)

Medical-Diagnosis-2-callout-EN1

Below are actual pictures of Ascites in mesh-injured patients. These four women have shared these intimate photos in hopes that their injuries will help YOU, the reader, or another injured person you may know.

THANK YOU TO THESE MESH WARRIORS!

Ascites_Picture_Mesh_Injury

 

“While a tense abdomen filled with fluid is easy to recognize, initially, the amount of ascites fluid may be small and difficult to detect. As the amount of fluid increases, the patient may complain of a fullness or heaviness in the abdomen. It is often the signs of the underlying disease that initially brings the patient to seek medical care.” (SOURCE: emedicinehealth.com)

As I explained in yesterday’s blog, when a patient goes to the doctor with a symptom that doesn’t present in the most common medical context, many doctors do not pursue further understanding about why a common symptom is presenting in an uncommon way.

For example, the most common cause of Ascites is cirrhosis of the liver. So, say a mesh-injured woman presents to her physician with Ascites, but has no history of liver disease or alcoholism, and no cirrhosis of the liver. What happens next; or more appropriately, what should happen next?

The process of diagnosing the underlying cause of any symptom is performed by using the method of differential diagnosis. In the case of Ascites, one other possible explanation for the symptom is:

“Those who have spontaneous bacterial peritonitis (an infection of the peritoneum) develop abdominal pain and fever.” (SOURCE: http://www.emedicinehealth.com/ascites/page3_em.htm)

It is now well known that mesh can cause life-threatening and recurrent infection. So it seems to me that further investigation would be crucial to any patient with mesh who presents with Ascites.

Differential Diagnosis – the determination of which of two or more diseases with similar symptoms is the one from which the patient is suffering, by a systematic comparison and contrasting of the clinical findings.

Physicians are taught to follow these procedures to continue to rule out every cause, until a fotolia_5910589_XSshort list of possible causes remain. Ruling out underlying causes of any symptom(s) is carried out through a sequence of examinations and diagnostic testing.

With this symptom in particular, I am hearing from many women who are sent away by their doctors with some variation of an excuse, claiming ignorance, or at best, simply treating the condition with pharmaceuticals while refusing to perform simple diagnostic procedures and testing that could provide that doctor with more information and eventually to a better form of treatment, or cure ,and the underlying cause of the symptom.

So, when a mesh-injured patient presents with Ascites, and the physician has ruled out the most common cause of this symptom (cirrhosis of the liver), then his training requires that he begin to rule out additional possible causes.

In graph form, the process of ruling out causes for Ascites might look something like this:

ascites

 

Doctors are trained to use the above method with every symptom or illness. It is part of their daily scope of work, so why do I so often hear from women that they go to the ER, to their family physicians, to their OB/Gyns, and to their Urogynecologists with this disturbing symptom only to be told something like this, “I don’t know what this is,” or “I’ve never seen this before.”? The above process for differential diagnosis is relatively simple. Even the diagnostic testing is relatively simple, as noted above.

To find out more about testing used in the diagnosis of suspected Ascites, refer to the below pictures, and click on these links to learn more.

Abdominal Ultrasound

abdominal ultrasound

Diagnostic Paracentesis

drainas-300x206

Computed Tomography (CT Scan)

anatomy_of_a_CT_scan

These women describe to their physicians that this symptom is not simply uncomfortable, but it’s PAINFUL. They describe shortness of breath, difficulty breathing, naseau and vomiting, and the obvious limitations in lifestyle and decreased quality of life – not being able to fit into clothing, not being able to lie on their stomachs, pain when sitting, etc. Imagine all the uncomfortable symptoms of being nine months pregnant, except this situation doesn’t end in the birth of a beautiful new family member.

I find it maddening, sickening, detestable, and downright cruel that so many doctors refuse to treat mesh-injured men and women, especially when these patients present with odd or “out of the box” symptoms.

I encourage you to print and use the above graph if you suspect you have this symptom. Bring it to your doctor. Earlier this week, I spoke with a woman who went to her Ob/Gyn with this symptom, and he simply told her there was nothing he could do to help her. What?! She even asked for some of the testing in the above graph, but still the physician refused to help her.

