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Plaintiff’s Expert Outlines J&J’s Push to Market Prosima Pelvic Mesh

Peggy Pence, PdD and team at Symbion Research Intl.

Peggy Pence, PdD and team at Symbion Research Intl.

MND, September 23, 2015 ~ Wednesday was day three of the Cavness v Ethicon (Cavness v. Kowalczyk et al., trial, case # DC-14-04220) being heard in the 95th District Court of Dallas County, Texas before Judge Ken Molberg.

Dr. Peggy Pence took the stand all day.  Pence, a PhD and expert in regulatory affairs has more than 40 years in the business of bringing drugs and medical devices to market.

Her background is not only in designing clinical trials, but in analysis of that data. She’s worked with more than 50 companies and has prepared numerous regulatory submissions to the U.S. Food and Drug Administration (FDA).

Dr. Pence has been an expert brought into numerous pelvic mesh trials including Jo Husky, Linda Batiste, Linda Gross and Joan Budke, among others.

She is clearly experienced at giving expert testimony, turning to the jury frequently to explain, in a concise, calm manner, terms to a layman audience.

Tim Goss, Freese & Goss

Tim Goss, Freese & Goss

Thanks to Courtroom View Network for allowing Mesh News Desk to observe a feed of the proceedings before Judge Ken Molberg.

Predicting the questions that Defense will ask, Tim Goss (Freese and Goss) asked Pence if she is being compensated?  Yes, she said, at a rate of $500 an hour, a common rate of compensation for an expert witness, Pence said was her understanding.

PROSIMA PELVIC FLOOR REPAIR SYSTEM

Prosima was to be the newest pelvic floor polypropylene mesh intended to  treat pelvic organ prolapse (POP).  J&J was in catch-up mode. Competitors had launched their own version of POP repair kits to hold up sagging pelvic organs – the Pinnacle (Boston Scientific) and Elevate (AMS).

Piet Hinoul MD, Ethicon Medical Affairs

Piet Hinoul MD, Ethicon Medical Affairs

Piet Hinoul, a young ambitious urogynecologist had left a small practice in Belgium in September 2008 to join Ethicon in Europe as director of Medical Affairs for Women’s Health and Urology. Dr. Hinoul said in an email exhibit shown to the jurors,  “As both these products are ready to start hitting Europe, and Pinnacle is already giving us a headache in the US, there can  no delay with proceeding with Prosima with its current mesh.”

Dr. Marcus Carey, U of Melbourne AU

Dr. Marcus Carey, U of Melbourne AU

No worries. Prosima was predicted to bring in $300 million each year it was used in a projected 500,000 surgeries annually.

In 2004, Dr. Marcus Carey, a surgeon from the University of Melbourne, Australia had the idea for Prosima. Ethicon ( J&J) purchased the intellectual property rights from Dr. Carey in September of that year for $500,000. After marketing began he would make another $400,000, then $100,000 with the publication of his work in a peer-reviewed journal. Dr. Carey would also receive royalties based on sales.  His studies, along with a Dr. Mark Slack, would provide  the data needed for a projected mid 2007 launch. It never happened. 

Prosima received FDA 510(k) clearance in February of 2007. It was finally launched for sale in the U.S. in January 2010, despite a chorus of waving red flags.

Ms Cavness received her implant on April 24, 2012, a date that would be repeated often as Tim Goss (Freese & Goss) recounted the chronology of events that brought Prosima to market.

THE RED FLAGS 

Prosima was made with Gynemesh PS (Prolene Soft) the same mesh used in the Prolift, another large mesh kit launched by Ethicon in 2005.  Prosima would be a smaller mesh kit, anchorless unlike the Prolift, with only two fixation points. Its predicate device, the basis for an FDA clearance, was Prolene Soft, a hernia mesh.

Dr. Pence continued in her chronology of the lifetime of Prosima.

