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Boston Scientific Wins First Pelvic Mesh Trial

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

After a two week trial, Boston Scientific won its first product liability trial over transvaginal mesh. The jurors returned the verdict around 5 pm Tuesday, July 29.

On March 9, 2010, Diane Albright received the implant made by Boston Scientific – the Pinnacle Pelvic Floor Repair Kit.  According to her complaint, Albright suffered mesh complications including mesh erosion, infection, and chronic pain, among other complications.

She alleged the polypropylene mesh implant was defective in its design, manufacture and construction, the warnings were defective and that the Pinnacle did not conform to the warranty promise by Boston Scientific.

The trial went to the jury Monday after closing arguments. The jury rejected the defective product argument and decided that users received adequate informed consent. Eleven of the 13 jurors  had to agree to the questions in the Boston Science Verdict Questions.

There are currently 12,804 similar cases filed in federal court in Charleston, West Virginia and almost 63,000 product liability lawsuits filed in the same federal court against six other manufacturers.

This state action was filed in Middlesex Co in Massachusetts, where Boston Scientific is headquartered.

The defense reportedly brought two witnesses forward – a scientist who did animal studies on the mesh and an ob-gyn.  The plaintiffs survived a directed verdict motion on design defect and failure to warn.

Albright was represented by Fidelma l. Fitzpatrick and Jonathan D. Orent of Motley Rice.

Bloomberg reports (here) a Boston Scientific spokesman said:

“We are pleased with the outcome,” Denise Kaigler, a spokeswoman for Boston Scientific, said in an e-mail. “Patient safety is of utmost importance to Boston Scientific and we dedicate significant resources to deliver safe, high-quality products.”

The news source says the next vaginal mesh trial for Boston Scientific will be held in state court in Wilmington, Delaware.

The Pinnacle Pelvic Floor Repair Kit is no longer on the market in the U.S.

On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

 

First Lost Action

This represents the first transvaginal mesh trial that has been decided in favor of the defendant.

In February 2013, nurse Linda Gross was awarded $11.1 million in her product liability case filed against Ethicon, a division of Johnson & Johnson.  See background here.

C.R. Bard lost its case in a Bakersfield, California state court to Christine Scott who alleged permanent mesh-related injuries.

In the same Charleston, WV court, Donna Cisson won a $2 million jury award against Ethicon and in Dallas

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

earlier this year, Linda Batiste was awarded $1.2 million in her case against Ethicon. See background here.

Last year, the Queen case against C.R. Bard settled on the  day trial was to begin. See background here.

The Lewis case (Ethicon) did not survive a directed verdict motion filed by Johnson & Johnson and granted by federal Judge Joseph Goodwin.  (background here).

The Complaint

Albright did not, according to her complaint, receive any informed consent about what could go wrong or mesh injuries which was “negligently designed and manufactured,” according to her complaint.

Neither Albright or her doctor were warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse. She was diagnosed with a recurrent cystocele.

The complaint said Boston Scientific should have known about the complications associated with its product, according to the  Albright Stamped Complaint

Those complications include the design and manufacture of the mesh, the raw plastic edges made of polypropylene, a polymer plastic that incites immune and foreign body reaction. The transvaginal placement introduces bacteria into the body; the biomechanical issues that result from the bio incompatibility of plastic mesh and delicate tissue; the pelvic mesh anchors placed too near major nerve routes; and the degradation of mesh over time.

*New- Still Ahead

August 11, the same court will be the setting of the next pelvic mesh trial, Cardenas v. Boston Scientific.

The plaintiff attorney is Michal Appel of Sugarman Rogers of Boston.  Here is his link

http://www.srbc.com/SRBCTeam/AttorneyBios.asp?id=14

 

87 Comments

  1. sandy says:

    This is sad very very sad

  2. Donna Hart says:

    How could they rule that the product was safe when they themselves sent out a warning about it and then recalled the product? This happened over a year after she had the implant placed. What am I missing here?

    • Jane Akre says:

      They ruled it wasn’t defective…. slightly different than saying it’s safe… a distinction without a difference but that is legal lingo…

  3. sandy says:

    Can someone please tell me how this jury came to this verdict when all others have been in favor of the plaintiff? What do the deem enough informed consent and how can they say these products are not defective when there has been a ton if evidence that they are defective and harmful to the human body. Women are not making up the pain they have experience d. Please someone explain this to me!

  4. sandy says:

    I agree Donna there’s something wrong here you almost wondering about jury tampering

    • msm says:

      If BS employs a lot of the people in that area and they see BS as vital to sustaining the local economy, how could that jury be impartial?

