12 Days of Christmas: The Mesh Warrior’s Guide to Handling the Holidays

My blog this week over at Baron and Budd’s site: 12 Days of Christmas: The Mesh Warrior’s Guide to Handling the Holidays.

A Christmas Playlist & The Christmas Pickle!

Hi Angels;

What kind of Christmas music do you like? Do you like it at all? It can be too cheesy for some, and many songs are silly to be sure! Nonetheless, I can easily put that aside this time of year. In fact, I even kinda like it. Music is so powerful. Like a long-forgotten scent, it can instantly transport us to another moment in time. Which songs do that for you?

I’m quite sentimental when it comes to Christmas in general, and Christmas music for sure. I enjoy relishing in the memories of the traditions of my family of origin, including those of my now deceased maternal grandfather and paternal grandmother. Here is a playlist for you to enjoy if you like traditional Christmas music like I do, mostly Nat King Cole, Frank Sinatra, gospel and the like.

https://soundcloud.com/aaron-l-johnson-horton/sets/tmws-christmas-playlist

Nat & Frank - Who sings your favorite Christmas tunes?

Nat & Frank – Who sings your favorite Christmas tunes?https://soundcloud.com/aaron-l-johnson-horton/sets/tmws-christmas-playlist

My grandfather loved the music of Jim Reeves, and I remember the song “Dancing the Christmas Polka,” played every Christmas, more times early and OFTEN! I could tell then that it was a really old and cheesy song by the way my parents reacted when Granddad played the song. But to me it was a very funny song, and my sister and I laughed at the word “Polka.” I wondered, “How do you dance the Christmas Polka? How can I dance the Christmas Polka?” It sounded silly and fun. I never thought to ask the question aloud. It made my grandfather smile, and sometimes sing and dance with a silly grin while raising his eyebrows up and down. He was otherwise a very stoic man, so I liked when he put on Jim Reeves. Reeves’ music seemed to transform my granddad into an animated version of himself, full of the magic of Christmas too – just like me.

We called my paternal grandmother “Honey,” and she loved to cook, and boy was she good at it! My Dad and sister got that gene, and I just pretend I did, usually being a faithful “sous chef” during holiday gatherings. My Honey loved my sister and I as if we were perfect little porcelain dolls. She loved to dress us up and treat us like little baby angels. She also loved to decorate for Christmas. She always used her fine China, and even on the wages of a secretary, somehow the table looked as if it had been prepared for royalty. She lived for holiday gatherings. I miss her. I use her china now.

german-christmas-pyramid-wooden-candle-powered-carousel-xl

German Christmas Carousel

My favorite decoration at Honey’s was a very small carousel, made of Balsam wood, which had its distinct location every year on the formal dining room coffee table. It had small candles, which when lit, caused the windmill atop to whirl around almost instantly. Its animation by fire was just another sweet slice of Christmas magic and miracles at her house. How did it work? As soon as I gave the obligatory kisses and hugs, I always checked to make sure my favorite magical decoration was still there. It always was.

The Christmas Pickle!

The Christmas Pickle!

In my adulthood I found a fun tradition online many years ago, and began the tradition of  “The Christmas Pickle.” This is a really fun one for kids!

 

Tell me what some of YOUR FAVORITE songs, memories and traditions are. Tell me about your favorite Christmas recipes. Together, let’s celebrate the good stuff in life and celebrate the Good News of Christmas. We may have been brought together by the mesh mess in our lives, but my prayer this Christmas is that what holds us together is much stronger than plastic. I pray that the bonds of human love, friendship, compassion, forgiveness, and empathy for one another is what will overcome all in the end.

Merry Christmas & Happy Hanukkah!

Aaron

The light shines in the darkness, and the darkness has not overcome it. – John 1:5

 

NEW MESH PRODUCT CLEARED THROUGH FDA 510k PROCESS!

Speak up!

Speak up!

MORE HERE: http://tinyurl.com/ozm6fd4 

CONTACT THE FDA AND 
HOLD THEM RESPONSIBLE!
Here is the link to the FDA's Summary of approval, citing "substantial equivalence."
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K141560.pdf


FDA MEDWATCH:
https://www.accessdata.fda.gov/scripts/medwatch/
Report ANY and ALL Adverse Events (negative side effects/symptoms) to the FDA.

Report ANY and ALL Adverse Events (negative side effects/symptoms) to the FDA.









DEVICE: 
Parietex Monofilament Polyester Mesh 
(new name: Parietex Lightweight Mesh)
Parietex Composite Mono PM Mesh 
(new name: Parietex Composite Parastomal Mesh)
Parietex Composite Ventral Patch
Symbotex Composite Mesh

SOFRADIM PRODUCTION             
ATTN: Eric  Jague               
116 AVENUE DU FORMANS           
TREVOUX  FR 01600
510(k) NO: K142908(Special)
PHONE NO : 33 474 089000 
SE DECISION MADE: 14-NOV-14
510(k) SUMMARY AVAILABLE FROM FDA

Post a picture of your Christmas Tree!

CHRISTMAS TREE PICTURES

Take a snapshot and share! Here is mine. Since I’m not at home, it’s a very Texican Christmas indeed!

Do you have your shopping done? Don’t forget to peruse our products at The Yes M.A.M. Market for an injured loved one in your life. I am very proud of the quality of these products and believe they will build HOPE and UNITE our community.

Merry early Christmas!

My "Texican" Christmas Tree!

My “Texican” Christmas Tree!

#TMWF’s NEW “Yes M.A.M. Market!” just in time for gift giving!

#TMWF’s NEW “Yes M.A.M. Market!” just in time for gift giving!

#TMWF’s NEW “Yes M.A.M. Market!” just in time for gift giving!.

#TMWF’s NEW “Yes M.A.M. Market!” just in time for gift giving!

Hello Mesh Angels;

We at #TMWF are so excited to launch our e-store TODAY, December 1, 2014! Here is the link to our NEW “Yes M.A.M. Market!” e-store! Wow, a store just for YOU!

https://yes-m-a-m.myshopify.com/collections/all

Give the gift of HOPE, HELP and progress towards HEALING. Visit tmwfoundation.org and our new "Yes M.A.M. Market!" estore.

Give the gift of HOPE, HELP and progress towards HEALING. Visit tmwfoundation.org and our new “Yes M.A.M. Market!” estore.

The store is also accessible via the foundation’s website: www.tmwfoundation.org. Just click on “Yes M.A.M. Market!”

100% of the proceeds from each of the #TMWF Awareness items go right back into The Foundation so that we can continue to layer in more programs and more of our MISSION | VISION | and VALUES as the foundation grows. As we grow in funding, we are able to grow in the services we’re able to provide for the mesh injured and their families!

The “Yes M.A.M. Market” will be part of what helps us fulfill our monthly financial obligations, so that we are not solely reliant on donations and the continued support of sponsorships and fundraisers. We will still need traditional fundraising efforts, but the e-store will help raise awareness and keep us solvent.

Peace on Earth; Goodwill Towards Men

Peace on Earth; Goodwill Towards Men

You will see more items added to the store as we are able to buy more inventory. In the meantime, please check out what we’ve created with our mesh-injured loved ones in mind! We’ve thought about everything from very creative and stylish “#TMWF Awareness bracelets” to “Hospital Helpers,” a line of cross body bags for injured patients going into surgery.

We welcome your suggestions, product ideas, and feedback on the products you buy

Merry Christmas and Happy Hanakkuh!

Merry Christmas and Happy Hanakkuh!

for yourself and/or others. It’s our hope that the holiday season will deplete our current inventory, so that going into 2015, we have a great springboard to delve more into the help we’d like to provide and the programs we have planned to launch next year!

