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Day Five: Lewis v Ethicon: Ticking Time Bomb

Plaintiff Lewis, art by Akre

Plaintiff Lewis, art by Akre

Lawyers for the plaintiff Carolyn Lewis (C.L.) wrapped up their defective product case against Ethicon (Johnson & Johnson) on Friday, February 14th, Valentine’s Day, capping off the day with C.L. on the stand. Before that there was more testimony via videotape from scientists working with Ethicon to show the company knew it had a problem but opted not to change out the Prolene (polypropylene ) mesh that made up the TVT (tension-free tape), an incontinence treatment that Lewis had implanted in 2009.

C.L. is the first of four bellwether cases selected to gauge legal theories before a jury and just one of more than 15,000 defective product cases filed against Ethicon, a subsidiary of Johnson & Johnson, in this federal court in the So. District of WV.

She is represented by Tom Cartmell (Wagstaff Cartmell), Ben Anderson (Anderson Law) and Richard Freese (Freese & Goss).

Since she is from Texas, Texas law applies in this case. The standards for proof by a plaintiff are very high in Texas, a state that has wholly embraced the tort reform movement in the name of limiting “frivolous lawsuits”  while at the same time protecting corporate interests, the same interests behind the tort reform  movement. (See SourceWatch, The Center for Media & Democracy here).

Under Texas law one must show that another product existed that was a safer alternative to the defective product used. It creates a higher burden of proof for the plaintiff, C.L.

Your Editor, Akre is not an attorney so lawyers should feel free to join in the discussions about the law presented in this story. Law firms following this litigation via the Mesh News Desk are asked to make a contribution via PayPal on page one of the website for the research, court reporting and links provided. See here bottom right hand of the page.

In the Morning- Dan Lamont, Director of Post Marketing Surveillance, Ethicon

As much of this trial has been conducted, Dan Lamont appeared to the 10 jurors via videotaped deposition. He worked for Ethicon (Johnson & Johnson) as a quality engineer during the time the company began producing laser cut mesh to minimize the sharp tangs left from a mechanical cut version. Polypropylene mesh (PP) was cut using a sharp blade but that left exposed edges, not unlike a softer version of a window screen that could irritate delicate pelvic tissue.  In an effort to improve the product and minimize waste, as was said on the stand yesterday, the company experimented with laser or ultrasound cutting of the mesh sheets.

Lamont was asked: “Ethicon continued to sell the mechanically cut TVT knowing it had the potential to fray, rope and send off particles right? Lamont admitted the potential for those defects can exist but to make TVT fray and rope it would have to be elongated 50 percent, an extreme test that would not represent clinical use (ie, in a patient).

He added he did not see trending reports on those defects that would require any investigation into the two types of mesh products.

Dr. David Robinson- Ethicon

Dr. David Robinson- Ethicon

David Robinson- Worldwide Medical Director Ethicon

David Robinson, MD might be familiar to Mesh News Desk readers.

He appeared via videotape in the Linda Gross Ethicon trial in New Jersey one year ago. Before working for Ethicon, Dr. Robinson was a Topeka, Kansas-based paid consultant for Ethicon and the ob-gyn was early on approached about using the new tape. At first he wasn’t interested but then saw how a colleague was benefiting from the association. The colleague had an all-expense paid trip to Sweden, where TVT was developed in the late 90’s, to be trained on the new procedure. Those initial hand-picked doctors would then become trainers or preceptors for others when they returned to the states.

Dr. Robinson decided to jump on board and he was glad he did. In his videotaped deposition he said “It was revolutionary and changed my practice immensely.”  He said he went from 20 Burch procedures a year, a basic method to sew up the sagging pelvic organs with suture, to 100 TVT procedures annually. Dr. Robinson said he was poised to grow his practice and that happened coincidentally at the same time he began offering the TVT.

Allison London Brown, a marketer at Ethicon, asked Dr. Robinson to help sell the product, “without overtly admitting the current product may have some aesthetic problems,” a memo said.

In 2005, Dr. Robinson was employed by Ethicon in charge of TVT products for Ethicon and he had learned about its risks – vaginal scarring, chronic pain, dyspareunia (painful sex). All surgeries have risks, he said, but admitted the company had those reports.

Still TVT offered significant advantages, according to Robinson – it was stronger and more reliable than a Burch procedure with a 90 percent effectiveness rate, a shorter recovery time and TVT was less invasive. On tape, Cartmell showed a study that showed the Burch procedure and TVT had an equal rate of cure.

Cartmell: “Is it your testimony that TVT has a longer cure rate than the Burch?”

Robinson: “There are papers that say that, yes.”

