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Transvaginal Mesh- Emerging or Resolving?

MTMP agency wrapping up meshMesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day – areas ahead for future litigation or areas that are waning.

As you might have guessed, transvaginal mesh is on the list.

Know that active litigation has been ongoing for close to four years so one can only imagine that it is in the “wrapping up” category.   Attorney Henry Garrard (Blasingame Burch) will be addressing the topic.

POWER MORCELLATOR

Good to see that other areas are being addressed such as the power morcellator, another experimental medical device that was cleared for use on women by the U.S. Food and Drug Administration (FDA) under its 510(k) fast-track clearance program.

Last year the FDA warned doctors against using the power morcellator because it can spread hidden cancers hiding in the uterus.  The morcellator grinds up a uterus during hysterectomy making it easier to remove.

The power morcellator was approved beginning in 1991.  Johnson & Johnson makes one brand.  Although it has not been recalled and doctors are warned about its use, power morcellator remains a tool some doctors still insist should remain in their “toolbox.”

BACKGROUND:  See the Wall Street Journal article:

The Short Answer: How Medical Devices Like Morcellator Get to Market

The WSJ reports over the last 20 years, the FDA cleared at least 10 such power morcellator made by various companies.

The 510(k) process was created by Congress in 1976 and today at least 90% of medical devices are “cleared” for marketing under the provision.  There are roughly 3,000 new medical devices that enter the U.S. market every year.

In contrast, under the FDA,  new drugs must undergo clinical trials and PMA or premarket approval to prove safety and efficacy.  According to the WSJ, there are about 30 new drugs approved for the U.S. market annually.  #

 

33 Comments

  1. msm says:

    Well, after visiting the site and seeing the emphasis placed on various subjects, it appears that mesh is “wrapping up” or just being swept under the rug. It’s listed under “read more” on the program. Mesh is listed with 10 other topics. The session is scheduled for 11:15am on the final day of the conference which adjourns at 1:15pm.

    So, 11 topics to be presented in two hours (1.5 hours max with breaks accounted for and about 1 hour with time to switch presenters, etc). That’s 6-8 minutes max for each topic. Transvaginal Mesh is listed last and one could assume that many earlier presenters have run over their allotted time. Mr. Garrard might get a word in if he’s lucky.

    Who will he be speaking too? Probably 60% (max) of the original attendees. The other 40% left Friday morning due to early flights, boredom, hangovers, etc. Yep, TVM has either being swept under the rug and/or is old news (AKA no progress). There are too many mass torts that promise to be easier and more lucrative.

    OR (to be optimistic AKA unrealistic)

    They saved the best for last and all attendees will be anticipating a wonderful presentation by Mr. Garrard. There won’t be an empty sat to be found ! Mr. Garrard will give a presentation fitting of a lead attorney for the MDL’s. A standing ovation follows and all of the attendees return home with a new enthusiasm to work hard for their mesh clients and to push for justice for all mesh injured people!

    You choose…..

    • Bejah Blue says:

      This is the firm the referenced attorney was with at the time but not sure he still is or why he may not be. Also not sure you have spelled his name correctly. Can not discuss this further.

      The Mass Torts attorneys at Bernstein Liebhard LLP have taken leading roles in some of the largest and most important drug and medical device litigations currently underway in U.S. Courts. One of the Firm’s partner attorneys has been named to the Plaintiffs’ Steering Committees in multidistrict litigations established in West Virginia Federal Court for transvaginal mesh lawsuits. This Firm partner was also appointed Co-Liaison Counsel in two pelvic mesh litigations underway in New Jersey Superior Court for claims filed against Ethicon, Inc. and C.R. Bard. In 2013, our attorney also served on a trial team that recovered over $11 million for the Plaintiff in the nation’s first trial involving an Ethicon transvaginal mesh lawsuit.

      • msm says:

        I will suggest that you rely on the court documents for this information.