We continue to EDUCATE | ADVOCATE | and BUILD COMMUNITY as the core of who we are as an organization, and the pillars of our Mission Statement. Thank you for being part of our community, and part of the solution to create a customer-centric healthcare system. After all, we are the consumers who pay in ways we should, and in PREVENTABLE WAYS – ways that we certainly never should have – MEDICAL HARM that we paid for with our dollars and with our lives, and that we continue to pay for after we’ve been egregiously harmed by a healthcare system we believed was trustworthy.

At #TMWF, we believe the more we HELP, the more we HOPE and the more we advance towards HEALING as a “Family of Chance.”

Much love to you and your family this holiday season, and as your friends consider where they might spend their charitable dollars this giving season, please ask them to consider helping the ONLY NON-PROFIT that exists solely to help you, the mesh-injured patients and your families.

Thank you for being a part of our growing community!

Your humble servant warrior,

Aaron Horton/The Mesh Warrior

PART II: GREEK MYTHOLOGY and A MODERN DAY RENAISSANCE MAN – Dr. Dionysios Veronikis

PART II: GREEK MYTHOLOGY and A MODERN DAY RENAISSANCE MAN  – Dr. Dionysios Veronikis

 An open-source article bylined by The Mesh Warrior

and contributed to by his patients

November 26, 2014

_______≈_______

Dr. Veronikis

Dr. Veronikis

We begin Part II of the II-Part Interview with Dr. Veronikis where we left off, with this quote by Dr. V:

Third Edition, “Vaginal Surgery,” by David H. Nichols and Clyde L. Randall

“Dr. Nichols taught me how to do slings.”

 

TO MESH OR NOT TO MESH,

THAT IS ALWAYS THE QUESTION

After he runs through his list of mentors and/or collegues, Dr. Veronikis rapidly lists his use of differing protocols for repair of POP and/or SUI, some using organic material or the body’s own material, some using polymers, INCLUDING SYNTHETIC POLYPROPYLENE MESH.

YES, DR. V STILL USES MESH.

Specifically, he lists these procedures and products by name:

  • Fascia Lata Sling

(Source added by author: http://emedicine.medscape.com/article/447951-overview)

  • Abdominal Fascia Lata Sling

(Source added by author: http://www.mayoclinic.org/diseases-conditions/urinary-incontinence/in-depth/urinary-incontinence-surgery/art-20046858)

  • Mersilene Mesh

(Source added by author: http://www.ecatalog.ethicon.com/hernia-repair/view/mersilene-mesh)

  • Polyetheline Synthetic Sling

(Source added by author, Google Scholar: http://scholar.google.com/scholar?q=polyethylene+synthetic+polymer&hl=en&as_sdt=0&as_vis=1&oi=scholart&sa=X&ei=MERpVOvqIZPksASOhoKACg&ved=0CB0QgQMwAA)

  • Polyethylene Terephthalate

(Source added by author: http://www.britannica.com/EBchecked/topic/468536/polyethylene-terephthalate-PET-or-PETE)

Dr. V. makes reference to studies done by others, some I recognize, as they are often cited in the courtroom by both plaintiff’s and defense attorneys (specifically the now-infamous  Ulumsten study). He’s still doling out the information as if throwing tennis balls for me to catch in rapid succession, and I am grabbing them all out of the sky somehow in a juggling act of words and phrases. His speech is an impassioned rant of sorts, and finally, this statement:

“If they aren’t slings, they’re swings.”

Dr. Veronikis punctuates his list with a sentence.

 

FROM SLINGS TO SWINGS

Dr. V. continues:

“A Mersilene Sling could give us enough material to suture the sling to the abdominal fascia, so these things fail the least. When we are doing abdominal slings, that’s not enough material so you have to attach a suture onto it. “

He stops to ask me a question, as if teacher to student,

“Aaron, think of a swing, where the rubber seat attaches to two chains and attaches to the bar at the top. When the swing breaks, where do you think that happens?”

I answer, “I would think where the rubber seat connects to the metal chain.”

“Yes,” he says, “You are a very smart woman.” I actually said, “Thank you. I know that.” Not sure where that came from, but Audrey Hepburn once said, “You know you have become a lady when you’re able to graciously accept a compliment.” Not sure I was so gracious, but I guess I felt the question to be condescending. It seems obvious to me, like common sense, basic physics. I’m sure he was trying to teach me with good intentions, because he’s a teaching physician, so I think that was a bit snappish on my part.

Anyway, I am trying to keep up with him, because the question I asked originally was:

“When and how did you first learn about mesh?” And what was your initial reaction? How did you think through the new procedure and device?”

. . .  and I’m still waiting for the answer. We are now well into an hour of our conversation, and still I’ve not found a succinct answer to my first question amidst this list of connections and colleagues; credentials; products; procedures and polymers; or even buried somewhere in his hasty pace – quite rapid indeed.

Nonetheless, I appreciate his thorough education. It is a very good base education for all of us. I am appreciative of his time in this regard and I gave my full attention to every word he said, though, at this point, I’m wondering if he’s trying to front-run me so I don’t capture all the info, or if he’s just pressed for time. I would think if it were the latter, he would just answer the question, but still he continues at this rapid pace, talking about history. No matter; I like history, so I’m still intently listening and typing away.

He continues, “In 1994 we were already redoing and undoing procedures. They’d [the patient] then either get a Fascia Lata Sling or a Mersilene Sling. The ideal approach then was Rectus Fascia Retropublic, to the abdominal ‘swing,’ where the “chain” goes to the pole all the way around,” (this a reference to his earlier analogy of a rubber swing hanging from two chains, where the rubber seat connects to the metal chains, as in a swing set). . . . “From the poll, to underneath the swing to where the swing connects to the rubber. Suture attached to the sling, and it will almost always fail.”

Veronikis cites a “98-99% cure rate for SUI, with the synthetic Mersilene Sling,” (petro-based polymer sling, produced by Johnson & Johnson). This fact pulled from the mid 1990s he says.

“[As doctors] We’re trained to care about people. We view medicine as a calling, not a business.” This sentence seems to conclude the answer to the question, which I feel clearly seemed to “set him off” somehow.

ETHICON COMES TO VERONIKIS FOR AN EDUCATION ABOUT SLINGS

. . . and, finally, the answer to my first question!

The first approach by Ethicon came while Veronikis was still a fellow in 1997 and again in late 1998 and 1999 in St. Louis at his practice, he says. The salesman’s name was Will Irby. When Mr. Irby came to visit, Dr. V. listened to him:

“I base my decision on common sense and the philosophy of ‘should I consider this?’ I told him [Mr. Irby] that his procedure is flawed. There is no way they [J&J] put something together that has common sense.”

Dr. Veronikis makes an interesting point, and he makes the point as if it’s common knowledge. “They are engineers and scientists, not doctors,” when he refers to the developers of the device Mr. Irby is pitching to him. This writer would have thought a team of doctors would be working together with engineers and scientists in the development process. Now, that IS new information to me. It seems like that collaboration amongst these disciplines would be as obvious as the collaboration between an architect with a builder to supply a client with a custom-built-to-spec home.

Anyhow, the visit(s) from Ethicon also include a man named Brad Patel at some point. Dr. Veronikis tells them, “You didn’t go to the experts to ask these questions…. Why? You put this in the hands of untrained surgeons.” And then Dr. V asks the Ethicon team to leave his office. At hearing Dr. V say this, I feel a sense of hope: He asked them “Why?” At least now I know that someone in a position of authority asked someone else in a position of authority the simple question, “Why?” and asked that person a long, long time ago. In my opinion, so many more doctors should have acted as Dr. V did. When I was watching the the Linda Batiste vs. Ethicon trial, I watched Dr. Tom Margolis testify. His response to these sales reps was the same. In my own words, on the stand during Linda’s trial, Dr. Margolis testified that he basically said, “What are you people nuts?! I’m not putting this horrible stuff in women!”

And Dr. Margolis made the decision from the beginning, to never put ANY polypropylene mesh in women, not even once, as he testified.

