Mesh 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.
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.”
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.
“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.
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 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
The 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.
“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.”
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.”
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. ###