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Ethicon Media Monitoring 11/08/16
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Urogyn Society Closes Door on Mesh-Injured Women
Nov 7, 2016 | Mesh Medical Device Newsdesk
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. -
Health Sentinel: Treatment available locally for women who have urinary incontinence, pelvic floor disorders
| News Sentinel
By Jennifer L. Boen
Though it affects every one in three of them, women are very reluctant to talk about this important health issue. However, the number of TV and magazine ads for such products as Discreet and Poise should be a giveaway for just how common urinary incontinence and other pelvic floor disorders (PFDs) are.
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Urogyn Society Closes Door on Mesh-Injured Women
Nov 7, 2016 | Mesh Medical Device Newsdesk
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 to attend the conference was returned by AUGS.
Coleen Hughes, Associate Executive Director of the AUGS, wrote to Janet:
Janet thought there must be some misunderstanding. Surely attending as a patient advocate would be welcome, she thought. She tried again.
Colleen,
I am sorry if I somehow answered a question wrong on your form. I wish to attend as a patient advocate. I truly believe if we can all work together on the very important topic we can come up with a few ideas by using the input of a patient advocate. I would very much like to participate in a professional way at your conference. I look forward to hearing from you.
Thank you,
Janet Holt
The answer – Thanks but no thanks.
Hughes repeated that the session “is only open to scientists and clinicians who are actively engaged in research or practice of women with pelvic floor disorders. Stakeholders participating in the conference include investigators/researchers, funding agencies, industry partners, and patient advocacy groups.”
Her $75 would be returned.
Janet tells MND, “I was disappointed. I believe I am more than qualified to speak either as a “comment” or to have taken part in a group discussion. 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
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, educational outreach or research.
“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, 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.”
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. ###
http://www.meshmedicaldevicenewsdesk.com/urogyn-society-closes-door-mesh-injured-women/
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| News Sentinel
By Jennifer L. Boen
Though it affects every one in three of them, women are very reluctant to talk about this important health issue. However, the number of TV and magazine ads for such products as Discreet and Poise should be a giveaway for just how common urinary incontinence and other pelvic floor disorders (PFDs) are.
An estimated 377,000 women underwent surgery in 2010 to correct a bladder control problem or pelvic organ prolapse in which the bladder or uterus descends into the birth canal, according to the National Institutes of Health. With an aging population, the number of these surgeries is projected to rise significantly in the next decade or two.
Surgery, however, is not the only treatment for PFDs, which can also include painful bladder, bladder leakage, increased urinary frequency, difficulty urinating, fecal incontinence and difficulty having regular bowel movements. Women should also not assume that, for the rest of their lives, their only option is to use those oft-touted products in TV ads worn by an entertainment star who strolls down the street in Spandex jeans, daring you to “see” the protective garment hyped to be just like your underwear.
PFDs can affect women of any age. Erin Fogg, 36, knows all too well the pain, physically and emotionally, of living with PFD symptoms, and the Fort Wayne mother of daughters ages 5 and 6 said the seemingly taboo topic caused her to delay treatment.
“We just don’t talk about these things,” Fogg said. And when discussed among closest family or friends, misinformation can abound.
“We still have these stories from our grandmothers or mothers that the only thing we can do is grin and bear it,” Fogg said.
Though some conditions within the PFD spectrum can affect men, they are more common in women. Pushing an 8- or 9-pound baby through the birth canal increases a woman’s risk, though symptoms may first appear, or worsen, as women age, Drs. Craig Hanson and Scott Boyd said. They are the only board-certified urogynecologists in this region.
At Women’s Health Advantage’s (WHA) Center for Urogynecology, 2518 E. Dupont Road, Hanson and Boyd, along with nurse practitioners Rachael Johnson and Kelly Fawcett, are offering women of all ages help for PFDs through a variety of treatments.
“We always explore non-surgical options first,” Hanson said.
Among the options is physical therapy to build up pelvic muscle strength. Hanson said the United States would do well to follow the practice of post-partum care in some other countries: “In Europe, every woman after delivery has a month of physical therapy,” he said.
For overactive bladder or interstitial cystitis, which is a condition that can causes bladder pain and frequent urination, oral medications may be prescribed. Other medications temporarily placed in the bladder can numb and calm the lining.
“Through the use of biofeedback, electrical stimulation, bladder training, a home exercise program and other techniques, our patients can find relief of problems such as incontinence, urinary frequency and urgency, frequent night-time urination and fecal incontinence,” Fawcett said. Botox injections into the bladder muscle are also used to treat leakage and urinary urgency and frequency.
WHA’s Center for Urogynecology has an array of diagnostic tools available, from more high-tech urodynamic equipment that tests bladder function, and cystoscopy, which examines the inside of the bladder, to low tech, albeit very important, information-gathering of patient and family medical history. All are key to getting the right treatment for the right problem.
“There’s no one size fits all in this,” Boyd said, noting, “When you don’t employ all the diagnostic tools is when you get into trouble.”
Women have traditionally gone to one physician for gynecological issues, to another for urological problems and still another for bowel issues. “It’s been piecemeal until now,” Boyd said.
Fogg turned to the Center for Urogynecology for what she said was a “bizarre constellation of symptoms.” The urinary retention she was experiencing was something usually seen in a person with a neurological condition such as spina bifida or multiple sclerosis.
She also had multiple joint dislocations, a hallmark sign of Ehlers-Danlos syndrome, and eventually was given that diagnosis. The condition affects connective tissues, including skin, joints and blood vessel walls.
“My case is pretty severe,” Fogg said. “The PFD symptoms were the worst.”
After trying physical therapy and other treatments, Hanson recommended implanting the InterStim sacral neuromodulator. Made by Medtronic, the device produces mild electrical pulses via an internal lead placed near her sacral nerve. The impulses help modulate and normalize neural activity from the bladder to the brain.
Even minor surgery in someone with Ehlers-Danlos brings risks, but Fogg said, “It was worth it to get back any quality of life. I only wish I’d gotten it sooner,” she said of the InterStim.
PFDs take a physical toll on those affected, but Fogg said too many women pay a greater price in their health and well-being due to shame and fear.
“We shouldn’t accept that urinary or fecal incontinence are just part of life," Fogg said. "The people who specialize in this stuff are some of the most empathetic, sensitive people you can find. You don’t have to accept a lower quality of life.”
http://www.news-sentinel.com/living/health/Health-Sentinel--Treatment-available-locally-for-women-who-have-urinary-incontinence--pelvic-floor-disorders
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