Cartmell: “There are also papers that say it does not, right?”

Robinson: “I’m sure.  I watched it evolve to the gold standard. I think it’s clear.”

But the TVT mesh (Prolene) had been shown to shrink up to 30 percent after implanted causing foreign body response (FBR), inflammation and contraction. That is what would be expected said Dr. Robinson but “you have to know if it’s microscopic and whether it’s clinically important,” said Robinson. He believes clinically FBR goes away.

Since incontinence is a quality of life issue, someone might not be willing to take as much risk with a medical treatment as a cancer patient right? Robinson agreed.

Dr. Ulf Ulmsten, Springer Media

Dr. Ulf Ulmsten, Springer Media

Since the 1990s the gold standard for research was being conducted by Dr. Ulf Ulmsten MD of Karolinska Institute in Stockholm, Sweden. An ob-gyn, Dr. Ulmsten went to Uppsala University Hospital in Uppsala, Sweden where he was Professor and Chairman until his retirement in 2003.

Dr Ulmsten died on March 4, 2004 at the age of 66 but his work was continued by his colleague Carl Gustaf Nilsson MD of Helsinki University, Finland. Together the two men would establish six locations for trials on the Prolene mesh that would eventually be expanded from hernia use to the TVT.  Ethicon today refers to the Ulmsten/Nilsson studies as providing proof of the highest level of safety and efficacy for the TVT.

Cartmell asked Dr. Robinson if he was aware the longest study on Prolene lasted seven years. The seven-year study showed a cure rate of 81.3 percent for the 80 women available then. Prolapse had returned in 7.8 percent, urge symptoms (incontinence) in 6.3 percent and urinary tract infections were reported in 7.5 percent. Had Dr. Robinson seen the actual data? Was the mesh tested even the same mesh, asked Cartmell.

“I don’t believe it to be significantly different,” said Robinson, I believe it was Type One macroporous mesh.” The classification for surgical meshes in 1997 was “imperfect and disputable” scientists have stated in recent years.  See Classification for Surgical Meshes here.

If Dr. Ulmsten was paid millions of dollars if his studies showed positive outcomes such as low complication rates and high efficacy; could that be a case for bias? Potentially, yes, agreed Robinson.

Previous testimony had established that Dr. Ulmsten was paid in excess of $25 million to deliver the TVT patent and six clinical studies on TVT- all for using an old heavy weight hernia mesh with small pores and for a now application- the TVT. See background story here. 

Dr.  Piet Hinoul, former Ethicon Medical Director, from Linda Gross trial

Dr. Piet Hinoul, former Ethicon Medical Director, from Linda Gross trial

Piet Hinoul

Dr. Piet Hinoul, a medical director for Ethicon, expressed some frustration to Dr. Robinson in an email shown to the jury. He had written a paper and submitted it to a professional journal for publication but the editor had declined to publish the paper because Dr. Hinoul worked for Ethicon. Robinson told Hinoul he wondered what the editor’s reaction would have been if Hinoul was only a consultant rather than an employee of Ethicon.

You were suggesting working for the company versus being just a consultant is a fine line, asked Cartmell. Yes, Robinson agreed.

In the memo, Robinson said to Hinoul it would be interesting to see if Dennis Miller’s manuscript is published. Miller is credited with creating the Boston Scientific Pinnacle Pelvic Floor Repair Kit, a polypropylene cradle of mesh to secure sagging pelvic floor organs.

Boston Scientific and Ethicon are two of the six manufacturers who are the subject of the more than 50,000 product liability cases filed in this court, more than have ever been amassed in any one court in history.

Dan Smith- Engineering Fellow Ethicon

TVT from Meshed Up UK

TVT from Meshed Up UK

Dan Smith worked for Ethicon for 36 years as an engineering fellow. His job was to find new materials to use for improved outcomes for women, essentially the next generation of TVT.

Animal studies on a lighter weight, large pore mesh would reflect better tissue integration and not much foreign body response when compared to the heavy weight small pore mesh that was Prolene used in the TVT.

Within the company Project Scion was created to find an alternative to the TVT mesh that was shrinking 30 percent due to excessive scarring. An animal test on rabbits in 2003 found the low weight, large pore mesh could replace Prolene.

But Ethicon decided not to put any new products in the continence field. It was a “business decision,” said Smith.

Smith was involved in the Matrix Project, again looking for a TVT mesh replacement. Matrix focused on the TVT-O PA (partially absorbable), which was his invention but the TVT-O PA project died in 2012. Even though it was fifty percent lighter than the Prolene mesh, in the cadaver lab testing in Morristown, New Jersey in 2011, it was found to be too stretchy.