      • msm says:

        In addition, I am referencing the event focused upon in the above article. (October 16, 2015). Mr. Garrard is indeed still with the firm although I did not mention that firm in my comment to avoid any promotion of him or his firm. His firm is correctly referenced in the above article. Documents listing each committee are available for each MDL on the West Virginia court website.

        • Jane Akre says:

          He is generally considered one of the top, if not the top lawyer for his knowledge of pelvic mesh. I’d say Adam Slater is the other… They have both spent years on the topic ……..

  2. Kitty says:

    It good to hear from you msm. If you dont mind would you please refresh us as to what his role was in what case?

    • msm says:

      He was appointed by Judge Goodwin to serve as a member of the “Plaintiffs Steering Committee”, the “Plaintiff’s Executive Committee”, and “Coordinating Co-Lead Counsel for the Plaintiffs” for each of the 4 largest MDL’s in the U.S. District Court Southern District of West Virginia. He is also an attorney for a firm that represents a huge number (thousands) of mesh plaintiffs. Based on his research pertaining to mesh and mesh litigation both locally and internationally, he is considered a leading “expert” in mass tort litigation for mesh. Soooo…..how does he do all of this? I have no idea. One might wonder who actually represents the clients represented by his firm. Someone who is very, very busy, I’m sure.

      • Bejah Blue says:

        MSM, Thanks for your posts on this…there is, of course, a section at the firm where these cases are handled. I expect satire would be inappropriate unless it were simply an expression of the great burden these cases do represent. My personal belief is that there may be far more personal interaction with clients concerning this issue at BL than at many other law firms.

        Bejah

  3. kitty says:

    Msm. are u being satirical?

  4. Janis Urban says:

    Once a Medical Device goes to market…no matter the harm and injuries there is no going back. The assaults on women’s bodies continue everyday. Total Abandonment. The MDL is creeping along slowing and close to being considered Abandonment as well. So quick to get you to sign on the dotted line.. filing a Client Profile….and then you wait. The initial Adverse Effects to a Pelvic Mesh Implant have worsen and your body starts to debilitate with infections that turn into diseases. You ask for advise from your Attorney when notifying them with each new complication and you are ignored. And as for the Medical Community after 17 years there has not been an established Standard of Care for the Mesh Injured. We are told It’s not the Mesh. The injuries from Mesh are so much more then what we all originally had filed our suits for.. a lot more. So, my question is what do we do with this information? Does it get somehow amended into the complaint? FBR, Infections, Autoimmune etc. are seriously effecting our health, it’s just not the damage in our Pelvic System or the Pain caused by the implants. It’s all messed up your damned if you do and damned if you don’t seek medical attention because no one knows what the hell is going on. A mesh injured person knows. So what! Who cares! The injures mesh caused are complex and complicated. So does this make our MDL as complicated . I don’t know? One would think so? Our we The Lost Women of Mesh? I have no doubt that we are! None! For our bodies and lives have been destroyed and ruined.

    • kitty says:

      You are so right on Janis—the assault on our

      Body’s ‘ are so obtuse (for lack of a better word) that they almost laugh at us and just let us fend for ourselves and we eventually will die. But WAIT…who is going to pay for the expensive surgical procedures ie pelvic, spinal,

      Or complications from long term auto immune ? It may well be a tragic documentary in years to come.

    • Bejah Blue says:

      Janice,

      How are you defining “abandonment” aside from the obvious? Thanks. I am assuming there is a legal definition of some sort. And then what happens post abandonment and do I really want to know.

      It almost seems there is more to this story, something is being hidden that is far more troublesome than what we already know and it almost seems like a conspiracy of silence but why? I think we need to go back to the beginning, the source material somehow. As they say in law enforcement, we need a break in the case. For the sake of the women (and men) who will be victimized in the future we must try to make headway.

      It makes me wonder what is in those missing files, emails, etc.