Dr. Lucente, preceptor for Ethicon

Dr. Lucente, preceptor for Ethicon

Key Opinion Leaders (KOL) were an important part of acceptance of a new product in the medical community.  Dr. Vince Lucente worked as a consultant for Ethicon and was considered a KOL and one of the original three surgeons in the U.S. to teach the procedure. He was also a preceptor (teacher/consultant) for the TVT (transvaginal tape) since its introduction in the late 1990s.

As the KOL of the Prosima project called Project Mint, and even though he was paid a total of $1.7 million for his work, Dr. Lucente didn’t feel Prosima was an effective procedure for a serious prolape as Ms. Cavness had, considered a Grade 3.  During a trip to Australia, one doctor reported about Dr. Lucente “he was quite scathing of Prosima being a reckless product.”

Doctors who had tried Prosima felt it  “might not provide an adequate apical support; the procedure was felt insufficient to treat lateral defects regarding the posterior repair, it was felt that just placing the arm of the mesh in contact with the sacrospinous ligament would not provide a strong attachment such as would suture or passage of the arm of the mesh through the ligament (Prolift).”

Lucente’s comments during a visit to Australia for the company “if true were unhelpful,” said Jonathan Meek in an email April 24, 2008.    “It appears that Dr Lucente may have some concerns that are being voiced via inappropriate channels that are unresolved” it said.

He was not alone. Dr. Martin Weisberg, the medical director of Ethicon, had earlier voiced his opinion in an email to the marketing director in September 2, 2005. “Why would we want to introduce a synthetic graft product that does no better than a native tissue repair?”

In other words, Pence reminded the jury, the benefit must outweigh the risk and an early failure rate of a prospective observational study at eleven investigation centers found a 28.4% failure rate. In fairness, some of the women did not show for their followups. Still, in research, that’s considered a failure, said Dr. Pence because usually they are having problems.

Dr. Pence called approval of Prosima then a clear “No Go.”  In April 2008 the Prosima failed to be launched for a second time under current CEO Alex Gorsky.

FDA’s FIRST PELVIC MESH WARNING

The U.S. Food and Drug Administration (FDA) was at work preparing to issue in October 2008 the first Safety Communication warning about pelvic mesh. It noted 1,000 reports of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

“Although rare, these complications can have serious consequences.”   Complications  coming into the FDA from surgical mesh manufacturers included mesh perforations, erosion  a significant decrease in the quality of life, discomfort, pain and dyspareunia (painful sex).

Dr. Pence reminded jurors as few as one in 100 event are ever actually submitted to the FDA’s MAUDE database of complications.

That could be one in 100,000? asked Goss?  Right, she said.

ETHICON’S KEY OPINION LEADERS cropped prosima

Johnson & Johnson celebrated its successes at a conference in the Orange Blossom Bowl in Orlando February 7, 2009. with opening remarked by Renee Selman, World Wide President.  The Prolift pelvic mesh kit was on the market and on the agenda as was Prosima, which was 11 months from being launched.   The TVT-Secur, a polypropylene single incision sling marketed for use in SUI had bad results coming in. The perception of the product was a negative for the company.

In an email from Andrew Meek, Professional Education manager for the US team, to marketing’s Jonathan Meek on the day of this summit, says a number of KOLs (key opinion leaders) liked the +M (Prolift) and planned to use it, the feelings were very negative towards Prosima.  Concern was expressed about the lesser experienced surgeons or “less skilled generalists.”

“At a time when the scrutiny against mesh is at an all time high, why would we want to put a product with questionable date in this groups hands?”  “One KOL said they would no longer work with the company as matter of principle if we launched Prosima.” Others called it a “Big mistake” Don’t do it.” 