      • liz says:

        You got it. Unfortunately Motley Rice was very stupid to file that case in state court. It should have been filed in Federal court like most others. I bet your not patting yourself on the back this time Joe.

  5. msm says:

    What were the judge’s instructions to the jury and how do they differ from instructions given to the jury in other cases where the same or similar complaints were filed and evidence presented. Did the attorneys rest on their laurels of other verdicts and not present the case as well as it could have been? Only a full transcript will tell. Unfortunately, the recall was for a problem that didn’t occur in this case. But, how could a jury look at the injuries and not see that the mesh is the cause? Or did it come down to informed consent only? Did her surgeon testify that he warned her and discussed alternatives? If so, the attorney should have known beforehand if that would be the testimony. Somebody dropped the ball, in my opinion.

    We know the truth because we live with mesh everyday. So many things can be twisted in a courtroom. So many technicalities and legalese. My heart goes out to her and it brings tears to my eyes thinking of the devastation of the injustice done.

    • Kitty says:

      How could mesh eroding thru the vagina not be defective. Maybe we need to say “placed in a defective manner: Tell me—– are the Doctors that were listed on a previous blog in consult with the defense ie Dr Dennis Miller et al.

      • Kitty says:

        Just as i suspected Dr Dennis Miller and Dr Vincent Lucente attended the 2014 AUGS conference in Wash DC this past week July 22-26 with big sponser Boston Scientific and AMS. A Cadaver workshop was on the menu. “Head em in –roll em out rawhide”. . Whoa to you all of little faith.

    • Jane Akre says:

      MSM- jury instruction sheet is now in the story!

  6. kristine says:

    I am disgusted at the out come of this trial. I feel a big loss for this woman. I was never told by my doctor the complications of transvaginal mesh. I was never offered another method of surgery like using my own tissue. Mesh Has caused hell in my body . My life will never be the same. My urologist denied that mesh was causing my problems. I found out differently . Its not fair that I can’t have sexual relations with my husband . I can’t sit right anymore I can’t stand . Muscle cramping. Hip pain. Pelvic pain . Buttock pain. Nerve damage. A feeling like I’m in labor having bad cramping in my abdomen. Infections. Hospital stays. I have been through hell and back so, I will pray for this lady that some how some way she gets the money she needs and deserves. God bless her.

    • Kitty says:

      I read the Albright stamped complaint and I guess I can see how she may have lost the case. It was a global report about all the damages of various women and FDA reports el al. Why didnt it describe the injury and describe her pain and ber specific about her inuries. I am so disgusted and about this.

      • jade says:

        Kitty – Totally agree. This complaint was stamped March 8, 2011 – maybe at the height of the frenzy for lawyers to register clients! Anyway, it said NOTHING specific re: Albright – and the Complaint was filed by two well-known Motley Rice attorneys! She was almost surely set up to lose. This was 100% a Defense case – it was a slam dunk for them. I also agree that it’s hard to get a fair trial in MA if the defendant is a corporate giant in that state, as well. Think about it. How many Jurors know about the revenue brought into their state by BS; worked with or know someone who works for BS; has a friend or relative who benefits from BS. This poorly represented woman from Ohio comes after their treasured “GOLIATH”! How could she??? Bottom line is that her Complaint was vague, weak and poorly executed. Yes, and I also do think that we, as victims, are being setup to think our claims are not worth much. Afterall, what price would the World put on a woman who has “served’ her purpose by birthing and raising children and is now “over the hill” in comparison to a young, sexy woman without pain? Take a look at advertising – you won’t see many older women depicted as a younger man’s girlfriend – quite the opposite!

    • only 29 says:

      Now just imagine you’re pregnant.

  7. Mary pat says:

    Remember everyone, Motley Rice sold out their AMS clients so their law firm will get paid big bucks knowing full well that their clients will get little to nothing. Is it any surpriise that Motley Rice ran this case into the gutter? They probably gutter balled this case hoping to discourage their other clients into accepting the paltry settlement they negotiated. Scare tactics? Shame on Motley Rice!

    • msm says:

      It sets up BS to offer a ridiculously low global settlement scares women to accept ANY amount in a settlement. It may also affect the acceptance of offers currently on the table by other manufacturers. ALL of it serves to benefit all attorneys. Would a case worth 1 million be sacrificed for settlements worth 300 million? Interesting timing. Diane deserves the 300 million for the heartbreak of this decision and the life of pain and suffering caused by this material that is not compatible with human tissue.