“Again it was a side project, it was determined not to put resources into that,” said Smith. “Your work with Matrix was a low priority, right?”

“It was considered low priority, yes,” said Smith who added that the budget for a discovering the next generation of TVT was extremely limited.

In direct examination on videotape Smith was asked if the light weight mesh offered more flexibility and less scar tissue, increased the quality of life of the recipient. Smith agreed.

On cross exam, Smith said the TVT classic (Prolene) is the only mesh that been used in the 15 to 16 years of the TVT. The Gynemesh PS (Prolene Soft), developed during this time, had limited stretching characteristics and not enough elongation properties and the UltraPro, a large pore mesh roped and narrowed when it was stretched.

Earlier in the week, Dr. Bruce Rosenzweig had testified there were no studies ever done on TVT with the primary end point as safety.

Dr. Axel Arnaud, the medical affairs director for Europe the Mideast and Africa taken during a deposition July 2013 said, in his deposition read to the jurors, that the company didn’t want to change out the TVT for an alternative because the company would “would reduce the value of the clinical trials,” referring to the Ulmsted/Nilsson data which was the cornerstone of the company’s marketing efforts and gave Ethicon the bragging rights for its TVT.

C.L. Takes the Stand

If there is any star of the show in a trial it is certainly the plaintiff and at 1:25 on Friday, C.L. slowly walked to the stand.

Born May 30, 1954, C.L. lives in about 55 miles south of Dallas with her husband, a truck driver. She had on a grey sweater, slightly darker than her pulled-back grey hair. Her voice was pleasant and smooth with a slight southern accent. She had worked as a waitress, at a bank and worked at a coal mine in Fairfield, Texas, the same place she met her husband.

Together they liked to travel in an RV, go fishing and hunting, “normal stuff,” she said.  They have six cats and two dogs and at various times have kept livestock- sheep, goats, pigs, calves, pheasants. She kept the family finances and together they would chop and haul wood for heating the home. The couple has a son.

The jury seemed attentive to everything she said.

In telling her story C.L. seemed like a nice lady, the sort of pleasant neighbor you might befriend, not someone who might file a lawsuit for personal gain after hearing lawyer ads as the defense suggested in its opening statement.

C.L. was not the picture of health. Standing about five feet tall she was heavy, had suffered back pain and had surgery for a bulging disk, went to a dermatologist for psoriasis and a cardiologist for an irregular heartbeat. An ear, nose and throat doctor was treating her for Meniere’s disease, a disorder of the inner ear that causes dizziness. She told the jury she attributed many of her ailments to “getting old” even though she is just 59.

Dr. Muriel Boreham

Dr. Muriel Boreham

At some point her incontinence got progressively worse and she lived with it for about a decade before deciding to do something about it around 2005. A friend recommended urogynecologist Dr. Muriel Boreham who worked at Baylor University. The doctor diagnosed stress urinary incontinence (SUI) and suggested they could put in a “tape” so she did not leak.

Recall that a “failure to warn” is off the table in these proceedings so any questions about what C.L. was or was not told in the form of a warning was strenuously objected to. The judge sustained the objections.

What was allowed was her understanding about what would happen.

“What I understood was she’d go in and it was a fast procedure, minimally invasive, in and out with no problems” C.L. told the jurors.

But the reality was not the same thing. C.L. had to have an overnight hospital stay because her bladder had been poked during the procedure with a needle by a surgical assistant. She was told to take it easy for six weeks – no lifting, housework, no sexual activity.

“I love my husband dearly,” she said when asked, “We had a very active sex life.”

At a six-week checkup she was told there was more healing to go. Sweeping or housework was difficult. C.L. said she had pain when she moved and she didn’t feel like loading wood. Sex was painful and made her cry.  She took hydrocodone for pain. When asked, C.L. said she could distinguish between the back pain she still occasionally felt and the sharp pain in her abdomen.

C.L. never went back to Dr. Boreham but over the next three years she did visit her doctors for her skin, the rash on her hands and feet, her heart, her inner ear. The defense suggested in its open that she visited 30 doctors and never once complained of her chronic abdominal pain to a single doctor.

C.L. was asked if she complained of pelvic pain to her dermatologist? No. Why not? “Because he was looking at my feet!” she explained highlighting the absurdity of the question. Did you cardiologist give you a pelvic exam? No. Was he trained in gynecologist? No.  Your orthopedic doctor for your knee, did you complain of pelvic pain?  No. Is he a gynecologist? No.  Did he suggest a pelvic exam?  No. Did you ask him? No.