Another surgeon, Fah Che Leong, MD a Professor of Female Pelvic Medicine and Reconstructive Surgery at Saint Louis University School of Medicine wrote to Scott Jones, a marketing director at Ethicon, as shown in an exhibit:

“I am currently involved in getting a patient to the OR who had an anterior and posterior Prolift implanted by another physician. She will likely lose any coital function as her vaginal length is now 3 cm, and there is mesh extruding literally everywhere. Also there is a large stone in the bladder from a bladder perforation with the anterior arm.”  “I will hold off on doing any of these procedures. The bottom line is that I bet a majority of the practitioners using these mesh kits are not qualified to do so. I taught perigee apogee in the past – no longer.  This patient will have a permanently destroyed vagina and I am only hoping to get her out of this without more morbidity.” 

Pence told jurors the comparisons are fair because the Gynecare Prolene Soft mesh is the same in the Prolift as the Prosima.

Even Dr. Piet Hinoul, warned against overpromising success with the Secur SUI mesh  (90%) and the Prosima.

“I feel that sticking to one of the predefined outcome measures would be more appropriate and less misleading: I’d quote that 88.3% of patients  were above the level (not at) of the hymen in the treated compartment. This is still a very good result and will strike the surgeons as believable. Quoting a 94% success may lead the surgeons to have unrealistic expectations.”

Pence called this good behavior for a company but not enough to delay the launch of the Prosima. Remember, Piet Hinoul was mindful that his company must compete with the Pinnacle and Elevate and “aggressive sales techniques.”

Goss: “Would a reasonable manufacturer put this on the market?”  “No,” said Pence.

What was the next thing they did?   Launch the product in January 2010.

By the end of the first quarter a inner company email from Kevin Frost said:

Subject: 1 Million Dollars !!!!!! “We have hit a very significant milestone with the Prosima launch, $1 million dollars in sales! This makes Prosima one of the fastest launches ever, in the mesh kit market!” fda meeting with ethicon

 

THE FDA CAN’T SEE THE FOREST

The FDA continued to monitor the MAUDE database of adverse events coming in concerning pelvic mesh and hernia mesh products.   Two months short of a second Safety Communication notice, which would now call mesh complications “not rare,” Ethicon requested a meeting with FDA officials to have an “open dialogue about SUI (stress urinary incontinence) and PFR (pelvic floor repair). That meeting took place May 3, 2011.

“FDA is in learning mode” said the talking point notes.  “Listening to advocacy groups and KOL’s.”   The FDA Ob/gyn branch admitted it was “Green” in understanding the use of surgical mesh for SUI and POP repairs.  Even with sparse information, the agency concluded that adverse events for stress urinary incontinence are low and said it “understood the risk vs. benefit of mesh in SUI vs. traditional repair.”  

fda is green in its understandingThe opinion notes say the “FDA is overwhelmed by all of this and cannot see the forest.”  Ethicon promised individual product meetings would help show the FDA the safety and effectiveness of new products.

This will be easier in SUI vs PFR (pelvic floor repair) mesh.”

The second FDA notice in July, 2011 came at a time the agency was under investigation by the Office of Criminal Investigation.  It is now ten months before Ms. Cavness is implanted. The FDA had received an additional 1500 reports of mesh complications associated with POP mesh.

Did the new adverse event reports make it into the product’s label, the Instructions for Use asks Mr. Goss.   No, answered Dr. Pence.  Is there anything in the IFU about multiple surgeries will not resolve the complications. Is that in the IFU?  No, she said.

Should a reasonable manufacturer do that? “Absolutely,” said Pence.

Would a reasonable and prudent manufacturer put that inability to engage in sexual intercourse in the IFU?  Did the company change the IFU at all after the FDA warning?  No, it did not.  Would a reasonable and prudent manufacture take action to make sure surgeons knew about this notice?

“Yes,” said Dr. Pence. “The doctors are on the front line if they are not aware of this information they are missing this safety information helps to guide them in making appropriate choices to offer their patient.”

The FDA expert panel convened in September 2011 and concluded “vaginal placement of mesh for POP repair may not be more effective than native tissue without mesh,” and that “the  risk benefit of vaginal placement of mesh for POP repair is not well established.”

