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

SongbirdSpectrumWC391

“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

EDUCATE YOUR COMMUNITY ABOUT MESH!

Hello Warriors;

It's time to get out and EDUCATE our communities. The media isn't doing it.

It’s time to get out and EDUCATE our communities. The media isn’t doing it.

Today I’m launching an initiative to educate our communities. Following JnJ’s winning verdict yesterday in Ms. Carol Cavness vs. JnJ’s Prosima mesh, I feel it’s imperative that we unite and take action to educate our communities.

I gathered from the reporting and conversations with our community’s “boots on the ground,” that the jury was confused by legalese and terminology, a practice often deliberately used by defense teams to confuse jurors. I wish I could give you first-handle knowledge, but I was not able to attend the trial. However patient advocates, who were in attendance, told me that on Friday, the jury seemed to understand the specifics they were to deliberate; but by Monday, something had changed. The question sent out of the deliberation room on Monday gives us a hint that the jury was confused about foundational definitions like, “Proximate Cause.” Judge Molberg of the 95th district court in Dallas, Texas, reminded the jury in a written statement:

Judge Ken Molberg

Judge Ken Molberg

Proximate cause means a cause which was a substantial factor in bringing about an injury and without such cause the injury would not have occurred. In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company using ordinary care would have foreseen the injury or some similar injury might reasonably result there from.

There may be more than one proximate cause of an injury.

Ordinary Care means the degree of care a medical device manufacturing company or ordinary prudence would use under same or similar circumstances.

If you have answered either question one or two you should redeliberate using the definition I have given you in the supplemental charge because it is a proper legal definition.  It is the only answer I can give you at this time.”

Many of us can attest to mesh injury by Proximate Cause – again, meaning a substantial factor in bringing about an injury and without such cause the injury would not have occurred. It seems simple to understand that, had Ms. Cavness NOT RECEIVED the JnJ Prosima mesh implant, subsequently she would not have been injured by it.

In defense of the jury, these trials are exceedingly technical in nature, as companies defend each product in relation to other very similar products, in an effort to prove that “this mesh” (in this case, the Prosima mesh) was better than any of JnJ’s predecessor mesh products, or that other, safer solutions for her condition, were not available at the time of her implant. Pore size, tensile strength, laser cut vs. mechanically cut mesh – all of this terminology can be overwhelming to learn about in a 2-week trial, as is required of jurors.

Often, the trial is set on-course to be won by one side or the other during the juror-selection process. Jury selection is a joint effort involving the plaintiff’s counsel, the defense council, and the judge. The stated goal is to select jurors who are unbiased towards either the plaintiff or defense. Unfortunately, this process often results in the selection of jurors who actually have less knowledge or education than the average American about the very concepts that will be discussed during trial. One could easily conclude that the selection of jurors who have less knowledge about concepts to be discussed during trial could be a significant bias in itself – in favor of the defense. I don’t know if that is what happened in this case. I just know that the jury asked a very foundational question well into the deliberation process, which arguably, means they may not have understood other foundational concepts well.

My point is: These trials will continue, and we need to do what we can do – what we are able – to do. WE CAN EDUCATE OUR COMMUNITIES. That is something JnJ is doing every single day through advertising, public relations and directly to patients in exam rooms using implanting physicians, who often are not aware of the severe and permanent nature of adverse events resulting from polypropylene mesh implant.

Screen Shot 2015-10-06 at 10.52.10 AMFor example, I wonder how many implanting physicians know about this recently-published article about polypropylene mesh implant in the Journal of Biomedical Materials Research: 

Degradation of polypropylene in vivo: A microscopic analysis of meshes explanted from patients (August 28, 2015).

Or this research article on implant of permanent polyethylene materials: 

Surface modification by plasma etching impairs early vascularization and tissue incorporation of porous polyethylene (Medpor®) implants (September 2015)

Or this research about characteristics of polypropylene in abdominal repairs using mesh:

The influence of mesh topology in the abdominal wall repair process (June 2015)

#TMWF USB Medical Bracelet - in black

#TMWF USB Medical Bracelet – in black

Do you think your urologist, urogynecologist or ob/gyn is a regular reader of the Journal of Biomedical Materials Research? I suggest you ask him/her, and bring the research with you to your appointment on your #TMWF USB Medical Bracelet. 

Courtesy of Dave deBronkart (@ePatientDave), and his study and subsequent article titled,17 years for new medical practices to be adopted, I learned at #MedX 2015 that widely-accepted research by the scientific community, TAKES AN AVERAGE OF 17 YEARS FOR HALF OF DOCTORS to adopt as a treatment option available to their patients! That is unacceptable. That is, in fact, terrifying news.

Average 17 YEARS from discovery to adoption in practice! We don't have that much time!