      Also, does the FDA have an approval application from BS outlining and reporting the results of these alleged animal studies? Did they actually receive FDA “clearance” rather than “approval” because of these studies? If those studies existed and resulted in data proving the safety and efficacy of the mesh (as opposed to the polypropelene sutures) then wouldn’t they seek full pre-market approval? By law, that would have protected them from later liability. I would really like to read the detailed studies and see the others involved. No study is conducted by just one “expert”. The documentation must have been submitted into evidence.

    • Kitty says:

      That is an interesting thought. Big guys don’t even know how to present the poor womans case.

      • Kitty says:

        My Question: Can Albright appeal her case? Can she get a different attorney and present this in a different light?

      • Kitty says:

        Pam Perhaps Jane is concerned that you are very outspoken and very angry for what has been done to you and others by Drs,m nurses and big companies. . I believe she took one of my comments off too. Just continue being yourself and don’t worry too much., You are getting paranoid like me —we don’t know if some one is an informant or whatever. Take care Pam I hope I can meet you some day. We will be passing thru Tennesee to get to Daytona on Aug 16. I will think of you and hope you will find healing just like me. Kitty

        • Jane Akre says:

          Kitty– I’ve never removed your comments…. I have edited “Pam” because she got vulgar… and she goes on Waayyyy too long, but I do not edit her. Editing is something that must be done sparingly in my opinion… otherwise you are accused of “why did you edit this” and “why not edit this” It is a no win. And I figure people can all learn from each other. In other words, err on the side of disclosure. I may have to reconsider that. As long as people are civil, that’s how I see it. Thank you~ your editor, ja

  8. Renee says:

    How could this be? Something about this isn’t right. Is this the end of the plaintiffs options?

  9. Jane says:

    Something is not right here. Didn’t BS pull this product off the market themselves?

    I could be wrong but that’s what I thought. Regardless, isn’t that saying the product

    was defective.

    I’m just in shock. If Albright was the only person filing a claim I could understand this.

    So now BS is going to offer a BS settlement to claimants. Watch.

  10. only 29 says:

    Is there anyone who had the mesh put in and then became pregnant?

    • msm says:

      This is from Boston Scientific. Please print it our and take it to your doctor. He should know your concerns and this might remind him of contraindications. You should be sure to discuss this with him.

      http://www.bostonscientific.com/templatedata/imports/HTML/PFI_Patient/mesh-faq.html

      • Jane Akre says:

        MSM- That is outstanding…. great research! How many people would consent if they had this info first and were told there was a 20-30 percent chance it could happen to them!

        • Jane says:

          If I had read the BS information on the sling before scheduling my surgery, I would not have scheduled.

          I did research online for many hours before the surgery looking for reviews and/or complications.

          This was in 2008. There was one woman I think that had problems.

          And because nothing was reported, I had my surgery.

      • Jane Akre says:

        Cancer should also be a contraindication I would imagine.

        • msm says:

          There are many more serious contraindications than I realized. Some of which should preclude mesh being implanted in anyone who is fertile, in my opinion.

        • Paula LeCompte says:

          Jane,

          YES!! Cancer should be a contraindication!!! I got breast cancer! There is no breast cancer in my family! Mine was estrogen driven, high grade (very invasive and very aggressive)! My attorney, Jonathan Orent from Motley Rice (the very one who represented Diane Albright) told me late last year that there had been several studies done connecting mesh with breast cancer. These studies were to be published in medical journals in January. They weren’t. When I asked him the reason, he said they have been delayed publication indefinitely. hmmm! I asked him the reason and he said we both know why and he was going to work on proving it. I have emailed him many times about the issue to no avail. Finally, the last email I wrote, I demanded a copy of the studies. I still haven’t heard from him.

          • Jane Akre says:

            Hi Paula-….That is the next frontier isn’t it….connecting the dots on why so many autoimmune issues are connected to mesh. Is it the polypropylene, what it’s treated with or what it erodes into.. That is the 64 billion dollar question. Not unlike tobacco which was treated with so many chemicals it became a chemical soup linked to cancer far beyond the simple tobacco leaf. All it takes is millions of dollars and a solid scientific plan to go into uncharted territory…. which law firm will be willing to go there? When will that happen? You can’t blame them for not want to spend 20 million, let’s say, with no guarantee of results.~ ja

      • stopmeshimplants says:

        This is such important information. Thank you msm. I cannot believe the precautions and the warnings included on this link Never, not once, was I ever informed of any of this prior to my surgery. I wish I had this information years ago prior to my surgery. Still, I am dumfounded as to how these manufacturers can continue to market these products and doctors still implant them today. So wrong and so disgusting for all.

