GynecologyGynecologyГинекология2079-56962079-5831Consilium Medicum8940810.26442/20795696.2022.3.201423REVIEWОБЗОРReview ArticleCurrent status of transvaginal mesh implants use in the surgical treatment of stress urinary incontinence and pelvic prolapseСовременное состояние проблемы применения трансвагинальных сетчатых имплантов в хирургическом лечении стрессового недержания мочи и пролапса тазовых органовhttps://orcid.org/0000-0003-2450-70444013-7450ShakhalievRustam A.ШахалиевРустам Алигисметович
Russian Federation

obstetrician-gynecologist

врач – акушер-гинеколог урологического отд-ния Клиники высоких медицинских технологий им. Н.И. Пирогова

rustam.shahaliev@yandex.ruhttps://orcid.org/0000-0002-8655-7234ShulginAndrei S.ШульгинАндрей Сергеевич
Russian Federation

Cand. Sci. (Med.)

канд. мед. наук, врач-уролог урологического отд-ния Клиники высоких медицинских технологий им. Н.И. Пирогова

shulginandrey74@mail.ruhttps://orcid.org/0000-0001-5189-4639KubinNikita D.КубинНикита Дмитриевич
Russian Federation

D. Sci. (Med.)

д-р мед. наук, врач-уролог урологического отд-ния Клиники высоких медицинских технологий им. Н.И. Пирогова

nikitakubin@gmail.comhttps://orcid.org/0000-0002-3900-3933KuzminaIrina N.КузьминаИрина Николаевна
Russian Federation

Cand. Sci. (Med.)

канд. мед. наук, доц. каф. нормальной анатомии

iirina.kuzmina@yandex.ruhttps://orcid.org/0000-0002-0649-9434SuchkovDenis A.СучковДенис Александрович
Russian Federation

urologist

врач-уролог урологического отд-ния Клиники высоких медицинских технологий им. Н.И. Пирогова

denis.urolog@yandex.ruhttps://orcid.org/0000-0003-0489-3451ShkarupaDmitry D.ШкарупаДмитрий Дмитриевич
Russian Federation

D. Sci. (Med.)

д-р мед. наук, зам. дир. по организации медицинской помощи, врач-уролог Клиники высоких медицинских технологий им. Н.И. Пирогова

shkarupa.dmitry@mail.ruSaint Petersburg State UniversityФГБОУ ВО «Санкт-Петербургский государственный университет»Kirov Military Medical AcademyФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны РоссииSaint Petersburg State UniversityФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны России090720222431741802911202128032022Copyright ©; 2022, Consilium MedicumCopyright ©; 2022, ООО "Консилиум Медикум"2022Consilium MedicumООО "Консилиум Медикум"https://creativecommons.org/licenses/by-nc-sa/4.0https://gynecology.orscience.ru/2079-5831/article/view/89408

The use of synthetic implants in stress urinary incontinence and pelvic prolapse surgery is being actively debated today, not only among experts in the field but also in the media, the patient community, and even in legal and political set. Such response has had a natural effect on the clinical application of the technology. An absurd situation is observed in some countries: the bans imposed by the authorities have directly or indirectly restricted patients' access to the most sophisticated technologies with proven efficacy. This literature review aims to systematize the perspectives of the scientific and regulatory communities in leading countries on the use of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic prolapse.

На сегодняшний день идет активная дискуссия об использовании синтетических имплантов в хирургии стрессового недержания мочи и пролапса тазовых органов не только среди экспертов в этой области, но и в прессе, пациентских сообществах и даже в юридических и политических кругах. Подобный резонанс не мог не отразиться на клиническом применении технологии. В ряде стран сложилась абсурдная ситуация: введенные властями запреты прямо или косвенно ограничили доступ пациентам к наиболее изученным технологиям с доказанной эффективностью. Целью данного обзора литературы является анализ взглядов научных сообществ и регулирующих органов ведущих стран мира на применение сетчатых имплантов, устанавливаемых трансвагинальным доступом, в лечении стрессового недержания мочи и пролапса тазовых органов.

