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)

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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!

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“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

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Computed Tomography (CT Scan)

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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.

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*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.

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*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.

Dr. Raz Debates: To Mesh or Not to Mesh?

Shlomo Raz, MD

Shlomo Raz, MD

Dr. Shlomo Raz, known wide and far by our Mesh Warrior community as the preeminent surgeon for full transvaginal mesh excision, debates a fellow urogynecological surgeon at the 2015 American Urological Association Annual Meeting, held in New Orleans in May of this year.

Below is the video of the debate.

 

What do YOU think about the merits of each position?

2015 Debate: Surgery for Stress Incontinence – With vs. Without Mesh

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Dr. Raz Debates at the AUA’s 2015 Annual Meeting in New Orleans, taking the position that mesh SHOULD NOT be used to treat SUI.

*WARNING – There is graphic medical content including live-action film of genitalia and surgical interventions.

NCHR’s Patient Advocacy Workshop: What I Learned

Hello Warriors;

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A snapshot I took of a beautiful vigil held at the Rochambeau Statue in Lafayette Square in D.C. after the Paris attacks.

This past week/weekend, amidst the worldwide panic and sorrow over the terrorist attacks in Paris, I attended the National Center for Health Research’s second Patient Advocacy Workshop in Washington, D.C. It was strange to be there under such uncertain circumstances. I couldn’t help but worry about if one of our nation’s capitol cities, even D.C., could be next. Thankfully, that was not the case, and all of us returned to our homes safely, despite concerns at the three D.C. airports: Several People Removed from Spirit Airlines on flight departing BWI.

 

 

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Fellow Patient Advocates at the NCHR Workshop

I felt at home, as I was surrounded by 30 or so patient advocates; individuals just like me, who advocate for a loved one, or by their own injuries, effort daily to raise the public’s awareness about the breadth and depth of medical harm. Many of these folks touched my heart. Like all of us, they each struggle to comprehend how so much harm has befallen so many and has come from the very institutions meant to promote good health and protect and preserve health as stakeholders in the health of our nation.

 

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If you are mesh injured, and you don’t think this post is for you, keep reading.

Patients and advocates came from all corners of the nation for this conference: Hawaii, Pennsylvania, California to Tennessee; and everywhere in between, including Texas! Each attendee was invited for differing healthcare concerns, but we were all there for the same purpose: To unite as advocates who are committed to bringing real-world patient voices to industry and government.

After breakfast Friday morning, we began with a test to gauge our current knowledge base and understanding of the FDA and its regulatory practices. We took a follow-up test at the end of the program to gauge what we learned from our training sessions. I don’t have my results yet, but I promise to share them once I do!

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Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Our training began in earnest as we learned the ins-and-outs of the FDA and its regulatory policies from our host and the founder of the National Center for Health Research and the Cancer Prevention and Treatment Fund, Diana Zuckerman, Ph.D. Dr. Zuckerman has a lengthy career as a scientist and researcher, as a faculty member at Vassar and Yale, and as a researcher at Harvard. Her work on Capitol Hill has ranged from Congressional staffer to AAAS Congressional Science Fellow and former senior policy advisor to First Lady Hillary Rodham Clinton. She has spoken dozens of times before Congress, federal agencies, state legislative committees, and even the Canadian Parliament! Formally trained in epidemiology and public health at the Yale College of Medicine, her work at NCHR now focuses on creating a stronger FDA. She serves on the federal Medicare Coverage Advisory Committee and on the board of directors at The Reagan-Udall Foundation and the Alliance for a Stronger FDA.

We then took time to introduce ourselves, our areas of interest, and what we hoped to gain from our attendance and training. Those moments were some of my favorites. That time gave me hope, because there are so many individuals who have made great strides in their advocacy. It reminded me that the possibilities for our mesh-injured community are endless. It renewed my hope in our shared cause. As is most often the case, it is the individual human being who has the capacity to make the most significant changes for good. I am reminded of the famed quote by author, seeker, academic, anthropologist and all-around troublemaker, Margaret Mead, who said,

“Never believe that a few caring people can’t change the world, for indeed, that’s all who ever have.”

I met more than a few caring people at the workshop.

I met a man who suffers from Ataxia; a congenital, degenerative neurological disorder that progressively affects coordination, speech, and swallowing. It must have required enormous effort each time he spoke, but I am forever changed by the confidence with which he uttered each word. Unafraid to ask for help, as he should be, he introduced himself and offered, “If you don’t understand what I say; ask me to repeat it.” What a powerful message, one from which we all can learn. Find out more about Ataxia from The National Ataxia Foundation, established in 1957, and dedicated to improving the lives of persons with Ataxia through support, education and research.