Average of 17 YEARS from discovery to adoption for HALF of doctors to adopt in practice! 

We simply don’t have that much time.

We can shorten this timeline by educating ourselves, our families, our friends and our neighbors – and yes, even our physicians. 

You may already be making a huge impact, just by telling your story to another person – while waiting in line for a prescription, or at the grocery store, or maybe while on an airplane, or in the waiting room at your doctor’s office. Keep up the good work! It matters! It really does make a difference.

CASE IN POINT: Last year, I shared my family’s story with a Stanford University employee whose mother-in-law was in the Screen Shot 2015-10-06 at 12.27.03 PMprocess of speaking with doctors about mesh implant. Because of that one conversation, a year later, I met that man’s wife at #MedX 2015. I learned that, because of one conversation, and a daughter’s commitment and courage to educate herself; her mother is today healthy, happy, and MESH FREE! She is exercising and enjoying life at a whole new level. We will never know what the outcome of mesh implant would have been; we just know that education changed the course of one family’s decision. And because of that, their matriarch is not injured, not worried about the other adverse events of mesh implant, not destined to become disabled by polypropylene mesh.

If the media won’t educate the public; and the FDA will not remove this harmful device from the market, then WE MUST EDUCATE OUR FELLOW HUMAN BEINGS until the threshold of pressure causes the media, the FDA and/or the general population to take notice of this predatory behavior by the healthcare industry and device manufactures and the medical atrocity that will come to define a generation of families.

Who’s with me?

Sunday Reflections – October 4: Fake Plastic Trees

Almost invariably, I wake up each morning with some song rolling around in my mind. This morning I woke up with Radiohead’sFake Plastic Trees,” in full-on live streaming mode.

This band and song was one of my favorites, back in the day, when pop culture began to be defined by the “Grunge” movement: flannel shirts, ripped jeans and broody-moody song lyrics as musicians returned to a rock sound with their grungy, gritty, back-to-the-roots of rock-n-roll aspirations. Bands like Pearl Jam, The Smashing Pumpkins, Nirvana and Metallica were the sounds that defined my young adult years, a time when most all of us – no matter the generation – begin to relate to music more deeply as we individuate and become more of the person we will be as an adult.

Fake Plastic Trees,” got me to thinking about plastic in general and when we, as a society, decided it was the wonder substance, to be used for everything under the sun. Plastic, as we obviously know, has real limitations. Certainly VERY REAL to all of us in the mesh community. How did our society go from deciding that glass Gatorade bottles were the enemy of our children’s basketball and volleyball courts (OH MY GOSH! The bottle could possibly break, and then could possibly hurt someone!) to “Plastic – It’s the NEW glass!” Where is the societal OUTRAGE over the ways plastic has hurt, maimed, killed, and sickened so many individual people?

The media whipped everyone into a frenzy several years ago over the ubiquitous use of BPA (Bisphenol A), just ONE type of plastic. The pace has slowed, but the use of BPA is still a hot news topic.

BPAbpa_freeRecent Studies State Chemical In Plastic Liquid Containers Contain Tox

“We can’t have our water bottles made with BPA,” they say. “Don’t store food inside BPA-containing tupperware, and don’t you dare commit the unpardonable sin of heating your food in the microwave in these plastic containers with BPA! Down, down with BPA! Kill the enemy!”

Oh, and, by the way, “SAVE THE PLANET! BPA is going to KILL THE PLANET!”

Hysteria ensued, and early-adopting consumers decided they would not go near a plastic product made with a single molecule of BPA. We began to see the marketers respond – labels on everything – “BPA-Free!” they said. We didn’t know what BPA was; we just knew it was REALLY, REALLY BAD, and it was becoming socially unacceptable to be seen in public – with our kids in tow – carrying the ostracizing, made in China, “Non-BPA free” reusable sports bottles.

The social pressure of early adopters changed the social norm of what was the acceptable use of this plastic and what was not.

Now, most every food-grade plastic is “BPA-free,” and the “theys” tell us, THIS PLASTIC (every other plastic polymer, especially Plastic #1, PET or Polyethylene terephthalate) is safe for your baby’s sippy cup, safe for you to drink from during your “Power Yoga” class, safe for the lining of metal cans that house baked beens, baby food and beauty products. But the truth is that BPA and PET are simply two canaries in the coal mine, warning us that plastic isn’t the world’s greatest invention since sliced bread.

