Impact of the 2011 FDA Transvaginal Mesh Safety Update on AUGS Members’ Use of Synthetic Mesh and Biologic Grafts in Pelvic Reconstructive Surgery

Clemons, Jeffrey L.; Weinstein, Milena M.; Guess, Marsha K.; Alperin, Marianna; Moalli, Pamela; Gregory, W. Thomas; Lukacz, Emily S.; Sung, Vivian W.; Chen, Bertha H.; Bradley, Catherine S.

doi:10.1097/spv.0b013e31829099c1

Cited by 79 publications

(42 citation statements)

References 5 publications

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“…Survey questions were developed based on the type of questions sent to members of the American Urogynecology Society to assess the impact of the 2011 FDA transvaginal mesh safety update regarding the use of synthetic mesh for pelvic reconstructive surgery [18]. The survey was pilot tested by experts in minimally invasive gynecology before final implementation.…”

Section: Methodsmentioning

confidence: 99%

Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Lum

Sokol

Berek

et al. 2016

Journal of Minimally Invasive Gynecology

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Section: Methodsmentioning

confidence: 99%

Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Lum

Sokol

Berek

et al. 2016

Journal of Minimally Invasive Gynecology

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“…Recently, a big debate started concerning the standardization of surgical techniques for treatment of pelvic floor dysfunc-www. journals.viamedica.pl/ginekologia_polska tions, especially those due to Food and Drug Administration (FDA) statements regarding the use of artificial prostheses in urogynaecology [4]. Surgeons should also remember that advanced age itself, regardless of accompanying comorbidities, will increase the risk of postoperative complications when compared to younger counterparts undergoing the same surgical procedures [5].…”

Section: Introductionmentioning

confidence: 99%

Prevalence of common comorbidities among urogynaecological patients

Rechberger

Nowakowski²,

Rechberger³

et al. 2016

Ginekol Pol

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Objectives: Due to prolonged life expectancy, regardless of the fact that elderly women are more likely to suffer from comorbidities, urogynaecologists worldwide should expect a growing demand for counseling and effective treatment for patients with pelvic floor defects. The aim of the study was to investigate the incidence of popular comorbidities among urogynaecological patients. Material and methods:The retrospective analysis included clinical data of 4,065 consecutive female patients who underwent surgical treatment in the 2 nd Department of Gynaecology at the Medical University of Lublin due to urogynaecological disorders between January 2005 and December 2014. Patients were divided into two groups (< 65 years and ≥ 65 years). The vast majority of patients affected by stress urinary incontinence were treated with mid-urethral slings. Most of patients affected by pelvic organ prolapse underwent reconstructive vaginal surgery with reinforcement using anterior and/or posterior meshes. Statistical analysis was performed using STATISTICA 10.0 PL (unpaired Student t-test, U Mann Whitney, χ 2 test) Results: In both study groups, overweight and obesity were the most common disorders affecting urogynaecological patients (72.6% overall). Furthermore, the elderly patients suffered more often from the most common comorbidities, such as hypertension (p < 0.01), coronary artery disease (p < 0.001) and diabetes mellitus (p < 0.005) Conclusions:Common comorbidities such as overweight and obesity, followed by hypertension and coronary heart diseases, are usual among urogynaecological patients. Changes in lifestyle leading to a decrease in obesity should be considered as an important line treatment when counselling urogynaecological patients.

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“…In a survey at the November 2011 meeting of the American Association of Gynecologic Laparoscopists (AAGL), 72 % reported that they performed surgery for prolapse and/or incontinence, and 53.7 % reported changing their methods of counseling after the FDA 2011 warning [15]. The American Urogynecologic Association (AUGS) sent an electronic survey to its members between January 2011 and December 2012 and found that 40 % of its members who answered the survey reported decreased use of transvaginal mesh for prolapse while 12 % stopped its use altogether [16].…”

Section: Prevalence Of Use After 2011mentioning

confidence: 96%

Native Tissue Surgery for Prolapse versus Graft/Mesh Use: Current Trends in Reconstructive Surgery

Ferrante

Kay

Kirby

2016

Curr Obstet Gynecol Rep

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Pelvic organ prolapse, characterized by a descent of the vaginal walls or vaginal apex, can be treated surgically in symptomatic women who decline or have failed conservative management. Because prolapse can recur after surgery, mesh and biologic grafts have been developed to augment repairs. Use of transvaginal mesh materials quickly increased in the early twenty-first century; however, since the FDA warnings about potential serious complications from transvaginal mesh in 2008 and 2011, use has decreased dramatically, and many mesh products were removed from the market. Even through the peak of mesh use in prolapse surgery, native tissue repairs have remained the most common type of repair.

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Impact of the 2011 FDA Transvaginal Mesh Safety Update on AUGS Members’ Use of Synthetic Mesh and Biologic Grafts in Pelvic Reconstructive Surgery

Abstract: Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Cited by 79 publications

References 5 publications

Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation

Prevalence of common comorbidities among urogynaecological patients

Native Tissue Surgery for Prolapse versus Graft/Mesh Use: Current Trends in Reconstructive Surgery

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