I met parents who have lost their young adult daughters to the often downplayed, lethal risks associated with hormone-based contraceptives. These parents have taken action; not because someone told them to, but because they want to honor their daughters’ legacies and raise awareness, with the hope that they will prevent others from experiencing the devastation of losing a child. Their heartbreak was so palpable that it was like another advocate in the room. Many people, from all walks of life, say that there is nothing in life so painful as the loss of one’s child.

Richard and Dianne Ammons honor the life and loss of their daughter, Annie, to YAZ, a drospirenone, hormonal contraceptive. They raise awareness through their Letters To Annie website. Other advocates Joe (www.birthcontrolsafety.org) and Dru (www.birthcontrolwisdom.com) honor their daughters’ legacies and raise awareness about deadly blood clots associated with the Nuva Ring hormonal contraceptive device.

I met a charter member of Washington Advocates for Patient Safety, who though injured by a metal-on-metal hip implant herself, still advocates for others, even as she continues to suffer daily. In fact, The Center for Medicare and Medicaid Services,  just yesterday, announced their Comprehensive Care for Joint Replacement Model (CJR), saying,

Hip and knee replacements are the most common inpatient surgery for Medicare beneficiaries and can require lengthy recovery and rehabilitation periods. In 2014, there were more than 400,000 procedures, costing more than $7 billion for the hospitalizations alone.”

I met a man, now disabled for life, who was implanted with a spinal medical device used off-label by his surgeon. With access to the best care in the world and a powerful family to boot, not even he could escape the long arm of medical harm. His story speaks to how overwhelming the issue of medical device harm has become. It does not discriminate. 

I met a U.S. veteran from Austin, TX who was exposed to Agent Orange during his service to our country and has suffered and survived prostate cancer as a result. He now facilitates a Prostate Cancer Support Group, a group that I imagine my husband’s grandfather, a fighter pilot in the Vietnam and Korean Wars, would have benefited from greatly. 

I met mothers whose children suffer from rare diseases, and for which it is so difficult to raise awareness (not so different from mesh injury in that regard). I met many women who suffer from rare heart disease, yet are stigmatized. We agreed that no one deserves to be judged by any health condition, especially the number one killer in the U.S. for both men and women: heart disease.

I met a woman from Essure Problems who was involved with the recent FDA public hearing addressing Bayer HealthCare’s Essure System for permanent female sterilization and the adverse reactions associated with the permanent contraceptive device. Somewhat shy and reserved, it was hard to imagine that she recently spoke to the FDA. I point out this fact, because it is proof-positive that anyone can be an agent of change. All that is necessary to become an influential patient advocate is that you care deeply about others, and that you’re willing to push through any fear that could hold you back or keep you silent.

IMG_1167Two representatives from the FDA gave a brief presentation to explain how patient advocates can become involved in patient-centered policy at the FDA.

We also heard from PCORI, the Patient Centered Outcomes Research Institute  and how, in just three short years, the newly-formed organization has funded many research projects with the aim of measuring outcomes which relate to the patient’s perspective and well being. We learned that, far too often, research in healthcare is designed to test and measure factors that may impact the patient, but may not always be designed to assess the benefit of any given outcome to the quality or quantity of patients’ lives.

Susan Molchan, MD, a decorated physician and scientist provided an eye-opening perspective. Having worked in private practice, as a staff psychiatrist for the National Institute of Mental Health (NIMH), and as a medical officer at the FDA, she is a walking library of experiences! She has returned to clinical work and writing in her areas of interest: healthy aging, health literacy, and conflicts of interest in medicine. She now serves as attending psychiatrist at the Walter Reed National Military Medical Center in Washington, D.C. She spoke to us in her capacity as a member of the board of directors for the National Physician’s Alliance, an organization which champions “The Unbranded Doctor,” and the core values of the medical profession that many would say have been lost: Service, Integrity, and Advocacy. I’m glad to know the NPA exists, for surely there are many physicians who care deeply about the core values of their chosen profession and realize that so much trust between patients and physicians has been broken. It’s a great resource for us, as patients and advocates, too.

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Desirée Walker, two time Breast Cancer Victor

We heard inspiring talks by longtime patient advocates like Desirée Walker, who having survived breast cancer twice, refers to herself as a “Cancer Victor.” Desirée works with the U.S. DOD-funded breast cancer research program and has made such an impact for good towards the search for a cure.