Dr. Veronikis tells me he himself went to Ethicon’s training courses in Cincinnati. He was trained by AMS in Chicago for the Apogee & Perigee systems. He was trained by Avalta in the Twin Cities (Minneapolis/St. Paul) and attended training seminars in 2005 for Bard and was sought out by the VP of C.R. Bard.

He tells me he once confronted the president of J&J saying, “You all are engineers, not doctors,” regarding the Prolift product which he said has “way too much mesh.”

Dr. V continued, “Vaginas are supposed to be soft and pliable – ‘Yiasoo!’” he says. I giggle and ask if that’s a Greek colloquialism. He chuckles briefly and keeps talking.

“TVT (referring to Ethicon’s TVT Team) came and talked to us in Boston.” He says he stopped getting invited to trainings. The reps would come by and give him the DVDs. “Prolift was the most radical,” according to Dr. V.

DOES DR. V STILL USE MESH?

In a word, “Yes.”

In a whole lot more words, Dr. V. told me he’s performed more than 10,000 procedures using polypropylene slings. The Suburethraeal Retropubic Sling is a procedure that uses mesh, and it’s my experience that most established, well-experienced OB/GYNS or Urogynecologists use the mesh for this specific procedure and maintain that the procedure and products they use are safe and effective in the hands of a skilled surgeon (themselves). When Dr. V. told me he’d performed approximately 10,000 polypropylene slings, he stressed that he used Uritex® (made by C.R. Bard) but that the company “got rid of that.”

Bard's Align Mesh Product

Bard’s Align® Mesh Product

 

He switched to a product called Align® (Link to PDF Brochure), also made by C.R. Bard. When Bard came out with that product, he began putting in about 550 slings per year, but he says he never liked it. He tried it for a month or so and saw that too many patients were having problems, so he stopped using it.

 

Caldera Desara® Mesh Product

Caldera Desara Mesh Product

 

 

Dr. Veronikis now performs approximately 700 slings/year using Caldera Desara® (Link to PDF Brochure) for SUI and C.R. Bard’s Alyte® for Sacral Copoplexy, a procedure for Pelvic Organ Prolapse or POP, as it’s most often called (Source added by author: http://www.atlasofpelvicsurgery.com/2VaginalandUrethra/9SacralColpoplexy/chap2sec9.html).

Again, this practice to correct vaginal prolapse using mesh is NOT UNCOMMON among OB/GYNs and other female pelvic health specialists and surgeons. As one who believes there HAS NEVER BEEN ADEQUATE SCIENTIFIC STUDY DONE ON THE PERMANENT PLACEMENT OF PETRO-BASED SYNTHETIC, POLYPROPYLENE IN HUMANS, I respectfully disagree with Dr. V’s continued use of mesh. My role in this MESH MESS is to educate patients so they can make their own decisions, with Dr. V. or whichever doctor any patient might choose to treat SUI or POP. One’s own health and other factors like co-morbidities make a one-size-fits-all recommendation impossible and irresponsible. I would not choose for myself to ever have synthetic, petro-based polypropylene implanted in me anywhere, ever. In my experience, the mesh “cure” has proven to be worse than the original problems of SUI and/or POP. That’s my decision for myself.

In fact, my own OB/GYN’s practice in Dallas, Women’s Health Central, uses mesh for the Suburethraeal Retropubic Sling procedure. I called my doctor, Dr. Francesca Perugini, whom I have adored for many years. I asked her to call me personally by leaving a message with her nurse. She returned my call within the same week, and I told her my family’s problems (and that of many other women and men) with the mesh and spoke about the scientific papers and FDA warnings I could share with her. She became a bit exasperated and hurried the conversation. I told her, regretfully, that I would not be able to come back as her patient, after many years of loyalty, because she was choosing not to take my comments and the research I offered seriously enough to read or even entertain the notion of a “conversation” about it, like one where we might sit in her office. Is that kind of appointment even billable? I don’t know. So, that is how I held my doctor accountable. I do the same with the mesh manufacturers like Johnson & Johnson. I hold them accountable where I can and where it matters to them most – with the use of my dollars. I do not buy their products, not their Q-tips, not their air fresheners, not their cleaning products, not their hair or skin care products- none of it. I believe when it comes to companies and service providers, the only way we can hold them accountable is to take our hard-earned dollars away from them, use them with companies who do actually honor customers and families. If we do not like the way they behave in the marketplace, which is RUN BY THE CUSTOMER, and if we can gain access to being informed consumers, then we can choose to invoke our own punitive damages, not awarding them our dollars. I know this is difficult to do with many of the manufacturers since they are mainly Business-to-Business service providers, not Business-to-Consumer service providers, but you can experiment with informing yourself about everything J&J makes. It’s a good place to start to take back some of your own power in this equation.

 VERONIKIS’ PATIENTS WEIGH IN

“ANONYMOUS”

A Patient Treated by Dr. Veronikis:

“He was my surgeon and used mesh. It eroded into my bladder but he was doing what he could to repair something no other surgeon would touch. I now have a permanent urinary diversion. I hold noting against him.”

TMW:

When I tell the doctor about the patient above (who approached me without using her name). He said, “She is the only one.” He asked if I would relay a message to her, asking that I invite her to email him.

MY conversation with Dr. V has been well over an hour, close to two now. I haven’t even asked the second question on my list!

TMW:

“How has your opinion about polypropylene mesh changed after the last many years and after removing it?”

DR. V.:

“Hasn’t changed much from my initial perception. The least amount possible [of mesh] if you have to use it, placed precisely by high-volume surgeons who are trained. Not all polypropylene is created the same.”

Dr. V. concedes he has become aware of some immune issues and says he is still learning about that. He says he’s always believed the least amount of material in the right spot is the best option.

TMW:

“Do you have the additional three years of urogynecological surgical education that, for example, Dr. Michael Hibner has? Do you think it’s necessary?”

DR. V.:

“He [Dr. Hibner] went away for six months, to think about things. “Dr. Hibner wants them [patients] to know how much mesh is left in them.”

Dr. Hibner has gone to his hospital administrator and lobbied, pleading “Please do not allow mesh kits in this hospital.” The same is true for Dr. Veronikis. In the case of Dr. V’s lobby, his actions created a credentialing process. Dr. Veronikis sits on the credentialing board for Mercy Hospital in St. Louis and considers POP repair using POP Kits with mesh to be an experimental procedure. He sits on the board that certifies doctors in female pelvic medicine and reconstructive surgery.

The admirable actions by Dr. Veronikis took the POP Kits off the table at Mercy Hospital in St. Louis. As a result of his actions, POP Kits cannot be used in his hospital at all now, by any doctor with privileges there. That is a demonstration of his care and character as a physician. He is in a position of authority, and he used his position within his sphere of influence to make things better. If we’d only had more people on the manufacturers’ side of the equation making small steps towards the right direction, things would probably be quite different.

According to Dr. V., “Any overseeing medical board will not tell any hospital what they can or cannot do in their credentialing, Dr. V informs me. Boards use the ‘Practice Bulletin’ – as the official published communication, which creates the acceptable “Standard of Practice.”

In the experience of this patient advocate, this “Standard of Practice” is a code most doctors follow rigorously, as it comes with the support of their credentialing authority, in this case, The American Board of Obstetrics & Gynecology. The many and varied medical boards across the nation are very, very powerful, and doctors pay a fee to belong to the boards and retain their credentials. For purposes of discussion and elucidation only, you can think of any medical board as a “doctors’ union” of sorts, just as an easy comparison. If a doctor is following his or her credentialing board’s “Standard of Practice,” then in my experience, the doctor does not feel it necessary to question that standard, for example by questioning the still-sanctioned Suburethraeal Retropubic Sling procedure, which can and does use any number of mesh/synthetic polymers. I believe it also adds to the psychological belief held by many doctors that they need not do or accept further study or research on any procedure or device, because if it’s sanctioned by a “Practice Bulletin” than research could only serve to strengthen the view that is already held, or conversely, present unanswerable questions which cannot be answered by a “Practice Bulletin.” I assume that could be an uncomfortable place for a doctor to be in – go along with the flow, or create a decision point, a fork in the road between what the doctor may think is the best course of action for any treatment and what the accepted “Practice Bulletin” says is best. It’s at least a good question to offer you, my reader, in my opinion.

