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*Update* Cook Medical Transvaginal Mesh Bellwether Trial Will Not Begin in May

cook website**UPDATE –  The cases of  Ailey and Lingo are dismissed and will not be pursued. The next two cases scheduled, Hovey and Watkins were also dismissed with prejudice by the plaintiffs on April 16th. 

See the So. District of WV Cook MDL page here.    

There are no further Cook Medical product liability trials scheduled.

These would have been the first product liability cases naming mesh manufacturer – Cook Medical.  The rest of story stands.  The litigation alleges the Cook mesh product – a porcine mesh- has a high recurrence rate, i.e. it doesn’t work in many women, the pig intestine leads to a latent inflammatory response in some women, infections, scarring which causes pain and dyspareunia in some women. Like its polypropylene cousin, the pig mesh is implanted transvaginally, meaning it is going through a clean-contaminated field. 

So far in pelvic mesh litigation, the name of mesh manufacturer Cook Medical has not been heard. That is about to change.

The federal court in Charleston, West Virginia, home of  more than 70,000 product liability cases, is about to start a series of trials claiming defendant, Cook Medical, produced a defective product that has injured women. Charleston was chosen by a panel of federal judges to attempt to move similar pelvic mesh cases through the courts under one judge. Cook is one of seven defendants facing bellwether trials in this jurisdiction to test legal theories.

Pamela Ailey v. Cook Group, Inc.; Cook Incorporated; Cook Biotech, Inc; Cook Urological Incorporated; Cook Medical Inc., of Bloomington, Indiana, (case number is   2:13-cv-18888) is set to begin April 20, 2015. Lingo v Cook Inc, et al. 2:13-cv-20359 is the backup case that will be tried only if Ailey is dismissed or otherwise not ready for trial.

Ms. Ailey is a resident of Pleasant, Iowa. Her mesh was implanted in Huntsville, Alabama.

Cook is one of the smaller mesh manufacturers. At this writing, there are 377 product liability cases filed against Cook Medical, Inc. that have been consolidated from around the country to this federal court in West Virginia before The Honorable Judge Joseph Goodwin.  

Judge Joseph R. Goodwin, overseeing bellwether mesh

Judge Joseph R. Goodwin, overseeing bellwether mesh trials

The action claims negligence, negligent misrepresentation, negligent infliction of emotional distress, breach of express warranty (promising safety, withholding information), a failure to warn her physician about the risks associated with the product, gross negligence for the rights of others, violation of consumer protection laws (for Iowa and Alabama, her implanting state), unjust enrichment, and knowingly marketing a dangerous medical device (strict liability). Ailey also asks for punitive damages to send a message to the company.

Her complaint is written by Erin Copeland of Fibich, Hampton, Leebron, Briggs and Josephson, LLP, Houston, TX . See it here:

Ailey v Cook April 2015 Complaint

Background

biodesign logoPamela Ailey was implanted with a Surgisis Posterior Graft July 29, 2009 to treat SUI (stress urinary incontinence) and POP (pelvic organ prolapse).  As a result, she claims she’s experienced mental and physical pain, permanent injury, physical deformity, corrective surgery, financial loss and lost wages.

This is not only the first bellwether trial for Cook Medical but is the first trial for a mesh that claims it is made from a material other than polypropylene, the polymer-based synthetic so common in hernia and pelvic meshes. Cook claims to be advancing the next generation of technology that include biologic/ device design. See more here. 

Cook claims its product are biomaterials from natural tissue sources using a porcine small intestinal submucosa (SIS) and therefore are resistant to infection and result in complete remodeling. The inflammatory response is limited to the area where synthetic sutures are/were utilized during surgery, according to Cook promotional materials.

Surgisis Biodesign Urethral Sling (510(k) approval September 23, 1999),  510(k) approval here

Surgisis Biodesign Tension-Free Urethral Sling (approved 510(k) April 9, 2002)

Surgisis Biodesign Anterior Pelvic Floor Graft

Surgisis Biodesign Posterior Pelvic Floor Graft

Surgisis Biodesign Vaginal Erosion Repair Graft (all cleared 510(k) on September 23, 1999)

All were derived from hernia products. Cook began in 1999 to market and sell products for POP and SUI. 

http://www.cookbiodesign.com/discover-biodesign/continual-improvement

https://www.cookmedical.com/data/resources/productReferences/SUR-BMRM-HFB3-EN-201407_M3.pdf?905860Surgisis  

 

Defendants Claim

The Defendants called it “A breakthrough technology, it incorporates the best attributes of a biologic graft –resistant to infection and complete remodeling – with the added benefits of moderate price, ease of use and widespread availability.” Here

Cook claims here of its Biodesign products “And unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.”

The Ailey complaint notes studies that support the product. Studies also show Surgisis Gold was inferior in aiding in the growth of fibrinolytic activity of human mesothelial cells; integration was insufficient; foreign body reaction was pronounced and shrinkage was excessive.

This is one of four cases being prepared for trial. Others include: 

Connie Jean Lingo 2:13-cv-20359

May 18, 2015 – Toni Watkins 2:13-cv-20370

June 8, 2015 – Mary Hovey 2:13-cv-18900

Last year, U.S. Magistrate Judge Cheryl Eifert ordered Cook, and two related defendants, may not “discuss any aspect of the care and treatment of a plaintiff with the plaintiff’s former or current treating physician, regardless of whether the physician is an expert or a consultant,” she said. A treating physician may not be retained as an expert in these cases to opine on their own patient unless, “those opinions were documented by the treating physician in the patient’s medical record before the physician was retained by Cook to act as an expert,” Eifert said.

Of the seven mesh manufacturers, Johnson & Johnson (Ethicon) has suffered a series of losses in recent cases and settling cases for an undisclosed amount in some instances. Boston Scientific was successful in a couple of cases in a Massachusetts courtroom before it lost a monumental $73 million case last year in Dallas. That amount was later cut in half due to tort reform but still sets a record for transvaginal mesh litigation. AMS (American Medical Systems) is in the process of settling its cases.  #

 

68 Comments

  1. PLC says:

    Jane,

    Is Judge Goodwin going to be setting more dates for bellwether trials for J&J since they kept settling

    before or during court just so there was no “bellwether “outcome??

