Navigation Links
AUGS Issues Statement Opposing The Restriction Of Surgical Options For Pelvic Floor Disorders
Date:3/26/2013

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 www.augs.org.

Contact:
Cindy Rahman
(703) 739-8342
crahman@brgcommunications.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... -- According to a new market research ... by Therapeutic Area (Oncology, Cosmeceutical/Plastic Surgery), by Application (Drug ... Hospitals/ Clinics) - Forecast to 2021", published by MarketsandMarkets, ... the forecast period of 2016 to 2021. This market ... from USD 117.3 Million in 2016, at a CAGR ...
(Date:5/25/2016)... IRVINE, Calif. , May 25, 2016 /PRNewswire/ ... of testing for their new reference materials that ... workflows from sample collection to analyses. The rapid ... the demand for researchers to have standard methods ... data being generated. Biases inherently exist at every ...
(Date:5/25/2016)... Florida , May 25, 2016 ... Conference & Expo earlier this month, the numbers and ... revenues continue to climb into the billions, more research ... newly released 4th Edition State of Legal Marijuana Markets ... a cannabis-focused data-analysis firm, much of the increase in ...
Breaking Medicine Technology:
(Date:5/30/2016)... ... May 30, 2016 , ... Shaolin ... warrior 8-day-8 and 8-night special intensive summer training camp starts on June 17th ... camp offers families and children a fun and unique experience with an opportunity ...
(Date:5/28/2016)... ... May 28, 2016 , ... SuperCloset is proud to officially launch our ... day issues, struggles and obstacles veterans’ need to overcome in order to face their ... or retired military veteran(s) with a donated SuperCloset product based on the needs and ...
(Date:5/27/2016)... Angeles, CA (PRWEB) , ... May 27, 2016 , ... ... of Health, so it is not surprising that bariatric surgery has received increased attention ... Business Journal explains. Of course, when it comes to weight loss, most people are ...
(Date:5/27/2016)... ... 2016 , ... With over 60 percent of acute stroke survivors being left ... to aid in the rehabilitation process has steadily increased. Ekso Bionics had been working ... due to stroke. , Ekso Bionics has now received clearance from the U.S. Food ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... bolstered by inspiring human interest stories, courtesy of leaders in the nursing and ... within the industry, from leading advocates and associations—namely Jones & Bartlett Learning. , ...
Breaking Medicine News(10 mins):