The question we should be asking is “Why?” The action we should be taking is to educate ourselves about our own bodies and what our bodies are trying to communicate to us through symptoms. Our physicians must understand that we know they are refusing treatment, and we know that it’s wrong to do so.

Stay tuned for tomorrow’s “Spotlight Symptom.” I hope this information will help you when you visit your doctor, seeking treatment and a better quality of life.

The_Mesh_Warrio_Flower_logo_150x150_thumbnail

*I am not a doctor. This information is for educational purposes, and is based on my own experiences. Seek medical attention for this or any other symptom.

 

 

 

MESH INJURY – “Spotlight Symptoms”

Hello Warriors;

Today, I’m starting a blog series called, “MESH INJURY – Spotlight Symptoms.”*

TVMI encounter an alarmingly typical and recurrent problem when advocating for and with mesh-injured patients. It goes something like this:

  1. Mesh-injured patient develops a disturbing symptom.
  2. Mesh-injured patient visits his/her PCP or a specialist to seek diagnosis and treatment.
  3. Physician performs a physical exam, and says something like, “I don’t know what that is,” or I’ve never seen anything like this [symptom].”
  4. Patient is confused and bewildered and asks if there are tests that could be done or another doctor or specialist who would know more about the symptom.
  5. Physician says, “No,” and doesn’t perform any diagnostics to find out the underlying cause of the symptom (environmental cause, disease process, injury, or infectious pathogen).
  6. Physician prescribes medicine to mask or alleviate symptom(s) (e.g. topical creams for rashes, antibiotics for a suspected infection, maybe some other pharmaceutical to control pain or discomfort, or even an invasive or non-invasive form of treatment).
  7. Patient goes home still symptomatic, with no diagnosis, and with one or more pharmaceutical or other treatments to consider, which may or may not work, since the UNDERLYING CAUSE or UNDERLYING PATHOLOGY, which caused the symptom to manifest, was never studied in depth by the treating physician.
  8. Patient goes home and follows pharmaceutical regimen or advice for treatment.
  9. Pharmaceuticals and treatments do not alleviate symptom(s). Symptom(s) continue.
  10. Patient is left untreated and without a next step.

Paternalistic-vs-Patient-CenteredOftentimes a physician will refer to a symptom as “idiopathic,” which in layman’s terms simply means, “Who knows where it came from?” There is a responsible use of this term, but I see it used irresponsibly too often.

Some diseases are generally agreed to be “of idiopathic origin,” because no one in science can definitively identify an underlying cause. In this case, “idiopathic” is often part of the name of the disease or syndrome itself. Some examples are:

  • Idiopathic Thrombocytopenic Purpura (sometimes called Acute or Chronic ITP) is a bleeding disorder, in which a patient has abnormally low blood platelets, and thus their blood does not properly clot.
  • Idiopathic Hemochromatosis – is another bleeding disorder, in which an abnormal and dangerous amount of iron accumulates in the body’s tissues or organs, including the liver and lungs.

Both disorders are life threatening if left untreated. These disorders present with SYMPTOMS, and when doctors invest in diagnostic procedures, these diagnostic procedures, coupled with symptoms, lead them to a diagnosis, which then leads to a treatment or even a cure.

A serious problem arises when physicians use the word “idiopathic” irresponsibly. In all cases, any particular symptom or cluster of symptoms do originate from some cause, from something, from somewhere, and any doctor who does not search for the underlying cause of a symptom is negligent. “I don’t know,” would be a more accurate physician response in this situation, however; “idiopathic” sounds so much more, you know, medical and stuff. Odd or uncommon symptoms can often co-occur, simultaneously with other more salient symptoms, and when viewed together as a whole, the underlying disease process in these cases, can be more obvious, leading to a higher chance of diagnosis, or a more rapid diagnosis, which then leads to the correct treatment, to the best of the physician’s actual knowledge.

Puzzled male shrugging wearing lab coat

But, what if a patient presents with an idiopathic symptom that does not have a common accompanying symptom or cluster of symptoms that is easily recognizable to an average physician? In my personal experience, this situation is when physicians can get a bit lazy with the use of  the term”idiopathic.”

