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Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry

Caz Chisholm, Newcastle Herald photo

Mesh Medical Device News Desk, March 16, 2017 ~ Unlike the U.S. media,  Australian media is reporting on its transvaginal mesh debacle with citizens leading the charge.

Transvaginal mesh devices seem to be front page news overseas.

Joanne McCarthy writes for the Newcastle Herald, located about 100 miles north of Sydney, Australia. The paper is in the midst of a series of aggressive investigative reports on the gaps in Australia’s health regulatory systems.

That has helped galvanize the efforts of the Australian Pelvic Mesh Support Group and bring forward the voice of the injured. The reports have also highlighted the huge gaps in any safety net to assure patient safety.

An estimated 100,000 women in Australia have been implanted with transvaginal mesh.  More than 40 mesh devices for prolapse surgery were eventually cleared for use in Australia.

The Australian process for medical device approval mirrors that established by the U.S. Food and Drug Administration (FDA), that is cleared for marketing with no clinical evidence supporting safety and efficacy.

As a result of the publicity and patient activism, Australia is taking some action.

The Australian Pelvic Mesh Support Group initiated a Senate inquiry into the mesh scandal in Australia.  It is taking submissions until May 31 and a public hearing will take place mid-year with a report expected in November.

On July 4, 2017, Shine Law in Australia is representing about 450 women in a class action against Johnson & Johnson which could run up to six months.

It will be one of the largest medical civil actions in Australia.

A second class action involving 300 Australian women will be launched against American Medical Systems, maker of the Perigee and Apogee.

 

AU Sen. Derryn Hinch

McCarthy’s Reports Include:

Transvaginal mesh devices have left many women with permanent injuries.”3/14/17
A 2013 paper titled “The Transvaginal Mesh Decade” was written by Associate Professor Chris Maher. He blames the U.S. Food and Drug Administration and regulators in Australia for clearing transvaginal mesh devices without evidence of safety and efficacy.

Pelvic mesh victim in the dark about mesh implant for nearly a decade (here) 3/15/17
Lynda Garling didn’t even know she had been implanted with transvaginal mesh in 2004. She lost her business after being treated for a cluster of symptoms and pain.  Here is a video that accompanies the story.  Lynn Garling said “I feel like I’d been raped.”

Lynn G. mesh patient

“Dr. Peter Petros said he warned women about the ‘very frightening’ symptoms of his procedure” 3/15/17
In a 2004 court action in Western Australia Dr. Peter Petros, who brought one mesh to Australia, testified that women could experience a disgusting yellow discharge following an implant. That was “how the operation works” was offered as an explanation. The 45-year-old woman, who sued him, was awarded more than $136,000 as compensation.

Dr. Petros performed the first prototype IVS operation in Perth and in 1990 he filed for the IVS-Tunneller patent.  Dr. Petros collaborated with the late Dr. Ulf Ulmsten to develop the midline IVS operation.  He was compensate $15 per instrument of the IVS Tunneller he performed at about 400 per year, according to the inquiry. The story outlines his attitude toward the pelvic surgery and its associated complications.

In Australia just one company, the Adelaide firm TFS Manufacturing sold more than 15,700 devices from 2006. In November, 2014 TFS became one of the first mesh devices in the world to be deregistered after failing to provide evidence of its safety.

Newcastle doctor and Queensland colleague sounded alarm on mesh in 2003” 3/14/17
Two doctors who wrote a paper in 2003 sounding the alarm about pelvic mesh procedures after treating women injured by the products seen in Germany and Switzerland as well as Australia.

 

RADIO

The publicity is not limited to print. Radio show 2HD Radio Newcastle has broadcast two high profile interviews.

  • A radio host calls the mesh debacle, “The biggest medical scandal since Thalidomide.” 2HD Radio Newcastle interviewed the founder of the Australian Mesh Support Group founder Caz Chisholm. Chisholm had her mesh removal in St. Louis by Dr. Veronikis.
  • Senator Derryn Hinch is interviewed (here) by 2 HDRadio says because the word “transvaginal”, the media won’t touch it. Here is his testimony to the Senate, The Age newspaper, Women are, “kept in the dark like mushrooms, fed bullshit.”

 

dr. Peter Petros, father of IVS Tunneller

The Newcastle Herald Inquiry

The newspaper finds the IVS Tunneller was tested on 13 large dogs in Western Australia in 1987. It became the first transvaginal mesh used in Australia beginning in 2001.