      Bejah

    • Debbie Edwards says:

      Janis, I totally agree with you about signing up fast. I started all this four years ago, and was told it would take 18-24 months.Well now it has been four years and nonothing. I check in with my lawyer every few month, but I am told the same story over and over. “We are trying, but J&J have deep pockets and they are not budging”, well that is BS. I do believe they are trying, but J&J are NOT above the law!!!!! I think the judges are scared of them, and money talks and justice walks. I dont think this is going to end…..more like just go aaway.

    • Bejah Blue says:

      Janice, We may indeed be “The lost women of Mesh” but Jane and others will retain all of the data accumulated and one day something may be done with it that will help others, that will help to drive policy in a direction that supports the long term survival of the people and the country. Without the people there is no country, there is no economy and there is no future. I personally grant Jane permission to do what she wishes with anything I have ever posted here or ever will, after I am gone.

      What we need to do is take care of our health first. Many experts who sympathize with us and who are us, have said this over and over. Take care of your health first, not the legal stuff. What can you/we control? Not the legal matters…what we have some hope of controlling is our health and worrying endlessly about cases is detrimental to our health. We have given enough to that. I see little or no evidence that the Department of Justice or the FDA, etc. care about us at all. Quite the opposite. Let it go. It will be what it will. You are have case numbers. Let your legal representatives handle it all now. Justice is not being served and there seems little or nothing we can do about it. This does not mean we are giving up…we are just turning our focus to our own bodies.

      Bejah

  5. Worried says:

    Sorry but I want to know when is the date of the meeting or summit I want to be there!

  6. Debbie Edwards says:

    All of this makes me sick!!!! I truly believe we are being thrown in the trash. It sicking,I wish I had hope but it is being lost day by day. I truly appreciate all the work our lawers are putting into our cases, and the cost of trial is out of their pockets unless they win……but there is NO WINNING, there is only more trials. I believe in our justice system and I believe in me lawer, but the reality is it isn’t ever going to be settled and we will never see justice. I am sorry for being so strong on my options and I pray I’m wrong, but I don’t see it. I pray for all the women and pray for the justice system to make this right.

  7. Worried says:

    Please does somebody know when Levine Papantonio will host this conference I would like to meet them since they’re representing me in my case I would like to know what to expect because our lives are in their hand n I just don’t want to a file in the stack I demand to be a person

    • msm says:

      Sorry, but the conference was Oct. 14-16. You should still consult them if they are representing you. They are supposed to be working for you and that huge percentage they will receive.

  8. Worried says:

    Ms Akre, do you know what happened in the meeting hosted by levinpapantonio, i would like to know the outcome

    • Jane Akre says:

      If you are referring to the MTMP (Mass Torts Made Perfect) which is a national seminar attended by approximately 600 lawyers and held twice yearly, it occurred last week. I was there to see what was going on with mesh and to look for some business model or support…… I will write what I found.

  9. janet says:

    Well it is not wrapping up the mesh cases

    Spoke with my attorneys on Wednesday

    We are looking at another 6,7,possibly 8 more years they said

    Boston is wanting to go to trial on these cases because they are winning there fight

    Along with Johnson and Johnson

    • Kitty says:

      Do they still do transvaginal mesh or does it go thru abdomen? I believe the transvaginal was the blind surgery and that may have hit the nerves—they guided it the best they could I imagine. But to cut thru the vagina with all the nerves is really a gruesome thought.

      • Jane Akre says:

        It is still done transvaginally…. though the recommendation from the expert panel gathered by the FDA was for the Gynecare to be placed through the abdomen, likely to avoid any litigation.

      • Bejah Blue says:

        Please remember that those who were implanted abdominally have also suffered. Some of us were implanting using both methods. It is a fantasy to state that only those implanted vaginally suffer. The cause of suffering is primarily the mesh, not just the method of implant. But Jane is right, they knew what they were doing, there was premeditation and thought they could avoid considerable litigation if they implanted abdominally.

