Free Case Evaluation
Connect
With Us

Largest Class Action in Australia Blames J&J for Hundreds of Pelvic Mesh Injuries

Outside federal courthouse, Sydney, News.com.au

Mesh Medical Device News Desk, July 5, 2017 ~ As the U.S. celebrated its Independence Day, more than 700 Australian women joined in a pelvic mesh trial blaming Johnson & Johnson for their mesh-related injuries.

The largest class action in Australia may take up to six months.

It’s estimated as many as 100,000 Australian women may have been implanted with pelvic meshes made by Johnson & Johnson,  C.R. Bard, Boston Scientific and AMS (American Medical Systems).

Tuesday, July 4, hundreds of those women took Johnson & Johnson (J&J) and its Ethicon medical device division to court in the largest class action in recent memory in Australia that’s expected to last up to six months.

This is the first legal action in Australia naming a defendant pelvic mesh maker. Australia fashions its regulatory approval of transvaginal mesh after the U.S. Food and Drug Administration (FDA) and the meshes named have all had FDA clearance for use.

This trial is headed by Shine Lawyers of Australia and will be held in federal court in Sydney.

Attorney Jan Saddler tells CTV News that the women involved have experienced chronic pain, mesh erosion, chronic inflammatory response, as well as an inability to have intimate relations.

Nine pelvic meshes are named, five are off the market, voluntarily recalled by J&J.

See MND story on J&J pelvic mesh voluntary recalls here.

ALLEGATIONS OF INJURY

Allegations are that while J&J aggressively marketed its meshes, it was negligent for failing to warn doctors and inform patients about the risks associated with transvaginal mesh.  Testing was inadequate before marketing and the transvaginal mesh was defective in its design, not fulfilling the purpose for which it was created, says the plaintiffs’ complaint.

Gai Thompson tells CTV News in Canada,  “No amount of compensation, money, could ever replace what we’ve lost with our lives, with our families, our health, our emotional health,” Thompson told reporters outside court. “My prayer is that this mesh would be banned and that no woman would suffer what we suffer.”

In a statement, Johnson & Johnson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide, and said the majority of women who undergo the surgery have had a positive result.

The New Jersey-based healthcare giant says it’s only aware of 200 complication reports in Australia, reports Reuters.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event,” spokeswoman Meshlin Khouri said in a statement.

News.com.au

 


NO RECALLS

In the U.S., an estimated 140,0000 women have filed defective product actions against mesh makers, many in multidistrict litigation (MDL).

Johnson & Johnson and its Ethicon division represent the largest number of U.S. actions filed, with 38,921 lawsuits filed in the federal MDL court as of today, July 5. Among those, 7,420 are listed as closed.

An Australian Parliament Committee is holding an inquiry into transvaginal mesh implants and a report is expected to be issued in November.

Australia has not recalled any pelvic meshes, following in the footsteps of the U.S. Food and Drug Administration, which also has not recalled or banned use of transvaginal mesh.

U.S. companies regularly send their medical devices overseas, including Australia. It’s estimated at least 100,000 transvaginal mesh medical devices have been sold in Australia.

Joanne Maninon tells The Guardian, “It can’t go on. There’s too many women who have gone through the pain, the complications, it’s lifelong.”

Women in Australia have not found doctors who can remove the mesh which is intended to be a permanent medical device. A few doctors in the U.S. have had some success at full mesh removal, best known among them is UCLA and Dr. Shlomo Raz.

OPENING DAY- VALUABLE MARKET

In the opening day of this class action, Tony Bannon spoke for the plaintiffs. He said the risks were either minimized or not communicated to the surgeon or patient by J&J.

“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” Bannon told the court.

Prof. Bernard Jacquetin, TVM patent

He said the company saw a “valuable market” to be gained and convinced doctors it would be easy and quick to implant a pelvic mesh device.

Bannon quoted one of the French Ethicon team, Bernard Jacquetin, who said he wouldn’t like his wife to undergo that treatment and, “I don’t think I’m alone.”

Jacquetin was a consultant to J&J who received royalties from the healthcare giant.

Read about him from the Linda Gross trial held in New Jersey in 2013 here.

 

MORE CLASS ACTIONS AHEAD

News.com.au reports another 300 women in Australia have enrolled in a second class action lawsuit against American Medical Systems (AMS). The AMS Apogee was developed in Australia and cleared for use in the U.S. by the FDA  in 2004.

It was quietly removed from the market by AMS.  Read MND about AMS recalls here. 

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA),  has not banned mesh devices in that country, similar to the U.S. Food and Drug Administration which, despite a Safety Communications that implant injuries are “not rare,” has taken no action to curtail pelvic mesh implantation.