 

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Tim Horn, 20+ year survivor of HIV and HIV/AIDS patient advocate

Tim Horn, HIV Project Director at the Treatment Action Group, reminded us that the long journies of HIV/AIDS patients and advocates, who came before us, can serve as an example for all of us. Though the road is long, significant change can be brought about by our long-term commitment and the continued courage to speak out, even through setbacks and progress that seems to come far too slowly for those who are suffering and dying.

The lives of these patients and advocates and the stories they tell are just like ours.

We are most certainly not alone in our fight against the epidemic of preventable medical harm and the diseases, common to all, which require the FDA to get involved in service of America’s public health. We even share the hurt that all patients suffer under the guidance of a public health system that can be much too bureaucratic to mobilize in the face of infectious disease. We’re experiencing that very problem now, as the irresponsible use and administration of antibiotics continues to hasten antibiotic resistance.

In sharing these insights, my hope is that no person in our community would feel abandoned or alone. We can connect to others through our shared suffering, but once connected, we can live our lives alongside one another to create a “new normal” which can draw us out of the isolation and loneliness of chronic illness. Suffering is suffering. We all experience the common feelings of anger, loss, regret, sorrow. . . and hope. As Desirée says,

“He who has health has hope. And he who has hope has everything.”

Though many of us have lost a great deal of our health, and we grieve that loss; we can also choose hope, for we still have health.

Thank you to the staff members at NCHR and PCORI for allowing us to learn from one another and together, as individuals working in concert, help us to gather our voices so that each of us may be heard louder still.

And for those of you who actually read this far, here’s a funny for you. If it’s one thing I think we all agree on, it’s that humor is often the best medicine, and sometimes the only medicine for our broken bodies and hearts.

~ For my mother, whom I love with audacious action. ~

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“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” – Dr. Steven Kleeman/Cincinnati, OH and “A Dose of Hope”

Hello Warriors!

Steven Kleeman, MD practices in Cincinnati, and West Chester, OH at Bethesda North Hospital, Good Samaritan Hospital & TriHealth Hospital, Evendale

Steven Kleeman, MD practices in Cincinnati, and West Chester, OH

Here’s your “Doctor a Day.”

READ ON FOR “A Dose of Hope!”

If you live in or around the Cincinnati area, please be aware that this doctor is recruiting new patients for a prospective cohort study which would include the implant of NEW WOMEN with Coloplast’s Restorelle Direct Fix for repair of POP. Here is the study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Please share with any friends and/or family members who live in the area, and please take action, yourself, by calling or emailing the doctor to share with him why you think this study is dangerous, or whatever your personal thoughts may be. We may never know who we’ve helped with a single phone call or email.

Dr. Steven Kleeman practices at at Bethesda North Hospital,
Good Samaritan Hospital, and TriHealth Hospital, Evendale.

Good Samaritan Hospital

Contact: Vivian Ghodsi, RN, CCRC    513-463-4308    vivian_ghodsi@trihealth.com

Cincinnati, Ohio, United States, 45220 

Principal Investigator: Steven Kleeman, MD, FACOG 


A Dose of Hope

I am extraordinarily grateful and humbled to have been accepted and awarded a scholarship to participate in an important patient advocacy workshop next week in Washington, D.C.!

Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Diana Zuckerman, Ph.D. and President of the National Center for Health Research AND the Cancer Prevention and Treatment Fund

Diana Zuckerman, Ph.D., President of the National Center for Health Research and the Cancer Prevention and Treatment Fund is the workshop’s organizer. Not only does Ms. Zuckerman have a lengthy and impressive career in advocating for patient health and safety; she is also very knowledgeable about mesh and has been speaking out about its risks more than a decade! In fact, she participated in a briefing on Capitol Hill with Dr. Shlomo Raz/UCLA a few years ago.

I am BEYOND GRATEFUL for the scholarship and for this opportunity to learn from, not only Diana, but also her colleagues and the other, 30-or-so, attendees.

The workshop is a two-day learning seminar, and I’m preparing this weekend so I come with a fresh mind, ready to listen and learn. If you have any questions you’d like me to bring up at the workshop, please email me at: themeshwarrior[at]gmail[dot]com or comment on this post with your question.

Helping, Hoping for Healing . . . 

Aaron/The Mesh Warrior

“A Doctor A Day” – Costas Apostolis, MD/Akron Urogynecology Associates AND What Would You Say?

Hello Warriors;

Here is your “Doctor A Day,”  Costas Apostolis, MD at Akron General. You know what to do!