    • valencyspeaks says:

      Yes, I got pregnant and had a baby after I had the J&J Prolift implanted. It was the most hellish 9 months of my life. The only safe option for delivery is a planned c-section as early as possible. If you are pregnant and your doctor has any questions, please have her call Dr. Christine Isaacs at VCU Medical School in Richmond VA. She is the one who cared for me during my pregnancy and will be able to help your ObGyn with understanding the risks.

  11. terri white says:

    I promise you there is more to this than you could ever began to believe. Ms. Albright just got thrown under the bus. By the way what is 40% of 830 million ?

  12. msm says:

    I have noticed the delay in Bellwether trials and that most settle just before the trial. There are other cases in line if a settlement occurs, but that is at a later trial date and then that case is settled right before trial as well. On and on it goes. During this time, the company gets to see how the verdicts are going in cases outside of the MDL which do not affect the MDL cases.

    So, instead of trying cases chosen by both sides from the pool of MDL cases and those cases being approved by the judge as representative, they get to see other cases tried that have no effect on the MDL cases. They also get to work out their strategy based on evidence presented in those trials.

    So what is the use of having bellwether trials scheduled other than to delay the whole process. The companies know they’re going to settle that case before trial date. It’s a logical (though unethical) strategy.

    How many bellwether trials have actually taken place in the MDL’s? How many have settled right before the trial? How many years has it taken? Just curious…

  13. David says:

    This issue needs to be correctly framed as a human rights abuse. The right of each and every patient to legal consent to the reality – that they are willing to sacrifice their life-time of safety, compensatory to the device industry’s success in regressively training a surgeon to prey upon the vulnerabilities of their patients, must be recognized. Current U.S. laws are not setup to recognize patient rights; they function to unjustly enrich the profiteers, who exploited opportunity, upon predatorily undermining the rights of others.

    • Jane Akre says:

      Well said David!!!! Thank you.

    • Kitty says:

      The training was on going at the AUGS convention July22-26 2014 in Wash DC. They were literally training Drs to implant mesh in a cadaver—here–right now in DC.

      • msm says:

        The Fellows’ Cadaver Course is supported by:

        AMS

        Boston Scientific

        Medtronic (just bought Covidien who supplies mesh to Bard.)

        SURPRISE ! SURPRISE !

  14. msm says:

    From BS Patent filed in 2002:

    “The crevices and voids of the surgical mesh may harbor bacteria or other pathogens that contaminate the surgical mesh during implantation. Following implantation of the surgical mesh in the patient, the bacteria or other pathogens harbored in the mesh are introduced to the anatomical site where the surgical mesh is implanted. Typically, the anatomical site being repaired is poorly accessible to antimicrobial drugs applied intraoperatively to combat bacteria or other pathogens that may be picked up and introduced to the anatomical site during the surgery to implant the mesh.”

    Here’s the whole article if you have the patience to read it:

    http://www.freepatentsonline.com/6936052.html

    From AMS patent filed 2001

    “Because the tension of the sling is an important part of the sling procedure, surgeons will nonetheless attempt to adjust the tension of a sling even after the sheath is removed. TVT mesh is elongate, substantially flat and elastic. […] Under excessive deformation, the holes of the TVT mesh become significantly smaller, and risk deterring tissue ingrowth. Without tissue ingrowth, the potential for infection is believed to increase. In the excessively deformed state, the edges of the mesh tend to curl up and present a relatively sharp, frayed surface. In this curled or deformed state, the edges of the TVT mesh present sharp surfaces that can readily abrade or otherwise damage adjacent tissue such as the urethra, bladder or vagina.”

    AMS claims that its mesh has large pores making it less susceptible to infection, but here it is clear that the pore size can change depending on the tension. Did docs know this?

    http://www.freepatentsonline.com/6802807.html

    Both of these patents are for instruments used to implant the mesh but it clearly demonstrates knowledge of side-effects that I have not read before in any publication for M.D.’s or patients. I encourage anyone with time on their hands to explore the patents further. I was actually hoping to find evidence of the animal studies but have not yet.

  15. msm says:

    “Specially Assigned Transvaginal Mesh Implant Cases”

    What exactly does that mean. Why are these cases all being tried on BS’s home turf rather than a neutral venue? Seems that would be reason enough to appeal the decision to a higher court. Oh wait….the attorney has more incentive not to appeal.He is on th Plaintiffs’ Executive Committee so he also gets paid for that. His big money comes from clients agreeing to settlements. Or was there an agreement of both sides to try the cases close the BS for their convenience? I would think there would have to be a court order to that effect. The web gets more and more tangled….