    • Jane Akre says:

      We have the Ramirez case coming up in San Antonio in July and Edwards v Ethicon August 24, 2015 in Charleston. Cavness v Ethicon is September 21 in Dallas. Raviola v. Ethicon is in Austin, Texas Oct 26. To answer your question the Edwards case would be a bellwether. That’s all I’ve heard of so far.

      • PLC says:

        Thank you Jane. I don’t know what we would do without you.

        Your website, updates and knowledge has provided so much information and support to so many of us who felt

        we were all alone.

        Jane, Your an amazing woman! Once again, thank you for all your support

    • Thank you…I was thinking the same thing for a long time now

  2. justme says:

    Jane, thank you and please don’t go away. My family and I have come to depend on you and the other mesh family members, the for mesh victims attorneys and strangers who post here offering help, giving us mesh victims hope and up to date information. Everything in mesh world moves so slow. As women age out, health time is going to run for some of us before final decisions are made and that is so sad. Insurance companies won’t pay for the surgery, doctors won’t accept insurance, and Obama care does not pay for revisions, nor does Medicare or Medicaid.

    I was denied SS disability. I am in shock as I am so sick.

    Mesh is still not recognized as a medical issue at all by the government or doctors or the general population. It just is not. Doctors are not as educated as patients think they are and many are clueless outside of their own field of medicine. They tend to believe pharmaceutical companies over patients over contradictions of drugs and medical devices. We tell them the devices don’t work, are defective, and the doctor still listens to the company. Same thing on drugs. Doctors listen to the reps who push the drugs and doctors ignore patients when they try to tell them the side effects. Doctors are STILL writing RX’s for drugs that have killed people like Risperdal (another J&J Drug that was recalled, and doctors are still prescribing J&J baby Tylenol another J&J drug that was recalled and J&J was fined millions of dollars last week due to metal being in the children’s version of Tylenol.)

    • Jane Akre says:

      Hi Justme. I’m not going away until I see the mainstream media pick up this story and run with it. Remember, ideally we have a documentary on the issue in production. All it takes is dollars. BTW- the open letter to insurers is what we all need to present to Social Security. Being denied the first time is very common and almost always happens, no matter what the need. That’s what requires you all to get an attorney and file an appeal. The truly needy need to jump through hoops in order to weed out the loafers I guess. Anyway, here is an open letter to insurers which is the type I think is needed for social security. Let me know your variations on it and we can finesse it for SS. Thank you.

      http://meshmedicaldevicenewsdesk.com/open-letter-to-insurers-concerning-mesh-injuries

    • kitty says:

      Medicare pays for surgery. Please don’t spread rumors

    • Msm says:

      Some doctors and their office staff are telling some women that Medicare will not cover revision or removal. If that is your case, call Medicare directly and ask.

      Numbers can be found at

      Mymedicare.gov

      The doc may just not want to deal with it because Medicare reimbursement is next to nothing.

    • Carly says:

      I Was denied twice with S S and then went to court and was awarded. I Know several people on here that is on SSDI.

  3. stopmeshimplants says:

    I have got to believe these plaintiff attorney’s are prepared and have all the facts. I am praying for these women and their families that justice will prevail. I don’t care how big or small these companies are. I believe the truth will come out and these manufacturers will fall one by one. The word is getting out. Slow but sure. The more bellweathers, the more verdicts on behalf of the plaintiffs, the more news coverage. WE have all just got to believe. There is power in numbers my mesh friends! It is a challenge, every single day for many of us. But we have got to have something to look forward to each and everyday!

    • Mary says:

      This is amazing just to hear your inspiring words that we just have to believe. That is all I have is God’s promises.Jehovah Elohim (The Lord of Host) He is our God of justice and might. He will repay when evil has been done. He will restore what has been lost. I trust God, He’s all I have left. I have lost everything and everybody. During this time of mesh horror…

  4. Cindy Walraven says:

    Jane have you heard anything about coloplast cases and howany cases against them etc.

  5. jane says:

    I had mesh surgery and within 6 months started having problems within a year it had eroded into my bladder. I had abdominal surgery to remove it. This product was one of ethicons. I’m incontinent,nerve damage in my hip,depressed, and can no longer be intimate. I see where these cases are going to court one by one..when will they be settled in multiple s? This will take years for all the cases are heard. Isn’t there a way to bring this to the medias attention to get them settled sooner? The pain unbearable!

    • Jane Akre says:

      Hi Jane-

      No one knows when J&J will stop fighting women in court and instead help them. Perhaps this year. We are doing all we can to raise awareness and more and more journalists are figuring out this is a huge story! It is painfully slow though. You may need another surgery and I hope you can find competent help in your area…. There are few and far between docs who are knowledgeable… we are seeking them out. If you find out, please write… thank you. janeakre@meshnewsdesk.com

  6. I’m going next month for a consultation with Dr. Veronikis in St. Louis and I am looking at possibly a second revision surgery. I have found out a lot of information from your readers. I want to thank God for helping me find others that understand what’s going on with our bodies. I Can’t meet with you all but will be there in spirit.

    • Jane Akre says:

      No doubt you will meet others when you visit Dr. V. At least you are not alone….. Best wishes for a complete and final surgery!! You deserve it.

    • Jan says:

      Joanne, I just had mesh removal surgery with Dr. veronikis 2 weeks ago. I would be happy to give you info on my stay and surgery with him. Please let me know if I can assist.

  7. tonia christie says:

    I am at my Witt’s end I need a revision surgery my vagina is unusable I’m forced to catheter daily to avoid uti I’m engaged to be married the end of the year iv been trying to find a local doctor who can at least attempt to fix me but I’m finding that even tho they admit “something is not normal” I’m being passed around via referrals because my bladder mesh was made by ethicon ,.my latest attempt to find help has me finding a special doctor trained to preform revision surgeries ..these doctors are few and far between and hours or states away I feel pike I’m being passed around like the proverbial “buck” I’m a 46 yr old woman who wants her life back !