“Of idiopathic origin” is so much more dignified on a patient’s chart than:

“I have no friggin’ idea, but it’s not my problem, so I gave the patient some samples.”

So, has your physician ever told you, “I’ve never seen that symptom,” or “Your symptom seems to be idiopathic and will most likely resolve on its own.”?

If so, I’d love to hear from you.

Have you had the experience I describe above?device-transvaginal-mesh-edit

If you have, what was the symptom?

Did you ever get to the bottom of it?

Did the physician suggest diagnostic testing, or did you ask for such if he/she did not?

Did you find your doctors to be helpful in assisting you as you continued to pursue a cause, or did you find that your doctor quietly excused himself from your care, and left you to find some other doctor who might help?

Tuesday we’ll talk about the first of many symptoms which are commonly seen in mesh-injured patients, but for which doctors often say there is no explanation or that physician seems to have no drive to find an explanation.

With this series of blogs, I hope to highlight some very common symptoms, for which mesh-injured patients are turned away, left with no medical solution to pursue. Let’s use our collective knowledge as a community to help one another and to help those who don’t understand the realities of ongoing mesh injury.

The_Mesh_Warrio_Flower_logo_150x150_thumbnail

*I am not a doctor. This information is for education purposes only and is based on my personal experiences. If you have a symptom, please find a doctor who will help you identify and treat your symptoms.

“2 Doctors 2Day” – Dr. Kevin Benson of Sioux Falls/Dr. Vincent Lucente of Allentown, PA

Hello Warriors;

Coloplast Restorelle Direct Fix for POP; the device used in this FDA 522 study.

Coloplast Restorelle Direct Fix for POP; the device used in this FDA 522 study.

Below are two more physicians who are participating in the prospective cohort study, ordered by the FDA:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

If you live in or around Sioux Falls, SD or Allentown, PA, please be aware of these recruiting physicians, and please share this post with friends and family members who live in these areas.


Kevin Benson, MD, MS of Sioux Falls, SD

Kevin Benson, MD, MS of Sioux Falls, SD

Sanford Research

Sioux Falls, South Dakota, United States, 57104

Contact: Jessica Howard/605-328-1389

jessica.howard@sanfordhealth.org  

Principal Investigator: Kevin Benson, MD, MS




Dr. Vincent Lucente, a Coloplast Proctor, recruiting new women for implant with Coloplast Restorelle Direct Fix.

Dr. Vincent Lucente, a Coloplast Proctor, recruiting new women for implant with Coloplast Restorelle Direct Fix

The Institute for Female Pelvic Medicine and Reconstructive Surgery 

Contact: Marcie Taff, RN/610-435-9575   

mtaff@fpminstitute.com   

Principal Investigator: Vincent Lucente, MD, MBA  

It is no surprise that Dr. Lucente is recruiting for the Coloplast Restorelle study that would implant new women with a Coloplast product. The doctor touts his role as a “Proctor” for Coloplast. A proctor is usually a doctor, paid by a manufacturer, (in this case, Coloplast) to tour the U.S. or other parts of the world to teach other physicians how to use the manufacturer’s product(s). In this case, Dr. Lucente has been touring Australia, teaching physicians how to use Coloplast’s “Altis Single Incision Sling” for SUI. Many of Coloplast’s products under litigation, for SUI and POP, are still sold.

See below for a video describing the placement of the “Altis” device.

The important point here is that many doctors (and very obviously Dr. Lucente) have an incentive to recruit patients for these studies, because THESE DOCTORS ARE PAID BY THE MANUFACTURER TO DO SO. To me, that represents a clear conflict of interest for any FDA-ordered follow-up study (522 study) to render unbiased science.

Coloplast “Altis” Procedure Animation


I wouldn’t necessarily say I’m ending this post on a high note, but I am ending it on a note. . . from the great Billy Joel and his famous song, “Allentown.”

Dear Allentown, PA:

Don’t let the manufacturers of ANYTHING “take all the coal from the ground” again or return under a new name to take your mothers, grandfathers and fathers who “met at the USO” and fought and survived World War II at home and abroad. Mesh manufacturers, too, will “crawl away” leaving a generation of your families demolished by polypropylene mesh. 