  16. Terri says:

    Now, I am certainly not an expert, but if you go down each section on this recall, the FDA determined cause DESIGN (DEVICE DESIGN) Now, Sure sounds like to me that it’s a design defect.. So, could this information have been barred or withheld from the Jury? Something smells here!

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100416

    • Terri says:

      OK, if Albright’s device was not part of these specific lot numbers, that would be the reason it wasn’t brought to the attention of the Jurors.Since it wouldn’t pertain to her Device / Case. Each Device has a specific lot number- Expiration Date etc. ( 3 year shelf life I believe for most, but meant to be a permanent implant in our bodies) makes perfect sense right?

      Class 2 Recall

      Pinnacle Pelvic Floor Repair Kit Anterior/Apical, and Pinnacle Pelvic Floor Repair Kit Posterior see related information

      Date Posted August 03, 2011

      Recall Status1 Terminated on November 15, 2011

      Recall Number Z-2931-2011

      Recall Event ID 58852

      Premarket Notification

      510(K) Number K071957

      Product Classification Mesh, Surgical, Polymeric – Product Code FTL

      Product Pinnacle Pelvic Floor Repair Kit–Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit–Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

      Code Information Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.

      Recalling Firm/

      Manufacturer Boston Scientific Corporation

      100 Boston Scientific Way

      Marlborough, Massachusetts 01752-1234

      Consumer Instructions Contact the recalling firm for information

      For Additional Information Contact Cindy Finney

      508-683-4678

      Manufacturer Reason

      for Recall The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

      FDA Determined

      Cause 2 DESIGN: Device Design

      Action Boston Scientific Corporation sent on May 10, 2011 an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678.

      Quantity in Commerce 540

      Distribution Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.

      Total Product Life Cycle TPLC Device Report

      1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55

      2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

      510(K) Database 510(K)s with Product Code = FTL and Original Applicant = BOSTON SCIENTIFIC CORP.

      • Kitty says:

        Terri—-Thanks for the info—-but for most of us this mumbo-jumbo—-Also David what do you mean “Framed the response” ?

      • msm says:

        The reason for the recall wasn’t alleged to be the cause of her injury in court. If I understand correctly, it was a problem with the connection of the needle that is used to pull the arms of the mesh through at the time of implantation. The surgeon would have to either start with a new product or (most likely) reconnect the mesh to the needle in order to pull it through again.

        “Manufacturer Reason for Recall:

        The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”

  17. David says:

    In regards to the trial outcome –not only was it unjust, but what I think will be understood by the Plaintiff’s attorneys, for why this miscarriage of justice happened, is that the Judge Goodwin also “framed” the Defendant’s argument to illicit the jury’s response.

  18. David says:

    I think it should be considered if there was any meaningful difference in jury instructions between the previous trials.

  19. Jane says:

    I don’t know if anyone saw this article. It’s old. But Dr. Nygaard was the doctor I saw when it was discovered that I had mesh erosion. It’s pretty much saying the mesh slings are all faulty.

    http://www.nbcnews.com/id/43886793/ns/health-health_care/t/risky-pelvic-mesh-highlights-worries-about-fda-process/#.U9mKnuNdUTI

    • Jane Akre says:

      Hi Jane… readers of Mesh News Desk also know the SUI mesh has as many problems as POP mesh not to mention hernia mesh… its all polypropylene! Thank you.

  20. Nikki says:

    I’m starting to wonder about Judge Goodwin… Am I wrong?

  21. jade says:

    This is who “owns” AUGS and regulates their decisions. I don’t think these corporate sponsors of AUGS would be happy if the came out with a pro-mesh victims policy since they are funding the organization!

    http://www.augs.org/p/cm/ld/fid=24

    • Kitty says:

      Go to AUGS convention site and look at a list of their breakout sessions—It appears that they are innocent Choir boys and girls that care very much for their patients

  22. jade says:

    Judge Kottmyer is a State employee and a Politician, as well, in the State of Masschusetts. I’m sure she is keenly aware of the monies contributed by BS to the State and to the State organizations. BS is a major player in the MA economy and a major contributor to health, education, community organizations within the State. No political figure in MA would want to put a black mark on their career by offending Boston Scientific. Kottmyer chose a Defendant’s case to put on FIRST – and, of course, that would be the Plantiffs’ WEAKEST case – ensuring a huge psychological blow to the mesh victims. And, as stated above, quiet possibly a perfect segway for Plantiffs’ lawyers to lower victims expectations of compensation without appearing to be the “bad guys”! If this scenario is true, or even partially true, we are being lead down a “no-win” path by those we have entrusted with our cases. Judges will receive a thumbs up from their corporate giants for behaving the way they are suggested to; Plaintiffs’ lawyers will be paid millions, if not billions, in settlement percentages; and we, the mesh victims will be left with literally no monetary compensation nor avenues of hope for all our years of suffering and hard work on supplying our lawyers the paperwork they need. We, the mesh victims, are FAST becoming the stepping stones of one of the largest industry/physician/legal conspiracy in the history of this Country!.

    • msm says:

      Well said. Isn’t there a higher authority to appeal to? Someone to review the entire lawsuit labrinth? Review all action of judges in all cases and review the transcripts of the instructions to the juries. How was “adequate warning” defined? And “design defect”? While details of the cases may be different, those definitions should be standard for all cases and across all courts. There is no reason for them to vary. There has to be someone watching the hen house besides the foxes.

  23. Kitty says:

    Hello Jane Akre—-The comment that disappeared was short—perhaps I forgot to press send. That is the only one that was missing—-shortlyafter that I was getting messages from Pam that had my name as the sender. It didn’t happen again (forgotten) and PAM—yes I know all about Clifton Clowers—Your going to climb upon that mountain and your gonna get the one you love–(what?) dont get it though —don’t freak out on us Pam Luv Ya

    • Kitty says:

      Pam your in good form today–and yes I do know that Clifton Clowers was “mighty handy with a gun and a knife” (ha ha) Stay Happy. I didn’t realize FDA went thru—I and some family members sent comments CONGRATs to Jane A and all !! “WE Will Survive”

    • Kitty says:

      I miss you Pam—-we were so miserable together Hope you are all right.

  24. marilyn says:

    My Boston Scientific sling was defective! It had broken in two as discovered by Dr Raz when he did surgery to remove Pelvicol and the BS sling [ha! No pun intended but it fits] I had/have major pain and new autoimmune disease development.

    Jane, should I be contacting my attorney firm to give them supporting articles Ive found on gov sites, this “questionnaire” etch to make sure they know how to present my case or not- and assume they won’t be idiots like Motley Rice.

    How much correspondence should we have with our legal reps? Ive had 2 more surgeries since I signed up with the legal firm s year and a half ago and have never heard from them. Maybe there are others who also want to know what is appropriate to make sure we will be represented well? Consider writing an article addressing this. Thank you again for your site- I didn’t even know I had mesh in me, until I found your site and Dr Raz from your readers. This info has literally saved my life.

    • Kitty says:

      Marilyn—I hope your mesh was saved and sent to a lab

    • msm says:

      If they are like my attorney(s), they won’t acknowledge receipt of the new info even though it involves further surgeries. Before settlement talks began, they were very concerned, stayed in contact, checked on me after surgery (probably to see if they still have a living client). Now, I can’t even find out if they were successful in obtaining my newest surgical records. Nothing. I’ve never experienced anything like this with any business. I hope you have better luck.

    • Kitty says:

      Marilyn—was the pelvicol a mass of scar tissue?

  25. All Meshed Up says:

    These Lawyers are looking at the end result, which for them is a huge payoff. MSM’s story about her Lawyer and lack of follow up is exactly what I have heard from Hernia Mesh Victims involved in the Rhode Island MDL. There is also the changing of status within the Categories. If you were at first deemed to have damage to indicate that you should be on the first or second tier, the Lawyers are coming back and asking if the Victim will accept being a tier 5 victim. By doing this, the Lawyer has just put this victim at the bottom category and cutting the settlement to a third of what it should have been. They are also sending out questionnaires asking what is the lowest amount you will accept. I am also being told that getting up to date info is almost impossible with Paralegals fielding the questions.

    The only people that are getting any substantial monies from these MDL’s are the Lawyers. The victims are getting the shaft! I have not spoken to one Hernia Mesh Victim that has gone through the MDL process express any form of happiness about their experience or settlement. Most get nothing for their 7 years of waiting. But the Lawyers sure as hell make out great. Why are there advertisements on TV every 5 minutes from Lawyers trolling for Gynecological Mesh Victims telling them about the 11 million dollar settlement “1 woman got and you could too!”? I have no respect for these vultures especially the “Big Boys” like Migliori, Patterson, or Motley Rice ( the Motley Crew ). They use us as you would toilet paper.