    • Jane Akre says:

      Tonia- You need an expert. Few doctors understand the mesh complications and pass you around as you call it. Your experience, unfortunately is not unusual. Where are you located?

      • tonia christie says:

        I live in north Mississippi I’m told Memphis has the kind of doctor I need but my insurance or At least part of it will not cover out of state doctors

      • Debbie says:

        Jane, I was reading recent posts and came upon one from Tonia Christie in north Mississippi. She is the first one I have seen from even close to my area. I too am at wits end n would greatly appreciate being able to correspond with her if possible. I am in the process of trying to locate a facility that will do the translabial ultrasound as recommended by Dr. Raz from UCLA. With what has happened to us you would think there would be more help available but as I have encountered, physicians avoid u like the “plague” when you mention the word “mesh”. Thanks

        • tonia christie says:

          Hi Debbie its true saying the word .mesh gets you a crazy look and directions to the parking lot … It has me feeling angry and while I have faith the lord will get .me thru this I can’t help feeling like I’ve been insulted when someone says I don’t think I can help you feel free to email me anytime having someone who gets it would be great Tonia at 24ktonia@gmail.com I look forward to hearing from you

  8. justme says:

    If asked, I would like to be a part of the documentary. My story is truly unbelievable.

    Kitty, one of the doctors office on this site told me Medicare and Medicaid did not pay for the surgery? To spread falsehoods would never be my intention as mesh patients are honest when it comes to what they have been through. Who would lie about something so evil as mesh?

    I was denied SSI, EBT and Disability. That was with an attorney doing the filing. I just got the first letter of denial. Thank you so much for the link for the letter. I didn’t know most were denied the first time. I am truly grateful or any help.

    Dear Everyone,

    Please pray for me on Wednesday night & Thursday morning, and I can’t tell you why yet, but I can tell you it will be the worse day of my life and for my family. We are very scared and worried.

    • Disgusted says:

      I will pray. Only God knows the torture that we and our families have endured. Others come in contact for a brief period, but they don’t really know!

    • kitty says:

      Just me. I will pray for you

      It is devastating to get the denial letter

      • addison says:

        Kitty, have you heard if the arms are polypropylene — consistent with the main body? The trocars, instruments used to penetrate tissues and muscles for placement, are stainless steel. As you mentioned, these tools don’t stay in the body; the arms remain, but we weren’t informed of material. Also, have you found more on location and what is being said about their permanency? A friend asked if any or all are anchored to my bones or very near nerves, and I’m a little embarrassed and ashamed not knowing. Thank you!

      • addison says:

        Kitty, I was referring to the POP kit discussed a couple weeks ago but am wondering about both, this and the sling. Sorry for not specifying in my first comment.

  9. Dorothy Carpenter says:

    Have faith, some surgerys do come out well. Mine was last July and I’m much more comfortable than before.

  10. Janis Urban says:

    Hello Everyone……. My Gyenecare TVT EXACT Incontinence System has been completely removed. 99.999%. Doctor Christopher Rooney, Urogyencologist, Specializing in Reconstructive Pelvic Surgery, Akron, Ohio. 88 minutes was scheduled but it took 3.5 hours. Where he thought would be difficult to remove was not.. My pubic stab incisions were placed much higher then the norm may have been why it was so easily removed. But the sling attached itself to my Pelvic Bone on the left side? I have a lot of pain from the incision but each day will get better. I have know idea how this sling was placed and why it would attach it’s self to the Pelvic Bone. But if you have a mesh implant that is dyed blue, I would recommend Dr. Rooney. Take care….and Thank you…

    • Msm says:

      The ” arms” of a mid- urethral sling are brought up through the retro- pubic space so they sit between the bladder and bone. I believe this one reason there are so many issues with mid- urethral slings. When gravity takes over what happens to that “space? Do some surgeons place it closer to bone or bladder? It is a “blind” procedure. Adherence to bone is not addressed by the manufacturers. So you could end up with a plastic sling running under the sensitive urethra and up past the bladder and bone both of which it could adhere to. Think of all of the forces and jostling that occur with daily life and with sexual activity. Is it any wonder why there are problems? Our tissues are made for that but not with plastic integrated with those tissues and possible fused to bladder or bone. This is overly simplfied and just my opinion.

      • Disgusted says:

        The sling being attached to pubic bone is not uncommon. Dr. Raz had to dig it out of my pubic bone on the left and right sides, the left side still hurts although it’s five years later. I know several women who’ve had this same issue. The fact that the mesh can embed itself in bone is scary. But I guess it goes through pelvic organs, why should I be surprised?

    • addison says:

      Hi Janis. How are you feeling tonight? We hope you’re doing ok. Praying for you!

  11. kitty says:

    It depends what kind of mrsh you have. I had pop sling and posterior.From what I learned on Jane’s Web site is we have to have transvaginal ultrasound

    MOST URO-GYNS WILL REFUSE TO DO THIS. There are specialists who do this but you have to do your research and find them.

    I had a partial for mesh erosion and now the pain is like I never had before.

    • kitty says:

      THEY Usually Attach To Sacral ligaments. My understanding is it grows onto bone.

    • addison says:

      Thank you. Is it that most specialists don’t have the necessary imaging machines, translabial ultrasounds? I read a comment regarding one used by Dr. Raz and colleagues with few in use outside of UCLA Urology. Transvaginal ultrasound machines and scans don’t seem to pick up what’s deep in the tissues. Is this always the case? For me, exposures were seen and felt, but scans didn’t show the erosions, and my doctors can’t see any of the remaining arms during ultrasounds and scans.

