Nav: Home

Careful patient selection is the key to achieving the best results for vaginal mesh surgery

July 19, 2018

New York, July 19, 2018 - The high number of reported complications from transvaginal repairs for pelvic organ prolapse (POP) using vaginal mesh have led to a significant decline in its use, despite its initial promise. Following a six-year analysis of California records of pelvic organ prolapse repairs, investigators reporting in the Journal of Urology® conclude that use of vaginal mesh may be appropriate in specific cases provided the risk of surgical complications is carefully weighed against the risk of repeat surgery for recurrent prolapse.

"Early research on vaginal mesh demonstrated excellent results similar to our trusted midurethral slings, so we rejoiced at the opportunity to offer women a longer term reliable prolapse repair option and incorporated these procedures into our practice," explained lead investigator Christopher S. Elliott, MD, PhD, Clinical Assistant Professor, Department of Urology, Stanford School of Medicine, Stanford, CA, and Santa Clara Valley Medical Center, San Jose, CA, USA.

However, while the story of vaginal mesh was still in its infancy, reports of complications unique to vaginal mesh prolapse procedures suggested greater than expected problems. Specifically, it was suggested that complications might be associated with synthetic mesh itself, surgical technique, or patient specific characteristics. This study focuses on these three specific causes on a population-specific level.

Investigators used data from the US Office of State Health Planning and Development to review the records of more than 110,000 women in California who underwent a pelvic organ prolapse repair from 2005-2011 (with and without a synthetic mesh). Sixteen percent underwent mesh augmentation. They chose this study period to reduce any bias that a 2011 FDA warning on mesh use might have created. They then identified all women who underwent a repeat surgery for either recurrent pelvic organ prolapse or a mesh complication.

The researchers found that neither mesh use itself nor surgeon experience was independently associated with the risk of a repeat surgery. Rather, it was likely related to placing mesh in a specific subset of women. Their data indicated that vaginal mesh use for pelvic organ prolapse repair may be appropriate on a population level, specifically if strategies to balance the risk of surgical complication versus the risk of surgery for recurrent prolapse are used.

"Our results show that the mesh itself and surgeon experience do not appear to be the problem, rather we may not be choosing wisely who receives a mesh implant," concluded Dr. Elliott. "We hope our results can be used as a benchmark of first generation mesh outcomes to compare to future generations of vaginal prolapse mesh and further the discussion of vaginal mesh use for prolapse in light of recent negative reports."

"The saying 'Hindsight is 20/20' is an appropriate one in the setting of POP surgery," commented Alexander Gomelsky, MD, of Louisiana State University Health-Shreveport, LA, USA. "It is quite reassuring that in the right hands, mesh surgery for POP can lead to a positive benefit-to-risk ratio. However, the right patient for these operations currently remains largely in our hindsight."

POP affects thirty to fifty percent of women in their lifetime, with around two percent developing symptoms. Transvaginal repairs using vaginal mesh were first used in the United States in the 1990s and were approved by the FDA in 2002. In 2010, at least 100,000 transvaginal mesh procedures were performed in the US. However, the increasing number of complications reported to MAUDE (Manufacturer and User Facility Device Experience), including infection, bleeding, painful sexual intercourse, recurrence of POP and urinary incontinence, and three deaths attributed to mesh complications, led to a strongly worded warning from the FDA in late 2011 that concluded that the complications exceeded any benefits. Its use has since declined significantly internationally alongside an increase in litigation and the withdrawal of several products from the market.
-end-


Elsevier

Related Surgery Articles:

Bullies and their victims more likely to want plastic surgery
11.5 percent of bullying victims have extreme desire to have cosmetic surgery, as well as 3.4 percent of bullies and 8.8 percent of teenagers who both bully and are bullied -- compared with less than 1 percent of those who are unaffected by bullying.
Methadone may reduce need for opioids after surgery
Patients undergoing spinal fusion surgery who are treated with methadone during the procedure require significantly less intravenous and oral opioids to manage postoperative pain, reports a new study published in the May issue of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists (ASA).
New, persistent opioid use common after surgery
Among about 36,000 patients, approximately 6 percent continued to use opioids more than three months after their surgery, with rates not differing between major and minor surgical procedures, according to a study published by JAMA Surgery.
Refusing access to surgery recovery area at a UK hospital unless WHO Safe Surgery Checklist is fully complete
New research showing that refusal to allow surgery teams to take the patient to the recovery room after surgery unless the full WHO Safe Surgery Checklist has been complete is a highly effective way to improve use of the checklist.
Robotic surgery just got more autonomous
Putting surgery one step closer into the realm of self-driving cars and intelligent machines, researchers show for the first time that a supervised autonomous robot can successfully perform soft tissue surgery.
Ultrasonic surgery reduces pain and swelling after chin surgery
For patients undergoing plastic surgery of the chin (genioplasty), the use of ultrasonic 'piezosurgery' equipment reduces trauma, pain, and swelling, compared to traditional surgical drills, reports a study in the The Journal of Craniofacial Surgery.
Annual plastic surgery statistics reflect the changing face of plastic surgery
The annual plastic surgery procedural statistics from the American Society of Plastic Surgeons (ASPS), show that in 2015 there were 15.9 million surgical and minimally invasive cosmetic procedures performed in the United States -- up 2 percent from 2014.
Orthopedic surgery simulation
A unique training simulator for orthopedic open surgery (knee reconstruction with total joint replacement) has been developed by OSSim Technologies Inc. in partnership with three University of Montreal orthopedic surgeons.
Forum on how surgery can improve healthcare in SA
A national forum on surgery and anaesthesia and how it is an indispensable part of achieving universal health coverage will take place on Dec.
Meniscus injury: Real surgery or sham surgery -- which is better for patients?
Should the non-surgical approach be preferred over surgical treatment or are there still advantages offered by surgery.

Related Surgery Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Anthropomorphic
Do animals grieve? Do they have language or consciousness? For a long time, scientists resisted the urge to look for human qualities in animals. This hour, TED speakers explore how that is changing. Guests include biological anthropologist Barbara King, dolphin researcher Denise Herzing, primatologist Frans de Waal, and ecologist Carl Safina.
Now Playing: Science for the People

#532 A Class Conversation
This week we take a look at the sociology of class. What factors create and impact class? How do we try and study it? How does class play out differently in different countries like the US and the UK? How does it impact the political system? We talk with Daniel Laurison, Assistant Professor of Sociology at Swarthmore College and coauthor of the book "The Class Ceiling: Why it Pays to be Privileged", about class and its impacts on people and our systems.