Associate Professor Chris Maher blames regulators in the U.S. as well as his country.  The IVS Tunneller was cleared by the FDA in 2001 to treat prolapse in women. Using the 510(k) substantially equivalent standard it served as a predicate for a proliferation of prolapse mesh devices for the next decade.

Referring to the period from the 1980s to the 1990s, any safety measures suffered a system failure he says in his 2013 report, The Transvaginal Mesh Decade.

IVS Tunneller

While regulators were asleep, doctors provided an even bigger gap in the safety net.

Instead of protecting patients, doctors were ready and willing to hear the “aggressive marketing” messages from manufacturers and were largely silent. Surgical techniques were taught and developed by the manufacturers of the products and the lessons disseminated by key opinion leaders.

The ever-widening hole in any safety net is blamed on Australia’s version of the FDA, the Therapeutic Goods Administration (TGA). It was not able to share the percentage of women suffering adverse events after their mesh surgery.

The second mesh device used in Australia was the Tension-free Vaginal Tape or TVT, which resulted from a collaboration between Dr. Peter Petros and the late Dr. Ulf Ulmsten of Sweden, who developed TVT and sold it to Johnson & Johnson.

The TGA estimates it only receives 10% to 20% of all complication reports associated with mesh, largely because surgeons are not aware of that country’s adverse event reporting systems. ###

 

LEARN MORE:

Here is the 510(k) FDA Summary of the Covidien IVS Tunneller
https://www.accessdata.fda.gov/cdrh_docs/pdf7/K073164.pdf

IVS Tunneller trademark details
https://trademarks.justia.com/773/21/ivs-77321440.html

History of IVS Tunneller
http://www.laparoscopy.ru/article/ivs.html

Korean J of Urology Mar 2006 IVS for patients
https://www.icurology.org/search.php?where=aview&id=10.4111/kju.2006.47.3.263&code=1020KJU&vmode=PUBREADER

Maher writes about this in his 2013 paper titled “The Transvaginal Mesh Decade.”
https://www.parliament.nz/resource/mi-nz/50SCHE_EVI_50DBHOH_PET3197_1_A400626/98a708b5cc688bea76ab93ae3ab6a670cf58153e

Mesh News Desk, August 2016 ~ TGA Urges women to report Mesh Adverse Events,
http://www.meshmedicaldevicenewsdesk.com/australia-wants-report-mesh-adverse-events/

Mesh News Desk, October 15, 2012 ~ Australia’s Vaginal Mesh- Largest Class Action in History?
http://www.meshmedicaldevicenewsdesk.com/australias-vaginal-mesh-largest-class-action-in-history/

Mesh News Desk, March 6, 2012 ~ Australia’s Version of FDA Lax on Medical Device Safety
http://www.meshmedicaldevicenewsdesk.com/australias-vaginal-mesh-largest-class-action-in-history/

Mesh News Desk, July 12, 2016 ~ Mesh Mess- Banner Pelvic Mesh receives New Life as a Breast Lift
http://www.meshmedicaldevicenewsdesk.com/mesh-mess-banned-pelvic-mesh-receives-new-life-breast-lift/

TFS tissue fixation system made by TFS Surgical of Adelaide Australia, created by Dr. Petros in collaboration with the late Dr. Ulf IUlmsten, MD.
http://www.meshmedicaldevicenewsdesk.com/mesh-mess-banned-pelvic-mesh-receives-new-life-breast-lift/

 

14 Comments

  1. Lana Keeton says:

    The circular firing squad. What human in their right mind thinks it is okay to take a trocar “meat hook” and drag it through the most sensitive female anatomy with polypropylene mesh attached? How ANY doctor could ever do this to ANY woman and believe it is okay is ludicrous. I say to all doctors, “STOP the FINGERPOINTING”. “Each and everyone of YOU ARE RESPONSIBLE!” “STOP THE CARNAGE!”

    • Kitty says:

      Hi Lana…thinking of stringing mesh thru sensitive mucosa using the meat hook. Perhaps they should come up with something to string up the sagging scrotum of aging men. GROSS!

      • Still Standing says:

        Kitty, the doctor who implanted me is a female. I imagine some of the corporae decision makers were women as well. And some of the lead defendant attorneys are women. It was a failure of humanity that spanned both sexes.

        • Kitty says:

          Yes..SS..that statement was crude. It does bring to mind how women sabotage each other. Did u ever get a really glamorous haircut from a female hairdresser. They certainly don’t want u to be better looking then they do…..or it is said that RNs’ destroy and eat their new young nurses. I would imagine one cannot be thin skinned in the medical profession. I believe there are some. very good female Drs’…but many of them have been mentored by some very notable uro-gyns. But your right.

