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AU Investigation Questions Ethics Behind Mesh Study

Jill Hennessey, from The Herald, AU

Mesh Medical Device News Desk, July 5, 2017 ~ An Australian public health watchdog is launching an investigation into whether two doctors participated in a pelvic mesh study and implanted women without the knowledge of the women or the hospital. 

The Victoria Health Minister, Jill Hennessy, is behind an investigation into a Melbourne public hospital. Victoria is a state in southeastern Australia.

dr. Peter Petros, father of IVS Tunneller

Allegedly Dr. Richard Reid and Dr. Peter Petros assisted Dr. Max Haverfield in 2010 and 2013 without alerting the public or the hospital, and despite some conflicts of interest.

The paper was written by gynecologist Dr. Max Haverfield and published in 2015. See it here.

It concluded the device is “safe and effective” but Northern Hospital has no record of the trial or ethics committee approval, reports McCarthy.

The research study says “Ethics approval was obtained by the Ethics Committee, The Northern Hospital/Northern Health.  Safety of the study was monitored throughout. Written informed consent was obtained from all patients.” 

Dr. Richard Reid

Dr. Petros is the inventor of the TFS and was director of TFS Manufacturing at the time of the alleged ethics violation.

At the time, he and Dr. Richard Reid were being monitored by the NSW (New South Wales) Medical Council after it had received complaints from women injured allegedly by pelvic mesh surgery.

TFS was taken off the market in November 2014 because of a lack of evidence on its safety and efficacy.

Joanne McCarthy, reporter, The Newcastle Herald

The 24-month study included women who experienced grade two to four prolapse.

Here are the archives- coverage from Newcastle Herald.

Reporter McCarthy is recognized as the persistent journalist who uncovered wrongdoings of the Catholic and Anglican churches concerning child sexual abuse.

Her reporting is credited with the creation of the Royal Commission into Institutional Responses to Child Sexual Abuse.

She has since moved onto transvaginal mesh and the harm it has caused.

Mesh News Desk has written about Dr. Petros application to re-invent the TFS as a treatment for sagging breasts.  See the story here.  #

9 Comments

  1. Bejah Blue says:

    Doctors and hospitals routinely alter medical records, notes, and the people do not realize the extent to which this happens, they do it just as JnJ alters and/or destroys documents/evidence. Nothing is sacred. If you have a durable power of attorney for healthcare do not think the hospital will respect it. For example if a family member protests the hospital will probably not honor it. They know you can not afford emotionally or financially to sue them even if you have grounds and compelling evidence. The best thing to do is stay out of hospitals if you can at all costs or try to go to the best one and have the best doctor (skill and honor) but be prepared to suffer a breach of trust.

    Bejah

    • Jane Akre says:

      Agreed. I just had a neighbor who died in a hospital from a rather simple benign cyst removal. Tragic.! Case of left hand not knowing what the right hand is doing and no one was monitoring her. There are at least 200,000 deaths each year attributed to medical mistakes, drug overdose, wrong drug, or undertreatment, and those are only the numbers that are computed.

      • Bejah Blue says:

        My heart goes out to you over the loss of your friend Jane. It helps to believe that life is just a dream. Speaking of dreams last night I dreamt someone told me that I needed to drink more water. I think it was a male doctor who was kind but sharp tongued. I guess I better do what he said. I tend to take these things seriously. I believe that you will see your friend again. Check IONS website and consider the work being done there, for example. My mom passed away after “care” at Manor Care in Rancho Mirage and transfer to Eisenhower Medical Center and hospice. She had fallen and broken her leg and arm. Two months later she was dead. The truth is not enough to change things. I felt so helpless and that and rage make for strange bedfellows. The one beautiful thing was that mommy was peaceful and looking forward to going to Heaven. For 2-3 years before this we spent a lot of time reading about it and reading the Bible and meditating. I encourage everyone to do this. People who are dying often want to talk about it but everyone is so often afraid of the ultimate “elephant in the room”. I was very comforted by my mommy’s peacefulness.