Richard Freese stood at the podium and asked C.L. if she had seen lawyer ads for mesh injuries.  Her husband did and brought it to her attention, but she didn’t do anything for several months. Eventually in 2012 she called a Texas law firm and filed her defective product lawsuit. She had never filed a lawsuit before.

The stabbing pelvic pain continued and her incontinence returned. Her sex life with her husband did not.  Eventually C.L. was referred to Dr. Philippe Zimmern in Texas. He drew on a white board the anatomy of a woman.

Freese: “Did you discuss what would happen if you did not have it (TVT) removed?

Jones for the defense:  “Objection”

Judge Goodwin: “I’m going to allow it”

C.L. : “He said if I didn’t get it removed it’s like a ticking time bomb.”

Ticking time bomb is the same expression used by attorney Henry Garrard in the first C.R. Bard case which yielded a $2 million jury verdict in favor of the plaintiff. There is consensus among mesh critics that no one can predict what polypropylene does in the body long-term.

Surgically Dr. Zimmern said he would take as much out under the urethra that he reasonably could and he discussed the general risks of surgery, scarring, infection and death. She and her husband decided that day to proceed with the surgery.

In September of 2013 C.L. underwent surgery at the University of Texas Southwestern Hospital. Dr. Zimmern remained all but the arms of the TVT mesh which remain embedded in her pelvis. Today she is not 100 percent better she said but the pain is “tolerable.”  Unlike her past, her sex life is “bearable” now.

“I have no idea what the future holds,” she told the jurors.

Christy  Jones, Ethicon attorney

Christy Jones, Ethicon attorney

Christy Jones stepped up to the podium for the cross-examination of C.L. Jones is feisty, sharp- tongued and quick, not someone you would want to tangle with. She had to be careful not to bully the kindly C.L. but in defense of Ethicon had to poke holes in her story and credibility.

C.L. held her own and lightened up the proceedings by asking Jones to use the wireless microphone. “I can’t hear as good without my glasses,” she said. The jury chuckled.

You never went back to the implanting physician Boreham about any of the issues you complain about is in this lawsuit did you, asked Jones. “That’s correct.”

You didn’t seek any doctors for what you’re here for today?  “Correct”

“I must have made a mistake when I said in my open you’d seen 30 doctors, you have 30 visits,” Jones corrected herself.  C.L. was agreeable with Jones about the correction and acknowledged one or two of the visits was with an associate not a doctor.  This was not the sort of exchange in the Linda Gross Ethicon trial in New Jersey last year where Jones drove Gross to tears and shouting, upset at the aggressive questions.

Christy Jones, Linda Gross trial, Atlantic City NJ, Feb 2013

Christy Jones, Linda Gross trial, Atlantic City NJ, Feb 2013

Jones pointed out questionnaires that C.L. had filled out upon visiting the doctor as well as anatomical drawings where she circled the areas giving her pain. C.L. agreed she didn’t talk about her abdominal pain, urinary retention or her other symptoms.

Q: “After you saw the commercials you didn’t go to a doctor to see what was causing your symptoms?

A: “No.

Q: “After Dr. Zimmern, did you see any doctor or another doctor for a second opinion?”

A: “No I did not.”

The implication was she didn’t go to another doctor she instead sought out the help of a lawyer.

On re-direct examination Freese asked, “Have you exaggerated anything you’ve testified to today?”

“No, I have not,” she said.

Monday February 17th is President’s Day. Beginning on Tuesday, the defense gets to put on its case to the jury and if Judge Goodwin keeps his promise the case will wrap up and go to the jury for a decision on Friday. Stay tuned.

32 Comments

  1. Interested Aussie says:

    Thank you Jane, awesome coverage for us all to feel like we were there!

    Without you, this valuable information would not be available. Thank you from the bottom of my heart xx

  2. Linda says:

    Great coverage and interesting facts. Thank you!

  3. Kristine says:

    Thank you for this report. My eyes are filled with tears and my heart is sad. The suffering is something no one can truly understand until they are going through it. I’m suffering. I can only imagine being attacked by an attorney who has no idea!! Hospitalizations. Pelvic pain so bad it shocks you. Butt pain that feels like you constantly have to go #2 pressure in the rectum. Groin pain. Nerve damage so bad that I wake up feeling like my muscles are severely cramped. Urethra burning and have to be on constant antibiotics. I’m sad that we have to go through this. I would wish for one of those female attorneys to have this mesh implanted and see how it feels but I’m not an evil person and would not wish it onato be on placed into anyone’s body.

