Free Case Evaluation
Connect
With Us

Urogyn Society Closes Door on Mesh-Injured Women

always-there-bscMesh Medical Device News Desk, November 7, 2016 ~ After turning away two mesh-injured women who were enthusiastic about participating in an upcoming Prolapse Consensus Conference, the society then expels your editor from membership of AUGS.

Janet Holt, a mesh-injured plaintiff, learned about the upcoming Prolapse Consensus Conference to be held in Baltimore, November 10 and 11 on Mesh News Desk.

AUGS conference

AUGS conference

The American Urogynecologic Society (AUGS) had just concluded its annual conference (See coverage on MND here and here) and had scheduled this session to bring together “public and private stakeholders involved in current treatments and to research the current steps for improving treatment and reducing the impact of prolapse on women’s lives.”

Janet Holt

Janet Holt

Stakeholders included Patient Advocates.  Holt was enthusiastic.

“When I read “Attendees will have an opportunity to help shape the future action plan by participating in working in group settings,” I instantly said to myself I want to go. I want to participate. I want to be heard. I want to have input. I want you to see my face. I want to learn. I was so excited!”

She filled out the AUGS form for entry and booked a flight and hotel.

“After all Sherri Palm was quoted in her blog as saying if you want to know what the true impact of any condition is, ask the patient. I was pumped and ready. I am the patient. My hand is up. Ask me Ask me!”

Holt said she wanted to make an impact. She wanted to put a face with the hurt. She is one of 100,000 women in the U.S. experiencing complications after a transvaginal mesh used to treat incontinence or pelvic prolapse.

The timing was perfect for Janet Holt and Bev Pennington, another mesh-injured woman.

Both professional women, both mesh-injured had recently attended the Patient Training Workshop at the National Center for Health Research Conference, a Washington, D.C. – based patient focused group.  See story here

Patient Training Workshop

Patient Training Workshop

“At the conference I just attended we learned the importance of clinical trials. What the data should look at and what should be reported. I learned, once again, the importance of JUST SHOWING up,” Holt tells MND.

They felt they could provide a voice for patients who are injured by transvaginal mesh and are disabled and unable to travel, to give those suffering in silence a voice.

Holt had experience.

She had given testimony at the Institute of Medicine on public health effectiveness of the FDA’s 510(k) clearance process and had testified at the FDA’s executive panel on mesh implants.

 

THANKS BUT NO THANKS

Instead, Holt was told other Patient Advocacy groups would be present. The meeting was for those individuals “actively engaged in research of the condition and treatment options for prolapse.”  Their payments would be returned by AUGS.
augs-rejection-letter-to-janet

Janet tells MND, “I was disappointed. I believe I am more than qualified to speak. It is my opinion that patients are very much needed to be part of their planning going forward. The largest segment of baby boomers have now reached the age of 65. SUI and prolapse going forward is going to affect a large segment of the female population. I have always been respectful when speaking before AUGS. I believe innovation is needed to solve this problem that will affect so many. I want/believe clinical trial should be done on any implant that is put in the human body.  It has to be safe. If industry does not let us participate I believe harm to women will continue when greed overtakes patient safety.”

 

MND ASKS ON BEHALF OF PATIENT REPS, Oct 26 2016

As someone who had recently joined AUGS as an Affiliate member, and paid to attend its recent conference, I sent a letter to Ms. Hughes on behalf of Ms. Holt and Pennington to assure her that Holt and Pennington were not part of the “anti-mesh movement.”

AUGS president HALE had used that term to marginalize the mesh-injured during his address at the conference the week earlier. See the story here.

I wrote:

“I strongly urge that any “action plan to advance prolapse research” take into account the present. Good science requires discovery into successes and failures, and nothing less. 

Surely, physicians do not feel that women who are now disabled following their pelvic mesh implants to treat incontinence or prolapse are an acceptable outcome?

I would like to request bringing together these disparate groups, preferably at the upcoming session in Baltimore to include the real “stakeholder” voices of the most reasonable, intelligent and knowledgeable mesh-injured women to become part of the AUGS driven action plan.  

Time is of the essence.”

 

The first rejection letter, dated October 27, was polite reiterating that scientists and clinicians who are “actively engaged in research or practice of women with pelvic floor disorders are invited to attend this conference.  This is a very small meeting, less than 50 attendees, who will be developing a research action plan for AUGS.”

The second response from Hughes was less polite. The conference is not intended to bring together “disparate groups” but to “review current scientific research to determine where more research dollars and effort needs to be spent.”