Whether a product is “safe” or “effective” beyond any board’s “Standard of Practice” is at the discretion of any singular doctor or hospital alone to decide. As in the case of Dr. Veronikis, any doctor can approach his/her employer and appeal to them that a specific procedure or product used hospital or practice wide is an issue. But again, to do so, can be out of alignment with the accepted boards “Practice Bulletin,” which remember defines the “Standard of Care” for the bulk of doctors. Doctors making decisions outside the “Practice Bulletin” are taking some measure of risk to do so.

There are NO stupid questions! Especially when it comes to demanding answers from your doctor about your treatments.

There are NO stupid questions! Especially when it comes to demanding answers from your doctor about your treatments.

So, the battle for us, as patients and patient advocates, is to know the right questions to ask and to try our best to find out by any means possible:

1) Does our doctor think hard enough about the scientific and engineering questions like if the use of polymers is appropriate in humans at all?

  1. 2) What is the quality and quantity of research available and has my doctor reviewed it?
  2. 3) Was the research conducted according to solid scientific principles (Tier 1 Eithics) and using a diverse population that all demographics including both genders?

It seems to me that this level of participation and education regarding device manufacture and outcomes of procedures is knowledge a bit too in depth to require of any patient. These are complex issues, rigorously debated topics, even amongst scientists, physicians, and now attorneys. To require this amount of knowledge by any patient is quite unrealistic I think, especially since the patient is already ill and dealing with pain and suffering while trying to research and make an informed decision about a life-altering procedure that may be 4-6 hours in the OR for the doctor, but a lifetime of pain and suffering for the patient. All of these issues combined is why I think individual patient advocates and the notion of patient advocacy, as a career, WILL and SHOULD make its way into our healthcare system as an accepted and justified position very soon. My hope is that my work as The Mesh Warrior and as founder of The Mesh Warrior Foundation for the injured will hasten that day.

Still, Dr. Veronikis says, “The OB/GYN credentialing board is working on these issues, commenting that, “We need to create a fourth subspecialty.”

The board created a subspecialty last year last year for the first time ever. Dr. Veronikis tells me he took the credentialing exam, as did Dr. Tom Margolis of Bay Area Pelvic Surgery. “We passed, but we didn’t need to take it.”

 THE ROAD AHEAD AS DR. VERONIKIS SEES IT

Subspecialties will begin to be more and more required by the board certification authorities within any specialty including female pelvic health. He offers his thoughts about what subspecialties could be credentialed to ensure the right type of specialized physicians are well trained and prepared to perform specialty procedures. He gives some good examples off the top of his head to round out our discussion:

  • Board Specialty in Female Pelvic Medicine & Reconstructive Surgery with further refinement by also requiring a fellowship in Urogynecology
  • Board Specialty in Robotic Surgery
  • Credentialing by Experience, i.e.
    • How much mesh do you remove?
    • What kind slings do you remove?
    • What is the depth and breadth of your removal experience, etc.

MY ADDITIONAL INTERVIEW QUESTIONS and

MORE PATIENT COMMENTS

TMW:

“There is much confusion among the mesh injured about which doctor to go to (besides Dr. Raz of UCLA and yourself) because the cost of the trips is prohibitive for many. Is there any other doctor who you would personally and confidentially recommend for someone in this situation?”

DR. V.:

“The more doctors we can find who do full explants, the more chance there is that woman can afford to travel for surgery. (Author’s note: *See Part I of my interview with Dr. V for two suggestions, Dr. Issac Schiff in Boston, MA and Dr. George McClure in Tacoma, WA)”

TMW:

“Do you have any recommendations (besides narcotic medication) about how to control/minimize the chronic pain that is so often one of the main complications of mesh implant (could include books, specific doctors or specific therapies)?”

DR. V:

“By far and large, the vast number of patients have the pain cycle stop. Botox to paralyze muscles and nerves. I call the patient’s pain management doctor and tell them why they have pain, and where it is coming from.”

TMW:

“Have you confirmed any medically-resistant strains of bacterium in women with system infection or localized infection around the mesh?”

DR. V.:

“Removing the mesh is stirring the pot, making it an acute inflammatory response again. Your body recognizes the invader and recruits the immune system response and a brand new immune response begins: macrophages, polymorphonuclear cells, NK – natural killer cells, and these cells release a whole cascade of your body’s own chemicals and starts a whole new war. In this way, the infections leave with the mesh.”

TMW:

“Have you tested the infection for type of bacterium?”

Dr. V:

“No. After the first surgery, it becomes a real battle with the body. Tissue dies, bacteria feeds on it, then bacteria feeds on the necrosis [dying/dead tissue in the body].”

TMW:

“Would you be amenable to performing such tests routinely when it is apparent that there is infection? Would you be willing to share your finding informally with me [without patient-identifying information of any kind]? Some in the injured community have been diagnosed with very rare anaerobic bacterial infections, not usually seen at all within the human body. For example, some in our community have been diagnosed with a rare and resistant, but active Actinomycosis bacterial infection.”

(Source added by author: http://www.nlm.nih.gov/medlineplus/ency/article/000599.htm).

DR. V.:

“Sure.”

“ANONYMOUS” 

A Patient treated by Dr. Veronikis

“I had Dr. Veronikis remove my mesh. He was very rude to my spouse and I at the initial preop consult. He was very arrogant and insisted that he had women much worse off than me. He repeatedly asked my husband what he meant by, “he could feel it.” I understand that my being a nurse he might have thought he didn’t understand anatomy but for lack of a better way to put it that had been his playhouse for 24+- years! He told me he, ” would remove it if I insisted on it but he didn’t see how the mesh could cause what I was describing.” He told me that he refused to do repair w fascia because it shrank up too much and he would have to repair it again. (that was one of the biggest reasons I chose him. That and location.) He said that it would be different if he put mesh in because he would do it right.  He jokingly told my husband he would see if he could tighten things up a bit.  We went back to Haven House and were discussing packing up and going home! I decided since so many arrangements had already been put into motion for this to happen that if he would just remove the mesh I would see if I could find someone more local that will do a fascia repair. The day after surgery he came to discharge me to go home. When he showed me the picture of the mesh he removed he explained the process as follow: “on the right side it was stuck to the pelvic bone and was about like trying to remove bubble gum from the back of a chair you’re sitting in. The left side was the most extensive repair. The mesh was deep into the muscle and nerves to your leg, but basically that means I took care of your pain for you.” I asked him to please email me the picture he had just shown me. He told me that he didn’t want me to post it on the internet because he wouldn’t want anyone to steal his technique.

At that point I just wanted to go home finally mesh free! My mesh was done through my groin instead of suprapubic so this was how he had to remove it. I had 3 stitches vaginally and about a 3-4 inch incision in each groin w about 20 stitches each. But I was mesh free!

I returned for my pistol visit and he was bragging about a website or something he was developing to direct more women to him. I was very rushed w a quick 2 second finger probe and asked if it hurt and not even really given time to answer. He asked if I was leaking and I told him no more than I had prior to surgery. He said, “I didn’t think you would after surgery from me.” Then laughed and asked me if I was a satisfied customer. I very sarcastically said, “I asked you to remove the mesh and you DID REMOVE IT!” Either he didn’t hear or chose to ignore the sarcasm. He told me something about a heart. He told me, “write like your initials and surgery date something to identify you and you can write how much you love me, how I saved your life something like that.” There were a crowd of people in the check out area. I very illegibly scribbled, “thanks for removing my mesh.” Put it in the clear container and left.