    • Kristine says:

      On any one

    • Lynn says:

      Kristine, I feel your pain. I have the rectal pain, groin pain, leg pain, and sometimes right foot pain. And, now something is happening that feels like a hot burning sensation in the groin area. I guess this is nerve pain too. I am thankful that Jane is doing such a good job in her reporting on this issue. She is a voice for so many of us who are suffering and feel that we have nowhere to turn. I pray that the jury can clearly see the truth in the evidence that is presented to them. I pray for each of the victims that are having to go through this situation and telling their stories – stories that are embarrassing to have to tell publicly. And, I pray that our judicial system (jury of our peers) will work, and justice will be served as the cases are going to trial.

      • Betty says:

        I totally understand everyone here. I wake up at 3am and can’t move but have to pee and my legs are cramping so bad by then time I get to bathroom I have soaked my poise and pee is running down my legs. Sex life what is that I haven’t been able to have sex in over 3yrs. I have pains in my lower chest when I have to go and I can’t seem to get any doctor to listen. They all say it anit the mesh right. Then what the heck is it? They don’t know! What is this thing about autoimmune problems? Does anyone know?

  4. Shirley says:

    Kristine and Lynn I diffenatelly feel both of your pain and suffering as when I try to do ordinary every day house work I have to take breaks for pain in the groin area is one of the factors not to mention the pain in my legs and back. I waited two years suffering before I finally went back to my gynecologists who had put the device in during a routine surgical removal of my partial hystrectomy through the Vaginal area. I couldnt walk after having the surgery for days had so many complications but gynacologists didnt have much training with the product at the time and didnt feel the ned to investigate further why I had problems mind you this was in 2004. I went several years not knowing why I had painful relationships and my health was deteriating. Til one day I went to a foot doctor who sent me to a Pain Management doctor who after the second visit after hearing all my symptoms referred me back to my gynacologists for a follow up and during the exam she had admitted next day surgery of mesh erosion removal of TVT only to introduce a second mesh product which was a sling. The story I am getting at is in no way shape or form was I informed by attorneys on media sights to seek representation that choice came later. But this case is very important to me because I am a middle aged woman now and ten years ago I was just barely in my 40`s and feel like a lot of my life has been stashed away from me and never knowing if this product that lays dorment in my body (what was left after partial removal) is going to kill me. It is sad that these products were not fully tested on the markey before planting them inside so many women. Thank You Jane for you are an inspiration too all of us who are suffering. God Bless you! Good Job!

  5. Dawn says:

    Failure to warn is off the table 🙁 . That is the one piece of the puzzle that would have changed everything for me …. Had I been told there could be erosion in my vagina by this mesh I would have 100% had said NO to having the surgery .:( and yet that topic is off the table.. Why ????

    • John says:

      I think the failure to warn is off limits because the implanting physician had never read the brochure which contained the warning, that was the impression that I got from an earlier article. It seems to me to be a no brainer that if the implanting physician didn’t read the brochure then the implanting physician is negligent.

      • John says:

        I was mistaken, I went back and re-read, here is what it said;

        “Judge Goodwin has ruled there will be no failure to warn element of this product liability claim because her implanting physician had not read the product insert (instructions for use or IFU) since 2002”

        • Dawn says:

          Even so , just because she hadn’t read it since 2002. , why should that keep it out of the testimony ?? I feel it is very important to all of our cases. I don’t understand the judicial system I guess. 🙁

          To tell the truth, the whole truth and nothing but the truth ( unless the judge decides for himself he doesn’t want something known )……

          • John says:

            I agree with you, i’m thinking that if she read the IFU in 2002, that then is failure to warn if she didn’t present the possibilities to her patient.

  6. Mary pat says:

    Thank you Jane! Excellent job reporting. Our world would be very dark without you.

  7. Does the court allow this information about surgical mesh failures in other countries? http://www.dailyrecord.co.uk/news/scottish-news/health-secretary-alex-neils-medical-3127388

    Great reporting, Jane Akre, Mesh Medical Device News Desk! Many thanks!

    • Laura Stanley says:

      Thank you Jane for your great reporting. I just don’t see how this case is going to be won and I still don’t understand how they chose this case as a representative of a lot of cases. The woman didn’t go to doctors or complain about the pain. There are sooo many cases where the women have gone to many, many doctors and have had multiple surgeries. Why didn’t they use one of those cases? I just don’t see this case being a win for our side. This might be the one win on their side as I see it.

      • Linda says:

        Laura. I was told the plaintiff gets to pick two cases and the defendant gets to pick two. Of course J&J would pick

        The ones they Think they have the best chance of winning. They certainly won’t have any of the young women who have had the mesh erode into their colons needing colostomys, or crippling lupus from the plastic, or marriages ruined by the stress and medical bills as their pick. If this case is won it will be very positive for those of us injured by J&J greed.