 

THE WITHDRAWL OF PROSIMA FROM THE MARKET

In January 2012, the FDA ordered manufacturers including Johnson & Johnson to study its controversial meshes. The adverse event reports were coming in.  Under Section 522 of the Federal Food, Drug and Cosmetic Act, the FDA had the authority to require postmarket surveillance of the devices.  They would be called the “522 studies.”

Emails within Ethicon show the next step the company would take. If the Prosima and other problematic meshes were removed from the market, the company would likely not have to conduct the 522 studies.  The company would save face and save an estimated $4 million to $5 million dollars doing research.  Notes, shown to the jury and taken by a company rep chosen to do a deposition, said the decision to withdraw four meshes came before the FDA announced the 522 studies.

An email from marketing’s Laura Angelini said they arrived at the decision to withdraw four mesh products in June 2012  “after considering the commercial viability of the product in the United State in light of the complex of the clinical study requirements, the significant adverse publicity and the litigation environment. The size and competitiveness of the market place and the availability of other treatment options for women were also a factor in our decision.”

Attorney Goss reminds the jury 45 days before Ms. Cavness surgery, “this company has in place an exit plan” which was not communicated to anyone, especially her surgeon.

 

J&J CREDO

Tim Goss concluded the day by asking Dr. Pence, with her 40 years of experience if Ethicon had violated the postmarket safety of Prosima; a standard of care; the premarket development of Prosima and its own credo in putting Prosima on the market?

Yes, she said, they did.

“They violated their own credo and did not put patient safety, their doctors and patients first.” she concluded.  #

 

36 Comments

  1. Mesh Nightmare says:

    Thank you Jane for reporting Wednesday’s proceedings.

  2. kitty says:

    The facts are certainly in. Thanks Jane.

  3. Hal Lewis says:

    Wow.

    Just wow.

    No wonder they get hit for $73 million in these cases.

  4. Aaron says:

    Thank you for keeping us posted!! I hope to be back in Dallas before the trial ends so I can go.

  5. toni says:

    Wow the executive should be punished just like the other corrupt company leaders. It is criminal what they have k.owingly done to us while they make money we suffer for thier greed. Someone has to break this worldwide and bring them down for this. Aweful what this country is becoming all about greed.

  6. guest says:

    Jane,

    First of all, thank you for all you do and the amazing coverage. My family and I are beyond words grateful to you and to everyone who is a part of bringing this travesty called, trans vaginal mesh and the darkness it brings, to light.

    Second, I can’t get through even half of the articles on the trials without a severe emotional breakdown. The men and women who lied to make money off of mesh victims, knowing the damage is could bring, and even after numerous bad results to keep doing it, is astonishing. The doctors who went along with it is even more astonishing. And to add an even higher level of astonishment, doctors, hospitals and the health care community are being told that mesh patients are crazy, have emotional problems, are out for a quick buck with the lawsuits, and the lies keep trickling down year after year.

    There is no truth, honesty, or adequate medical help or assistance for a female mesh patient. It is impossible.

    Johnson & Johnson —what is wrong with these people? Are they from another planet? What is another court case suppose to prove? What do they want mesh victims to do exactly? If all of the cases were dismissed tomorrow, and there were never any more verdicts for the plaintiffs, mesh victims are not going to magically disappear. Many are quiet due to the attorney gag orders placed on them. But, once that is unveiled, the noise will be deafening. They need help. Lifetime help.

    So much is not admitted into the court room. I pray so hard for the lawyers defending this woman, the jury to see the truth, and for the Judge and his patience.

    Praying for a win in this case.

  7. Bejah Blue says:

    There is a problem with truth. Once we finally have it, then what do we do? What becomes of it. It has long been said that the one that wins the game, whatever the game is, is the one with the most money and the best attorneys where the law is concerned. We should probably add that the ability of that player to manipulate truth, to spin it ’round so it is unrecognizable is a feature of the dark arts employed by the most vile corporate citizens and those who by extension do its bidding, that leave the rest of us as dazed and lost as we might be after a nuclear attack on our homeland. I feel very subdued, a strange sorrow so I think I will go out in the garden and do some weeding and hope the air and the sun renew my spirits.