“The conference is not intending to discount the present reality patients experience; it is just not our focus.”

Oh, and one more thing, said Hughes

letter-hughesThe Affiliate Membership is for health care providers and anyone actively working in the field of female pelvic medicine and reconstructive surgery, clinical researchers and government officials, not for journalists, or researchers, or educational outreach.

“We will honor your membership through December 31, 2016; however we will need to refund your membership renewal for 2017.”

My membership was cancelled.

It should not come as a surprise.

Joleen Chambers, founder of the patient advocacy group, FIDA, Failed Implant Device Alliance, had a similar experience when she was excluded from an American College of Obstetricians and Gynecologist (ACOG) meeting.

 

Joleen Chambers

Joleen Chambers

“Gynecologists and obstetricians are in an ‘echo chamber’ of their own making. May 4, 2015 I was not allowed into the ACOG conference in San Francisco with my blog/media and 2010-trained FDA/CDRH Patient Representative credentials. So, I joined the ~30 Bayer Essure-harmed women outside for a 2 day ‘rally’. Never were they offered food/water or access to toilet facilities or an opportunity to speak directly to ACOG ‘leaders’. Patients ignored. Patient outcomes ignored. Harm continues unabated.
Sponsors happy & profitable.”

Jan B. had a similar experience.

“Many of our support group members have tried to join the APOPS Facebook support group. APOPS admins have sent a message to prospective members saying that if they are in an “anti-mesh” group they can’t join APOPS. We’ve also had many members who said they were booted from the APOPS group after they had mesh surgery that did not have a good outcome. If they speak up and say they had a negative outcome, they’re removed from the group. There is no discussion allowed from the perspective of mesh injured women. This horrifies me. Because Ms. Palm is held up as a “patient advocate” yet she is not advocating at all for patients who are severely injured by a mesh POP or SUI repair.

“It is impossible to believe that she or other AUGS members are unbiased, because they are financially tied to the mesh manufacturers. Whereas those of us advocating for mesh-injured women are tied to NO ONE financially – we have no reason to speak up about mesh, other than to warn others that it severely harmed us.”

PostScript* 

Holt reacts:  “ How could industry move forward from such a dark time of mesh implants? I wanted to see “the plan. If mesh was still going to play such an important part in women’s health. How did you change it? What surgical procedures were you going to do with it? What were the clinical trial you did? Who was in your study group? I wanted to voice clinical trials must be done. Data needed to be collected. My questions are almost infinite.”

“Then there is that nagging voice in the back of my head that asks has a treatment been developed that is better than “just tacking” it up. After 14 mesh removals and reconstruction surgeries my bladder was finally just tacked up. Just like my mother’s was tacked up. No one was harmed. Why do we even need to look at mesh? Shouldn’t we only look at other options if the “tacking up” fails too soon. Their response is that tacking up the bladder won’t hold. Well I don’t think I would have needed 14 surgeries to re tack up my bladder. My mom only had the one surgery. She is still just fine.”

SCOTLAND

This episode comes at a time one of Scotland’s leading gynecologists is publicly pronouncing that doctor’s reputations will be ruined over the mesh scandal.

Scotland has taken steps to halt mesh procedures until more is known.  After about 400 mesh injured women spoke directly to Parliament to talk about their injuries publicly. The issue is hotly debated and front page news headed by journalist Marion Scott who received Reporter of the Year 2015 for her coverage.

In the U.S., the issue barely makes the front pages unless there is a million dollar jury award.

Mark Slack, head of Gynaecology at Addenbrooke’s Hospital in Cambridge, said the tragedy was created by greed. He told the Daily Record, UK newspaper “The mesh scandal will remain as a stain on our behavior.”

Read it here. ###

25 Comments

  1. Disgusted says:

    Thank you so much for trying ladies. This makes me sick. The objective is clear and it counts dollars not sense. I’ve run into so many who have bought the industries and doctor’s lies. One person had hip surgery, her problem has not changed, but of course “the mesh was not involved”. I feel like getting a medical degree just so I can have a voice. Doubtful I’d make it very far in the door. There are other doctors sounding the warning and they are not really heard either. We are like sheep being led to the slaughter, so that we no longer have these problems that make us a PARIAH in our country. So many levels to be reformed. So many crooked leaders. Seems helpless. But with God we can do anything. At this point we need a MIRACLE!