I still have SUI but I WILL not have it repaired anytime soon and most definitely not by him! I would like to remain anonymous since my case is still not settled. I spoke with Jane shortly after my surgery and after our conversation she said she was going to remove him from her site. I understand that every case and everyone’s experience is different but this is my story as I lived it.

I just pray one day this whole nightmare will be over, and my body will stop fighting me everytime I get out of bed.”

__________________________________________

“DONNA”

A Patient Treated by Dr. Veronikis 

Dr. V. does go through many leaps and bounds to remove the poisonous mesh that has ravaged our bodies for years which I’m sure is a very complicated and tedious job for him. He works tirelessly to help us in many ways. He is a very unique doctor that does not give up on removing the most complicated of mesh messes. He removed my mesh when I have had many doctors say that they would not touch me even when it was eroding and plainly needed to come out. I drove from my hometown in Louisiana all the way to St. Louis just to consult with him. Upon consultation with him, I just knew he would be able to remove my mesh! I had lots of faith and the utmost respect for him. I was also having rectal pain and asked him if he thought that it would resolve with mesh removal and he truthfully said “no”. I was not happy with that answer but who would not be?? I needed to come to terms with that answer which I did. It is not Dr. V’s fault that the rectal pain did not resolve and I know that. I can say that he did remove all of my mesh and for that I am very thankful. Yes, I still have the pain but I believe that it is nerve related and am pursuing other avenues with a specialist that deals with the nerves in the pelvic floor area. No, I am not 100% because my pain was not resolved but according to Dr. V. I am mesh free! Everyone has their own opinions on every situation dealing with mesh, I mean look at Dr. V., he still puts it in. God has given us the free will to do what we want and if women want the mesh then it is their decision although I would try to persuade them not to have it done with every caring inch of my heart. Every woman has their own experience with Dr. V., it might not be all rosy but at least he is truthful. I did not like some of the things he said to me on my followup visit but it was the truth and I know that I have to come to terms with that. There is one thing I can say about Dr. V. and it is that he is only HUMAN just like the rest of us. It is okay to tell the truth even if your experience was not a good one. I believe that it is not bashing him but just getting someone else’s perspective on the whole situation. We are all suffering and Dr. V. is our glimmer of hope. My overall experience with Dr. V. is that he tells the truth which we do not want to hear because we just want to hear that we will be whole again which can be impossible for one doctor but at least he was willing to remove my mesh mess so for that I am very thankful. I love all of my mesh sisters! I will always respect those who respect me and others. I believe that we should live by Gods word to be kind to others and live our lives loving others. I always want to find as much information on mesh as possible and that is why I would love to read the Mesh Warrior’s interview with Dr. V. When I was implanted with this disgusting stuff, I did not know a thing about mesh but sure wish I would have done my homework. I trusted my doctor and now my body is ruined. Unfortunately, we have to become our own advocates and do our own research and if it was not for the information from other women on these pages with their stories and information we would be alone in that cold dark place called depression. We could all use more information. I will not give up on my endeavor to become pain free so that my husband could get his wife back and my children can get their mother back! Much love to the Mesh Warrior and to all of the ladies on here! May we all become mesh free and pain free so that we can be free!

 MY ADDITIONAL QUESTIONS THAT DIDN’T MAKE IT INTO OUR INTERVIEW. OBVIOUSLY, MY CONVERSATION WITH DR. V PROVED TO BE VERY RELEVANT AND INFORMATIVE DESPITE THE FACT THAT WE NEVER MADE IT PAST QUESTION #3.

THIS FACT REALLY SERVES TO PROVE HOW MUCH THERE IS TO DISCUSS BETWEEN DOCTOR AND PATIENT, BETWEEN DOCTOR AND PATIENT ADVOCATE.

  • I know that every person is different, but if there are some conditions which you KNOW will prohibit you from safely attempting an explant, what would those be (e.g. uncontrolled diabetes, etc., etc.)
  • Anecdotally and within the mesh-injured community, it seems to be the consensus that a PARTIAL EXPLANT is MUCH worse than a FULL EXPLANT.  What is your medical opinion on that subject?
  • For full disclosure, are you currently consulting to any of the mesh manufacturers?  If so, which ones and why?
  • How many fellows or residents do you have in training under you, if any?  Given your the as-of-now very uncommon and highly-sought-after expertise for this kind of surgery, many of the mesh-injured fear there are not enough doctors to handle the hoards that coming.

 _______≈_______

THE VAGINA DIALOGUES: A SERIES – Dr. Dionysios Veronkis/Part I

The Mesh Warrior:

Don’t forget to read: The Vagina Dialogues Series- Part I of my II-Part Series, an interview with Dr. Veronikis of St. Louis’ Mercy Hospital. Part II comes out today!

Originally posted on The Mesh Warrior:

GREEK MYTHOLOGY and A MODERN DAY RENAISSANCE MAN  – Dr. Dionysios Veronikis

An open-source article bylined by The Mesh Warrior and contributed to by his Patients

November 24, 2014

 _______≈______

Screen Shot 2014-11-16 at 7.41.45 PM

Dr. Veronikis (“Dr. V”)

DrDionysios Veronikis

FELLOWSHIP: Vaginal Surgery & Urogynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA

RESIDENCY: Obstetrics & Gynecology Baystate Medical Center, Springfield, MA

INTERNSHIP: General Surgery, Morristown Memorial Hospital, Morristown, NJ

MEDICAL SCHOOL: University of Patras Medical School, Patras, Greece

ADDITIONAL RECOGNITIONS:

Diplomate of the American Board of Obstetrics & Gynecology

Diplomate of the American Board of Female Pelvic Medicine & Reconstructive Surgery

Fellow of the American College of Surgeons; Chief of Gynecology – St. John’s Mercy Hospital – St. Louis, MO

Director of Reconstructive Pelvic Surgery & Urogynecology – Mercy Hospital – St. Louis Obstetrics/Gynecology

Residency Program Director – Mercy Hospital – St. Louis Society of Gynecologic Surgeons Active Member

LANGUAGES:…

View original 4,776 more words

THE VAGINA DIALOGUES: A SERIES – Dr. Dionysios Veronkis/Part I

GREEK MYTHOLOGY and A MODERN DAY RENAISSANCE MAN  – Dr. Dionysios Veronikis

An open-source article bylined by The Mesh Warrior and contributed to by his Patients

November 24, 2014

 _______≈______

Screen Shot 2014-11-16 at 7.41.45 PM

Dr. Veronikis (“Dr. V”)

DrDionysios Veronikis

FELLOWSHIP: Vaginal Surgery & Urogynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA

RESIDENCY: Obstetrics & Gynecology Baystate Medical Center, Springfield, MA

INTERNSHIP: General Surgery, Morristown Memorial Hospital, Morristown, NJ

MEDICAL SCHOOL: University of Patras Medical School, Patras, Greece

ADDITIONAL RECOGNITIONS:

Diplomate of the American Board of Obstetrics & Gynecology

Diplomate of the American Board of Female Pelvic Medicine & Reconstructive Surgery

Fellow of the American College of Surgeons; Chief of Gynecology – St. John’s Mercy Hospital – St. Louis, MO

Director of Reconstructive Pelvic Surgery & Urogynecology – Mercy Hospital – St. Louis Obstetrics/Gynecology

Residency Program Director – Mercy Hospital – St. Louis Society of Gynecologic Surgeons Active Member

LANGUAGES: • English • Greek


 

OUT-OF-THE-CLEAR-BLUE SKY, BUT A MOST WELCOME EMAIL

My first voice-to-voice interview with Dr. Veronikis was in August (2014). I had written him in December of 2013 requesting an interview, but he was not able to respond to my questions (understandable, of course, with his busy schedule). A very friendly and brief email discussion ensued. I shared a bit of my mother’s journey with mesh; that I am a patient advocate and writer and a hearty “Merry Christmas.” I also shared an email with him, containing each question I’d be asking so he could easily prepare on his timeline. He was very friendly and amicable, responding:

“I would be happy to answer your questions. It may take me a few days. I am glad to restore the quality of life for women.”