In the U.S., there are approximately 140,000 lawsuits pending against seven mesh makers and an unknown number of cases have been prepared for settlement but have not been filed.

Besides Australia and the U.S., J&J/Ethicon is facing defective product lawsuits over its pelvic mesh in Canada, England, Israel, Italy, Belgium, the Netherlands, Scotland and Venezuela. ###

 

LEARN MORE

Mesh News Desk, June 2012- J&J Will Remove Four Meshes From the Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/

 MND, Day 20 Linda Gross Trial , February 8, 2013
https://www.meshmedicaldevicenewsdesk.com/day-20-linda-gross-v-ethicon-medical-director-mesh-exposure-15/

MND, Australian Inquiry into TVM leads to Inquiry and Trial, March 16, 2017
https://www.meshmedicaldevicenewsdesk.com/australian-investigation-transvaginal-mesh-leads-trials-senate-inquiry/

 

 

27 Comments

  1. Anon says:

    This can’t be true … Has anyone seen this in any previous trials? This article is titled “I would not want my wife to undergo this procedure: Pelvic Mesh Inventor http://www.thecourier.com.au/story/4771539/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=2452

    • Jane Akre says:

      It’s also in the story I just posted above your comment. Bernard Jacquetin….included in the Linda Gross trial, though I dont remember that comment….

  2. Bejah Blue says:

    Marvelous! Heartwarming. More logs for the fire! And Jane, it seems these days you give us interesting if not stunning news items every day even as the cost of operation must cause you increasing concern. It hurts me that those who have settled have evidently forgotten you. I will not. Thank you for this good news.

    Bejah

  3. Dy says:

    Jane, I have followed you since the beginning of this mess with the mesh. Although I just began to participate with a comment or two, because of that disclosure I signed
    I will now continue to follow you. I agree with Bajha. Your are giving us hope for justice for us women who are suffering at the fault of J J. Thanks for all you do and I do agree to contribute to what we can afford to send to you.

    • Jane Akre says:

      Thanks I appreciate it. I will try to solicit some advertising so I dont have to ask. Youall should be able to hang onto whatever you get…. though $3 a month is probably not a big deal to anyone. Thank you for being considerate!

    • Bejah Blue says:

      Hi Dy, How good to hear your positive message and to have you here at Janes’ “kitchen table” (credit Still Standing).

      Bejah

  4. Mary Dickson says:

    Jane,
    I long for the day of justice to come for J&J. Despite so many facts and lives ruined, they refuse to show any responsibility, remorse, or compassion for millions of victims worldwide.
    They have No Honor and deserve no mercy.
    They have riches matched by few, and yet, continue this obvious mutilation to people.
    Thank You Jane.
    4Mom

  5. caz says:

    Hi Jane I just want to clarify your statement where you say as many “as 8000 women are implanted…” – there are actually over 100,000 women implanted and as many as 8000 are estimated to have adverse events. Regards Caz

  6. Dy says:

    Jane, I to long for the day of justice for J&J, as Mary and for that matter, all of us mesh victims. Every day, zip wake up asking myself ” Is today the day?” The Lord will make sure that we get our justice. Thanks,
    Dy

    • Bejah Blue says:

      Keep the faith. This may be the issue that rips a hole in their monopolistic conduct that the FED can not ignore or excuse. That ripple effect could change the face of the nation, re-energize small business, co-ops, the way the nation does business and treats its people. I pray every day for a better path for our nation.

      Bejah

  7. Bejah Blue says:

    I thought this might be of interest to us and it is very recent, research out of Europe. I posted only the conclusion para. It is a lot different than what we used to read about “the gold standard”, etc.

    PATIENT SUMMARY:
    Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres.
    Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.
    KEYWORDS:
    Consensus statement; Mesh; Pelvic organ prolapse; Stress urinary incontinence
    PMID: 28413126 DOI: 10.1016/j.eururo.2017.03.048

  8. Bejah Blue says:

    Can someone access this paper? It is pub by entity I do not have access to. Thanks.

    ormat: Abstract Send to
    Phys Med Rehabil Clin N Am. 2017 Aug;28(3):603-619. doi: 10.1016/j.pmr.2017.03.010. Epub 2017 May 27.
    Iatrogenic Pelvic Pain: Surgical and Mesh Complications.
    Lee D1, Chang J1, Zimmern PE2.