    Bejah

  8. Angry says:

    Thank You as always Jane ! You really have helped so many of us. With out all of your efforts we would really be in the dark.

  9. guest says:

    If the mesh products are so great, where are the women who could testify on behalf of Johnson & Johnson, a family company, to help win their cases? Oh, that’s right. There aren’t any. Twelve months is not long enough to do a study on mesh. For some women the effects of the bad mesh products started immediately, for others it took longer for it to rot in their bodies and start popping out every where.

    J&J is really pushing it thin on the so called safety studies. Show me the women who say these products are safe and they have no issues with mesh, and I will face them and call them all liars as it is impossible.

    Yes, impossible. It may not come right away, but the pain and suffering will come.

    • Bejah Blue says:

      Dear Guest, Remember that some people, even victims in this matter, will say or do shocking things if a little money is put in their back pocket. File this under, “be careful what you wish for”.

      Bejah

  10. guest says:

    Johnson & Johnson does realize that once a woman has the mesh removed, if it can be removed, as for many that is NOT an option, that a woman’s vagina and rectum, and other organs, have to be fixed and put back in place. It is not an easy surgery.

    Mesh erosion. As bad as environmental erosion, Ruins everything in its path.

    That information was not in the pamphlet given to patients that your insides will be torn to pieces if you have mesh inserted into your body.

    But, the memos and other notes were given to many doctors telling them there was a problem with the mesh, and yet, many continued to make that ching a ling and used it on women anyway. They never once considered that women were important and human beings. They wanted the money, it was all about production and bringing in the bottom line. Many doctors DID know the outcome was bad for women and some men. They did not care and they don’t care today. Many are not being sued and I am perplexed as to how they are not responsible for some of the mesh cases too, even after they leaned it was bad, they continued to book the surgeries,

    • Bejah Blue says:

      Time for a little truth telling…thank you Guest for your comments. Forgive me if I spill my guts a little…. I was implanted without having any idea what was being done to me. I was implanted at UCLA Medical Center by Dr. Ha-Jong Kim. I trusted UCLA. I was retired from the great University. Immediately in the hospital post surgery I had problems with pain that were not adequately addressed (The pain med pump was not dispensing sufficient pain medication to address my pain) and I was constipated and not released when I would otherwise have been. At discharge I was supposed to be given a script for narcotic pain medication and the punk assistant surgeon assurred me that I would be given that script. When I got home (after driving about 150 miles, alone) I discovered that he had given me a prescription for Acetemenephen, when the surgeon had ordered a narcotic medication!

      While unconsious in surgery the cornea of my left eye was scraped and I was given a script for antibiotic eye drops. I also had scrape marks and black and blue marks on my abdomen that were not consistent with the surgery. When we are unconscious we are completely vulnerable. How do you think that made me feel. What else may have been done to me while I was in that state.

      I had not gone to UCLA due to prolapse complaints. I had gone because I had just discovered I had malformations in my abdomen that I was very concerned about that had nothing to do with prolapsed organs. In the weeks and months that followed I sent numerous emails to the surgeon complaining about what I was experiencing and at the same time researching to try to learn what may be causing them. Finally I came to Intersistial Cystitis. I wrote to her saying I thought I must have that. The first surgery report said nothing about this but later this was added as a diagnosis!!!! And through all of this the urinary tract problems, the constipation and unbearable firey pain in the vulva area continued to worsen. I never had any of this before this implant. None of my emails were ever returned.

      I was told by my counsel from the beginning in 2013 when I finally realized what was causing my agony and sought legal representation, that one did not file an action against the surgeon or the medical center but focused on the manufacturer (To assure maximum probability of a just resolution…and probably an opportunity to have at the defense in court I suppose).