      • Laura reading about CL and how she didn’t go for help because she was a private woman about her sexual relationship with her husband and her pain in her abdomen she might of had no idea why she had it and never related to her Mesh. I think she thought it was urinary incontinence was gone and she was fixed. I just had mine implanted for Rectocele within six months I had a erosion and ready for Dr to fix when I saw a info commercial on what was happening with Mesh… I never would of put it all together so soon but thank god for that commercial because the Dr who implanted the Mesh was going to resew the Mesh back in…

        • Eve says:

          I’m so sorry Virginia. I went to the second doctor who explained to me after removing the eroded mesh that more would be placed in and it was a different kind and I of course thought a “doctor” knew what he was talking about. Then the pain started really bad like someone took a steel rod and shoved it right up to my ovary. Then the leaking which I asked if it didn’t work would it be removed and was told it would work. Then after traveling one and 1/2 hours to the second doctor who will now NOT be removing any of it, I’m traveling 2 and 1/2 hours away to make sure that the third doctor doesn’t waste any more of MY life!!! Never, never, never allow ANYONE to put foreign material into you!!! This is an outrage!!! A disgusting, sickening, money making scheme that I am paying for.

  8. Jamie says:

    This certainly appears to be a plantiff approved by the defense team. With failure to warn off the table, this is going to be an uphill struggle. Judge Goodwin should allow all important information allowed. How can possibly be a fair trial?? Thanks Jane, excellent coverage>

  9. Tammy says:

    Thank you so much Jane. I believe you are the only person whom cares enough to report the truth re: mesh. I looked forward to hearing your report. We would all be in the dark if you wasn’t reporting. Thank you again and God Bless

  10. Anna says:

    I am pretty sure that the plaintiff and defendant each get to choose two cases each for bellwether. The point of the bellwether trials is to get a general read of how things are going to go and they need to see cases that represent both ends of the spectrum. We have seen the results of some of the more serious cases (big wins for the plaintiff) and now we get to see how the jury responds to this one.

    This is a great case in my opinion because if Ethicon has to pay ANYTHING in this case, then I imagine they will have to start thinking of settling. There are a lot more women out there like this plaintiff whose lives weren’t ruined but who endured pain and complications because of the mesh. The point of the MDL is to look at these individual cases to get a feel for the whole group of plaintiffs.

  11. Eve says:

    OMG I’ve seen three other doctors besides the one who put the mesh in. I’ve had four surgeries w/one or more to go. Wonder why My case wasn’t chosen. I don’t think cristy would get away w/her antics then.

  12. Sherri says:

    All of this has been my worst nightmare! I so just want my life back. As much as I mourne what was for myself and my family, I feel so bad for the women who are still being told that mesh is the best option for them. Women are still being lied to all the time. That needs to stop. I just don’t understand why they just don’t stop putting it in women.

  13. Wow! CL has certainly been through it, as have so many other women who’ve trusted their doctors. I did go back to my gyn and he told me that my surgery was fine and just gave me a script for the leakage. He promised me nothing was wrong. At that time I was already having groin pain, painful sex, as well as anal pain.

    The blasted thing is still roaming around inside me. I’ve had anal surgery to rebuild that area and that doc swore it had nothing to do with the mesh! Why do they defend one another?

    If I bring up mesh to any of my doctors, family doc included, they change the subject. The only one who listens is my Psychologist…LOL!

    Thanks Jane, it’s good to know someone is keeping us updated!

  14. Barbara Dykes says:

    Whats being ignored here is the fact that prolapse, hernias, etc. used to be repaired with stitches that lasted for a couple of decades. I have a family member who had hers repaired 30 years ago after last child. Never had a problem. This is the main reason…its a win/win for Mesh Companies and doctors. Some Doctors make a great living because the mesh is a quick procedure in comparison with the hand stitches. Mesh Makers get rich, Doctors charge large amounts for these “quick” mesh inserts so they WIN and we lose. I could feel wire in my vagina the first week after.We have to have faith in Judge Goodwin. I hope J&J has not gotten to him because he was very angry about their decade of missing documents/hard drives erased.This company has been covering their “tracks” for a full DECADE. THAT leaves me speechless. I always loved J&J products…I think of my first baby powder and all I can say is PLEASE don’t be fooled by these crooks .

    • Jane Akre says:

      Hi Barbara- The More Mesh the More Mess is the common wisdom here and a suture represents just a fraction of what is put in a mesh implant. There is a great visual somewhere ( I have to find it entered in the case) comparing the amount of mesh… there is NO Comparison! It’s apples and oranges! Maybe I missed it but I didn’t see alot about the amount of mesh in the proceedings… maybe in the closing.