  12. kitty says:

    My urologist says the arms and tvt are in tact and she can feel

    Refuses TV ultrasound. All big medical complex have equiment. I believe the blue stripes in mesh are visable. Another urogynocologist refuses ultrasound. Says it does not work. Dr Raz uses ultrasound

    • Disgusted says:

      Hi,

      Dr. Raz’s exact words to me were “I had to pry it out of your pubic bone, it took a lot longer than expected.” All I know is mesh is not something to play with. The translabial ultrasound did show all the mesh on my scan. However, it just gives an approximate location. Dr. Raz is skilled enough to read them himself. I know of a few other places that do them, however they told me directly that they didn’t have the team or the experience to read them. They put a bomb on the market and didn’t have anyway of handling the fallout. Also, partial removals will cause more pain – I can attest to that. Getting out the part that hurts complicates the issues. I felt better (but not whole) after the full removal. If at all possible stay away from mesh of any kind!!

  13. bookworm1958 says:

    Is there any information on Boston Scientific and when their next trials are? I have been waiting almost 5 years.

  14. tonia christie says:

    I’ve been hearing a lot of people say that revision surgery will not stop or fix the damage already sustained by bladder mesh I’ve been trying to get answers about how many surgeries are the norm for mesh removal and if I decide not to have the revision surgery as of now I have to use A self catheter daily ..sex is out of the question pain is my constant companion but what are the chances that revision surgery could make thi ngs even worse and if I choose to keep this torture devise in my body . are there any studies of what will happen in say 10 or 15,years ..I’ve had it since 2008 and I started having trouble immediately last year my doctor did a recticil but he would not touch the mesh so again I suffered from abscesses and infections and e erything he did did not take so now I’m in worse condition than before I just want someone to say ” we can repair this mess ” will I be worse off after more surgeries? Jane akre are there any statistics about how often does the surgery make thing e end close to normal?

    • Disgusted says:

      Hi Toni,

      Seriously, in my opinion your best bet is Dr. Raz. Yes, he is older and he is willing to go to no-man’s land to get the mesh. Not too many will really do that. I could not walk – in a wheelchair – from a sling. I had a partial removal (thought it was greater than a partial), and had the worse pain ever. I had no life at all. Just pain pills, muscle relaxers and prayer to get through the day. I can now at least walk. Sex is out of the question still. I’m nowhere near my former self, but I’m not popping as many pills. If you had abscesses from the mesh, then I’d say your quality of life is awful. Get it out if at all possible. You’re always at risk for another infection from this crap. Your immune system was not meant to handle all of this. I’ve searched for studies on the removal of mesh – there are a few. However, they do not paint a true picture in my opinion. The studies I’ve found have made it seem like removals are just routine. What a lie that is. This is serious stuff. I will add that Dr. Raz states that 70% of women who had slings removed by him are much better 70-95% better. The other 30% are somewhat better to the same pain as before. If all your mesh is still in, then your chances are higher of getting better. Also, the length of time the mesh is in our bodies makes a difference. The longer it is in, the worse the outcome. I hope you get the answers you’re looking for.

    • Disgusted says:

      Hi Tonia,

      Seriously, in my opinion your best bet is Dr. Raz. Yes, he is older and he is willing to go to no-man’s land to get the mesh. Not too many will really do that. I could not walk – in a wheelchair – from a sling. I had a partial removal (thought it was greater than a partial), and had the worse pain ever. I had no life at all. Just pain pills, muscle relaxers and prayer to get through the day. I can now at least walk. Sex is out of the question still. I’m nowhere near my former self, but I’m not popping as many pills. If you had abscesses from the mesh, then I’d say your quality of life is awful. Get it out if at all possible. You’re always at risk for another infection from this crap. Your immune system was not meant to handle all of this. I’ve searched for studies on the removal of mesh – there are a few. However, they do not paint a true picture in my opinion. The studies I’ve found have made it seem like removals are just routine. What a lie that is. This is serious stuff. I will add that Dr. Raz states that 70% of women who had slings removed by him are much better 70-95% better. The other 30% are somewhat better to the same pain as before. If all your mesh is still in, then your chances are higher of getting better. Also, the length of time the mesh is in our bodies makes a difference. The longer it is in, the worse the outcome. I hope you get the answers you’re looking for.

    • Bejah says:

      I would ask others in our population to comment because my comments are subjective. I have come to believe, and what we need from eachpther is straight talk, not magical thinking….that if you do not have it removed it will probably be a death sentance as at some point something where the mesh is the catalyst or the direct cause will happen and you will probably die from that, perhaps not immediately, there may be continued pain and suffering for a couple of years or maybe a dozen years. If you do not have the removal surgery as soon as you can the mesh may become so….eeh hemmmmm…enmeshed in your tissues and bone that it cannot be removed without killing you. Someone commented earlier that her lawyer told her of classifications of settlement. I do not take that seriously and would like to know what law firm it was. But it is interesting that she states that if there were no revision surgeries one has no case. Not very funny where physicians have refused to attempt any revision surgery and that is why you did not have one. I have no doubt they would try to pull that…anything to get rid of the case load.

      Also I would ask Jane….Some of us seem to be under the impression that offering a settlement is optional for Johnson and Johnson. It is not. They can be ordered to either settle or go to court unless they can figure out a way to have 70,000 and counting cases thrown out on technicalities or dismissed for cause.

      Getting back to Tonia’s situation, if you go to a doctor who is not experienced and you should get referrals or contact numbers for doctors that are truly qualified. You know how men are, they will never tell you (OK, almost never) that they do not know how to do comething. Maybe Dr. Veronikis can refer you to someone in your state or maybe you can get an exception. Have you called Medicare to ask. Sometimes if we don’t ask we don’t know. Or maybe friends and family could help pay for the Greyhound Bus to LA so you can see the great and powerful Raz.

      Really, if you have it removed by anyone who is not the best you risk lifelong complications. It is a hard decision. Try to talk to people here who have done it and maybe seek counsel at church. Best wishes.