Notice in the chart below, BPA is plastic #7 – the most dangerous of plastics – which can interrupt our endocrine systems and attack our balance of hormones, causing all manner of discomfort and illness. Since I found this chart, (unknown source) I’ve seen #9 inside the friendly triangle shape – a black plastic container holding cupcakes I bought. Now, all plastics must be labeled with its commensurate triangular icon and grade/number of plastic. No, the familiar, triangular arrow DOES NOT mean “recyclable.” Usually imprinted on the bottom of any given container, this triangular symbol tells you what kind of plastic you are recycling, eating from, or what kind of plastic is implanted in your body. I bet you didn’t get to turn over the mesh product placed in your body to look at which kind of plastic was being used, or even THAT plastic was being used in your “safe” medical implant at all.

The mesh community’s ENEMY #1 is Plastic #5 – Polypropylene.

Johnson and Johnson, Boston Scientific, Endo/AMS and other medical device manufactures put Plastic #5 – Polypropylene – in the bodies of millions of people for the repair of SUI, POP and/or hernia.

Polypropylene #5 is just two meager steps away from the source of our nationwide outrage – BPA, #7.

BPA - Just the worst off the worst.

BPA – Just the worst of the worst.

HEAR THIS: The PLANET will survive plastic; it is the human beings who live on the planet who will not.

CAN WE UNITE UNDER THAT CREDO?

Can we join forces under a shared goal – environmentalists, politicos of the anti-oil sort, advocates for quality in consumer products, and advocates for quality in medical-grade materials? The oceans and the Earth will adapt and survive. Apparently, it’s the most powerful human institutions that will not adapt, and the humans under their tyranny who will not survive. But in understanding how the social environment and its BPA frenzy CHANGED the socially accepted uses of BPA, we have a blueprint.

We have a more common shared enemy: the misuse of plastic.

All plastic is a petrochemical waste product that became a gold mine for all types of industry.

From toy makers – Remember wooden toys? What was so wrong with them?

To the manufacturers of food storage containers – Remember RUBBERmaid containers and Ball Jars? Rubber and glass are natural substances.

To manufacturers of food and beverage – Remember when Gatorade bottles were glass?

To clothing manufacturers – Our clothing is now largely made from plastic polymers or polymer blends (polyester, acetate, nylon and spandex being some of the most well known). Cotton, wool and denim were working fine, weren’t they? Try to find a pair of pure-denim jeans these days. Good luck, and bring your savings account.

Plastic works well for some uses. After all, it’s durable. It’ll be here for tens of thousands of years according to scientists. Plastic is convenient, disposable and inexpensive, right?

Or is it?

Polypropylene plastic mesh has not been convenient, disposable OR inexpensive for mesh-injured patients. The expense of the use of polypropylene mesh could never even be quantified. The precious injured ones and their families are PRICELESS. The financial and human losses of dignity, freedom, and quality of life FAR exceed even the most attractive legal awards ($73.5M, Salazar v. Boston Scientific).

Maybe our voices will be elevated to BPA-hysteria levels if we can connect with environmentalists; political ideologues, who loathe the oil-producing industry for so many reasons; and hovercraft, Soccer Moms who just want to make sure their children are not being poisoned.

Think about it.

Maybe we’re on to something. Maybe our cause and cries are more similar to those of Beth Terry at My Plastic Free Life than with those of anyone else.

If the healthcare industry and the FDA won’t listen to us, maybe the truly consumer-based industries will listen to us – when we stop giving them permission to make poison with our hard-earned dollars.

fake_plastic_trees

“Fake Plastic Trees”

Her green plastic watering can
For her fake Chinese rubber plant
In the fake plastic earth
That she bought from a rubber man
In a town full of rubber plans
To get rid of itself

It wears her out, it wears her out
It wears her out, it wears her out

She lives with a broken man
A cracked polystyrene man
Who just crumbles and burns
He used to do surgery
For girls in the eighties
But gravity always wins

It wears him out, it wears him out
It wears him out, it wears him out

She looks like the real thing
She tastes like the real thing
My fake plastic love
But I can’t help the feeling
I could blow through the ceiling
If I just turn and run

It wears me out, it wears me out
It wears me out, it wears me out

If I could be who you wanted
If I could be who you wanted all the time

All the time…
All the time…

 More about BPA:

The Baltimore Sun – October 4, 2015

ScienceAlert.com – September 29, 2015

Scientific American – September 25, 2015

Stanford University News – September 23, 2015

TIME Magazine – June 3, 2015

Let’s support Carol Caveness as she takes on JnJ/Ethicon’s Prosima Mesh!

The layout of a typical U.S. CourtroomHello Warriors;

I understand how hard it might be to even imagine getting out… but IF YOU CAN, please try to attend one or two days of Carol Caveness v. Ethicon’s Prosima. Remember, Prosimia was taken OFF THE MARKET. How will #JnJ defend from that position?

NEED TO KNOWS BEFORE YOU GO!

1) Read below article from Law360* about the details of the case.

2) Read refresher blog on how to attend court with confidence as a citizen observer.