    So, I hope I am wrong about these MDL’s you women are hoping on. But if what I know about the Hernia MDL’s is even half truth, you all are not going to be happy with the Lawyer or the settlement.

    • msm says:

      I thought 5 was the highest tier with 3 or more surgeries. Maybe it’s different for the other MDL’s.

      From reading the master settlement agreement with AMS in June 2013, my understanding is that the more clients a firm has in the upper tiers, the more that firm gets from the $830 million. Then it is the FIRM and not the court who decides who gets what. If they are submitting one thing to the court to get their money and then trying to alter the tier assignments of each client, THAT would be criminal and could be prosecuted as fraud and perjury. Wouldn’t it?

      According to the court orders in the AMS MDL, two of the firms have set up a “Special Master” to oversee it all. Not sure what that means but I’m sure we’ll be paying for it. Wonder what the other firms are going to do….

      http://www.wvsd.uscourts.gov/MDL/amsinc/pdfs/PTO_175.pdf

      • Jane says:

        I get a letter or email from my attorney about once a month. It’s an update of current issues regarding the law suits. I was told the office is prepared to try each case individually.

        I have opted out of surgery. My urogyn said it won’t help much to remove the eroded mesh. And she said I was lucky because so far I have not gotten an infection from it.

        My sling broke twice during surgery, surgeon had to put a new one in. My sling is in the wrong place so

        does nothing for me. I have nerve damage, left leg, myofascial pain and lymphedema in my legs.

        But the law offices have pushed for surgery. It won’t help me and may make my nerve damage worse than it already is. I can’t take that chance until it’s mandatory to have the mesh removed.

        • Jane Akre says:

          Jane if you had complications why in the world would you have more mesh implanted?

          • Cybil says:

            Jane – I believe there are three more trials scheduled in 2014 against Boston Scientific in Massachusetts State Court ( August, September and December). Can you provide names of Plaintiffs in each?

          • Jane says:

            I only had one surgery. The sling itself broke twice during the only surgery so they had to get a new one.

            I’m trying to avoid any surgery. But don’t know how long I can hold out because of the erosion.

    • Kitty says:

      How clever MOTLEY CREW—-Perhaps you can get a job as “writer” while you are rehabbing

  26. msm says:

    Jane Akre, do you know if this is true?

    “According to a report by Law360.com, pretrial rulings by the Massachusetts state court judge presiding over the case prevented the jury from hearing certain evidence related to the warnings and defective.”

    • msm says:

      Sorry. I missed part of the last sentence:

      “According to a report by Law360.com, pretrial rulings by the Massachusetts state court judge presiding over the case prevented the jury from hearing certain evidence related to the warnings and defective nature of the mesh, which plaintiffs are considering appealing.”

  27. msm says:

    Hospital expects me to pay for the surgeon to remove the stitch he put through my bladder and took him 3 months to find. No wonder people sue. Sorry to be off topic but you people understand better than anyone.

  28. msm says:

    Concerning animal studies from March 2013:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3374602/?tool=pmcentrez

    This study may interest you greatly because of recent “expert” testimony

    concerning animal studies. The above is a link to a study that shows why

    different species were chosen for different tests with pelvic mesh and the outcomes.

    Baboons, rodents, sheep and pigs. All were considered compatible for

    various reasons but there were shortcomings for each. Basically, none of the animals allowed complete testing of how the female human body reacts.

    Here is just one paragraph of many. This is an easy to read study in the

    National Library of Medicine in the National Institutes of health.

    “Animal models can be used to test the local reaction to surgical

    implants, such as meshes. They also can be useful for testing

    biomechanics and other material properties after implantation in a

    biological system. However, no animal model replicates the IAPs in

    humans due to the different postural orientation of different animals;

    humans are the only ones with a strictly bipedal posture.”

    another out take:

    “In light of the recent US FDA warning and the controversies

    surrounding the use of synthetic mesh for vaginal prolapse repair and

    its complications, NHP and sheep may also be invaluable for studying

    extrusion/intrusion, one of the most relevant complications of surgery

    with mesh. The fact that sheep develop mesh extrusion at unusually high

    rates makes them an excellent model for investigating vaginal surgical

    mesh.”

    If anyone can provide the name of the “expert” who testified about his

    animal studies, his studies should be published here as well. I encourage you all to search Science.gov

    for transvaginal mesh. Especially if you have an upcoming trial and your attorney knows nothing about these studies. Make sure they know the facts. Quiz them. If they know nothing, you might consider a new attorney. Know how your attorney plans to argue your case!!!!! Don’t be led like a lamb to slaughter .