        Bejah

  10. Nanny Bug says:

    I’m just wondering Jane I recently found out that I had two mesh put in me at the same time. One doctor that did a removal stated he removed two pieces of mesh. How big are the implants that are put in us ? Why did I have two ? I also two months a go found I had become diabetic . I read about other ladies that has become diabetic how does this happen ? Also I’m being treated for pudendal nerve damage & sciatic nerve damage . My teeth are going so fragile & bad ! It’s like Poor Janis said we are falling to pieces & don’t know how to stop this rolling ball of fire . I’m so scared Jane my eyes have gotten so terrible with cataracts . Any other ladies have these issues ? I AM LOOSING SO MUCH OF MYSELF I DONT EVEN LOOK LIKE MYSELF ANYMORE !!!! Thank you for all of your support Jane at least we know you truly care for us !!! God bless you & UOYR arrival that came out 13 hours a go was amazing too .

    • Jane Akre says:

      It could be one mesh that broke into pieces…… do you have your medical records? That will tell you the type and brand. Look it up on the manufacturers website as to the length in cm. Then compare that to what was removed. Your medical notes, nurses notes, operative notes should tell you if you have one or two meshes AND your law firm should be helping you with this.

  11. msm says:

    Back to the original article and comment, I feel my comments have been somewhat misinterpreted. After visiting the website Jane referenced and reviewing the agenda in detail, it was apparent to me that virtually no time or emphasis was placed on TVM litigation. Mr. Garrard was going to have a very limited amount of time for his presentation. That hardly seemed fair and is indicative of a lack of interest from mass tort attorneys as a whole. Mr. Garrard, being one of the foremost experts in mass tort litigation involving TVM, was probably not going to get the time or the attention from the conference participants that he deserves.

    Because that seems quite negative and recognizing that anything is possible, I included the best case scenario. It is up to the reader to choose. I think Mr. Garrard has dedicated his time and money for many years to study mesh and has traveled the world to speak to and learn from medical experts. He is an advocate for mesh injured women and I believe he deserved a larger forum at this conference. While he is not the only expert nor the only member of the committees serving the court in the MDLs, he is the only one listed as a presenter at the conference for Mass Torts referenced above.

    If that was not clear, I apologize. As for satire, that is for the reader to decide after considering all of the information available. I would never attempt to tell anyone how they should think nor critize for their choices .

  12. anonymous says:

    As stated by msm, Mr. Henry Garrard is an attorney with the firm referenced in the article (Blasingame • Burch • Garrard • Ashley, P.C.), and he is a highly regarded expert on transvaginal mesh implants and litigation. Mr. Garrard is informed on the production, properties, placement, and outcomes of these products. He certainly is a busy man.

    You’re right, msm…some must wonder how Mr. Garrard represents clients in addition to his travel and commitment to learning. I know others at the firm often speak with his clients. In my experience, they’ve been helpful. I assume those currently facing trial have more time with Mr. Garrard and that he will communicate directly if possible and important to a client. Most matters can be discussed with partners and staff. There are surely other great law firms, and everyone deserves an attorney who isn’t just “in it to win it” but for the good of people.

    Do you think TVM litigation is in the end stages, Jane? I’m sorry if you’ve discussed in more detail elsewhere. I’m having a hard time and for some reason missing or forgetting quite a bit recently. I see msm is afraid it’s wrapping up as in being “swept under the rug.” Several women, including Janet, have been told resolution is likely five to ten years from now. Does anyone think there are many attorneys and doctors who care about the injured though? Is there any hope for settlements covering extensive past and future medical? I’ve read pain and suffering, loss of income, and being on disability aren’t included. Maybe Mr. Greg Vigna can weigh in if he sees this?

    • Jane Akre says:

      Unfortunately mesh is still being used so no I do not think its at the end stages…. I’m curious how many have back off from its use. From what I understand, the mesh experts no longer use TVT-O, they consider it defective…. TVT is still used by some. If you smoke and have some form of prolapse… now is a very good time to stop! Mesh kits have largely disappeared. I guess medical schools will have to begin teaching surgical options again.

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