I wouldn’t say it if I hadn’t seen it myself.

Generations of families are being wiped out by an enemy of a different name.

The rest of the country thinks of your community as the great, sturdy, American, Allentown.

Stand up to mesh in your community!

“Allentown” Lyrics/Billy Joel (1982)

Well, we’re living here in Allentown
And they’re closing all the factories down
Out in Bethlehem they’re killing time
Filling out forms
Standing in line

Well, our fathers fought the second World War
Spent their weekends on the Jersey shore
Met our mothers in the USO
Asked them to dance
Danced with them slow

And we’re living here in Allentown
But the restlessness was handed down
And it’s getting very hard to stay

Well we’re waiting here in Allentown
For the Pennsylvania we never found
For the promises our teachers gave
If we worked hard
If we behaved

So the graduations hang on the wall
But they never really helped us at all
No they never taught us what was real
Iron and coke
Chromium Steel

And we’re waiting here in Allentown
But they’ve taken all the coal from the ground
And the union people crawled away

Every child had a pretty good shot
To get at least as far as their old man got
But something happened on the way to that place
They threw an American flag in our face

Well, I’m living here in Allentown
And it’s hard to keep a good man down
But I won’t be getting up today

And it’s getting very hard to stay
And we’re living here in Allentown

“A Doctor A Day” Keeps This Study Away/Novant Health Urology Partners, Winston-Salem, NC

Hello Warriors!

Dr. John J. Smith, III of Novant Urology Partners in Winston-Salem, NC

Dr. John J. Smith, III of Novant Urology Partners in Winston-Salem, NC

Please be aware if you live in the Winston-Salem area. Dr. John J Smith, III of Novant Health Urology Partners is recruiting for implant of new women in a study sponsored by Coloplast and ordered by the FDA.

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Novant Health Clinical Research

Winston-Salem, North Carolina, United States, 27103

Contact: Kim Robinson       krrobinson@novanthealth.org

Principal Investigator: John J Smith, III, MD


A Crazy Little Thing Called Hope

In the midst of working our way through the crazy-making maze of our healthcare system as it is now, how do we stay HEALTHY? How do we avoid danger?

I am not suggesting that you follow this physician’s advice, but I find it very telling. The last time I was in the ER with my mom, her admitting ER physician came to speak with me about some of her test results. Completely unsolicited, the FIRST thing he said to me was,

“The best way to keep your mom healthy is to keep her away from doctors.”

WOW! This unsolicited advice from a doctor I had NEVER met, who knew very little about my mother’s medical history! Honestly, I was not surprised he said it. I was just surprised it was the FIRST THING OUT OF HIS MOUTH!

While we still have the ability to CHOOSE which doctor we believe will best provide care for our speciality care needs and our total health, we can continue to educate ourselves – about our personal medical history, medical terminology, and the benefits and risks of any medications or treatments that may be recommended to us by our healthcare professionals.

Pause-iconLately, I’ve been learning to “push the pause button.” Stop and think. If my doctor recommends a treatment, it’s responsible for me to research the risks and benefits and then ask for a second consultation once I have more education about any treatment that will affect my body and my life.

So today, as you think about your own life, your own body, your own health; think about pressing the pause button. Stop. Think. Research. Consult. Decide. All of those actions do not have to be done in one consultation with your doctor.

YOU are the most important person in the room when you’re with any doctor. After all, it’s your life. With “pressing pause” comes hope and a renewed sense of control over your own health destiny. I hope this little, seemingly obvious, technique helps you regain a sense of your options and a sense that YOU are the MVP in your healthcare decisions.

“A Doctor A Day” William Porter, MD of Charlotte, NC . . . and An Apology

Hello Warriors;

Here is your “Doctor a Day.” You know what to do. Call, email, question. Always question.

William Porter, MD of Novant Health Urogynecology, Charlotte, NC is actively recruiting for the FDA’s 522 prospective cohort study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

William Porter, MD of Novant Health Urogynecology in Charlotte, NC

William Porter, MD of Novant Health Urogynecology in Charlotte, NC

Novant Health Urogynecology

Charlotte, North Carolina, United States, 28210

Contact: Christine Mackey    704-574-5157

Principal Investigator: William Porter, MD


An Apology . . . .