    • Kitty says:

      msm—are you referring to Henry Gerrad–attorney for CR Bard in Cisson trial that stated they did research on a “few rabbits, rats, and sheep?

      • msm says:

        No,I was referring to one of the two “experts” called by BS in the Albright trial. I believe Gerrard is a plaintiffs attorney. Lead on the plaintiffs counsel for mdl.

  29. Sandy says:

    I thought AMS had a trial with Patterson in Aug or have they taken a settlement too????

    • msm says:

      “By PTO # 172, the remaining bellwether in this MDL, Pattison v. AMS, 2:12-cv-7154, has been continued until further order of the court. ”

      No surprise. They’ll probably wait until the deadline passes for the settlement that’s on the table. If I understand correctly (no guarantee) that will be around September 1 (120 days). But, who knows….

  30. msm says:

    ” “While we were disappointed with the verdict, it was a privilege to represent Mrs. Albright and to give a voice to her story,” said her lawyer, Fidelma Fitzpatrick of Motley Rice.

    Amazing….just amazing… Sounds like they just washed tere hands of the case with no concern about procedural issues like the exclusion of evidence and no appeal.

    • Kitty says:

      someone may pick her up. It is so ugly It is very hard to stay strong when the disabilities are so formidable. Recently–I was doing some research and came upon HERS and the problems when a woman looses her uterus to hysterectomy,. I have never been the same since the Dr. pulled outs my Uterus and implanted 3 meshes at the same time. I had a perfectly healthy uterus—just the prolapses’—Just disrespect and disregard for a woman. I wonder how he would feel if a surgeon popped out his healthy testicles because they are handing now due to older age.

      • Kitty says:

        oh—I forgot to mention—The surgeon would have to implant mesh after the castration-perhaps string it thru the prostate to help lift the sagging scrotum.

        • Kitty says:

          What I posted would be a horror to a man—-but from what I read from “meshed Up” is that this horror has happened to him somewhat with a mesh implant he received from hernia—from what I can ascertain from his post that the mesh must have entangled in his scrotum an he lost a testicle. How can mesh be justified if this can happen to anyone? How can any MAN at the FDA allow this?

    • msm says:

      Apparently, BS moved to have evidence excluded weeks before the trial. Don’t know about this case exactly, but if the surgeon didn’t rely on the BS information , then it can’t be shown that BS didn’t’ provide adequate warning because warning or not, the surgeon was going to implant the mesh. So the doc can’t testify that warning was inadequate. I guess they weren’t required to provide direct warning to patient. But the surgeon should have but he wouldn’t have bothered since he didn’t rely on info anyway. Its a merry-go-round. The patient couldn’t have known beforehand because the surgeon probably didn’t think it mattered and the patient wouldn’t know what was being used.

      Had there been a recall issued, all parties would have known but the FDA did not require a recall or warning to the public. If the gas cap on your car could unexpectedly fall off, there’s a recall announced on all forms of media. But when there’s a problem with something implanted in the body, and it is swept under the carpet until testing shows there are enough injuries to maybe issue a warning. But only to docs not to the public. When does the public learn? When lawyers start advertising on TV.

      If I had seen any warnings, I would have at least known to talk it over with the doc. But the urogyn organizations have said that public knowledge of problems might prevent women from having this wonderful procedure. It would also prevent surgeons from doing hundreds of these 22 minute procedures and raking in the $$$ They might have to bother with discussing options with the patients and that would slow things down.

      I will stop ranting now and go get another ice pack to sit on.

  31. cheri says:

    Yes I agree, Ms Albright was thrown under the bus. She has my deepest sympathy and condolences. I’m sure she had a multitude of symptoms or motley rice wouldn’t have taken her case. I was never told of the damages the sling could inflect, just the usual retort of infect and or death from surgery. I would have NEVER have consented to that. I’m sure the same thing was done in her case. SHE DIDN’T KNOW. Just the facts of no usual FDA approval should have been a red flag warning. It was not tested , but implanted in our bodies. I hope to hell she can appeal or another law firm retry her case. A horrible injustice has occurred. Ms Albright u will be in my thoughts and prayers tonight. 🙂

  32. Dean says:

    Wow you ladies have said a lot and you all have been through HELL my wife had the TVTO Mesh she had a Parsifal removal then saw Dr Razz to get this horrible thing out of her Faith the new trial coming up is or has totally different Lawyers so let’s see justice has to be served

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