Unfortunately, I did not from him again for many months, and thought he wouldn’t be able to make the time, but then very much to my surprise, and somewhat out-of-the-blue, he contacted me by email, August 7, 2014 – a full eight months after our initial email exchange.

His email read:

“Aaron,

I am not sure I ever responded to your email. It fell off my radar. 

I still help women and that is my focus. 

I have put together a website to educate women on mesh removal. It is under construction. 

www.vaginalmeshremovalsurgeon.com

It shows the breadth and depth of mesh removal.”

And my emailed response:

“Thank you Dr. Veronikis. This is helpful. Perhaps a brief phone interview would help as well. Let me know open times in your schedule, and I’ll work around your availability. Thank you for helping the women.

God bless,

Aaron”

This manmade catastrophe is a job for every person with a heart to help.

This manmade catastrophe is a job for every person with a heart to help.

So on that footing, and from that context, we set a Sunday morning time to speak and began a conversation in earnest in August, the kind I enjoy immensely: real people speaking to one another about a REAL BIG problem, which must be solved by many different kinds of people working in collaboration: doctors, nurses, scientists, patients, patient advocates, hospital administrators, family members, communications experts, writers and journalists, even lawyers, insurance companies, and yes manufacturers, not to mention the FDA and other “safety net” government entities like Medicare and Medicaid. That’s how big this problem is. Using the analogy of a train wreck, which I often do, we in the community of injured patients and family members call the wreckage “MESH HELL.”

The list of people needed to aid the injured is literally endless, as train cars still crash into the back of this devastatingly-long and brutal scene of immensely profound and often irreversible harm and injury continues daily.

The mesh is still on the market; still being used; still being implanted; still maiming.  

 

OUR PHONE CONVERSATION BEGINS

TMW:

“How much time do you have?”

DR. V:

“How much time do you want? I’ve allocated an hour.”

In both the writer’s mind and as one who’s starting a non-profit, I consider this a green light to ask every single question I can possibly think of, and I’m already excited that Dr. Veronikis has called right on time and seems to be focused in a quiet room somewhere. Maybe he’s flexible I think, as in: ”Let’s have a conversation, flexible,” not a formal, stoic interview kind of exchange.

Cool. That’s my style. I think doctors and patients should have more good, old-fashioned conversations and less 15-minute “consultations.”

I start out with the usual questions – background, education, personal history. We talk about my name and how he thought it was funny that in some of my bios, I have written about my name, making sure to advise people ahead of phone and email conversations that I’m not, in fact, “an elderly Hebrew or Jewish man (though I certainly do like most elderly Hebrew and Jewish men I’ve met).” I clarify that because I don’t want new colleagues to be confused when a 30-something woman who claims to be a writer on the internet, this “Aaron,” answers the phone with an obvious higher pitched female voice.

If you can “rib” someone during a conference call; I certainly did, answering Dr. V’s conversational serve with a volley, “You wouldn’t happen to be Greek would you, ‘Dionysios Veronikis?’” He chuckled acknowledging he’s always liked his name, and that “it’s a good name to have in his culture.” In Greek and Roman mythology, Dionysios means, “the god of wine, fertility and drama.” We laugh again because, after all, we’re having a conversation. We run through his credentials and schooling quickly, and there is no doubt, his accomplishments are prestigious and many. The man is well qualified and he knows it. . . as he should.

After attending medical school at the University of Patras in Greece and completing his residency at Baystate Medical Center, he began his 20-year career in his current, chosen specialty with a three-year fellowship in Vaginal Surgery at Massachusetts General in Boston. He is now Chief of Gynecology and Program Director for the OB/GYN Residency Program at Mercy Hospital, St. Louis. Certainly, these are no small accomplishments.

In this current version of our healthcare system, doctors are expected to be, not only exceptional doctors or surgeons, but also businessmen, marketers, managers of cross-departmental teams, philanthropists, leaders in their communities and many other roles you can probably imagine. “Dr. V” as he likes to be called is a busy man to say the least. These additional roles are sometimes referred to by industry as “down pressures.” This, not coming from Dr. V. but from my learnings and speaking with other physicians.

Where we land jointly at the end of our opening volley is a quotable moment. Dr. Veronikis offers this:

“What you take away from all your education is common sense,” he says.

These two words (common sense), music to my ears, as I reflect on the story I wrote more than a year and a half ago now about my family’s journey to help my mom find out what had gone so terribly wrong with her mesh implant surgery. I assumed the good doctor read my bio as he’s cited my writing once already, and I wonder if he read my family’s story as well before our scheduled conversation. He seems prepared for our talk, and that is admirable and honorable to me, a quality we should all aspire to posses.

I remember, very specifically, struggling to find the right phrase when writing the portion of my family’s story related to what it was that so many of my mother’s treating physicians seemed to be lacking. I couldn’t quite put my finger on it as I stared at the pages I’d written, but then the thought occurred to me, “This is all common sense,” and so I wrote it that fateful day last July (2013):

AN EXERPT FROM MY STORY:

“How is it that I am the only one asking these questions?”  I’m no doctor or specialist, but this is logic, project management, common sense.  Why aren’t any of these doctors interested in the cause of such an enigmatic syndrome?  Why don’t they have a hunger to know more, or at the very least, a compassion that would drive them back to the curiosity of their med school years?

The question persists more than a year later, for both Dr. V and me. “Where has common sense gone?” we both wonder, for him in the misuse of mesh products and its commensurate procedures; for me in this entire living, breathing medical organism that is our (often deadly) “health” coupled with ”care” system.

Dr. Veronikis adds:

“Some of these mesh procedures [as previously performed by other surgeons in many of his patients] make no sense. Some of this was experimentation, maybe, but I’ve always approached every surgery I do as an obligation,” (again music to my ears). If you, as a surgeon, aren’t very confident that you can take care of any complications that arise, you don’t do the surgery. I also take on complications that other surgeons won’t take on. Sometimes I will do surgeries, and I don’t know the outcome of it, so I tell them [my patients] that they are partners in the surgery – I am doing if for them, with them.”

It’s nice to hear a doctor, in his own words, speak of working together with patients and their families to make the best decision based on the medical truths he can offer them. He concedes but not with conceit, “I have a skill set, a gift, blessings, etc.”

Personally and professionally, I am so grateful that Dr. Veronikis has chosen to take this horrible, highly injurious product OUT of women, for I believe mesh removal is the first step towards recovering the bits and pieces of one’s former quality of life or growing anew towards another, different life – but with hope for a better quality of life, one WITHOUT MESH.

I interrupt and say, “I completely agree with you and understand you are a gifted surgeon and this surgery is very difficult, but let’s see if we can take off our respective hats; me in my writer’s hat and you in your doctor’s hat. Let’s you and me just talk – human as to human.” He agrees, and then I say, “I’m not a journalist. I’m really more of a writer.” He says, “What’s the difference?”

I like this question.

It shows so many of his cards at once, and I now know; (At least I hope I’ve read his curiosity correctly.) this is a humble man’s correct assertion that none of us knows it all, so we should ask questions when we don’t know the answer. After many visits behind the closed doors of exam rooms with my mother, and “consultations;” with doctors; some bordering on and possibly right over the line into psychological and mental abuse of my mother as a patient, I’m grateful on my mother’s behalf to hear Dr. V’s words, and I take it to mean Dr. Veronikis and I respect one another. Mutual respect is part of the “common sense” part that was lacking in much of the doctor-t0-patient behavior I saw behind those closed exam room doors with my mother’s treating physicians:

I hope our even hand is revealed in equal parts in all suits.

SPADES in what I hope I perceive correctly as humility to admit we don’t know everything there is to know.

The suit of HEARTS, reflecting a desire to find answers to questions in this pursuit to render aid to the injured.