Costas Apostolis, MD is currently recruiting new patients for mesh implant in Akron, OH.

Costas Apostolis, MD is currently recruiting new patients for mesh implant in Akron, OH.

Akron Urogynecology Associates

Akron, Ohio, United States, 44333

Contact: Connie Cottrell    330-344-7681

Principal Investigator: Costas Apostolis, MD


Science with Hope

Many of you may have seen the recent video posted by Dr. Shlomo Raz and his team at UCLA. Associate Professor, Division of Pelvic Medicine and Reconstructive Surgery, Department of Urology, Ja-Hong Kim, MD, and a fellow of Dr. Raz, hosts a 20-minute video presentation titled, What You Need to Know About Vaginal Mesh for Female Pelvic Surgery.” Dr. Kim opens her talk by saying, she will provide a “clear, concise overview of mesh.” Finally, a well-respected surgeon is putting transvaginal mesh in plain English. This video will surely provide a much better education for women who are considering mesh as an option for repair of POP or SUI. Please watch the video below, and then read the rest of my post.

  • 1:25 – Dr. Kim defines Stress Urinary Incontinence (SUI) as a loss of urine during physical activity due to weaknesses of the pelvic floor. Dr. Kim notes that a woman’s lifetime risk for developing SUI is 20% – 40%. A 20% variability represents several standard deviations. I believe it is the most conservative approach to cite the highest level of known risk in treating SUI with mesh: 40% LIFETIME RISK.
  • 1:42 – Dr. Kim defines Pelvic Organ Prolapse (POP) as a vaginal bulge of pelvic organs resulting from weaknesses of the pelvic floor and cites that a woman’s a lifetime risk for POP is 30% – 50%. Again, with a 20% variability, I believe the most conservative approach, when contemplating repair with mesh, would be to use the highest incidence of lifetime risk: 50% LIFETIME RISK.

The Coloplast Restorelle® Mesh Versus Native Tissue Repair for Prolapse study for which I’ve been posting “A Doctor A Day,” has INCLUSION and EXCLUSION criteria.

I’m concerned about two of the INCLUSION criterion, specifically:

  • Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
  • Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of “somewhat”, “moderately” or “quite a bit”)

These two criterion for INCLUSION are part of a longer list of criteria that defines a “good candidate” for the study. A woman who has early stage prolapse (Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl) and/or answers questions about how “bothersome” a “bulge” is with the answer of “somewhat” or “moderately” bothersome is considered a “good candidate” for the study.

In my many discussions with urogynecologists, some of them have been shocked, and even quite upset, that a mesh implant was used for a woman in early or moderate stage prolapse. These physicians said,

“Treatment of POP with surgical intervention and mesh implant should be a TREATMENT OF LAST RESORT.”

According to the University of Virginia, there are stages of POP, 0-4.

  • Stage 0 means that there is no prolapse. The pelvic organs like the vagina, bladder and rectum are perfectly supported by the ligaments in the pelvis.
  • Stage 1 means that there is virtually no prolapse. The pelvic organs are very well-supported by the ligaments in the pelvis.
  • Stage 2 prolapse means that the pelvic organs are not as well supported by the ligaments and have begun to fall down. In Stage 2 prolapse, the organs are still inside the vagina.
  • Stage 3 prolapse means the pelvic organs are beginning to bulge to or beyond the opening of the vagina.
  • Stage 4 prolapse means the pelvic organs are completely outside of the vagina.

Do you know which stage of prolapse you have/had at the time of mesh implant?

Do you think it is ethical for a study to recruit NEW patients who are in early-stage prolapse?

If you could talk to a woman who is considering participation in this study, what would you tell her?


NOTE: MY OBSERVATIONS SHOULD NOT BE TAKEN AS MEDICAL ADVICE AND SHOULD NOT BE A REPLACEMENT FOR SEEKING THE MEDICAL OPINION OF YOUR DOCTOR. THIS INFORMATION IS PROVIDED AS AN EDUCATIONAL TOOL ONLY. MY COMMENTARY IS MY OWN OPINION, BASED ON MY OWN RESEARCH AND MY OWN EXPERIENCE. THE QUESTIONS I RAISE ARE MEANT TO BETTER EDUCATE YOU, SO THAT YOU MIGHT HAVE A MORE PRODUCTIVE CONVERSATION WITH YOUR MEDICAL CARE TEAMS.