    • Mary D says:

      This is Unbelieveable and Completely out of Control! If I had been aware of this site or any information from DRS or Hospitals, 3 years ago, even, my Mom might have found a way to live.
      She died 9/2016. She was told her UTIs (15yrs) were resistant to all antibiotics in June. She had blood sepsis over a year.
      Her TVT was implanted in 2001. The rest of her life was indescribable.
      My sister lived with her until 11/11, when Mom went for “rehab” in Nursing Home to get her strength back so she could walk again.
      She tried very hard She fought for every breath her last night. She wanted to live.
      I was not prepared for her to leave me.
      I will do anything to help this cause.
      I am available, willing, and learning.
      Mary

  2. Kitty says:

    This doesn’t surprise me at all. JAne..ur were lucky to get as much info as u did. BRAVO!! I DON’T THINK AUGS had much love for the self serving agitators that u hung with. Your inside info on earlier post was bomy she’ll material.

  3. Diva 64 says:

    jane the information you have provided to us all has been so valuable, including where the autoimmune disease has been added to the list of complications of transvaginal mesh. The ladies who have had mesh surgery know more about the mesh than the manufactures want to admit, as we were the guinea pigs, Although Mesh Manufactures sled their product through on the backside of the originally approved, the original approved mesh was recalled within 2 years. Any of the doctors wanting to learn about pelvic mesh pelvic prolapse needs to hold a meeting with the patients being the key speaker, we may not be able to teach them the surgical procedure however we can certainly teach them why their should not and should not be any mesh surgical procedure going forward. Not only does the Uro-Gyn,Ob-GYN, need to learn, any GP, and ER doctors and nurses need to be educated in the complications, As I review my records, I see where so many test were written w/o (without pelvis) where that was the area I was seeking treatment for. So not only are the manufactures guilty the medical community is guilty as well. Without your news desk and the various organizations , many women would have had no support, and only doctors telling them this is in their head, not their bodies. Heaven help those that took an Oath To Do No Harm.

    • Jane Akre says:

      Diva your words are wise…. if doctors at AUGS would listen to you they would learn so much AND avoid being drawn into litigation. I do hope one doc who is pursuing guidelines for treatment of mesh injured women, will talk to those doctors who have had success with removal surgeries. I pointed him in the direction of one such doctor I know. I hope he followed up.

  4. Janis Urban says:

    Who are the organizers of this A N T I M E S H M O V E M E N T? Do they have a Web Site, Blog, Facebook, Twitter or any other page? There is a huge difference between Advocacy and Activism! Just wondering?

  5. Beverly P says:

    Dear Jane,

    Thank you for standing up for Janet Holt and myself regarding the cancellation of our attendance at the AUGS Conference, and I am truly sorry your membership was cancelled because you went to bat for us. Cancellation of my attendance to the conference was seriously disappointing, but it is their loss…maybe they were fearful to hear the truth.

  6. Still Standing says:

    Jane, I’m sorry you got expelled! Good grief. However,on the bright side, now you will have some extra Christmas cash when they refund your 2017 dues. However, I have a question you need to pose to the powers that be. Sherrie Palm is an invited advocate, yet, by reading over her stated curriculum vitae, she appears to not fall into the guidelines. At no place on her website does it say she engages in research. I cant even find where she has a college degree, much less be involved in scientific research. How could she contribute to the conversation about gaps in research or research design? There is just something not right with that picture. I’d like to see how they would respond to that query.

    That said, I do know that many in the medical community are taking a new look at research in today’s world. As the cost of research climbs and money for research is growing more scarce, research needs to become more focused and more translational. So, medical societies are trying to align their research needs with the actual funding areas, which are always driven by federal policy. I was part of a meeting not long ago where pain advocates were gathered to TEACH researchers the questions they need to be asking in research on pain. So, the fact that AUGS is having a consensus meeting for targeting research is not unusual, but the fact that they revere Ms. Palm’s input makes me scratch my head. She had prolapse, she had it successfully treated, and she states that it has been perfect. While that is a good thing for her, it in no way equates into being an expert in prolapse. Having a brain does not make me a neuroscientist. Having a prolapse , especially one that has been successfully treated rather quickly after the onset of symptoms, does not come close to equating to being an expert on the impact of complex complications that women experience from prolapse. Besides feeling just downright pissed about her expert status, it definitely marginalizes the thousands of women who DO deal with the very real fallout every single day.