      • My wife had her mesh put in , in 2004 and was told that it was. New product that has a good reputation and good outcome.Soon after she started feeling pain whilemaking love ang infection after infecton along withaburning felling.After years of this we have had togive.up on even trying to make love.And she still hasthe infections and a whole lot of pain andnfections .And Doctors still look at us like we are eather makeinf it all up or are crazy though they treat her for the infection w

  15. tammy says:

    One thing here is for sure mesh got us all here but every body is different i had my night mtare start in 2010 found a doctor in the medical. Center in houston uroginocologist in2012 he new the pain i was in he removed it gues i dont even really know cause i still had pain if i had sex stoped doing that foresure this has just gotten. To the point i do not trust much of anything. Anyway isuccessful people who came from nothing pray that’s. All can do at this point. I guess this is the price im going to for now because this is dragging on i feel like forever. I need to back to the doctor but a fraid the trust is just not there anymore.

  16. tonia christie says:

    I Am so glad I found a forum for discussimg these subject when i ask my obgyn he gives .e double talk when I couldn’t urinate after a recticil surgery he told me my inability to pee without a cath was all in my head and that my bladder sling had nothing to do with it i finally went my family doctor she is a womann a blessing she is going to refer me to a doctor who.can help me she is a little lady but when it comes to her patients she will get it done !

  17. How many days a week does a fed judge work and how much a week or month does he make…..because at 3 to 5 cases a year what is he being paid for the other 360 day a year. Vacation while these women suffer.

  18. Dr. Moore and Miklos Success Story says:

    I cannot stress enough that Dr. Miklos and Dr. Moore in Atlanta are fantastic and I would strongly suggest that anyone who is remotely near Atlanta consider them. YES they do still use mesh in some cases and they were the doctors who put my mesh in and were also the ones who took it out.

    AND I HAVE HAD NO PROBLEMS SINCE THEY DID! They did the mesh as part of a hysterectomy, bladder and colon surgery. It was my second surgery for colon prolapse and I had another mesh put in by my gastroenterologist then Drs. Miklos and Moore did the second part of the surgery which included the Ethicon mesh. This was in 2005.

    Within a few months, I was having unbelievable pain, my partner could feel the mesh poking through during intercourse and Dr. Moore tried nerve blocks and pelvic floor physical therapy but ended up taking the mesh out 7 months after they put it in. He told me prior to the surgery that he wasn’t sure what he was going to find because he had never seen a mass develop so big and so quickly and he told my family when I came out of the surgery that my insides looked like hamburger meat from all the adhesions. I lost an ovary because it got entangled in the adhesions from the mesh but otherwise, I have had almost no problems since they took it out.

    I can certainly sympathize with women who weren’t as lucky as I was because the pain I endured prior to the removal surgery was intense. I cannot imagine knowing that there was no relief in sight from that.

    I hesitate to post because I know that many of you have not had the same results I had and I don’t want to sound like I am being unsympathetic. I have read that many of you would not consider Miklos and Moore because they still use mesh BUT I can’t stress enough that they are amazing, caring, compassionate and delightful people as well as excellent and skilled surgeons. The reason they still use mesh is because for many women it DOES work they way it was supposed to and their complication rate is lower than most surgeons who are not as experienced as they are. And with their experience they have seen mesh evolve from the one they used for me in 2005.

    Please don’t let the fact that they still use mesh sway you from considering them for a mesh removal.

    • Jane Akre says:

      Agreed. Many doctors I’ve spoken to still use mesh as a last resort….. simply there is nothing better on the market yet to do the job in an extreme case of prolapse with no viable tissue. Having multiple surgeries to correct prolapse is not a good solution so something stronger sometimes has to be used is what I hear. Honestly, there are few docs who do not rely on the polypropylene mesh, at least as a last resort, so I would hope people would not rule them out because of that. They are the surgeons, they have the skills and the knowledge after all, far more than we do… I think we should respect that. My thoughts.

      • kitty says:

        Is the mesh polypropylene —and is it the mesh that should not be implanted in a human body? David is correct on the need for competent Docs and informed consent. Your not doing a 360—are u Jane?

    • David says:

      I am happy, for you, that you “have had almost no problems since [Dr. Moore and Dr. Miklos] took [your mesh] out.” It is, I believe, very encouraging for the women who have also been harmed by surgical mesh to know there may still be a limited treatment option left for them too, only if it is again, now with the use of mesh. Do you think, however, that your prolapse could have initially been addressed without mesh use? You wrote that “it was [your] second surgery for colon prolapse and [that you] had another mesh put in [I understand first] by [your] gastroenterologist….So granted that the outcome of the initial surgery resulted in a surgical intervention that necessitated, in my opinion, the then responsible/unavoidable use of mesh (to address mesh complications from the first surgery)…would it also be your understanding too that the severity of your original prolapse (in 2005) warranted mesh use?

      Furthermore, do you understand that your current “mesh success” may only be temporary? – if your Ethicon mesh is made out of polypropylene, polypropylene mesh is not inert in the human body. Therefore, your understanding of “success” is not without the fact that you were unable to escape the reality, that upon initial mesh impanation, your life-time of safety was first compromised with mesh use. Honestly, for the audience here – with the understanding that none of us can turn back time…but if you could – would you have acted to have prevented the first mesh implantation (upon proactively seeking out a competent surgeon to have responsibly treated the severity of your prolapse without mesh), “thus”* avoiding this man-made, mesh “treatment” plague?…Don’t forget the FDA’s current thinking on this matter was not available in 2005.

      * The FDA stated in its July 13, 2011, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: “in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications’. (Was the severity of your original prolapse, before mesh implantation, so severe that it was an exception to the FDA’s understanding that: “in most cases, POP can be treated successfully without mesh”?)

    • David says:

      A wolf in sheep’s skin, Kitty?…Or “behold, I am sending you out as sheep in the midst of wolves, so be wise as serpents and innocent as doves” (Matthew 10:16 – the English Standard Version).

  19. David says:

    To add my thoughts…There is risk to any surgery. That being said…I think it is medical malpractice to subject any patient to an unwarranted, heightened level of device risk.