      Also, I called the office of Medical Records at UCLA and asked about why there was no information in the section regarding the material implanted in me except the name: “Ethicon Prolift”. She seemed genuinely shocked and said it was a requirement that such data be listed in the surgery report and she would contact the Urology surgery nurse. That nurse told her (flippantly) that the tags, etc. were thrown in the garbage!!!! I believe it is a law that and device implanted in the human body must be kept (the tag) and noted in the surgery report in detail. Evidently laws do not mean much.

      It is now evidently too late for me to file against the University of California, as the statute expired last year I recently learned when my counsel said I could go ahead and file against them as well.

      Needless to say I will NEVER return to UCLA for any medical procedure.

      Did I mention that at the time the Head of the SOM was on the Board of Directors for Johnson & Johnson?

      Would you care to hear my theory about why the tag from the device was not retained?

      It is not possible for me to articulate the horrors of that experience and the years of devestation that followed as is the case for most of us.

      Don’t try to convince a jury that it is my age (about 60), or that I am a hysterical female, or that I have been diagnosed with major Depression…irrelevant!). I have only told you part of the tale, but enough to add a small chapter to this terrible story, a novel no one will read, a film no one would want to see except those who are my fellow victims and the heroic professionals who want to help.

      I say, I cringe when I hear anyone rave about UCLA or Dr. Raz. I never saw him, nor was he ever mentioned to me. I believe this should never have been implanted in my due to my internal malformations. I caution anyone who thinks UCLA is a safe place to have any urogenital problem addressed to consider other options and to avoid Dr. Ha-Jong Kim at all costs. If she would come after me for defamation of character or if the University would do so on her behalf I tell you…you do so at your peril.

      Bejah

  11. kitty says:

    Unbelievable —and why should we believe you at this late date? UCLA is one of the few places that does translabial ultrasound.

    • Bejah Blue says:

      I don’t know Kitty. I could not say anything until at that time earlier this year when the law firm representing me said it was OK for me to go forward with action against UCLA. I had asked them a year or two before that and they told me not do, that it would cause complications with their case and the best option was to focus on the manufacturer. I am hurt and shocked that you do not believe me. I have no reason to not tell you all the truth. You can do with it what you wish. I have been wanting to share this for a long time.

      Bejah

  12. addison says:

    Hi Bejah. How are you today? Do you mind me asking if you like your current team of doctors? If you need help or would like to talk, feel free to get our email address or number from Jane. As you know, outside of appointments and hospitalizations, I’ve almost always been home the past few years; you can contact me any day or time. If I can’t answer, please know I’ll get back with you as soon as possible.

    For some reason, I’m typically unable to type much in one comment box (possibly my phone?), so I’ll finish below.

    • Bejah Blue says:

      Hi Addison, and thanks.

      Your offer is very generous and I expect I will ask Jane so we can have a chat.

      Like most of us I try to take it a day at a time but I can not shake this feeling that I am dying from this. Even though my attorney says it will not kill me, she is, bless her heart, not a physician and she shares with me what I expect is the standard legal response…it will not kill me. I know she cares a lot about me and that is a great comfort.

      In my mind I ask then, if not death, are there not other ways in which one can be “killed” . I believe the answer is a definitive “yes”. The FATHER asks me to share what may lend hope to others, help in some way, and I do try to do that but every day I am more exhausted than the day before and I sleep so much now, in part to dream of a happier existence and escape the pain which is also worsening.