    • Jane Akre says:

      You are so right about Ms Palm… she has no college degree and is writing about study results. I wonder if she is getting help with that? Are right and I will take it up with them again. It appears they have curtailed any contact by me until the end of the year which I paid for…I cannot imagine this sort of response to some reasonable questions. A good PR person would tell them to answer the questions and quit making things worse.

  7. Kitty says:

    All kidding aside…the AUGS researchers had the opportunity to gather participants for their studies by chatting with Palm et al. What is taking so long..granted they would have to dig up corpses for their long term studies.

  8. Kitty says:

    Ladies ladies—what ever you do make sure the Uro Gyn you go to is not a member of AUGS. I believe a member would spit on their MOther’s grave to keep their reputation. Someday this will come out–but for now some of us were foolishly and brutely treated and examined by the devil him/herself.

    • Jane Akre says:

      Some members of AUGS are knowledgeable and are helping mesh injured women, so I would not agree with that blanket assessment.

      • Kitty says:

        ,I believe it is best …not to go to an AUGS member if u are looking for validation of your injuries

      • Kitty says:

        AUGS posit in is pro polypropylene mesh. Why would they admit that their standard has caused your pain?

        • Jane Akre says:

          Kitty- Dr Una Lee of Seattle is a member of AUGS and does mesh removals, expertly. Dr Miklos is a member, Dr Veronikis, Dr Donald Ostergard… all of these docs understand what is going on with mesh, eventually they are getting that the material may be the culprit. Many feel it is inexperienced docs who do the most harm….just dont throw out the baby with the bathwater….

          • Still Standing says:

            Jane, you are absolutely right about the AUGS membership. I would feel much less safe with a physician who had no professional affiliations. Many of them are trying to figure this out. Yes, AUGS still has a position on the use of mesh. I will tell you that I would be completely non functioning without a mesh product. After all of my posterior and anterior transvaginal avaulta mesh was finally carved out, my vaginal vault completely collapsed and it hung about 8 inches outside my vagina. At this point, after multiple surgeries I had no healthy tissue to use. There was no place to attach a biological graft or tissue to stitch together. Mesh was my only option. It was placed by a skilled surgeon that I completely trusted to make decisions in my best interest. So, there does have to be some acknowledgement that mesh products should be an option for certain women. Jane, you are right about the correlation between inexperienced doctors and higher rates of mesh complications. There are multiple research studies that suggest this. Of course, skilled doctors still produced complications, but there is a trend noticed in research that points to less experience= increased complication rates. I can bundle up the links to some of these studies if anyone is interested in taking a look at them.

            Jane, as we move into this season of gratitude, Im sure I speak for many mesh women in expressing our thanks to you and your unwavering, steadfast commitment to telling our tragic story and providing a space that educates and comforts us. The work you do on our behalf makes a difference.

          • Jane Akre says:

            Still Standing- Thank you for being a calm and steady voice that readers have come to rely on. I know you work through your pain and you have accomplished much. I greatly admire you and hope to meet some day.

            Best this holiday season to All! I pray for a day of peace for you in whatever way you can find it. !!! Happy thanksgiving.

  9. Kitty says:

    SS—-initially I did not want to respond to your post.
    As Kareem-Abdul-Jabar suggests we all have bias’. Let me give you some reasons for anti AUGS
    The most influential Doctors'[ at the head of AUGS were in the Netherlands mesh study group. They are very arrogant pro mesh disciples.
    Oh yes—— Dr Ostergard and M & M may be doing good things and helping ladies. I am not sure if either of them have received royalties from J&J and Boston Scientific and thus became millionaires.
    I do know that some ladies have been implanted by a certain doctors’ that have mammde millions from select companies. One such Doctor told a woman “The mesh is gone—- you are perfectly fine.” This Dr made millions and then went on to invent another mesh product that was pulled off the market. This Dr has been arrogant to many women. Foolisly some of these women went on from Dr to DR to find out if the mesh was gone–believing that they were hypochonriacal nut cases. Some of these other Drs blew them off as well. Another
    Dr that one may have gone to was involved deeply in research at AUGS—and then sent certain women for psychotherapy—which is not a bad thing. At least in psychotherapy a woman can tell their story—while they are on MPP which I am sure you are very well aware of. In conclusion most AUGS members are biased—biased for mesh. Again I say ladies—do your research and see what involvement your DR had/has. I believe Dr Raz and Drs’ Daniel Elliot are not involved with the organization. Do your research.