    When a surgeon is regressively trained to indiscriminately abuse a dangerously, unpredictably behaving surgical mesh device that surgeon is a threat to his/her patients. And as a result, every patient is forced to sacrifice their life-time of safety compensatory to that surgeon’s own need to abusively act out his/her industry indoctrinated training limitations. Unwarranted device risk could have been mitigated with the proper surgeon training to put the legitimacy of their patients’ needs (with ability to ethically perform non-device repairs) before the illegitimacy of their own. I agree with Jane, mesh should only be used as a last resort and NOT to address the failure resulting from its indiscriminate abuse. The infliction of unwarranted device risk, in my opinion, is not a treatment success for the patient, regardless if there is an adverse outcome or not.

    What I personally think is needed to address the danger posed to patients by the regressively trained industry surgeon are: the development and dissemination of historically relevant, responsible device use patient safety guidelines into clinical practice (via legally informed patient consent). And, to address the danger posed to patients from non-effectively regulated medical devices to: establish effective legislative control parameters around the understood least risky devices.

    • David says:

      The “development and dissemination of guidelines […] appropriate actions as the Secretary [FDA]” should, I believe, “[deem] necessary to provide such assurance” of safety and effectiveness (21 U.S. Code § 360c(a)(1)(B)) – for the clinical use of the “substantially equivalent” (“SE”) surgical mesh device – could be done via black box warnings. A black box warning, via a two-part, direct patient informed consent process, I believe, will begin to help make a “SE” surgical mesh device fit for its intended use….Or until all implantable medical devices are regulated in the U.S. to a pre-market reasonable assurance of safety and effectiveness understanding.

      • David says:

        What does the FDA think…as it would relate to POP? –“In most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications” (as stated in the FDA’s July 13, 2011, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse).

        • David says:

          Is “the risk of mesh-related complications” limited to just the POP indication for use?… Or can, for example, the majority of hernias “be treated successfully without mesh thus avoiding the risk of mesh-related complications” as well? The completely trained surgeon, not regressively trained to recklessly, indiscriminately abuse mesh, could, in my opinion, greatly help “[avoid] the risk of mesh-related complications” for their patients’ benefit. Are the medical school in the U.S. failing the American public they are purported to serve?

  20. I had a urine test that came back saying the phrase kidney atrophy I have been suffering from pain on the right side now the left side is joining in I have no sighn of infection in my kidney’s is the atrophy somehow related to bladder mesh and could someone email me contact info for Dr Riaz

  21. jane says:

    I just got off the phone with my attorney. Sad news saying Johnson and Johnson have deep pockets so it will be years before this is settled. I recently heard that it would be done by the end of the year. Sad thought that we will have to wait..and possibly die before this is settled. Why can’t this go to media so it get the attention we deserve. My God can’t someone help us?

  22. Bejah says:

    Jane, That would be sad news and I have been thinking about it…I am not sure I believe it. Could it be that they are trying to project this to discourage the plantiffs? It does not seem to my untrained “eye” to fit with everything else that has happened…the facts that tell us jury trials (No matter how exceptional) are favoring plaintiffs and some settlements are occuring. Even if this “deep pockets” scenario were true there will still be settlements. We are, of course, looking for blanket settlements so that all can move on. This kind of positioning reminds me of what I have read the NAZI’s did in 1945 when their world was falling apart. They were out of touch with reality. This organization does this all the time, they have a long history of settlements related to their “products” and build cost of failures into their business model and long range plans. I guess those deep pockets are paid for by us, and all the JNJ products we (the American people) purchase. I would like to know where this came from…was it JNJ spin doctors, who, where and when? A lot of us will be deeply saddened by this. I would be inclined to tell our people to not necessarily believe it, to take it with a grain of salt, etc. because this would be typical behavior for JNJ, to manipulate the affected public in this way. Media is for the most part owned by corporate America is it not…probably Bilderberg types or similar. In any case the high value cases would probably be an exception to the “deep pocket” strategy and the deep pockets would pay where those cases are concerned. Let’s think positive. It is our best option.

    Bejah

  23. David says:

    A patient goes to a surgeon for an opinion on how that physician would presumably, ethically act (in the patients’ mind), in an appropriate manner, to responsibly address the severity of their (that patient’s) specific disease/condition need or plastic surgery want. The principle reason, I think, inherent to why any patient would seek a surgeon’s opinion was “so that reasonable comparisons [could] be made between various treatment strategies”: (responsible, non-implantable medical device surgical/non-surgical options verse irresponsible, indiscriminate surgeon device abuse) – “to stratify for [that patient’s individual ‘disease’/condition] severity”* (or plastic surgery want) within a hierarchical, risk-based treatment stratification model (risk spectrum) – so that an unwarranted/unreasonable treatment risk could be appropriately mitigated. How is it anything but a one-sided, industry success when a “treatment” efficaciously and/or then narcissistically benefits a surgeon, while upon that surgeon’s excessive infliction of a once unwarranted past device risk, negligently compromised a patient’s life-time of safety? And, in so doing, that surgeon’s inherently negligent opinion lacked the validity of mitigating intervention “treatment” risk hierarchically – across the known historical practice of medicine treatment spectrum – because there was NO surgeon perspective-to-ability for a past, unwarranted device use….With the core problem being: Industry’s indoctrination, of mutually beneficial, one-sided, best physician practices.

    * Fitzgibbons RF Jr. (2002) Editor’s Comments in Nyhus and Condon’s Hernia 5th edn. Lippincott, Williams & Wilkins, Philadelphia, pg. 79

    Device risk is the reality; its potential benefit is of statistical probability, regardless of actual patient “benefit” recognition and/or its subsequent, then sustainability. If the insurance industry wrote polices to, however, address the statistical probability of adverse implantable medical device outcome recognitions, the elements of surgical risk would be deciphered. How is risk quantified for the surgeon verses patient? And how is a patient’s perception of that risk relevant to his/her informed consent decision?