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″

A DOCTOR A DAY KEEPS THIS STUDY AWAY/Dr. Ty Erickson & Lisa Boozer, CRC, of Rosemark Women Care Specialists in Idaho

Hello Warriors;

As I write what is now the fourth blog, citing “a-doctor-a-day” who is participating and actively recruiting for a study that would implant NEW WOMEN with Coloplast’s Restorelle Direct Fix mesh product, I realize that my blog posts could come across as a “witch hunt” of sorts. This notion couldn’t be further from the truth.

I have a genuine and deep concern for the 900 women who would be participants in this study if it proceeds, and I am trying to engage physicians. I reference fact-based evidence, cite published scientific research, and offer these doctors information about the FDA warnings regarding mesh implant, especially for POP.

If you are a mesh-injured patient, you are keenly aware that many of your physicians ARE NOT AWARE of the FDA warnings but became aware when you, yourself, brought it to your physician’s attention.

My letter to the FDA regarding: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

My letter to the FDA regarding: Restorelle® Mesh Versus Native Tissue Repair for Prolapse

View my letter to the FDA (left) and CLICK HERE TO READ MY BLOG ABOUT IT, citing specific reasons with third-party sourcing. You may want to use some of this information when you contact physicians recruiting for this study.

In addition to my posts here, I am calling and/or emailing EACH doctor/lead researcher personally. I IMPLORE YOU TO DO THE SAME.

I want our community to engage in a conversation with these folks to explain WHY THIS STUDY IS FLAWED IN DESIGN AND IS UNETHICAL.

I AM NOT MERELY “EXPOSING” DOCTORS OR TRYING TO HARM THE REPUTATIONS OF THESE FOLKS. I am trying to start a dialog, so that our community’s voices are heard, and so that these doctors know how large is our community of severely injured people.

To that end, today’s doctor to call/email is:

Dr. Ty Erickson and his colleague Ms. Lisa Boozer, CRC, of Rosemark Women Care Specialists.

Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
Contact: Lisa Boozer, CRC    208-557-2981    lboozer@rosemark.net
Principal Investigator: Ty Erickson, MD, FACOG
Dr. Ty Erickson, a physician actively recruiting patients for the Coloplast Restorelle Direct Fix vs. Native Tissue Repair.

Dr. Ty Erickson, a physician actively recruiting patients for the Coloplast Restorelle Direct Fix vs. Native Tissue Repair at Rosemark Women Care Specialists in Idaho.

As a gentle reminder:

When/if you call, start by listening and asking the doctor/liaison questions. Try to open an honest dialogue about why you think the study has the potential to seriously harm women, and why this harm is PREVENTABLE, since there is already a population of implanted patients to study.

When you call, be as clinical and brief as possible. Our stories are SO PERSONAL and of SUCH DEVASTATION, that we can be tempted to rely on any ear to listen to the horror of our stories.

I am suggesting that you call these physicians in an effort to help the patient population who is being recruited. Lean into your community for social support for your own injuries and for coping with the significant loss of quality of life that you endure.

The goal is making these calls is to INFORM physicians about the PREVENTABLE harm this study will cause. 

Here are some questions you might start your conversation with:

  • You might first start by asking listening. Document his/her answers.
    • WHY, doctor, are you participating in this study?
    • HAVE you seen the research proving mesh is unsafe as a permanent implant?
    • ARE you aware of the adverse reactions of the patients you have formerly implanted? Would you follow up with them and ask how he/she is doing 3+ years after implant?
    • ASK – What’s in it for you doctor? Are you aware of the legal implications?
    • ASK – Are you being personally compensated for this study and in what ways?
    • ARE you aware of the liability you face In federal Bellwether trials, some physicians who’ve testified no longer practice. Are you aware that significant liabilities may be of great future burden to you and your practice?
    • EXPLAIN the reasons you do not want this study to proceed.
    • EXPLAIN to them that your intention is to inform, give he/she more resources and information to have the chance to CHOOSE to halt participation in this study.
    • BUT, if he/she will not take your call seriously (or take your call at all) you will take other actions, like contacting your state’s AG.
    • INFORM he/she that you will use your voice online to dissuade women from becoming patients of their practice.

Below is a list of physicians/facilities I have already contacted. If you have not yet contacted one or more of these physicians, please click on the link for contact information, and please contact them immediately.

If WE do not make our voices heard, who will? We are PLAN B, and there is NO PLAN A.

Dr. Babak Vakili & Jennifer Mann, BSN RN: Delaware’s Christiana Care Health System

Dr. Sherry Thomas/Agoura Hills California

Dr. Arturo Menchaca/Paris Community Hospital of Paris, IL