  15. All Meshed Up says:

    The MAUDE data base was designed to track problems with drugs and medical devices so as to determine if investigation is warranted and a Warning or Recall is justified. In the case of Mesh (Gyno or Hernia), the one factor missing in the equation is the”Product” that is being blamed for damage or pain. The “Product” being the removed Mesh. Until there is a “Requirement” or “Mandate” that any and all Mesh that has to be removed be sent to the FDA and the Manufacturer for analysis, the MAUDE data base is useless. By reading through the MAUDE data base, referencing which ever make, model,lot# or manufacturer, the lack of the “Product” is the main reason that the majority of submissions are “Inconclusive”. If we as Mesh victims and the FDA, as our Governmental protector are trying to “discover” why so many patients are having (Clearly) the same symptoms, then a Law requiring said “Product” to be sent to the FDA/Manufacturer has to be made. Now, I know I’m just a disgruntled, old nobody with no medical training and not an expert in the intricate dance that the FDA plays with consumers and the Manufacturers, but it seems to me that when you have THOUSANDS of complaints about a “Product” you would do what was necessary to get to the facts. Well, the fact is that the FDA apparently, by it’s lack of action, does not want to do that when it comes to Mesh. If indeed it did, my Mesh, your Mesh would be under a microscope and not in the incinerator! Both Bruce Rosenberg and myself have had conversations with and have given documents and medical records to the FDA’s Office of Criminal Investigation concerning product failure and misleading advertising/statements. Among the 30 or so documents that I sent them was their own FDA letter, acknowledging my MAUDE submission. In that letter it states unequivocally “If we get 2 or 3 documented complaints about a product, we will issue a Warning about that product”. Anybody else get that same letter? I have 3 of them myself. So the FDA issues letters assuring victims of their tenacity for getting to the bottom of your particular complaint but actually do little if anything at all when it concerns Mesh. There can be no doubt about that then or now. Bruce has presented Video evidence via an Ethicon DVD that clearly shows that they were aware of and were trying to get away from the “heavy” Mesh and replace it with a lighter more pliant material. The Doctor in the video was very succinct when he said Ethicon/J&J will have a problem in the next few years because of the product Ethicon has made to be put into many patients. That evidence was and is ignored. Combine that with what you can read into the MAUDE data base and only one conclusion can be garnered, the FDA wants to keep the Status Quo to the detriment of Mesh Victim’s. Until the FDA requires the Mesh Product be sent to them AND testimony(honest) from the Doctor as to the condition of the Mesh, WHILE STILL IN THE BODY, our plight as Mesh Victims will continue. We, as Mesh Victims, will continue to be abused and lied to by the Medical community because there is no clear consequence to them until the FDA requires, by Law, to have removed mesh sent to them to be analyzed. There will be little or no consequences for the Manufacturers either, other than a small slap on the wrist and a little money to the lucky victim. And the longer they can put that off, the more of us will lose our chance at a lawsuit and the more of us will die in pain and poverty. I have little Hope that the Staus Quo will change.

    • Kathy Sabatino says:

      I agree with your findings of the FDA’s Device Adverse Event Database as being USELESS. I have tried on and off for years to list my case but cannot get the manufacture’s numbering correct, etc.

      I have tried calling only to be told to call another number, then another number until I get to a wrong number voice recorder. I hope my doctor reported it when she removed the infected mesh from my groin.

  16. All Meshed Up says:

    A quick explanation of why I believe the Surgeon, who removes a Mesh “Product”, needs include a documented description of the condition of the Mesh. I believe it would be to the Victims advantage of considering your body as a “crime scene”. Seriously. You have been and are in pain, bodily damage has and is being done and something foreign has been implanted in you. The MAUDE data base is full of “non conclusive” reports not only because of the Mesh not being sent in for analysis. If a “Mesh Product” has been sent in, usually in pieces, it too is deemed “non-conclusive” because the damage was done by the Surgeon removing it, whether or not that is the truth. How many Surgeons are going to go through the time and trouble to refute such a claim and possibly put themselves in cross hairs? So, treat your body like a “crime scene” becomes a necessity if a Victim wants to have any chance of being able to provide accurate, definite and irrefutable evidence. Diaries, friends/family and co-worker testimony and photographic/video evidence, including from the surgical room, is what is needed. Audio description along with video of the surgery, before, during and afterword of what the Mesh,organs and tissue look like is irrefutable. To me that seems the only way that the Judges are going be sympathetic to the Mesh Victim as it would the Victim of a Crime. Because that is what we are…….

