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Ethicon Media Monitoring 10/17/16
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AUGS Prolapse Consensus Conference Announced with Patient Advocates
Oct 16, 2016 | Mesh Medical Device Newsdesk
The AUGS 2016 Prolapse Consensus Conference will be held November 10-11, 2016 in Baltimore, MD to “bring together thought leaders representing private and public stakeholders who are actively engaged in prolapse treatment and research to identify the current, critical steps required for improving treatment and reducing the impact of prolapse on women’s lives.” -
The Business of Transvaginal Mesh
Oct 16, 2016 | Lawyers And settlements
By Jane Mundy
While countless women are suffering serious transvaginal mesh injuries, market researchers report on how “negative press” has impacted sales in the European and U.S. market. Perhaps 49,000 federal lawsuits against TVM makers are also to blame
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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AUGS Prolapse Consensus Conference Announced with Patient Advocates
Oct 16, 2016 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 16, 2016 ~ AUGS Prolapse Consensus Conference Announced. Patient Advocates work with industry for change.
The AUGS 2016 Prolapse Consensus Conference will be held November 10-11, 2016 in Baltimore, MD to “bring together thought leaders representing private and public stakeholders who are actively engaged in prolapse treatment and research to identify the current, critical steps required for improving treatment and reducing the impact of prolapse on women’s lives.”Scientists and clinicians actively engaged in research or in the practice of women with pelvic floor disorders are invited to attend. Stakeholders are invited too. Who are stakeholders?
Identified as the Stakeholders are:
*AUGS Investigators/researchers
*Funding Agencies
*Industry partners
*Patient Advocacy groups
Attendees will have an opportunity to help shape the future action plan by participating in working group sessions.
Who are the patient advocacy groups?
Patient represents include Missy Lavender and Sherrie Palm, and their nonprofit organizations.
Former businesswoman, Lavender is the Executive Director of the Chicago-based Women’s Health Foundation whose mission is to improve women’s pelvic health and wellness by, “Driving cutting-edge research initiatives,” as well as develop education and fitness programs and serve as a national resource on pelvic wellness.
The group was formed in 2004 after Ms. Lavender experienced POP, incontinence and sexual health issues. And soon afterward the organization shifted from information around specific dysfunction to a focus of pelvic health “Below the Belt,” as they describe it, “now embraced by industry as a goal for women and girls.”
The group recently partnered with HealthyWomen on a project which is supported by a corporate advisory board and Pfizer, Allergan, Poise, the Divacup, Osphena pill to treat dyspareunia made by Shionogi Inc. a Japanese drugmaker. See the Corporate Advisory Board.
Sherrie Palm, based in Wisconsin, runs the nonprofit, APOPS Association for Pelvic Organ Prolapse. Filed as a nonprofit corporation with the state of Wisconsin in September 2010, her website provides information about POP and links to health professional members of AUGS. She became an AUGS member in September 2012. Palm continues to support and promote surgical mesh telling that surgery without mesh often fails in one to five years.
On her website she thanks sponsors Coloplast, Boston Scientific, Thermi, Laborie, MD Custom RX, Incontrol, A Women’s Touch
Here is the APOPS page on mesh. APOPS on Questions to ask your doctor about POP mesh repair.
Her organization is for women who have been diagnosed with pelvic organ prolapse or suspect they are experiencing the symptoms. She advocates surgery as one option for women, the one she chose to find relief.
Palm believes industry is part of the solution, which she calls “building bridges.”
You can contact her for her fee schedule. She appears in this YouTube video.
She writes on October 12, 2016 in her blog:
“Last week I returned to home base following Astellas/AUA/Urology Care Foundation sponsored advocacy coalition round table in Baltimore. Advocacy coming together to generate positive change in policy is a good thing, especially when healthcare, industry, research, and academia participate in the process. Healthcare policy evolves slowly when one sector alone bangs the drum; it advances more effectively when voices from all sectors come together in a way that acknowledges patient voice is the cornerstone. If you want to know what the true impact of any condition is, ask the patient.”AUGS Prolapse Consensus Conference
November 10, 11, 2016
Hilton Baltimore
401 West Pratt Street
Baltimore. MD
Here is the announcement
http://www.augs.org/p/cm/ld/fid=824http://www.meshmedicaldevicenewsdesk.com/augs-prolapse-consensus-conference-announced/
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The Business of Transvaginal Mesh
Oct 16, 2016 | Lawyers And settlements
By Jane Mundy
While countless women are suffering serious transvaginal mesh injuries, market researchers report on how “negative press” has impacted sales in the European and U.S. market. Perhaps 49,000 federal lawsuits against TVM makers are also to blame
One disturbing comment from this recent market research report is how “The market is expected to continue a substantial shift from transvaginal mesh to sacrocolpopexy mesh”, and traditional transvaginal mesh sales “will decrease as physicians move towards sacrocolpopexy mesh at increasing rates.” The market researchers don’t mention why the shift to sacrocolpopexy mesh, but one obvious reason would be an attempt to increase sales.
After the FDA in 2011 issued a second warning against implanting TVM for pelvic organ prolapse (POP), use of the mesh decreased in New York from 30 percent to 23 percent. (Seven percent doesn’t seem that significant until one considers that more than 225,000 surgeries for POP are performed annually in the US.) Researchers published these statistics in JAMA Internal Medicine (Feb 2016). Compared to the first FDA warning in 2008, when use of the mesh went up from 21 percent in 2008 to 30 percent in 2011, the researchers believe the FDA’s second warning, which said complications are “not rare”, is partly related to the decline in mesh use. They also said the decline of mesh implants to treat POP after the 2011 warning suggests that “stronger regulatory warnings can influence physicians' use of potentially unsafe medical devices.”
And the FDA warning in January 2016 reclassified transvaginal mesh to repair POP from class II (moderate-risk) to class III (high-risk). The FDA has given manufacturers of surgical mesh 30 months to demonstrate their products are safe and effective for POP by way of a Premarket Approval application. Perhaps the manufacturers are counting on switching from polypropylene—the most popular material for transvaginal mesh—to sacrocolpopexy mesh in an attempt to pass the approval application.Another study published in JAMA (May 15, 2013) said that little is known about safety and long-term effectiveness of sacrocolpopexy mesh. The researchers concluded, during seven years of follow-up in two groups of women, that “abdominal sacrocolpopexy failure rates increased in both groups… sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion.” Let’s hope that the FDA read this study.
The market research paper went on to say that, “Modifications to the mesh, extra clinical trials to prove safety and pre-emptive marketing is helping to clarify the safety and health risks associated with mesh to curb the decline in procedures.” It would be interesting to note a different outcome than the 2013 study reported in JAMA.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/ams-transvaginal-mesh-lawsuit-lawyers-20-21783.html
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