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Pelvic Meshes Removed from Australian Market

J&J Gynemesh Prolene

Mesh Medical Device News Desk, September 18, 2017 ~ A Senate inquiry continues in Australia today and Tuesday as Johnson & Johnson and Boston Scientific present evidence on the safety and efficacy of the pelvic mesh devices.

Meanwhile two meshes have been removed from the Australian market.

Joanne McCarthy a reporter for Australia’s The Herald newspaper, writes Johnson & Johnson (J&J) has withdrawn two of its controversial pelvic meshes from the Australian market after feds asked for more evidence of device safety.

Instead of a quiet recall from the market, J&J told a Senate pelvic mesh inquiry in that country that it had “decomercialized” the Gynemesh Prolene and Gynemesh PSXL.  The meshes are made of polypropylene and are a bridging material for apical vaginal and uterine prolapse.

J&J Submission Report, Read the rest here:  file:///C:/Users/Jane/Downloads/JNJ%20Submission_Products%20Decommercialised.pdf

The instructions for use, the warning brochure within the package, had become cost costly to change.

Australia’s version of the U.S. Food and Drug Administration, the Therapeutic Goods Administration (TGA) required changes in the instruction brochure for the product.

“The costs of making a change only for the Australian market would exceed the total value of the sales of the product for 2016,” the company said in a statement.  J&J denies this is a recall and says the company “continues to have confidence in the safety and efficacy of these products,” the article quotes J&J as saying. 

There will be a public hearing Monday at the Parliament House in Sydney and another at the Canberra Parliament on Tuesday, all part of an inquiry by Victorian Senator Derryn Hinch.

Sen. Derryn Hinch, Au Senate

He has called the pelvic mesh debacle “one of the greatest medical scandals and abuses of mothers in Australia’s history.”

Johnson & Johnson and Boston Scientific will be present to give evidence on the Monday inquiry.

See Women Speak of Horror of Vaginal Mesh Implants story today here. 

The devices were cancelled from the TGA registry August 22.

McCarthy reports in 2013 there were 100 different mesh devices manufactured by 42 companies on the TGA register. Last month there were just nine mesh device companies making 22 mesh devices.

There are more than 700 Australian women who are in the midst of a six month class action lawsuit being heard in a Sydney courtroom.

J&J is facing more than 55,500 pelvic mesh product liability lawsuits filed around the globe, according to its recent SEC report. ###

LEARN MORE:

Johnson & Johnson Submission here.

2 Comments

  1. Bejah Blue says:

    More good news. That good news will never happen in “America, the land of the free and the home of the brave”…we never knew this delightful expression referred to corporations (free to do whatever they want to our people), not to the American people. I am getting really ready to be an ex-pat. The good people of America do not realize they are not so free until they come up against the wall and/or push against it. Bravo to the forces for good in Australia that have prevailed. A win for humanity is ultimately a win for us all. Notice though how the defendants are in a perpetual state of denial, no matter what happens. They will never admit anything, never back down, never relent unless they are forced to and even then they will create a backstory of lies , ever orchestrated by deception. I am reminded of the saying “Oh what a tangled web we weave when first we practice to deceive”!!!! (Does anyone know source of this?). Thanks Jane for the good news. Bejah

  2. Bejah Blue says:

    Autoimmune Disease, Psychosexual Function, and Other Illnesses and Conditions
    Animal studies of mice exposed to DES in utero suggest an increased risk of autoimmune disease in female mice. Studies in humans have yielded conflicting results. One study indicated that the incidence of autoimmune diseases was higher in women who had been exposed to DES in utero (DES Daughters) (246). However, no single autoimmune disease was found to have a statistically significant association with DES exposure in utero. Studies of this issue are ongoing.

    Some animal studies have suggested links between prenatal exposure to androgens or estrogens and cognitive abilities differentiated by sex. No human studies have documented consistent findings linking DES exposure in utero to any psychological or psychiatric condition, or to sexual dysfunction.

    For a complete list of the numbered citations on this page see DES References.

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    CDC Home | Search | Health Topics A-Z
    Well, this is strange….I posted something here a couple of hours ago and it just vanished I see. I wonder what happened to it.

    I was just reading about malformations noted in daughters of mothers who were talked into taking the drug DES when pregnant (It supposedly helped with miscarriage). Ha! It damaged young women, that is what it did. Did the manufacturers make lots of money? Did they ever go to prison? Doubt it. I think my mother took it as she told me she had a problem with miscarriage. She told me I did not want to be born. Now I know why. Here is the curious thing. I copied the paragraph below because it seems that women whose mothers took it gave their little girls a gift…autoimmune disease! Interesting, eh? What else gives us auto-immune disease? Could it be that auto immune response is a common response when the body is subjected to something BAD for it????
    Does your government, your nation care? NO. I just visited with a friend who is a social worker. She told me that it came to her attention years ago, that people who moved here from Europe told her America was a police state then. Now it is even worse and it is getting worse. My dermatologist told me Monday that she learned of the horrors of mesh several years ago when a man was referred to her who had hernia mesh put in him and was suffering. She did not go into detail.

    This page last reviewed September 19, 2017. United States Department of Health and Human Services
    Centers for Disease Control and Prevention. Autoimmune Disease, Psychosexual Function, and Other Illnesses and Conditions
    Animal studies of mice exposed to DES in utero suggest an increased risk of autoimmune disease in female mice. Studies in humans have yielded conflicting results. One study indicated that the incidence of autoimmune diseases was higher in women who had been exposed to DES in utero (DES Daughters) (246). However, no single autoimmune disease was found to have a statistically significant association with DES exposure in utero. Studies of this issue are ongoing.

    Some animal studies have suggested links between prenatal exposure to androgens or estrogens and cognitive abilities differentiated by sex. No human studies have documented consistent findings linking DES exposure in utero to any psychological or psychiatric condition, or to sexual dysfunction.

    Food for thought? Bejah (Can you tell I am feeling really pissed off?)

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