  10. Still Standing says:

    Kitty, I understand your position and I am sure many women feel that they cannot trust physicians. However, you mentioned the Netherland study group and I want to try to clarify what that study concluded. It is common to hear of a research study around pelvic mesh and think that is a blanket statement that physicians support the conclusions. Reading scientific literature and trying to translate it to practical knowledge is something that I do on a professional level so I want to give this a shot.

    Some of the things we look for in determining how well the study can be applied across a broader population is the number of participants in the study, how specifically the participants were defined, and what end result the researchers were looking for. There is no one piece of research that ” proves” anything. Scientific knowledge evolves over time as more evidence is gathered through studies. We should actually be glad for every piece of evidence that is discovered in the field of pelvic mesh. It is robustly studied right now, so positions change and evolve as as new layers of understanding are contributed to the greater body of scientific knowledge. It is important to know that scientific research is not ever set up to prove or disprove an absolute. Actually, research is set up to prove a hypothesis wrong. As variables are isolated and manipulated science can conclude that what they discovered cannot be a result of any other action, described as a probability confidence ratio. This study was actually building on other findings that women who had hysterectomy indicated by prolapse were 4.7 times more likely to develop additional prolapse and if prolapse was stage II or more, it was 8 times higher.

    The Netherlands study group was not set up to prove or disprove that mesh is safe. The research looked primarily at functional outcomes defined as recurrence of prolapse at 12 months and self reported impact in quality of life. Quality of life was measured by a validated survey that determined if the surgery improved their life 1year out. Functional success was defined as prolapse recurring at 0 or 1 stage at 12 months out. It is important to understand the selection of women to this study. All but one women who were participants had a prior failed vaginal vault prolapse surgery . All women had had previous hysterectomy because prior science indicated that women with prior hysterectomy had higher risk of additional vaginal vault prolapse. ( no women with SUI) . All the women had prolapse at stage 2, 3, or 4. 87% had stage 3 Or stage 4 prolapse, which is severe. 9% had more than 2 prior prolapse repairs. Their median age was 66. 45 women in the study had Prolift, others had vaginal vault compartment repairs, meaning that they had repair of only 1- posterior or anterior.

    The study wanted to know if a continuous tape( Prolift) reduced occurrence of additional vaginal vault compartment prolapse. In other words, which was the best anatomical outcomes for just this particular set of people.? Was there a reduced recurrence of prolapse with Prolift than those who had posterior or anterior repair?

    Women were followed for 12 months post surgery. Here are the conclusions:
    1. 93% of women who had Prolift fit the criteria for success which was defined no prolapse or . or stage 1 prolapse. ( pain, immune response to mesh, other complications were not studied in this research.
    2. Women who had compartment surgery had higher risk of another prolapse.
    3. They did incidentally see higher rate of mesh erosion a high (15%). They also said “In our opinion, the rate of mesh exposure is still too high and determinants other than those. already published need to be discovered to lower this incidence.” ( to me, this does not give a thumbs up to using mesh. It is a caution that there needs to be more research to determine why some women develop this complication. One interesting observation is that women who were in surgery longer had higher mesh erosion.)
    4. They documented a slight shortening of the vagina, not due to mesh shrinkage, but to tissue reaction around the mesh.
    5. 93% of the women self reported on a survey that they were much better or very much better at 12 month follow-up. They did suggest that they noticed higher erosion later in the 12 month follow up and said that women should be followed longer.

    They concluded the report by stating that ” whether this procedure is more effective and safe than other forms of prolapse surgery remains to be determined in randomised controlled trials”.

    Every scientific study will state the strength of the study then recognize the weaknesses or limitations of the study. This is what drives additional research by others in the scientific community.

    So, if anyone is still reading this too long post, please just understand that this is one of many studies on mesh. This one was very specific about the population they studied and it did not intend to make a determination of overall mesh safety. Small steps lead to better knowledge. One piece of mesh research cannot be read in a vacuum or be interpreted that the physicians completely support mesh.for everyone. I think these researchers did a good job highlighting the limitations of the study. This encourages other researchers to try to recreate the results and then take a piece of it to focus on by different scientists in another study.

    • Jane Akre says:

      Good Post Still Standing- Anatomical outcomes used to be the standard of measurement. As if, she is in extreme pain but the uterus is where it;s supposed to be. That viewpoint totally ignored the state of the patient. So it’s good to see that QOL – Quality of Life – was considered here. That is progress and not treating women like a cadaver. Thank you for this!

Post a Comment

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

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This news website is designed by NextClient.com.