    Abstract
    Female stress urinary incontinence and pelvic organ prolapse are prevalent conditions in adult women. Among treatment alternatives, more traditional methods of surgical intervention have been supplanted by synthetic polypropylene mesh kits. However, novel complications with mesh-related exposure, pelvic pain alone or with dyspareunia, and increased incidence of revision surgeries, resulted in 2 FDA warnings on transvaginal mesh use for prolapse repair. This review examines the anatomy of the vagina and urethra, the etiology of pain related to mesh use, and the relevant surgical techniques for management of this complication along with their outcomes.
    Copyright © 2017 Elsevier Inc. All rights reserved.
    KEYWORDS:
    Chronic pelvic pain; Prolapse; Stress urinary incontinence; Synthetic midurethral sling; Vaginal mesh
    PMID: 28676367 DOI: 10.1016/j.pmr.2017.03.010

  9. Bejah Blue says:

    Hi people, Does anyone know how I/we can access data at this site gratis? Sorry if i have missed something already covered. Sometimes my consciousness wanders off! Thanks.

    Annals of Surgery: A Monthly Review of Surgical Science and Practice Since 1885
    Official Publication of the American Surgical Association, the Southern Surgical Association, the Philadelphia Academy of Surgery, the New York Surgical Society and the European Surgical Association
    Editor(s): Keith D. Lillemoe MD
    ISBN/ISSN
    0003-4932
    Publication Frequency Published 12 Times Per Year (Monthly)
    Format(s)
    ………………………………………………

    Digression: I am making a birthday cake for a very special man in my life. He said his fav. is German Chocolate. I like to play with recipes as I am sure many of you do. I think cooking is good therapy and an effective method of re-focusing the mind away from pain especially if it involves eating! As long as you feel fairly OK it works but if you are in a lot of pain it does not.

    So can I ask you all what you think of my ideas for modifying a basic recipe for German Choco. cake and ask for your ideas as well? Celebration is July 18.

    (1) I was thinking of using a dark chocolate cake mix. (2) Also trying four levels (round). (3)Adding a lot more pecans and a little more coconut. (4) Adding a little rum to filling. (5) Adding a little heat and Tumeric and maybe chopped candied ginger.

    What say you? Too much? Maybe serve with Rum Raisin ice cream and a good coffee. Thanks for any ideas.

    He is going to be 48 so I thought I would put four very tall white candles and one little candle in the middle, the center will be maybe red (rep those eight years).

    Happy weekend…

    Bejah

    • Still standing says:

      Bejah, you are too funny. First, the cake. Don’t do dark chocolate or turmeric or ginger. That could be a taste challenger, especially for a man. I make mine from scratch, but if not, buy a German chocolate cake mix. The cake is traditionally three layers. If you use a cake mix, make your own filling. Grab one off the internet, Kraft has a good one. Here is the secret. Make 2x the recipe. You don’t completely frost a German chocolate cake. Just put filling in between each layer and on top. It is well worth the effort. Canned frosting not very good. I toast my pecans for added flavor. Yum, I haven’t made one in several years, but now I need to find an occasion to make one.

      Now, on the access to journals. The Annuls of Surgery has some articles that are open access ( free) but some of the articles are for purchase. You can look up an article in the table of contents of the issue. At the bottom will be a tab for free or to purchase. If the article you want is not open access, you can go to any library of a state university or larger library system and request the article. They have reciprocal agreements among library systems. They may have to request permission from another library system. . You may have to pay to print a copy. These articles are copyrighted material, so it is not something you can repost here in entirety. Always credit the authors if you want to quote or paraphrase the article. Sometimes, you can request a copy from the author. There are generally more than one principle investigators , but one will be named the corresponding author. However, generally, they will provide a copy to other researchers or people doing graduate work. If you cant get access, let me know the article specifics and I will try to get it for you.

    • Still Standing says:

      By the way, Bejah. My family puts five candles on a birthday cake once they get over twenty one. They represent health, wealth, happiness, long life and a wish.

  10. Bejah Blue says:

    Dear people, I was not sure if we all knew about this, about what Dr. Margolis did, but he has, I think many of us would agree, become more of a friend to our community with each year that passes. He was even willing to try commuting by train from home to his office when I told him about my wonderful experiences on the bay area commuter trains. This is pulled from the website written by a sister to us who calls her site Slingthemesh. It is I think an Aussie site. We should do more to keep in touch with women in other nations. Maybe by doing so we could get the attention of the United Nations and other relevant international organizations.

    America

    In the USA more than 100,000 lawsuits have been filed from women who have suffered permanent disabilities .

    Leading American surgeon Tom Margolis felt so strongly about the TVT product that he wrote to Scottish Parliament urging them to ban the operation, saying the use of the mesh : “Must stop immediately. The complications from this defective surgical theory and defective material far outweigh the potential benefits.”Read the letter: (See website for the letter)

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This is a Sundown Legal Marketing law firm website.