    When a surgeon is regressively trained to indiscriminately abuse a risky, long-term/permanently implanted (L-T/PI) medical device risk is not mitigated at the threshold, of the historical understanding, for the once unwarranted patient device need. This heightening of risk, resulting from the industry’s restriction of the surgeons’ efficacy “need” – into indiscriminate L-T/PI device abuse, is not then even surgeon quantifiable upon device selection. (As it would relate to an on-label use of the 510(k) cleared device, individual devices carry with them no assessment of risk**….Therefore, even more risky, “one size fits all” devices blanket indications to “gobble-up” as much of the market share as possible.) In my opinion, the regressively trained surgeon’s only ability to mitigate the unreasonable risk resulting from his/her indiscriminate L-T/PI device abuse is through habitual preferential use resulting from one-sided, quantitative efficacy bias (individually derived). There are no currently established responsible use patient guidelines to guide, or even begin to create, ethical surgeon behavioral norms. Therefore, it is my understanding that, a current “mob mentality” rules the surgeon collective (http://www.wisegeek.com/what-is-mob-mentality.htm).

    ** To quote Peter Barton Hutt with Covington and Burling, LLP from the IOM’s June 14, 2010 workshop on The Public Health Effectiveness of the FDA 510(k) Clearance Process, in the section, Welcome and Opening Remarks – Legislative History of the Medical Device Amendments of 1976: “Not all products are created equal”….Therefore, what constitutes a device that is not “equal,” if not THE deviation outside of significant, defining, dominant device technological characteristic traits (SDDDTCT) control parameters of – the componential design makeup – of the comparative device model (which should have acted to establish safety and effectiveness)?…Not possible for “the [510(k)] predicate device” comparator.*** “Substantial equivalence” “SE” was to the next, “new” “SE” 510(k) predicate device because there was not “a significant change in the materials, design, energy source, or other features of the device from those of the [current] predicate device” (21 U.S.C. § 360c(i)(1)(B)): a fragmented device comparator (via predicate creep) without an “[evaluation of…] safety and effectiveness” conjured-up in, the span of, the “SE” predicate devices daisy-chained between.

    *** Conclusion 7-1 from the Institute of Medicine’s (IOM) 2011, FDA sponsored report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.”

    With regards to how a patient’s perception of treatment risk is relevant to his/her informed consent decision, I think, risk is quantified relevant to each patient’s perception of their own individual disease/condition’s severity. If a patient had a more life-threatening ailment their tolerance for treatment risk, I believe, would be proportionally higher than the patient viewing their circumstances as more disruptive but not detrimental to their lifestyle (their…overall happiness and wellbeing). Preservation of the organism, therefore, would logically warrant, patient acceptance of, more treatment risk as reasonable. And, while it was only upon disease/condition “classification [,…] that reasonable comparisons can be made between various treatment strategies” – a disease/condition can then be “[stratified] for severity” – to objectively, mitigate an unwarranted L-T/PI device risk, proportional to a minimization of that treatment risk.

    To illustrate this preceding point, if a diagnosed cancer patient’s condition was classified as a stage 1 (less severe) and you subjected that patient to a stage 4 treatment regime, and the “treatment” resulted in adverse harm, what purpose did disease classification serve when an inappropriate infliction of risk was not mitigated – relational to the historical practice of medicine perspective – across the known treatment spectrum? On the opposite side of the treatment spectrum, if a diagnosed cancer patient’s condition was classified as a stage 4 (a more severe, very aggressive cancer), and it was physician addressed with a stage 1 treatment regime, this administration of the other extreme of the treatment hierarchy – without balancing benefit – would, in my opinion, also be physician medical malpractice. Why progress medicine if not to understand the infliction of an unwarranted past treatment risk and to scientifically hypothecate future preventable/avoidable harm? (“Insanity is doing the same thing over and over again and expecting different results” – Albert Einstein.)…

    An industry’s efforts cannot be understood as “innovation” for innovation’s sake! How is a man-made “treatment” plague even a “public health benefit” when patients are systematically denied (via current best industry practices) the risk-mitigated treatment benefits from past, once efficaciously viable–ethically surgeon performed, non-device surgical repairs? The unwarranted, very avoidable patient harm which results from the regressive training of a surgeon to abusively act out their own best practice of medicine with premeditation – upon dangerous, indiscriminate device abuse – is NOT reasonable, regardless if contextually, responsibly innovative. Patient exploitative standards of care, therefore, serve to insulate the surgeon co-perpetrator from medical malpractice liability, so a surgeon can continue to carryout own best, one-sided practices, without greater scrutiny, other than the review of the equally primitive, patient exploitative, peer collective.

    As it would relate, specifically, for surgical mesh indicated for the treatment of POP/SUI, in the American Urogynecologic Society’s (AUGS) March 26, 2013 Position Statement on Restriction of Surgical Options for Pelvic Floor Disorders, it stated: “[AUGS] strongly opposes any restrictions by state or local medical organizations, healthcare systems, or insurance companies which ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders.” How is it even possible that without restrictions (contraindications) on current, habitually dangerous, indiscriminate surgeon mesh abuse that any “SE” mesh device can be understood as “reasonably safe and effective” for its industry intended use, per its standard of cares? (Or, until every L-T/PI medical device’s real-world use is “framed in” by contraindicated, risk-based reasonable use patient safety thresholds, to balance patient treatment benefits, via efficaciously viable alternatives, across the patient effectiveness spectrum?) Why would all “SE” mesh devices NOT BE defectively designed, via their inadequate labeling, without accompany black box warnings?…And when still left unreasonably dangerous – upon 510(k) clearance – to the “SE” predicate/preamendment mesh device never even first FDA approved for safety and effectiveness understanding? An industry’s past ability to cover-up current, deceptive, rampant/systematic, premeditated patient exploitation, upon predatory infliction of unwarranted, excessive L-T/PI device “treatment” risk, is NOT evidence of safety and effectiveness!