And like compressed carbon, the suit of DIAMONDS; the ability to be diamond-grade professionals, lumps of coal, refined under tremendous amounts of pressure the result of which is what I hope helps turn something terribly ugly into something of rare triumph. And all at the same time, just being fellows in humanity, trying to figure out the MESH MESS, each with our God-given skill sets and blessings.

And of course, let’s not forget the suit of CLUBS/CLOVERS, for the good fortune to find answers by working in tandem to solve a multi-faceted problem; to discuss a very serious threat to the health of harmed patients and to the overall public’s health and safety. Maybe, working together, we can emerge from this MESH MESS with some tiny solution, a small victory that furthers all of us towards a better cure for those injured and safer treatments for the restoration of female pelvic health for future patients.

 

NO ONE PERSON (OR DOCTOR) IS ALL GOOD OR ALL BAD.

EVERY PERSON IS A MIXTURE OF PARADOX

I believe doctors do their best, in most cases, of due diligence when a medical device rep walks into the office with “the latest and greatest” drug or device and lunch for the entire (often underpaid) medical staff and office staff members. I believe most doctors do take this aspect of the medical profession with the commensurate grain of salt, and they absolutely think through the safety of what is being proposed to them by manufacturers, who bring an obvious motive, above and beyond patient health and safety – to increase sales. After all, they are are said to be in  “medical device SALES.” Consequently, I do my best not to vilify doctors; though, I do know many by name who are culpable for using their status and scalpels, at best, irresponsibly and, at worst, knowingly and unscrupulously for personal financial gain by performing unnecessary procedures or procedures for which a reasonable doctor would require additional training to safely perform.

But as any broad group of people, we cannot judge all to be the same. There is as broad a spectrum of competency amongst doctors, just as there is amongst mechanics or plumbers. The notion that “all doctors have the same level of skill or qualification” is the part of the common sense that we, as patients, have inadvertently abandoned, albeit, under illness and duress; cultural norms and pressures; and perhaps a lack of knowledge (for we are NOT doctors, nor should we have to be in order to give true and proper informed consent.) Not all mechanics are the same; not all doctors are the same. Some are more passionate about their professions and long to improve procedures and outcomes or invent better solutions; or even make medical history while others just want to make it home for dinner. The reality comes across the page as harsh, but it’s reality whether you choose to believe the reality does nothing to change it.

I believe Dr. Veronikis is in the latter group, a dedicated and curious surgeon, a true physician who desires and delights in his ability to be an instrument of healing for others.

I don’t make medical recommendations because I’m not a doctor, just as I can’t tell you what to do about that weird sound your car is making every time you turn right or why your sink backs up every time you wash clothes. I did not go to medical school or complete a mechanic’s or plumber’s apprenticeship. And I certainly did not complete one or more fellowships after medical school or (sheesh) use a scalpel on a passed-out person. And well Dr. V- he’s not a professional writer or marketer, or a COO, CMO and CEO. He has not been trained in the creative and production processes employed by writers and leaders of business groups.

Cool, again. We’ve already learned much from one another. I feel like we’re SOLVING, not DEVOLVING. We can approach the problem from different angles, and each bring solutions. That’s EVOLVED thinking.

I share with him that I don’t vilify doctors in this Mesh Nightmare and why. In addition to the above, I see any doctor with a heart to help, with regard to mesh explant and the whole attending tangled ball of yarn, as in the same situation as the rest of us. We are all bewildered, to an extent. How do we handle this toothpaste now out of its tube, so to speak. Developments in the courtroom, exam room, conference room, operating room, and even in the online chat rooms take many of us by surprise daily. Regardless of how this unprecedented and most twisted ball of yarn got into our collective hands; here we all are, holding some portion of string, or a knot. We’re covered in toothpaste; stuck holding the bag; whichever analogy you wish to use. We are ALL OF US, wondering:

“What happened? What is HAPPENING? What do we do to help ourselves? How do we help all these very ill and badly-injured people? We all must stop and render aid to our families and others using our various skill sets, blessings, etc. immediately. How can we best give assistance? And however we choose; it’s got to be STAT!

Dr. V and I are looking at this problem together, on a Sunday morning, in its sum-total, as we each understand it, from different angles. A Rubic’s Cube is the image I’m holding in my mind. Where to start untangling the yarn, what end to cut first, quite literally for him? I believe the most true answer to this question is: 

No one knows exactly what to do, including manufacturers and doctors, even very, very skilled surgeons; because no one has performed polypropylene mesh explants en masse after 5, 10, 12, 15 or more years of the intruding foreign body’s multi-year layover in a human patient’s body.

And every human is different.

Some have rare co-morbidities, clearly incompatible with mesh implant.

Some have pre-existing autoimmune issues.

Some develop inexplicable and rare symptoms and autoimmune disorders that were never present before mesh implant.

Human beings are not one-size-fits-all.

The mesh does not have the exact same effect on every human body, although there are certainly many patterns, significant similarities and common symptoms among most every injured person I’ve encountered.

How do I know that what I just said is true? For one, it’s my personal experience, now as a result of more than three years of be immersed in this community of injured patients.

More importantly: the manufacturers and FDA themselves told me. They told us all – BUT- mostly after the fact.

NO ONE, AND I MEAN NO ONE ON THIS PLANET, has ever done TIER ONE ETHICS, double blind, long-term, published and medically-accepted studies on LIVE HUMAN BEINGS, and there is certainly no follow-up study to measure outcomes and the effectiveness of these mesh devices . . . until now that is.

In this writer’s humble opinion, the general population was the tested upon (YOU, the patient!), which allowed for the foregoing of that pesky “Tier One Ethics” part of the R&D process for manufacturers, which is a costly and time consuming cost of doing businesses for manufacturers (as it should be). I believe PRE-MARKET, TIER ONE ETHICS STUDY OF ANY DEVICE OR DRUG is imperative and ethically necessary to safely develop OR REVISE a medical product, procedure or drug. Again, employing common sense here: If adequate studies are not/have not been done, how can a curious and dedicated doctor, such as Dr. V, even HOPE to give true informed consent to his patients (through no fault of his own)? How could he be what’s legally referred to as a true “learned intermediary,” the conduit filling the gap between the manufacturers and the real-life use of their products on the end users, who are the patients themselves? Without this medical and scientific analysis being done on the front end, before a product goes to market, how can ANY PERSON whether doctor, patient, nurse, nurse practitioner, patient advocate, husband, daughter or caregiver study and judge the safety of any medical device? And, again, through no fault of their own? The question remains: HOW COULD WE ALL BE FULLY INFORMED WITHOUT INFORMATION?

There are many hundreds of thousands, if not millions, of patients by now – worldwide – with polypropylene transvaginal and/or abdominally-inserted pelvic mesh and hernia mesh implants, a good sample size for a study done as an AFTER MARKET study, I’d say. Wouldn’t you? That bothersome problem of getting a patient’s true, ethical and proper “informed consent,” easily bypassed by the FDA’s deeply flawed policy, called the 510k Clearance process (also known as PMA/Pre Market Approval). 510k Clearance is a completely different process than the process of FDA Approval. Despite all claims of being a civilized, first-world country, medicine in the U.S. – at least from the patient’s point of view – becomes more and more like a drug cartel every year, and the more you know, the more you realize this nicely-dressed cartel is somehow legal in large part. To be certain, there are laws that manufacturers did break, which is why we are seeing the judgements against them coming out of courtrooms across America.However, let me be clear: there is no “War on Drugs,” against this cartel.

The best studies we have regarding long-term outcomes of polypropylene mesh implant, are from study done on cadavers and dogs (all euthanized by the 7-year mark), and dead people and dogs just don’t give very good advice on long-term outcomes, efficacy rates and how this device behaves (or misbehaves) in living, breathing, mothering, fathering, working, swimming, dancing, crying, suffering human beings. No one has ever done serious science on informed human beings, but the FDA and doctors alike are now taking note of the serious side effects, that, in my opinion should have been paid for and discovered by the manufacturers well before such devices were placed upon the free market to unsuspecting patients who TRUSTED their doctors.