As I was thinking this weekend, I realized that in sharing each doctor who is actively recruiting for this study that would implant NEW patients with Coloplast’s Restorelle for the repair of POP, I have been remiss in my “Doctor A Day” postings. I have not been doing what is core to my cause. I vowed to provide you with information, but I also promised to PROVIDE YOU WITH HOPE.

In these posts, I have not provided HOPE. For this failure, I ask, “Will you forgive me?”

hope changes everythingI hope you will. This blog is about providing you with helpful information, but it’s also about providing hope, for if we lose hope, then we have surely lost everything.

Science should be a celebration of human endeavor, the indomitable human spirit, and the ability of science, when used for GOOD, to overcome the barriers and burdens of Mother Nature that lead to human suffering and pain.

So, how does our mesh-injured community celebrate science when everywhere we turn, we seem to find another doctor who has minimized our suffering; another researcher with a clear conflict of interest; another underhanded tactic used by a lawyer; another failure of the FDA to protect us; and yet another layer of the onion, peeled back to reveal something even more horrendous?

We celebrate the true scientists among us. They are still out there.

As I’ve been sharing “A Doctor A Day,” a question occurred to me:

“What does it mean to be a ‘TRUE SCIENTIST,’ and when did the twin disciples of science and medicine begin to drift apart in such seemingly different directions?”

I immediately recalled the answer of a new friend, whom I met just recently. A chemist himself, I was truly curious and so asked him, “So, what is the difference between a true chemist and someone who uses chemistry?” I found his answer to be simple yet profound.

“A true chemist does chemistry for the sake of doing chemistry,” he said.

My friend’s answer provoked in me another question that I did not explore at the time.

“Where are our generation’s heroes of science, those men and women who, in their various hyper-intellectual specialities, are currently making history by ‘doing science for the sake of doing science?'”

And why do we now refer to scientists as “researchers?” I don’t think I like that term. At least for me, the word “researcher” carries with it a connotation that an appropriately educated person works for someone or something other than the cause of science itself, maybe even for a company who seeks to pay any given researcher to find the answer that company wants, not the answer that is scientifically valid. That is not “science for the sake of science.” That is “science for the sake of profit.”

Clearly, everyone must earn a living, but somehow the scientists of history did make a living, many times before they were employed at all. They were scientists because they wanted to be.

Maybe scientists became researchers with the advent of today’s modern Corporation, an entity whose highest value is profit.

The Corporation (Click link to view the informative documentary.)Screen Shot 2015-10-27 at 3.55.54 PM

In contrast to “researcher,” the term “scientist” conveys a sense of the noble pursuit of truth, as revealed by science. For me, this word offers more meaning. The imagery I get is one of anticipation, hope and a fidelity to the purity of the scientific method.

Dr. Neil deGrasse Tyson, astrophysicist, cosmologist, author, and science communicator. In 2015 for his "extraordinary role in exciting the public about the wonders of science."

Dr. Neil deGrasse Tyson, astrophysicist, cosmologist, author, and science communicator. In 2015 for his “extraordinary role in exciting the public about the wonders of science.”

I’m thinking we need to borrow from Justin Timberlake’s lyrics here and “bring sexy back” to science and scientists.

Why should our society revere doctors as if they were gods, and not think about from where their earthly powers come, the steady long-suffering pursuit of scientific knowledge by SCIENTISTS?

The lucrative “practice of medicine,” is rooted in the dreams of scientists, the discoverers, the curious among us, those with a deep-seated need to find and find out, those with a “keen sensing search,” as Nikola Tesla has been quoted to say. By this method, we uncover the highest calling to the scientist.

Sir Alexander Fleming in his lab at London University

Sir Alexander Fleming in his lab at London University

History-making scientists of the past brought us life-saving discoveries. Many of you may know the story of Sir Alexander Fleming, who in 1928, discovered the enzyme lysozyme and the antibiotic substance penicillin from the fungus Penicillium notatum. Sir Fleming is quoted as saying,

“One sometimes finds what one is looking for.”