    • Still Standing says:

      Bejah, we tend to believe that hospitals and other medical providers are legally responsible for carrying out our wishes with a durable power of attorney for healthcare decisions. The most important decision is choosing the right person to be your agent. You need to have a frank discussion with that person you designate so that they are very clear about it and are willing to make those hard decisions even when other family members don’t want to honor it. You should also only appoint one person. If you name another secondary agent just in case, they will both have to agree equally on what to do. This can tear families apart if it happens. Also, you need to have a copy on file at hospital, but also one in your car and visible in your home. If an ambulance is called to your home and a durable power of attorney document is not readily visible, they will legally have to start life saving measures. Once this happens, it is a battle to remove a ventilator or other life prolonging interventions. Ditto for a car wreck. If they don’t see it, they will have to seek extraordinary lifesaving measures. I saw this happen in hospice quite a few times. I redid my durable power of attorney after I watched my husband and his two brothers completely disregard their mothers wishes. She was 93 and had spelled out very specifically what she wanted. They caved until I told them I would never speak to them again if they put in a feeding tube. Mom died peacefully, but it could have been a different and tragic story. Everyone should complete this document and clearly inform your agent. Of course, your agent needs to have a copy as well. The breach of trust occurs between the patient and his/her acting agent. By the way, a durable power of attorney for healthcare is not the same thing as a durable power of attorney over your possessions. Healthcare only kicks in if you become unable to make decisions about your health. It conveys no other power.

      • Bejah Blue says:

        Dear SS and everyone….My mom named me as her Executor and Trustee. She had a Durable Power of Attorney for Healthcare. In the end she was transferred to Eisenhower Medical Center from Manor Care in Rancho Mirage because she was dying (from being left alone laying down flat in her bed for hours on end and developed a lung infection). My sweet and beautiful mother who was still living in her own home was left to die because she was a cost center for United Healthcare, a monsterous corporation. They wanted her dead. They did not want to pay for the expenses to keep her healthy and alive. All she did was fall and break her leg and arm getting the morning paper at my house when I was away at UCLA getting conned about surgery. A doctor came by once a week and did not touch her, did not come within three feet of her, not her doctor, the assigned doctor, a real pig. I had a copy of her Durable Power of Attorney for Healthcare, and I also hand delivered a copy to the physician on duty at the hospital. I wanted her transferred to hospice as soon as the Nephrologist came and told me her body was shutting down, it was near the end. Arrangements were being made, papers signed when my brother arrived from D.C. waving his credentials around. He was intimidating as he can be. He needs to be in control. My mommy’s wishes were not honored by the hospital or her own son. She had a mask strapped to her face with elastic so tight it left welts on her face. She tried to remove it. They tied her hands down. They did not turn down those horrible bright white lights. She could not speak or even try to. She tried to write me notes but the letters were hard to read. In part it said “I love you”. My brother who is not a person of faith intimidated the hospital staff, even the doctors evidently, my mother suffered while he exercized control insisting he was waiting for my son to arrive from Raleigh, NC. Because he was faithless he did not understand that mommy would have waited for Michael, the dying do that. Michael came and then my brotherallowed me to transfer my mom to hospice two blocks away where there was soft lighting and music, silence, peace, and relative comfort, no tubes or cords or masks or anything intrusive. We were able to feed her, a symbolic act. She was able to communicate if not talk coherently and she was finally at peace.She passed away there with “her boys” and me and tons of flowers from Trader Joes. She was happy to go to Heaven at last. Things between my brother and I have not been the same since. My son and I are OK. He tried to comfort both of us, it is the kind of thing he does in business. I went to an attorney who told me I had an airtight case against the hospital but he cautioned that it would take years and it would drain the life out of me so I did not sue since I felt the life had been drained out of me already and I did not know it then but there was more horror to come. I was and am so happy my mommy is safe in Heaven. People told me the hospital did not honor the durable power of attorney for healthcare because of my brother. I have heard since that it happens all the time so be prepared.

        Bejah

        • Jane Akre says:

          I’m sorry Bejah…. what a horrible ordeal for your mother and you. It just takes one ass….

          • Bejah Blue says:

            Jane, It is the opinion of his ex wife (a prominent physician) and I that he suffers from a severe Narcissistic personality disorder and probably Depression and other subset mental health issues as well brought on by what we call environmental issues: His life experience and perhaps a pre-disposition, I am not qualified to say but it is a great sorrow. We need to be as a nation more compassionate, more knowledgable, more aware and more accepting of mental illness. Unless we wrap our hearts around it, the problem will surely become worse.

          • Bejah Blue says:

            I want to add that even though she could not talk, I suspect she may have had a stroke, I don’t know, something extraordinary happened. I said I had to run home for a minute to feed the dogs and let them out (I lived just a few minutes away). My mother, in a clear strong voice, my mother who could not speak, said “You don’t need to come back”. I was stunned but it did not really sink in somehow until later. As soon as I got back the call came from my brother that she was dying now and I rushed back but I was too late so I got in bed with the body of my mommy and stayed there with her until my son came in and told me I had to select a mortuary as they could only keep the body so long. Mommy did not want me there when she passed away. She knew I would fall apart. I know her. When I got home there were so many signs she was around. Know that we go on. We do not end. Have faith people. Life and death can be so beautiful even in the midst of evil.

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