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

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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.

Sunday Reflections from Another Patient

Hello Warriors;

I have the great pleasure to share the thoughts of my friend, who is also a patient, and patient advocate.

Screen Shot 2016-04-10 at 8.21.52 AMMrs. Linda Radach and I met at the USA Patient Advocate Network workshop in D.C. last year, underwritten by the National Center for Health Research and the Patient-Centered Outcomes Research Institute (PCORI). Screen Shot 2016-04-10 at 8.21.37 AM

You know when you have the feeling that you’ve known someone forever, but you’ve only just met? That is the way I feel about Linda. Our friendship took mere hours to bloom, partly, I suspect, because she is a type of fertilizer for the soul.

Linda was injured by a failed hip implant, and she has suffered greatly as a result. Still, though her spirit is weary at times, she leans upon her faith in Christ and the Lord of the Bible for wisdom and strength. She has allowed me to share her faith and source of healing in a poem she wrote, Captured Free.

Scripture inspires her life and her writings. She has offered a collection of her thoughts and expressions of her pain in scripture here: Healing Worship – Lenten Study Notes. As a true believer, she runs further into the wisdom of God, so freely given to all, even in her suffering. I hope her words bring you comfort and serve as a salve for your aching soul. I know the many conversations we’ve had were powerful for me and healed some of the broken pieces in my soul. In the realm of human suffering, we are all alike. We all experience it in different ways, but suffering can bring those who sing, in spite of their trials, together – to make a beautiful noise to the Lord who hears our cries.

Here is a beautiful song to listen to, as you read Linda’s words and meditate on them.

Lord, Hear My Prayer

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“Captured Free”

 

Songbird sits, quiet and still

No warble or whistle, no song or trill

Once free to fly, with songs soaring high

On the perch where she sits

Her soul wooden and dry

 

The view from her cage – dark and drear

No light or shadow, only shades of fear

Dreams shattered

Heart tattered

Pain has silenced her praise

 

There must be a way to regain her song

But night after night the silence grows long

Freedom and joy – mere memories now

Still, faint though it be, hope wonders how

A melody stirs in the darkness

 

Slowly light dawns upon the small locked cage

Revealing the way known to the wise and the sage

In this new morning she would take a chance

To free her soul and rejoin the dance

Humming the melody of the darkness

 

Imperceptible at first, the cage doors released

Giving flight to her wings as imprisonment ceased.

Tearful, yet growing stronger, her song she raised

Offering up a sacrifice of praise

Giving thanks for the limitations of her life in the cage.

 

By Linda J. L. Radach

November, 2012

 

Look for these beautiful songbirds, and remember the Lord’s word.

He cares for you.

“Indeed, the very hairs of your head are all numbered. Don’t be afraid; you are worth more than many sparrows”. – Luke 12:7

“Even the sparrow has found a home, and the swallow a nest for herself, where she may have her young— a place near your altar, Lord Almighty, my King and my God.” – Psalm 84:3

bird-poster

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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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

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

Hello Warriors;

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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!

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

5 Important Reasons to Reserve YOUR FREE #TMWF Medical USB Bracelet

Hello Warriors;

Your_8GIG_Medical_USB_BraceletYou may have read that #TMWF is donating 150 #TMWF MEDICAL USB BRACELETS! These 8G (8 Gigabyte) wearable USBs ensure you have all your encrypted medical records in YOUR hands (or around your wrist!) at all times.

Reserve yours today by filling out the form at the bottom of this blog post from last week: #TMWF – OUR BIG FAT GEEK GIVEAWAY!

You may also be thinking that the government’s mandatory implementation of “Electronic Health Records” (EHR) has made it easier for your doctor to access important data for consideration in your treatment. If you made that common and seemingly-obvious conclusion, you would be wrong. And you are certainly NOT in the minority. Most of your doctors agree with you!

In contrast, the advent and mandate of the EHR, especially in its current, initial phase, has created extra work for many healthcare professionals as they often “double document” information using a hybrid of paper-n-pen plus technology. Migration of so many institutions to a new workflow process has proven more difficult than many anticipated. . . which brings me to my point.

I came across a jewel today, courtesy of spōk℠. According to the company’s website, spōk℠ is “a leader in critical communications for healthcare, government, public safety, and other industries.”

Screen Shot 2015-10-13 at 2.47.19 PMThe company released a report today titled, “BYOD TRENDS IN HEALTHCARE: AN INDUSTRY SNAPSHOT.” (BYOD=Bring. Your. Own. Device. – computer, smartphone, tablet, etc.). The report surveyed more than 450 U.S. hospitals to draw some conclusions about the healthcare industry’s use of personal devices for work purposes.

Download the spōk℠ report HERE, or jump to my Top 5 Takeaways (below): 


  1. 73% of the 450 organizations surveyed allow some form of BYOD. This high percentage likely means that your physician or an administrator has use of a “hospital-approved” computer with a USB drive. If your physician balks the first time you try to share info from your #TMWF USB, keep pushing – even citing this reference material if necessary. You should be able to update your own medical file with information that is necessary for consideration in your treatment.
  2. 91% of physicians and 79% of administrators are “allowed to participate” in their institution’s BYOD program. Again, if the doctor says, “No, I can’t take your information,” ask an administrator instead.
  3. 52% on institutions allow a BYOD environment for ease of communication among members of a care team. 35% allow a BYOD environment because they want greater access to patient information. With your #TMWF Medical USB Bracelet, you’re enabling your care team to access the information they want, and your #TMWF USB easily enables transfer of information from your device to theirs via a very widely-adopted technology: The USB Drive.
  4. Of the hospitals who do not currently allow a BYOD environment, 35% report that a BYOD program is a “future initiative” for the hospital. Just tell them you’re helping them to be ahead of the curve!
  5. Summary: Don’t stop at one, “No – we don’t allow that.”

YOUR #TMWF MEDICAL USB fits right in with the current hybrid system of electronic and paper data. 

Entrepreneurs have developed apps and softwares targeted to the personal healthcare professional which attempt, and often succeed, at improving workflow and communication across care teams, and as a result, patient outcomes. The mammoth industry we call “Healthcare” is struggling to keep protected health information (PHI) secure while allowing professionals to use these emerging technologies from/on their personal devices.

Hospitals and large practices don’t quite know what to do with the problem of allowing use of personal devices in tandem with their long-standing processes for communication and documentation between healthcare professionals and with patients. In conclusion, it’s likely that your physician has access to his own laptop or computer at his/her workplace. If your physician really wants to work as a team with you, he/she will adopt the attitude of “Where there’s a will; there’s a way.” And if your physician doesn’t adopt that attitude, I suggest you find another physician.

In the meantime, you’ll fit right in to the data-driven migration with your #TMWF Medical USB Bracelet. Order yours by filling out the form at the bottom of this blog post: #TMWF – OUR BIG FAT GEEK GIVEAWAY!