I love that quote. It acknowledges that Sir Fleming had the fortitude of character to know his endeavors might not reveal what he’d hoped, but, alas, that is the nature of science. Science reveals truth – not convenient truth, not truth meant for manipulation, not truth meant be to harm those whom it may benefit. Sir Fleming worked at London University.


Below are two living scientists, studying polypropylene and its effects on humans. They are to be celebrated! With many hundreds of articles published as first author, these men have C.V.s that echo what my chemist-friend said.

These men “do science for the sake of doing science.”

Thank you for chasing protons, mixing potions, and failing to find a convenient truth, but succeeding to find a scientific truth in service of humanity. 

Claudio Birolini MD, PhD, Abdominal Wall and Hernia Repair at the University of São Paulo, School of Medicine

Claudio Birolini
MD, PhD, Abdominal Wall and Hernia Repair at the University of São Paulo, School of Medicine

Dr. Claudio Birolini works for the University of São Paulo, School of Medicine.

Mesh Squamous Cell Carcinoma:

http://www.ncbi.nlm.nih.gov/pubmed/23604537

Authors: Birolini Claudio, Minossi JG, Lima CF, Utiyama EM, Rasslan S.


Dr. Vladimir Iakovlev St. Michael's Hospital, Toronto Implantology, Oncology, Pathology

Dr. Vladimir Iakovlev
St. Michael’s Hospital, Toronto
Implantology, Oncology, Pathology

Dr. Vladimir V. Iakovlev works for St. Michael’s Hospital, Toronto.

Long-term effects from the degradation of polypropylene in vivo: 

http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.33502/abstract

Authors: Vladimir V. Iakovlev, Scott A. Guelcher, and Robert Bendavid

A “Doctor a Day” Keeps This Study Away/Karolynn Echols/Cooper University Hospital, Camden, NJ

Hello Warriors;

Here is your doctor-a-day to call regarding the Coloplast Restorelle vs. Native Tissue Repair study, currently recruiting new patients for implant.

Karolynn Echols, MD

Karolynn Echols, MD

Karolynn Echols, MD

Cooper University Hospital
Camden, New Jersey, United States, 08103
Contact: Gunda Simpkins, RN    856-968-7547    simpkins-gunda@cooperhealth.edu
Principal Investigator: Karolynn Echols, MD, FACOG

“A Doctor A Day” – Douglas Van Drie of Grand Rapids, MI

Dr. Douglas Van Drie of The Institute of Michigan Female Pelvic Medicine & Urogynecology is actively recruiting for the FDA 522 Study:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Dr. Douglas Van Drie of Grand Rapids, MI is participating in the study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Dr. Douglas Van Drie of Grand Rapids, MI

Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States, 49503
Contact: Beth Rogers, RN    616-588-1800    brogers@grwh.org
Principal Investigator: Douglas Van Drie, MD

You know what to do MESH WARRIORS!

Previous “Doctor A Day” Blogs:

Dr. Arturo Menchaca/Paris Community Hospital, Illinois

Dr. Sherry Thomas/Angoura Hills, CA

Dr. Ty Erickson of Rosemark Women Care Specialists in Idaho

Dr. Babak Vakili of Delaware’s Christiana Care Health System

Dr. Oz Harmanli of Baystate Health System, Springfield, MA

A Doctor A Day Keeps This Study Away/Oz Harmanli, MD & Pam Behrens, NP of Baystate Health System/Springfield, MA

Hello Warriors,

Dr. Oz Harmanli, actively recruiting NEW patients for implant with Coloplast's Restorelle.

Dr. Oz Harmanli, actively recruiting NEW patients for implant with Coloplast’s Restorelle.

Among the 45 or so physician/practices and hospitals participating in a prospective cohort study to test mesh against native tissue repair is Dr. Oz Harmanli.

