Mesh News Desk, October 18, 2016 ~ The president of the American Urogynecologic Society (AUGS) admits some doctors were not in the 98th percentile in their ability to place transvaginal mesh while he called out the anti-mesh movement.
AUGS, the American Urogynecologic Society, was born in an Orange County, California living room in 1979.
Founder, Dr. Don Ostergard, was there, so was Jack Robertson, MD the first president, and four others. The first AUGS conference was held in New Orleans and attended by about 60 physicians from around the U.S. and Europe.
Last month, the society held its 37th annual conference in the Denver Convention Center. During the President’s Address, Dr. Douglass Hale, MD said the society has grown by leaps and bounds and now numbers just under 2,000 members.
He called “almost unreal” the AUGS $3.5 million growth in 2015, a jump of almost 300 percent. See his comments here.
Last year, the AUGS annual conference brought in more than half of its annual revenue of $5 million. As a non-profit corporation, support is tax deductible, and more than half of the support of this year’s conference came from mesh manufacturers and related industries.
The 2014 record shows 64% of AUGS Pelvic Floor Disorders is sponsored by industry. See the 2016 corporate support page
AUGS has, since its inception, been an industry magnet. Timing was everything.
Urogynecology was in its infancy when AUGS was born. The new subspecialty of gynecology focused on female incontinence and prolapse, pelvic medicine and reconstructive surgery.
The Food and Drug Administration’s (FDA) 510(k) provided a fast-tracked avenue to market where untested medical devices such as transvaginal mesh could be sold bypassing the costly burden of clinical trials.
For example, in 1996, Boston Scientific’s ProteGen hit the market and by 1998 Ethicon’s TVT (Johnson & Johnson) was ready to be sold in the U.S. Early adopter physicians flew to Europe eager to jump ahead of the pack to bring TVT (tension-free vaginal tape) technology to the U.S.
AUGS received industry support in 1997 when Kimberly Clark provided an endowment to create the June Allyson Foundation. Four years later the first AUGS resident scholars would be sponsored by Eli Lilly & Co.
It’s no surprise then that one cannot turn one’s head in the exhibit hall today and not be reminded of the industry presence – Medtronic, Allergan, Boston Scientific, Coloplast- Platinum, Gold and Silver sponsors spending hundreds of thousands of dollars to make their presence known.
AUGS AND ITS SUPPORT
The closing of Astora Women’s Health division last March “came as a complete shock,” said Dr. Hale to the nearly full room of 1,300 AUGS physicians attending the conference.
Astora was the division of Endo International that bought American Medical Systems in 2011. Unfortunately it also bought its liabilities. Facing future product liability litigation concerns, Endo/Astora shuttered its business operation last March.
Dr. Hale characterized it as a “business decision,” and he added thankfully there are four vendors they can still rely on to provide mid-urethral slings – J&J, Boston Scientific, Coloplast and Caldera Medical (which earlier this year said it was insolvent. See the story here).
And in a rare moment of introspection, Dr. Hale admitted not all physicians are up to the task of placing pelvic mesh.
“Are all slings wonderful, all slings given to surgeons, obviously not,” he said, pointing out that some doctors imagine themselves in the 98 percentile. But that’s not true. Not everyone operates at the 98 percentile.
“Surgeons are no different. Pick the surgery to match what you can deliver,” he warned.
Calling slings the “most studied procedure of all time,” he said thousands of patients have been satisfied with its outcome.
Like anything in medicine it comes with its risks, complications, he admitted, that have come from low volume users, doctors who do an occasional procedure.
AUGS has met with the remaining mesh makers to formulate a plan to “help protect the decision between a patient and her physician whether that decision is for a native tissue surgery or for a mesh surgery.”
Hale said the treatment decision should be based on science and not an “irrational” response, especially in this age of social media.
THE ANTI-MESH MOVEMENT
“The #PFDWeek hashtag has already been attacked by the anti-mesh movement and unfortunately, that’s not a surprise to us. That’s what we’re up against,” said Dr. Hale, not elaborating further (here).