Here is where I believe culpability of the doctor enters into the train wreck.

• Was your implant surgeon the kind of person who just wanted to get home for dinner or increase sales without a thorough review of the “science” given him by the polypro manufacturers’ sales reps?

• Or was your surgeon more like Dr. V. – extremely invested in the gynecological health of women, as evidenced by word and deed?

• How can we, as patients, tell the difference in a 15 minute “consultation,” time limits often set on doctors by their hospital administration. Time is related to profit.

Until now, why should we have had cause not to trust our doctors and hospitals, either way? After all, we’ve been told they know so much more than we; that we cannot know enough to make a judgement for our best care. “We must listen to our doctor’s advice and follow it diligently.” That is what we have been taught for generations by our culture, by our doctors themselves, by our insurance companies, by the manufacturers who tell us every night, “Take your health into your hands, and talk to your doctor about XYZ product today!” as if it’s a new kitchen appliance they are selling to us, rather than a life-altering, sometimes very, very dangerous drug or device.

So, guess what?

We did trust.

We did listen to our doctors.

We did listen to our FDA.

We did listen to the device manufacturers who advertised to us with glossy brochures and on 5:00 p.m. news commercials every night.

And now in hindsight, TRUST seems like a dirty word.

Still, Dr. Veronikis is highly-skilled and one of VERY FEW surgeons who can or will attempt to remove a device which has given way to one of the most complicated surgeries in history – polypropylene mesh explant. Without his talents; without his life story; without his CHOICE to use his skills and talents in this controversial way, where would many of us be? Much, much worse off.

WITHOUT MUCH HOPE AT ALL, that’s where. 

Dr. V. agrees. Still here we are, he and I on the phone, recalling as we speak, the many missed opportunities in the “safety net,” and how VAST is this problem.

I believe the problem absolutely includes willfully malfeasant manufacturers; those of former worldwide iconic status – the great American company, “the family company,” some started by physicians themselves, scientists, or entrepreneurs whose very name and legacy was intended to by synonymous with wholesome, family goodness and good health for all. But quite clearly something has taken over, someone or something else – sales and marketing perhaps? Greed perhaps? The pressure to fulfill Wall Street’s expectations maybe? An unholy alliance between manufacturers and politicians? It wouldn’t be the first time. A combination of all and more, yet to be discovered, is most likely.

AN ODD TWIST TOWARDS THE MORE PERSONAL

I ask Dr. V. if he knows what much of the mesh-injured community thinks about him, assumes about him. He’s quick to answer, a hint of escalation in his tone:

“What have you heard about me?”

His tone all of a sudden sounds like a demand, as if to a subordinate, instead of another professional.

I’m a bit taken aback as his tone hints at a possible personality conflict or a material disagreement. Having spoken at length with both Dr. Raz of UCLA and Dr. Hibner of St. Joseph’s Dignity Health Medical Center in Phoenix, I’ve not experienced this potential for hot headedness amongst the handful of doctors or practices who will even attempt to remove polypropylene mesh. I asked all of these doctors the same questions. In fact, I had thought first about doing one story, set up as a grid, with each column having one question and each row having each doctor’s name and answer. As it turns out, the answers and the doctors themselves are not that one dimensional, and it was quite naive of me to ever think otherwise.

As if surprised himself, he begins immediately to justify his tone with his professional experience, more data points, in line with what I would think a good doctor or scientist would do, albeit out of context in our conversation, in which, we both recognize he is a leader in his profession and well qualified.

TMW:

“When and how did you first learn about mesh?” And what was your initial reaction? How did you think through the new procedure and device?”

DR. V:

“Look, I came here on a boat across the Atlantic in 1962 with one pair of shoes. I’ve been doing surgery since 1982.”

I’m sensing frustration in his voice, as in: “Why do I need justify myself to you?”

I’m thinking, “He doesn’t need to justify himself to me, so why is he? It’s a simple and relevant question for which my readers will want an answer.”

I sense it’s not the first time he’s felt this way – a perception of confrontation by questions asked of him regarding the controversial use of mesh products.

He continued, “I went back to Greece for medical school, and I lived in an apartment complex there, and as I studied, a man in the apartment across from me read in his kitchen every night, and through our windows, we had discussions . . . every night. I learned so much from him, a general surgeon named Andrew. I asked Andrew once, ‘Can you give me the secret to doing surgery?’ His response was immediate:

Respect the tissue,’” Andrew had said.

Third Edition, "Vaginal Surgery," by David H. Nichols and Clyde L. Randall

Third Edition, “Vaginal Surgery,” by David H. Nichols and Clyde L. Randall

Dr. Veronikis’ tone is changing to a sense of nostalgic fondness now.

“Years later Andrew came to visit me in the U.S. as he himself became a colorectal surgeon. In my three-year fellowship in Vaginal Surgery alongside David H. Nichols [who literally wrote the book on Vaginal Surgery], I really started to do a lot of reconstructive procedures.”

Dr. Veronikis continues with a levity, perhaps an appreciation of female anatomy in a medical sense and totally appropriate – not a hint in his tone of anything but a deep knowing and respect for the anatomically-correct form of the female anatomy in which he specializes:

“A woman is perfect, and when she has a baby, that breaks; and we can never really restore it to as well as its original creator.” – Dr. Veronikis

I appreciate his deference to Our Creator, but I also find myself lost in thought about the part he said about how a woman’s body “breaks” and what specifically he means by that.

A woman’s body has not changed since his work with Dr. Nichols, but the way our physicians treat SUI and POP has changed drastically in the last 20 years. That much is clear from a review of the medical literature or a review of the sales of polypropylene mesh implants.

George McClure, MD of Tacoma, WA

George McClure, MD MultiCare Urogynecology & Pelvic Reconstructive Surgery Allenmore Medical Center Building B 1901 South Union Avenue Suite 2006 Tacoma, Washington 98405 P. 253-301-5120 F. 253-301-5130

Isaac Schiff, MD Vincent Obstetrics and Gynecology Service 55 Fruit Street Founders Building Boston, MA 02114-2696 Phone: 617-726-3001 Fax: 617-726-7548

Isaac Schiff, MD
Vincent Obstetrics and Gynecology Service
55 Fruit Street
Founders Building
Boston, MA 02114-2696
Phone: 617-726-3001
Fax: 617-726-7548

I cannot linger in wonder too long, for as quickly as he switched from agitation to nostalgia, Dr. Veronikis is back to a methodical cadence: a list of others he’s worked with: “Dr. Nichols became Chair at Brown; Isaac Shiff was at Mass General and retired at 65; at Harvard, a Dr. Kathy,  Colonel George McClure.” I am unfamiliar with these names, but I type rapidly as he speaks, and I’m grateful to be able to type so fast, because he’s rattling ‘em off to be sure.

We end PART I of the interview here, and Dr. V ends his list with,

“Dr. Nichols taught me how to do slings.”

 _______≈______

PART II AND THE WRAP-UP TO MY INTERVIEW OVER A PERIOD OF 8 MONTHS WILL BE POSTED TOMORROW. IN IT, YOU WILL READ COMMENTS BY HIS PATIENTS ABOUT THEIR EXPERIENCES IN HIS OFFICE.

PART II IS “OPEN SOURCE.” I’M ALLOWING ANYONE TO COMMENT INSIDE THE ARTICLE, BEFORE IT’S PUBLISHED, USING THEIR NAMES, PSEUDONYMS OR REMAINING ANONYMOUS.

THINK OF IT AS A WIKIPEDIA ENTRY FOR DR. VERONIKIS.

I AM TAKING COMMENTS UNTIL 5 PM CST TODAY,

SHOULD YOU LIKE TO ADD YOUR VOICE.