    • Barbara Dykes says:

      My attorney had me take a document to my removal surgeon (had to travel 200 plus miles back and forth a couple of times before my surgery) the document was a court ordered request of all the mesh and the anchoring pieces removed and sent to my local lab as evidence. It was completely eroded according to my OB doctor here and the one who explanted it .You are right…it was a crime scene and my implanting MD told me when I complained of being “Stuck in Atlanta” with severe pain/incontinence, et…She said after exam “oh you just need a little tacking up” but I will be unavailable for a month or so. She wanted no part of the mess. Therefore had another local Gyno MD look at it and he said “totally erroded”. Then he found me a “explant” MD in Tallahassee FL who removed it. Said he got most of it out but had to leave some in because it was “in” my vaginal wall.My ‘retirement” world turned upside down. We were getting ready to travel. Its too hard to be in a car/motor home for too long. Thank you Jane for this “support” site and your hard work. It helps to vent these bottled emotions from time to time.

  17. Jean says:

    Look at the companies web sites, at all of the support these companies get, those on boards of the companies, politicians , as I saw a ex vice president with his picture of board member, On one web site they showed the names of those that gave to their companies, invested money poiticians and more in positions of authority, for favors. .

    A lot of people in power have invested money in these companies, that give support, and turn their heads to what has been done to women, lies and covering up for those that get kick backs, after all they get the money they give wrote off by government. Do you think they would allow thousands of women damaged for life to interfere with those that made billions to tell their stories of hell, and name those doctors that lied , going from one doctor to another with most cruel, How many women have read your doctors reports and seen the lies they put into your records? not the truth at all of what took place on your doctors visit trying to get help?

  18. Richard Howden (AMU) says:

    First thing I want to do is Thank Jane Akre for her reporting and extraordinary efforts to provide the news you will not get anywhere else concerning Mesh. It is through her hard work that this site is still able to provide the information your Doctor may or may not know or want you to know about what mesh is and what it can do to you. If you are reading this post and can help Jane keep this site going, I am sure any contributions would be greatly appreciated. Secondly, to Jean and Barbara, your experience with Doctors who will not get involved with a mesh complication is not just a women’s issue or one that is solely exclusive to Gynecological Mesh. Men and Women who have had Hernia surgery using Mesh have and are finding the same mind set from their Doctors. I know of one guy here locally that had a sheet of Prolene used for shoulder reconstruction that went terribly bad. We, as Mesh Victims, I believe have all experienced this disconnect from the Medical community when we start to have problems or have informed, direct questions about Mesh. I find it hard to believe that there are so many General Surgeons that do not know about the consequences of using mesh but see mesh as a “quick” fix and a profitable one, too. They go to a weekend conference where they learn the implant technique from the Manufacturer of whichever Mesh “Product” and suddenly they are making fast money. But when the “shoe drops” and you or I complain( with or without some knowledge of Mesh) they blame us for our ill’s. It’s in your head, your hooked on pain killers, it’s just scar tissue pressuring a nerve, it’s nerve entrapment so we will ‘cut’ the nerve, we will shoot numbing medication into your gut so you will not feel what the mesh is doing to you etc, etc, etc. Any of this sound familiar? Private conversations with Pathologists that will NOT get involved because they do not want to lose their jobs indicates that they see shriveled, twisted, sharp pieces of mesh all the time that have been removed from patients. But our Medical records do not indicate why the mesh had to be removed, the condition of the mesh in the body nor is there a Doctor’s report of this to the FDA or Manufacturer required. It is suggested. I almost died because of my Prolene implant. I went to the ER so sick I could barely walk and death was an almost happy thought if I could just get rid of the pain. I had to have the mesh removed is all that is said of my surgery. There is nothing in my records to indicate why it was so important to remove the mesh so quickly other than it was a necessity. This is not what I would expect of an Emergency surgery that put me in I.C.U. for 4 days. Does this sound familiar to any of you? The Doctors are not putting complete explanations or descriptions into our records which then causes us to not have a case against the Doctor or the Manufacturer of the piece of plastic that has changed our lives completely and permanently. Do they do this to cover their own Butt? Or is it systemic throughout the Medical community indicating laziness, non-comprehension or Manufacturer pressure? Which ever it is, the result is the same. We do not have a case or a chance of monetary compensation from anyone and it makes us look like we are making this all up. Again, it’s in your head. Many of us look normal to our friends and family unless they know what we are going through daily. It is difficult for the uninitiated to understand what has and is happening to us. And the fact that our OWN Doctors contribute to this via our medical records is unconscionable.

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