    Again from the AUGS’s March 26, 2013 Position Statement: if “a complete restriction on the use of surgical mesh was not the stated intent of the FDA safety communication” (#1), and if it is indeed the case that “in some circumstances transvaginal mesh for pelvic organ prolapse may be the most appropriate surgical option” (#4), these statements would appear contradictory when “[AUGS] strongly opposes any restrictions”….(This is incoherently relatable black-and-white thinking….It is delusional to, the reality of, a the recognition for a patient effectiveness paradigm where unwarranted L-T/PI device risk is mitigated.) What specifically is AUGS apposing? To me, it appears that the real problem for AUGS would be if restrictions were imposed by “state or local medical organizations, healthcare systems, or insurance companies,” in an effort to propagate future, real-world, responsible surgical mesh use for the benefit of those women not currently implanted with mesh. Restrictions, I believe, would be very disruptive to this industry’s intent, because as #2 states: “[decisions] on surgical alternatives should be made by the patient and her surgeon”. What competency does the regressively trained, industry indoctrinated surgeon have to not victimize a women (a person) with indiscriminate surgical mesh abuse? And, what alternatives are left for patients? –No treatment = very narcissistic and industry immature.

    As #7 states: “instead of a ban on mesh we recommend the implementation of credentialing guidelines so that mesh procedures are performed by qualified surgeons,” how would the “implementation of credentialing guidelines” even address the known mesh dangers (the unreasonable risks) subjected to past women from this current surgeon infinity to collectively act out their abusive training limitations? In my opinion, this very avoidable patient harm is a direct result of a current, industry-wide, negligent failure to even recognize reason for disease or condition classification. And as a result, no “…reasonable comparisons can be made between various treatment strategies”. (Very primitive mentality playing out here–permeating from the repressiveness of the collective surgeon consciousness: surgeon need before patient need = reality on industry’s terms. Industry’s effectively tailored surgeon marketing campaign – following its regressive surgeon behavior norm indoctrination – seceded in filling in the holes smeared over its distortion of reality. With reality being: a non-device surgical alterative deprivation benefit for patients. The fact remains: the surgical mesh industry cannot predict the known injurious, predictably foreseeable, therefore, understood: dangerous performances of its “SE” devices in any patient’s body. And as a result: its “SE” devices are neither safety nor effective and are unreasonably dangerous for their current clinical use as labeled!)

    Could the solution be as simple as, instead of the “implementation of credentialing guidelines,” for presumably even more reckless, indiscriminate surgeon surgical mesh abuse: the ethical, industry-wide “[recognition] that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications”?**** And, that every potential surgical mesh recipient (women in this example) should be directly informed independent of a surgeon’s ability to try to convince them (behind closed doors) of this (FDA understood) illegitimate mesh “need,” via omission of the benefits from non-surgical options and/or patient appropriate non-mesh surgical alternatives (relevant to a individual patient’s disease/condition classification) which the regressively trained surgeon cannot even competently offer/perform. (This industry orchestrated “monkey see monkey do” surgeon training outcome – to fixate a surgeon’s own best, one-sided practice on reckless, indiscriminate L-T/PI medical device abuse – is failing the greater society at large….Not to mention the grave disservice to future surgeons paying for an education which regressively trained them to put of their own, artificially industry erected needs before their patient’s actual needs: the indoctrination of the regressive surgeon mindset to the demise of a civilized society.)

    **** As stated in the FDA’s July 13, 2011, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication

    In my opinion, if IT WAS the intent of a society of leading industry manufacturers and its unjustly enriched physician collaborators to continue to exploitatively maximize it one-sided benefits, they would issue a position statement strongly opposing restriction of surgical options ON surgeons.…With end result: NO non-device surgical option left for patients unless the reckless, indiscriminate surgeon abuse of surgical mesh…via an industry’s control over the regressively trained surgeon co-perpetrator, left alone (undisrupted by outside controlling facets) to follow his/her self-purported “gold-standard of care”….Or practice medicine in a way that best, efficaciously benefits them regardless of this historically, FDA understood, unreasonable risk premeditatedly inflicted onto past women implanted with mesh….(Our society of the few has decided: it is “reasonable” for our own, one-sided efficacious restricted benefit, to adversely victimize the totality of the patient population at large–targeted by our infliction of this “public health benefit” = an excess infliction of unwarranted, injurious “treatment” risk on the many.) What else would an industry do when choosing not to establish Responsible Use Patient Safety Guidelines (RUPSG) for the benefit of future patients but cling to a distortion of reality on its own terms?

    Why does the global medical device industry refuse to come to the table and address the outcome of it past, one-sided, self-serving efforts which resulted in this current widespread, systematic surgeon exploitation, of unsuspecting patients, with indiscriminate L-T/PI medical device abuse? Truth be told: This industry’s greater good will not be served when its profits are allowed to be restricted by legally recognized patient informed consent, via effective pre/post-market legislative control parameters. And, it is thereby, prevented from preying upon the vulnerabilities of more, future unsuspecting patients — to further maximize its own, one-sided, self-serving benefits. THE GREATER GOOD OF A CIVILIZED WORLD MUST COME BEFORE AN INDUSTRY’S INTENT TO PREDATORILY TARGET ITS CITIZENS FOR UNJUST ENRICHMENT!

  24. Scott blythe says:

    Did cook settle this case before trial?

    • Jane Akre says:

      The first two bellwethers were dismissed by the plaintiff, why I do not know. May 18th is Toni Watkins v Cook Medical in Charleston WV…. might be a good case to attend if you can…. June 8th is Hovey v Cook Medical also in Charleston WV.

  25. elaine b says:

    i had cook biologic mesh if i had been informed it was part of a pig i would have refused i have leakage pain 24-7 no sex since 2011 depression aaround eachbcesses no insurance and have to drag myself do not understandthe problem companies should beresponsible for womens medical bills thanks for your blog thx beb

    • Jane Akre says:

      If you’ve had problems, I hope you have a lawyer to help offset some of the costs associated with your pain and suffering…

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