3) Directions to the 95th District Court in downtown Dallas, Judge Molberg Presiding

J&J’s Ethicon Unit Defends Pelvic Mesh In Dallas Trial

By Jess Davis
Law360, Dallas (September 22, 2015, 9:29 PM ET) — Johnson & Johnson’s Ethicon Inc. unit told a Texas state court jury on Tuesday it is not responsible for injuries sustained by a woman who had the company’s Prosima pelvic mesh implant, in the country’s first trial involving the Gynecare Prosima Pelvic Floor Repair System.

In opening statements Tuesday afternoon, Ethicon told Dallas County District Court jurors that plaintiff Carol Cavness is suing the company for injuries its product did not cause, and defended the safety of its device. Cavness is seeking unspecified damages, including a punitive award, against Ethicon, which she says pushed an unsafe and defectively designed product to market despite knowing it had a high risk of complications like the years of pain she has been suffering.

Cavness’ attorney, David Matthews of Matthews & Associates, told jurors they would be the first in the country to see evidence of Ethicon’s internal development documents for the Prosima device and the warnings he said the company’s own doctors and consultants issued about the safety risks of the device. Excerpts from the documents he showed during the opening described Prosima as a “reckless product,” said “Prosima is not needed” and said the doctors had “low confidence in the data.”

“This company had multiple opportunities to stop a product they knew was dangerous but they didn’t because they pushed it for profits,” Matthews said.

He said Ethicon was told the Prosima’s plastic was too stiff for the vagina and that it was an unnecessary device because an existing surgical technique was available that achieved the same result with lower risk.

Cavness, an aircraft mechanic, was lifting a heavy object at work in April 2012 when she felt a groin strain, Matthews said. Within days, a doctor diagnosed her with pelvic organ prolapse and she had surgery to repair the prolapse with a Prosima implant, along with several other procedures.

Cavness filed suit two years after the surgery and claims that within a month of the Prosima implant, she began to have severe pain and difficulty walking. In the years since, she has had continued pain, chronic inflammation and massive scarring in the pelvis, makes weekly trips to her doctor and has developed depression and anxiety, Matthews told jurors.

Ethicon attorney Kat Gallagher of Beck Redden LLP largely steered clear of the safety of the Prosima device in her opening statement, instead concentrating on Cavness’ medical history and telling jurors the pain Cavness suffered was never caused by the Prosima mesh.

Gallagher said the pain was likely caused by “pelvic floor disorder,” a disease she was diagnosed with in May by a specialist who Cavness had not previously seen. Gallagher said an expert witness will testify that the pelvic floor disorder was triggered by the 2012 injury Cavness suffered at work.

She told jurors that though it took years to discover and that the company empathized with the pain Cavness had suffered, it was the pelvic floor disorder and not the Prosima mesh that caused her so much pain.

Gallagher did address Ethicon’s decision to pull the Prosima and other pelvic mesh devices from the market, but denied it was because they were unsafe. She said that health notices issued by the FDA about pelvic mesh scared women and made doctors fear litigation, translating to plummeting sales of the Prosima device.

Low sales figures caused by negative publicity about pelvic mesh, combined with the $4 million to $5 million cost of performing a safety study, is what made Ethicon pull the product, she said.

“This was a business decision by Ethicon in the face of what was happening,” Gallagher said. “A business decision.”

The first witness in the case will take the stand Wednesday morning.

Cavness is represented by Bill Blankenship of William F. Blankenship III PC, Tim Goss and Rich Freese of Freese & Goss PLLC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.

Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kat Gallagher of Beck Redden LLP. The doctor is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.

The case is Cavness v. Kowalczyk et al., case number DC-14-04220, in the 95th District Court of Dallas County, Texas.

Judge Ken Molberg, seeking reelection as a state judge, for the 95th District Court in Texas

Judge Ken Molberg, state judge, for the 95th District Court in Texas

Read Chapter 2 and Chapter 3: Steven Brill’s “America’s Most Loved Lawbreaker”

Writer and Journalist, Mr. Steven Brill

Writer and Journalist, Mr. Steven Brill

Johnson and Johnson has been put under the powerful microscope of Mr. Steven Brill, an author, speaker and graduate of Yale College (English major) and Yale College of law. If you want to know how the mesh massacre happened, his 15-Chapter “DocuSerial” will give you a good blue print.

He is posting one chapter per day on the Huffington Post’s Highline. Be sure to read yesterday’s, Chapter 2, and also today’s Chapter 3. Audio is available for every chapter as well! Here are my thoughts on his introductory chapter: CHAPTER ONE: You say “Credo,” I say “Crudo!”

What do you think about Mr. Brill’s “DoucSerial?”

Chapter 3: Sales Over Science

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Chapter 2: Blowing Past The Label

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