      Team of doctors, what team of doctors? My Urologist would not examine me the last time I saw him. He mumbled something about how it was good that I was going to see Dr. Blavis as he walked out of the room but I do not have the money to go see Dr. Blavis in NY and even if I did I now realize that neither Medicare or my Blue Shield will pay for either a consult with him or any attempt at explant surgery. My pain management doctor is sincere and does care about me truly and understands well enough what I face. I have not seen a Gynecologist for several years…it is a problem of trust and the perception of an obscene lack of knowledge. Now I have found one, Stanford trained (and she rides, owns her own hunter jumper) so we have that in common, and I am going to consult her this month. I told her the whole story and she still wants me to come, she is not afraid. I am also going to see a Rheumatologist but even if one does not need a referral, now if you want to see a specialist you do. I want to understand the strange red bumps that come and go, the itching back, the bloating, the wild fluctuations in my body temperature. Hopefully this will help with the symptom document I am trying to create for Jane also. I do see a Nephrologist and my kidneys (Actually there is only one) are in the pelvis where the mesh is and the ureters are wrapped around it tight like a rope strangling it judging from the images. This is one of the reasons no one will attempt the removal, condemning me to death I believe, and it is one of the reasons why this “Device” should never be put in anyone, and should never have been put in me. Don’t you agree? They just wanted the money.

      These defendants keep trying to talk about incontinence, changing the subject which is another classic tactic. I have never been incontinent and I am not now.

      They try to claim women bring problems on themselves because of their lifestyle and this is offensive and makes no sense but they subscribe to the philosophy that if you talk at people about something long enough they forget their truth and believe the line(s) you are feeding them (another classic tactic).

      But I digress as usual; I have a small team of doctors I trust and I do not need anyone on that team that is incompetent, can be bought and sold, is a good soldier and does what his or her professional association tells them to think or do or say, does not hold dear the sacred oath they took, or jumps when the AMA says “jump”. Sadly that does not leave many good doctors but there are a few. I am always searching, carefully, always researching first, new potential team members. I always check the state medical board now to see if there have been any problems. In the last five years I have found two doctors whose licences had been suspended! So the research is well worth doing.

      I remember simpler days when the ocean was clean and I could gather abalone on the rocks in Laguna, and I never felt I needed to investigate doctors before seeing them.

      This world of the 21st century of man is a sad world indeed and the future looks very grim for our children. Still hope never gives up, have you noticed? I do not know why that makes me smile faintly but it does. Let’s talk soon. GOD Bless.

      Bejah

      • addison says:

        You’re welcome, Bejah. Sorry to hear about your kidney and ureters. We see why surgery isn’t an option in your situation. I’m so glad you found a good gynecologist and have an understanding, kind pain specialist. Please let us know how things go when you meet with your new doctor. Good luck, and God bless you!

  13. addison says:

    I’m sorry to hear of your internal malformations and experience in California, Bejah. Please contact me if you need anything. Like you, I don’t use my first name, but I know you understand and won’t be confused.

    I closed everything and restarted my phone; it appears I can now type the rest here. If not, please accept my apology for finishing in another comment box.

    For anyone in need of a great doctor — I’d like to mention Mayo Clinic of Minnesota. There are a couple (likely more) wonderful gynecologists/urogynecologists as well as very nice, skilled gastroenterologists and therapists at Mayo. I’ve seen several specialists there, and all were helpful and genuinely kind.

    One of my main doctors through this is at Mayo, and he’s one of my favorite people. He is so intelligent and speaks with such sincerity and concern. He’s confident and one of the very best but is also able to relate as we all wish every doctor would or could. Regarding surgery, over the course of several hours, he removed as much of the larger implant as humanly possible. The follow-up care and everything since has also been extraordinary. It seems his partners are also great, and one can get an idea about some things via the many online reviews.

    To anyone with significant nerve damage and all that comes with this complication, please consider reaching out to Dr. Greg Vigna. He is a nice and very intelligent man — both a doctor and a lawyer. In speaking with him, it seems he’s an expert on pudendal neuralgia, damage of other nerves in the pelvic region, life-care plans and more.

    • Jane Akre says:

      With all the talk about long term care and what will be needed $$$ everyone should have a plan.