The short-term plan was to answer the anti-mesh movement was to issue a positive statement by all of the coordinated medical societies, AUGS, SUFU, AAGL, ACOG, Society of Gynecological Surgeons, American Urological Association, and National Association for Continence, Women’s Health Foundation. They all joined together and “put their egos aside” to create a position statement that supported a mesh option in June here.
Hale called a “new low” the act of some unnamed doctors who fly out patients to have a mesh removal surgery. After she has her sling removed, she expects her doctor back home to take care of her. The removal doctor never met the patient, examined or followed up after the mesh removal, he said critical of the entire process.
SUI SURGICAL REGISTRY
Big changes are afoot in the collection of electronic healthcare records which may allow the society to understand outcomes for the mesh implanted, something that didn’t happen during the late 90’s and into the mid 2000’s during the height of the use of polypropylene mesh.
Doctors can now perform their own data analysis to “inform better clinical decision-making” says the society. The American College of Cardiology and the Society of Thoracic Surgeons already use disease registries in this manner so AUGS is partnering with FIGmd, Inc. to develop AQUIRE, the AUGS Urogynecology Quality Registry, a stress urinary incontinence electronic surgical registry to monitor patient care, and evaluate patient outcomes.
The data will be used to determine physician reimbursement working with CMS (Center for Medicare and Medicaid Services) and its requirement of new physician benchmark tools.
AQUIRE will track performance measures against peers at the national and regional levels and act as post-approval monitoring, something not done before pelvic mesh was introduced into the market.
As Donald Ostergard, MD opined in 2007, clinical observations are not always accurate about the effectiveness of a particular material because women do not return to a doctor who they perceive has harmed them.
PELVIC FLOOR DISORDERS REGISTRY
The Pelvic Floor Disorders Registry (PFDR) is a multi-centered observational study of patients following treatment for pelvic organ prolapse (POP) to evaluate the outcomes of transvaginal/transabdominal native tissue repair, versus transvaginal mesh repair and sacrocolpopexy and a non-surgical management with a pessary.
By 2015 it had collected data from more than 1,000 patients.
It is supported by grants from industry including ACell, Astora ( Endo) Boston Scientific and Coloplast.
The registry will also fulfill the FDA’s request for the 522 post market surveillance for transvaginal mesh for POP, including industry-sponsored studies. AUGS is working with industry to give POP mesh one last chance after the FDA moved to reclassify it as high-risk. Manufacturers can conduct clinical trials to prove safety and efficacy or the FDA may allow manufacturers to rely on post approval monitoring to satisfy the three year monitoring and prove POP mesh is safe.
AUGS is reaching out to the public through its funded, Take the Floor: Voices for PFD website was launched in 2011 to talk about pelvic organ prolapse.
The “Voices” are underwritten in part through educational grants from Allergan, Astellas Boston Scientific, Medtronic and Pfizer. Women can dialogue with doctors through a Mobile Voices App or find a urogynecologist, part of AUGS.
Take the Floor tells the public that mesh may be appropriate for repair of pelvic organ prolapse in some cases.
“AUGS does not support the routine use of transvaginal mesh for the repair of pelvic organ prolapse, but there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate. Placement of transvaginal mesh for pelvic organ prolapse should be used cautiously by experienced surgeons with extensive training in pelvic surgery.”
Dr. Hale said AUGS has launched into the world of public relations and hopes to put out a positive message to the media.
In terms of future outreach, AUGS is hoping to have a presence at a 1.5 day conference March 30, 31, 2017 with the National Institutes of Health urinary incontinence conference “to stimulate research for the treatment of urinary incontinence” and to get in front of the NIH.
Even though AUGS picks conference sites five years in advance, the organization has pulled out of Charlotte, North Carolina, as the site for the 2017 AUGS conference.
“We need to protect our members,” said Dr. Hale.
He was referring to the North Carolina discrimination bill, signed by the governor in March, that prevents local municipalities from passing anti-discrimination protections for gay, lesbian, bisexual and transgender individuals.
Hale said, “This is not a political statement,” but he admitted AUGS checked with industry before it made such a move.
Fearing a financial repercussion, Dr. Hale added that the PFD Research Foundation is a 501c3 and it has its own budget and there was no financial risk to the nonprofit for making such a move.
So in 2017, the AUGS conference will instead be held in Providence, Rhode Island. ###