Navigation Links
AUGS Issues Statement Opposing The Restriction Of Surgical Options For Pelvic Floor Disorders

WASHINGTON, March 26, 2013 /PRNewswire-USNewswire/ -- The American Urogynecologic Society (AUGS), the leading professional organization dedicated to the treatment of pelvic floor disorders, issued a position statement today strongly opposing restrictions that ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA). Individualized treatment decisions should be made between patients and their surgeons, with the goal of providing the patient with the best, most effective therapy based on each patient's specific clinical need.

POP is a condition that occurs when the normal support of the vagina is lost, resulting in sagging or dropping of the vagina, uterus, bladder and rectum. As the prolapse of the vagina and uterus progresses, women can feel bulging tissue protruding through the opening of the vagina. The FDA first cleared the use of transvaginal surgical mesh for the treatment of POP in 2002. During such surgeries, a piece of synthetic mesh is implanted through the vagina to support the prolapsed organs.  

In July 2011, the FDA released a safety communication and white paper on transvaginal surgical mesh to highlight the potential benefits and risks associated with this therapy. Since that time, a few groups including a state medical organization, a healthcare system and a malpractice insurance company have considered restricting or have banned its use.  Such restrictions were never the intent of the FDA safety communication nor do they represent the findings of the FDA Advisory Panel.

"Women should have all treatment options made available to them. The decision of what surgical option is right for a patient should be left between the patient and her surgeon without outside interference or limitations," said Anthony G. Visco , M.D., Division Chief of Urogynecology at Duke University Medical Center in Raleigh-Durham, N.C., and President of AUGS.  "A ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women."

The AUGS position statement notes that it is essential for patients and their surgeons to have access to a full range of both non-surgical and surgical options and to have an open discussion during the informed consent process regarding the likely benefits as well as the potential risks of all options.  In some instances, transvaginal mesh for POP may be the most appropriate surgical option, such as in high-risk patients with recurrent prolapse or those with medical conditions where a more invasive and lengthier procedure may be more dangerous.

AUGS is the leading professional organization dedicated to the treatment of pelvic floor disorders, especially POP and stress incontinence, and its members are working closely with the FDA, the National Institutes of Health (NIH) and the American College of Obstetrics and Gynecology (ACOG) to develop robust mechanisms to continue to monitor the safety and effectiveness of transvaginal surgical mesh.  

AUGS recently developed two credentialing guidelines for POP procedures, one for transvaginal mesh surgery and the other for sacrocolpopexy.  These guidelines encourage hospitals and health systems to establish processes to credential and audit surgeons who perform these types of urogynecologic procedures. To achieve the best clinical outcome, it is important that surgeons are properly trained in these procedures. The AUGS credentialing guidelines provide specific recommendations for surgical training and ongoing maintenance of skills.

In addition to adopting the credentialing guidelines at the local and state levels, AUGS recommends the following over-arching strategies:

  • Establish a broad group of trained pelvic floor reconstructive experts to review cases and complications of both mesh and non-mesh prolapse repair.
  • Ensure appropriate resources and patient management systems are implemented to identify and manage both mesh and non-mesh related complications.
  • Track both surgeons and specific products being implanted, as these may each influence efficacy and complications.
  • Mandate a standardized informed consent process for mesh placement.

About AUGS

The American Urogynecologic Society (AUGS), founded in 1979, is the premier non-profit organization representing more than 1500 members including practicing physicians, nurse practitioners, physical therapists, nurses and health care professionals, as well as researchers from many disciplines, all dedicated to improving female pelvic floor disorders. As the leader in Female Pelvic Medicine and Reconstructive Surgery, AUGS promotes the highest quality patient care through excellence in education, research and advocacy. For more information, visit

Cindy Rahman
(703) 739-8342

SOURCE American Urogynecologic Society
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Icahn Issues Statement Regarding Amylin Pharmaceuticals
2. Patient Advocate Foundation Announces New Co-Pay Relief (CPR) Offerings for Patients Facing Health Issues Due to Electrolyte Imbalance
3. U.S. Patent Office Issues Sixth Patent Covering Zero-Footprint Medical Image Viewers to Heart Imaging Technologies, LLC
4. Upcoming Presentations on Global Market Access Issues and Trends in Health Economics and Outcomes Research at ISPOR 2012 by Novel Health Strategies
5. BD Issues 2011 Sustainability Report
6. Ameritox Announces Educational Resources to Help Physicians Navigate Complex Compliance Issues
7. OncoSec Medical Issues Letter to Shareholders
8. FDA Issues Complete Response Letter for 800mg PREZISTA® (darunavir) Tablet
9. PAREXEL International Issues Earnings Guidance In Conjunction With Investor Day
10. MLB All-Star Pitcher CC Sabathia Issues Fast Relief Challenge to Generate Donations for the American Red Cross
11. Carl Icahn Issues Letter To Howard Solomon Of Forest Laboratories
Post Your Comments:
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 /PRNewswire/ ... Diabetes Tomorrow,s Leaders Scholarship is any indication, the future ... today online at by the Diabetes ... stand in the way of academic and community service ... scholarship program since 2012, and continues to advocate for ...
(Date:6/23/2016)...  Guerbet announced today that it has been named ... . One of 12 suppliers to receive ... support of Premier members through exceptional local customer service ... to lower costs. ... outstanding customer service from Premier," says Massimo Carrara ...
Breaking Medicine Technology:
(Date:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
Breaking Medicine News(10 mins):