      • Bejah Blue says:

        Long term care is indeed expensive. I inquired about it several years ago when planning for the future seemed to make sense. Now there is no future, only darkness, at least for me. Long term care means you have access to high end nursing homes and presumably first rate care. Personally nursing homes are not in my life plan and never will be. I will go out on my own terms and that does not involving paying any blood sucking nursing home or insurance company.

        Bejah

    • Bejah Blue says:

      Wonderful, hopeful information Addison, thanks for sharing it with us, so much. I have, as many have, heard many good things about that Mayo Clinic location which I think is the original. Can I just take the train there, check in and climb in bed and fall asleap in that safe place?

      Good to hear from one who has visited with Dr. Vigna. I expect he is a fine resource and I am grateful to our dear friend Jane for introducing him to us.

      Bejah

  14. kitty says:

    If your interested I going to Mayo clinic call Dr Dan Elliot. You would have to be accepted based on your medical Hx. There are cheap places to lodge. I would suggest the Menonite house. BUSES GOING BACK AND FORTH TO APPointments. UCLA is closer and Dr Raz is the Guru of Urology

    • Bejah Blue says:

      If there is a guru of Urogynecology it would be Dr. Blavis in New York.

      • addison says:

        I’m sorry; my husband and I didn’t mention names because many are good. If it helps anyone, Dr. Christopher J. Klingele is not only a highly respected doctor and head of his department at Mayo of MN but extremely kind and compassionate. A referral might be needed — based on medical history as mentioned by Kitty — but if anyone can help while treating patients with the utmost respect, he definitely can. We’ve heard great things about Dr. Raz, and Dr. Blavis must be very good, too. It’s nice that we, as patients, can read many reviews prior to making a decision. Insurance and location (based on where we live) are definitely things to consider.

      • Kitty says:

        never heard of him but good luck

        • addison says:

          Hi Kitty. Others have referred to him as “Dr. K” so I know it’s difficult to know who that might be. We use this sometimes when talking with family and friends. I think Dr. Elliot is the Assistant Professor of Urology at Mayo whereas Dr. Klingele is the A.P. of Obstetrics and Gynecology. He’s educated in Urogynecology and Reconstructive Pelvic Surgery and in a seemingly small percentage able to perform extensive removals. Unfortunately, with certain implants or complications, no doctor can safely remove every portion, which Dr. Raz recognizes. You can probably tell I really respect Dr. Klingele.

  15. addison says:

    If anyone would like to read a few reviews of Dr. Klingele (by tvm patients), feel free to visit ratemds. In the search bar, just enter “Dr. Chris J. Klingele” and you will either go directly to his profile or have the option to click on his name. I think he has a lovely name. One of my nurses once referred to him as “Dr. Kringle.” Understandable, especially since his first name is Kris.

  16. addison says:

    Oops, sorry. Chris… not Kris. Chris Klingele and Kris Kringle. One is very real. Both are very nice! Guess it’s time to try resting again soon.

  17. addison says:

    Sorry, Jane. Here’s the rest for those wanting to know more. Mayo Clinic’s site: Christopher J. Klingele, M.D.

    Education: MS – Urogynecology and Reconstructive Pelvic Surgery, Mayo Graduate School of Medicine, Mayo Clinic College of Medicine • Fellow: Division of Urogynecology/Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Mayo Clinic Resident • Certifications: American Board of Obstetrics and Gynecology, Female Pelvic Medicine and Reconstructive Surgery • Academic Rank: Associate Professor of Obstetrics-Gynecology

  18. add says:

    If closer to South Dakota, Dr. Matthew Barker of Avera McKennan is a Urogynecologist with a lot of experience. He is the only certified Urogynecologist in the area.

    I feel bad for those posting who mention no place to turn and being treated poorly. Don’t give up, please. Travel might be necessary (especially with referrals to Mayo Clinic, UCLA or Arizona for Dr. Hibner), which is often difficult. Those of us with certain implants or complications can’t have complete removal, but there are doctors who will do everything humanly possible.

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