I have to admit, he looks like a nice guy. Maybe that means he’ll listen when we call to tell him how dangerous we believe this study is:

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Baystate Health System
Springfield, Massachusetts, United States, 01199
Contact: Pam Behrens, NP    413-794-7045    pamela.behrens@baystatehealth.org
Principal Investigator: Oz Harmanli, MD, FACOG

For ideas/suggestions for making your call, please see my previous posts:

Dr. Arturo Menchaca/Paris Community Hospital in Illionois

Dr. Sherry Thomas/Agoura Hills, CA

Dr. Babak Vakili and Jennifer Mann, RN BSN of Rosemark Women Care Specialists in Idaho

And I found this quote by Nikola Tesla to be very inspiring. Tesla is known for being a scientist at heart, a scientist for science’s sake. I am inspired by his words because they summon a time when man’s pursuit of science was much less adulterated by a motive to profit, a time when science and humanity served in concert to produce a better quality of life for all. Also regarded as a futurist, even in 1905, Tesla knew that through “the strife of commercial existence . . . what is ridiculed, condemned, combatted, suppressed,” will emerge triumphant.

My hope is that his words will prove true, and that by science in service of humanity, “so [will] we get our light.”

Mesh Squamous Cell Carcinoma: http://www.ncbi.nlm.nih.gov/pubmed/23604537

Thank you scientists and authors: Birolini C, Minossi JG, Lima CF, Utiyama EM, Rasslan S.

Long-term effects from the degradation of polypropylene in vivo: http://onlinelibrary.wiley.com/doi/10.1002/jbm.b.33502/abstract

Thank you scientists and authors: Vladimir V. Iakovlev, Scott A. Guelcherand Robert Bendavid

Tesla, aged 34 Born: 10 July 1856 Smiljan, Austrian Empire (modern-day Croatia) Died: 7 January 1943 (aged 86) New York City, New York

Tesla, aged 34
Born: 10 July 1856
Smiljan, Austrian Empire (modern-day Croatia)
Died: 7 January 1943 (aged 86)
New York City, New York

“It is not a dream, it is a simple feat of scientific electrical engineering, only expensive – blind, faint-hearted, doubting world! […] Humanity is not yet sufficiently advanced to be willingly led by the discoverer’s keen searching sense. But who knows? Perhaps it is better in this present world of ours that a revolutionary idea or invention instead of being helped and patted, be hampered and ill-treated in its adolescence – by want of means, by selfish interest, pedantry, stupidity and ignorance; that it be attacked and stifled; that it pass through bitter trials and tribulations, through the strife of commercial existence. So do we get our light. So all that was great in the past was ridiculed, condemned, combatted, suppressed – only to emerge all the more powerfully, all the more triumphantly from the struggle.” – Nikola Tesla “The Transmission of Electrical Energy Without Wires as a Means for Furthering Peace,” Electrical World and Engineer, January 7, 1905″

Taking a Break from “A Doctor A Day” to report some GOOD NEWS!

Hello Warriors;

JoleenChambers_EsperanzaWorley-10-21-15

Ms. Esperanza Worley, Deputy District Director for U.S. Congresswoman Eddie Bernice Johnson (left) and Joleen Chambers of FIDA speak passionately about preventable harm by med devices.

This morning was a great morning. Fellow patient advocate, Joleen Chambers of FIDA (Failed Implant Device Alliance), and I met with Ms. Esperanza Worley, Deputy District Director for U.S. Congresswoman Eddie Bernice Johnson of Texas’ 30th District. We met with Ms. Worley for more than an hour, and we covered quite a bit of ground.

We asked that the Congresswoman, a former RN herself, take immediate action regarding the serious, life-altering and PREVENTABLE injuries affecting mesh-injured patients and patients of Bayer’s Essure device for permanent female sterilization.

Jeffrey_ShurenWe emphasized the FDA’s lax, highly-negligent oversight of the medical device industry in general, even calling for the resignation of, Jeffrey Shuren, Director, Center for Devices and Radiological Health since 2010, who has come under scrutiny regarding clear conflicts of interest, which render him unfit for such a position with the FDA. Read more from Joleen’s FIDA blog, here: Injured Device Patients Blitz CDRH’s Shuren.

Allison W. Shuren, Partner and Co-Chair of the FDA/Healthcare Practice Group at D.C.-based Arnold & Porter, LLC.

