News | AUGS

Update on FDA Announcement on Transvaginal Mesh for Prolapse

I write today to update my last Presidential Message from April 18, 2019 on the April 16th FDA Announcement ordering both manufacturers of the three surgical mesh products for transvaginal repair of prolapse to stop selling and distributing their products in the U.S.

FDA Announcement on Transvaginal Mesh for Prolapse

Apr 18, 2019 10:40 AM

AUGS received notice from the FDA on Tuesday, April 16, of the simultaneous public notice, “FDA Takes Action to Protect Women’s Health; Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices”. The notice orders all manufacturers of surgical mesh products for transvaginal repair of prolapse to stop selling and distributing their products in the U.S. immediately.

AUGS to Testify at FDA Advisory Committee Meeting

On February 12, 2019, the FDA plans to convene an Advisory Committee Meeting to share the available evidence and seek expert opinion on the evaluation of the benefits and risks of trans-vaginal mesh devices for anterior pelvic organ prolapse. This will provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions.

President’s Perspective: Statement on Gender Identification

Oct 31, 2018 12:49 PM

The U.S. Administration recently notified the media that they are considering the adoption of a narrow definition of gender. The new definition limits gender to male or female, based entirely on an assessment of genitalia at birth.

President’s Perspective: Meeting Code of Conduct for AUGS Members

Sep 11, 2018 01:00 AM

PFD Week is just around the corner, and Chicago in the early autumn is beckoning! The Program Committee has put together an outstanding lineup of all of the science, updates, addresses, and networking that you have come to expect from our annual meeting. Bring your energy, curiosity, enthusiasm, and an open mind to this exchange of expertise and ideas. Bring your concerns and your solutions to the many AUGS Volunteer meetings and activities that go on around the meeting.

Energy-Based Devices and Vaginal Rejuvenation

Aug 08, 2018 04:16 PM

As you may already know, the FDA released a Safety Communication on July 30 which provided a public warning regarding the use of “Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures.” It was very clear in addressing this warning to patients considering undergoing the treatments, and to health care providers who offer them.

AQUIRE Expansion Focuses on SUI Surgery

Jun 06, 2018 11:23 AM

“May you live in interesting times,” goes the somewhat mischievous blessing. These are indeed interesting times, when many of us face the daily paradox of taking care of women with stress incontinence, seeing the benefits most women enjoy from midurethral sling procedures, and then witnessing the public assault leveled at them nationally and internationally.

Gynecare TVT Abbrevo and TVT Obturator

Jun 05, 2018 04:37 PM

The U.S. FDA recently reclassified the manual surgical instruments (Helical Passers and Winged Guide) utilized for the Gynecare TVT Abbrevo and TVT Obturator from Class I to Class II. Accordingly, Ethicon is now required to obtain a 510(k) clearance to distribute and market these instruments. Ethicon has filed a 510(k) submission and it is currently under review by FDA.

The Role of Volunteers in AUGS

May 22, 2018 12:47 PM

Have you ever logged on to the AUGS website and really looked around at all the things that AUGS is doing? It is a truly impressive array of activities and services; I hope you will take a moment to peruse the site and learn about some project, committee or member benefit of which you had not previously been aware. And what makes all of that happen? It’s our volunteers.

AUGS is Neither Pro-Mesh; nor Anti-Mesh - AUGS is Pro-science and Science and Evidence Must Lead the Way

May 16, 2018 04:46 PM

AUGS advocates for evidence-based options that enhance the choices available to members and their patients who suffer with pelvic floor disorders.