          • Still Standing says:

            That would imply female doctors can’t think for themselves. We just have different ways of looking st things. I have had excellent female hairdressers, never thought they we sabotaging me. Have also worked with RNs many many years and didn’t get that vibe. There are male nurses, too. Interesting how we all perceive the world based on life experiences. That’s why pain is such a difficult thing to treat because we all
            bring different assumptions

      • Kitty says:

        Actually..this is an issue with men and why hasn’t transcrotal mesh been used for men? Why?? This os very private issue. …very private. I couldn’t imagine hurting a man by doing this procedure on him. I am very sorry for suggesting this. We are waiting for our apology.

  2. Anonymous says:

    Can someone please tell me why United States press is not doing a story on this? Why is no one reporting about these big medical companies and all the lies they told all these women who are been left with permanent catastrophic injuries? It really makes me wonder how corrupt the United States really is. It’s just a very sad time in history for all women we are still treated like we don’t count as much as men.

    • Jane Akre says:

      just my opinion from when I used to work in mainstream media- if you as a reporter grab onto a topic and dig into it, you are looked at as an “advocate” or an “activist”…. reporters would rather be objective and disconnected and their bosses are all for them turning many stories, not quality reporting into one topic. Not to mention that J&J carries some heavy weight as an advertiser AND they have expensive lawyers who will counsel news executives on the “truth”…. From what I see Joanne McCarthy in Australia and Marion Scott in Scotland have both taken the lead on this story and they are driving the public interest, as are the groups of injured patients. That’s what good journalism used to do…

      • Anon says:

        It is my prayer……………… that one of these countries stand up for these permanently injured women and press Criminal charges against these pharmaceutical giants someday.

  3. Kitty says:

    just to clarify. DRs’ have always covered for each other. ….always. Who said women were not as good as men. Older Nurses are noted for “eating their own” Gay men are the best hairdressers. I’m sure that there are exceptions to the rule.

    • Still Standing says:

      I’ve been thinking about assumptions. They can generally be made about every RN or every hair stylist and they are demeaning suggestions….To infer that women doctors were mentored by men, so they would follow the advice of those men who mentored them instead of using their own intellect?…. The trouble with assumptions is that we all have them and we try to put everyone into a particular peg hole. We like to make assumptions, but don’t like to have them made about us. So, if you look at magazines that women read, one might assume that the most important thing to a woman is to look sexy and feel sexy. Scan the headlines on all of them that aren’t recipe centered and the majority, even Women’s Health, have articles about how to look thinner, younger and be hotter in the sack. So imagine if that assumption is carelessly carried into a corporate board room where the assumption is made, based on magazine articles, that all women have is a priority to feel and look sexier, so designing mesh kits to “help” them tack up sagging pelvic organs or stop incontinence is good, even if the women experience “minor” discomfort. Or think about the doctor who doesn’t have any patients who have had serious complications from mesh. can they keep their assumption that mesh is ok because all the women they know like the surgery. Think of APOPS. They are women who LIKE mesh and they promote it while making the assumption that all women will like it and that the mesh injured are making mountains out of molehills. The mesh injured are pretty solid evidence that assumptions were made about the safety and efficacy of mesh but that those assumptions were seriously flawed. We are aghast that anyone made those assumptions without solid scientific evidence to back it up. There have been other unkind assumptions made about mesh women. They are of course untrue, but making sweeping generalizations about groups of people opens up our own group to the negative impact of people who base their decisions on what they think instead of what they know.

      • Kitty says:

        SS it’s all relative and I stick with my assertions. For me to assume would make as ass out of u and me (assume) This brings back memories when i was teaching and stated that to a student. She went to the director and accused me of calling her an Ass. Subsequently we both learned a lot from each other and she sent me the most beautiful thank you note I have ever received. NOW…enough of that. Thank u for all your input and knowledge and taking time to engage with me. Karim Abdul Jabar…very brilliant scholar and basketball player stated “we are all biased and we have to be aware of that” I don’t know who the APOPS and what their schtik is. I do know that women have tangible injuries from Transvaginal Mesh placement. Some have has a slow downward sporal that has now disabled them…but thanks to the 1.800 #s they realized what was happening. I never said women were not competent..but honestly most women do not go into that intense Medical Practice as men do. I have research to back that. The ones that do are no doubt good..or are they?

  4. Caz Chisholm says:

    Thank you Jane for putting Joanne’s stories in one story, it makes reading all the very valuable information easy to read and easily accessible. Great Job.

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