Allison W. Shuren, Partner and Co-Chair of the FDA/Healthcare Practice Group at D.C.-based Arnold & Porter, LLC.

Also of great concern, Shuren’s wife, Allison W. Shuren, is a partner at Washington-based law firm Arnold & Porter, LLP and is co-chair of the firm’s FDA/Healthcare Practice Group. As her bio states, she “advises a broad group of clients, including pharmaceutical, medical device, and biotechnology companies, physician practice management companies and physician practices, hospital and academic medical centers, ambulatory surgery centers, healthcare professional societies, diagnostic imaging centers, and Internet-based healthcare companies.”

Notice Arnold & Porter makes the list of Large Public Policy Practices in Law Firms. *Source: National Law Journal

Arnold & Porter – In “The Influence 50” as one of the number of law firms that counted almost $100 million or more in revenue from work intended to influence federal policy.

One can easily conclude that the couple’s entire household income is dependent upon the success of a failing and harmful tax-payer-funded regulatory agency – maybe the most important regulatory agency responsible for the domestic safety and protection of the American people. Read the National Law Journal’s article in its entirety here: How Large are the Public-Policy Practices Within Law Firms?

Ms. Worley and I discuss important patient safety issues and the failure of the FDA to serve the American people.

Ms. Worley and I discuss important patient safety issues and the failure of the FDA to serve the American people.

We found in Ms. Worley a sympathetic ear, and as a woman herself, she took great interest in our shared causes. She was emphatic that she would share the information we provided her with EBJ and Washington TODAY! We spoke at length about the preventable harm that is befalling so many patients under a regime of stakeholders who stand to benefit from rushing devices to market and keeping them on the market.

I shared my family’s story of the horrors of mesh, and I shared about the recent and tragic death of my mesh-injured friend, Linda Batiste. Other topics we covered:

  • The FDA’s MedWatch Program for reporting adverse events: Passive and reactionary, MedWatch is a convoluted interface that’s difficult to navigate and not well-publicized to patients who would seek to report complications. MedWatch doesn’t serve those who have no internet access and/or are not technophiles, and thus, contributes to the under-reporting of serious adverse events.
  • Issues with Informed Consent: How is a patient enabled to provide true, informed consent when the medical device company, who stands to benefit from the patient’s consent, is responsible for educating that patient’s doctor and thus, the patient (conflict of interest, perhaps)? And how were doctors or patients to know of PERMANENT adverse events when vaginal polypropylene mesh was not studied long term before coming to market?
  • The FDA’s antiquated and deeply-flawed 510(k) process for clearance of medical devices: The current legislation for regulation of medical devices was put into effect in 1976! The FDA’s website states, “The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.” What has legislation done to protect the millions of harmed patients since then? Clearly, it’s time to modernize this legislation, as the healthcare climate was SUBSTANTIALLY different in 1976 than it is now, almost 40 years later.
  • The FDA’s 522 post-market surveillance program often churns out faulty science. A current 522 study seeks NEW participants to compare Coloplast Restorelle vs. Native Tissue Repair.
    •  This 3-year study cannot possibly accurately reflect outcomes and complications from the implant of a PERMANENT DEVICE.
    • The study is recruiting patients as young as 18!
    • The study seeks to “exclude” patients with “a known sensitivity to polypropylene.” How are doctors going to measure that? To my knowledge, there is no test for “sensitivity to polypropylene,” and if there is, WHY wasn’t this metric used BEFORE millions of people were implanted?
    • Why is the FDA 522 study a prospective study, rather than a retrospective study? The latter would measure outcomes from a patient population already available, which seems a MUCH safer approach and the study could be longer than three years, giving more comprehensive and longitudinal data.

I am ENCOURAGED today, for this is another step towards exposing the dangers of our country’s Healthcare System AND its primary regulatory agency, the FDA. Thank you Esperanza for giving voice to our community, and for opening your heart and mind to our pleas for help.

Thank you Ms. Worley and Congresswoman, Eddie Bernice Johnson!

Thank you Ms. Worley and Congresswoman, Eddie Bernice Johnson!