Current status of transvaginal mesh implants use in the surgical treatment of stress urinary incontinence and pelvic prolapseпролапс тазовых органовстрессовое недержание мочисетчатый имплантWu JM, Matthews CA, Conover MM, et al. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201-6.Ellington DR, Richter HE. Indications, contraindications, and complications of mesh in surgical treatment of pelvic organ prolapse. Clin Obstet Gynecol. 2013;56(2):276-88.Downing KT. Uterine prolapse: from antiquity to today. Obstet Gynecol Int. 2012;2012:649459. DOI:10.1155/2012/649459Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989;157(2):188-93. DOI:10.1016/0002-9610(89)90526-6Гвоздев М.Ю., Попов А.А., Беженарь В.Ф., и др. Свободная синтетическая петля: предварительный анализ Российского опыта 2002–2012 гг. Экспериментальная и клиническая урология. 2012;4:29-37 [Gvozdev MIu, Popov AA, Bezhenar' VF, et al. Tension-free-tape. Preliminary analysis of russian experience 2002–2012. Experimental & Clinical Urology. 2012;4:29-37 (in Russian)].FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm/ Accessed: 01.08.2021.Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl. 1990;153:7-31.Wohlrab KJ, Erekson EA, Myers DL. Postoperative erosions of the Mersilene suburethral sling mesh for antiincontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20(4):417-20.Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia. 1997;1:15-20.Schimpf MO, Rahn DD, Wheeler TL, et al. Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014;211(1):71.e1-27.Slack M, Sandhu JS, Staskin DR, Grant RC. In vivo comparison of suburethral sling materials. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(2):106-10.Julian TM. Efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall. Am J Obstet Gynecol. 1996;175(6):1472-5.Petros PE. New ambulatory surgical methods using an anatomical classification of urinary dysfunction improve stress, urge and abnormal emptying. Int Urogynecol J Pelvic Floor Dysfunct. 1997;8(5):270-7.Cosson M, Caquant F, Collinet P, et al. Prolift mesh (Gynecare) for pelvic organ prolapsed surgical treatment using the TVM group technique: a retrospective study of 687 patients. International Continence Society Meeting Abstracts – Montreal. 2005, p. 121-2.Moore R., Miklos J. Cystocele repair utilizing anterior wall mesh graft placed via double trans-obturator approach approach (Perigee system). International Continence Society Meeting Abstracts – Montreal. 2005, p. 595.Davila GW, Beyer R, Moore R, et al. Restoration of vaginal apical and posterior wall support with the apogee system. International Continence Society Meeting Abstracts – Montreal. 2005, p. 597-8.Maher C, Baessler K, Glazener CMA, et al. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27(1):3-12.Heneghan CJ, Goldacre B, Onakpoya I, et al. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval processю BMJ Open. 2017;7(12):e017125.FDA Safety Communication: UPDATE on Serious Complications Associated With Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. Available at: http://wayback.archive-it.org/7993/20170111231226/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm/ Accessed: 01.08.2021.Obstetrics & gynecology devices panel. September 8–9, 2011. Available at: https://wayback.archive-it.org/7993/20170404140420/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM271769.pdf/ Accessed: 01.08.2021.Clemons JL, Weinstein M, Guess MK, et al. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191-8.Souders CP, Eilber KS, McClelland L, et al. The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg. 2018;24(1):21-5.Petition Women’s Health Physicians: Ensure Ethical and Fair FDA Mesh Research. Available at: https://www.change.org/p/women-s-health-physicians-ensure-ethical-and-fair-fda-mesh-research/ Accessed: 01.08.2021.Glazener CM, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet. 2017;389(10067):381-92.Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11(11):CD004014.Summers A, Winkel LA, Hussain HK, DeLancey JOL. The relationship between anterior and apical compartment support. Am J Obstet Gynecol. 2006;194(5):1438-43.NICE Guidance – Urinary incontinence and pelvic organ prolapse in women: management. 2019;123(5):777-803.The Royal Australian and New Zealand College of Obstetricians and Gynaecologist (RANZCOG) and Urogynaecological Society of Australasia (UGSA). Polypropylene vaginal mesh implants for vaginal prolapse. Available at: https://ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical-Obstetrics/Polypropylene-vaginal-mesh-implants-for-vaginal-prolapse-(C-Gyn-20)-Review-November-2016.pdf?ext=.pdf/ Accessed: 01.08.2021.The Royal Australian and New Zealand College of Obstetricians and Gynaecologist (RANZCOG) and Urogynaecological Society of Australasia (UGSA). Position statement on midurethral slings. Available at: https://ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical-Obstetrics/MUS-(C-Gyn-32)-Re-write-July-2020_1.pdf?ext=.pdf/ Accessed: 01.08.2021.Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015;7:CD006375.Nambiar A, Cody JD, Jeffery ST. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2014;6:CD008709.Government of Canada, Summary Safety Review – Surgical mesh products made from non-absorbable synthetic (polypropylene) material that are used for the transvaginal repair of pelvic organ prolapse (POP) – Health Canada. Available at: https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00229/ Accessed: 01.08.2021.Government of Canada, Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada – Health Canada. Available at: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70563a-eng.php/ Accessed: 01.08.2021.Government of Canada, Summary Safety Review – Single incision mini-sling (SIMS) made from non-absorbable synthetic material (polypropylene) – Health Canada. Available at: https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00246/ Accessed: 01.08.2021.European Commission, Directorate General for Health & Consumers (2015) SCENIHR-Opinion on the safety of surgical meshes used in urogynecological surgery. Available at: https://ec.europa.eu/health/sites/default/files/scientific_committees/emerging/docs/scenihr_o_049.pdf/ Accessed: 01.08.2021.AWMF: Leitlinien. Leitlinien-Detailansicht. Weiblicher Descensus genitalis Diagnostik und Therapie. Available at: https://www.awmf.org/uploads/tx_szleitlinien/015-006l_S2e_Descensus_genitalis-Diagnostik-Therapie_2016-11-abgelaufen.pdf/ Accessed: 01.08.2021.Chapple CR, Cruz F, Deffieux X, et al. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017;72(3):424-31.Roy N. Urogynaecology Training in South East Asia (SEA) and Asia. Majalah Obstet Ginekol. 2019;27(1):1-4.Gillor M, Langer S, Dietz HP. A long-term comparative study of Uphold™ transvaginal mesh kit against anterior colporrhaphy. Int Urogynecol J. 2020;31(4):793-7.Shkarupa D, Kubin N, Shapovalova E, Zaytseva A. The resurrection of sacrospinous fixation: unilateral apical sling hysteropexy. Int Urogynecol J. 2020;31(2):351-7.Клинические рекомендации. Недержание мочи. Под ред. Г.Р. Касяна, З.К. Гаджиева, А.В. Зайцева. 2020 [Klinicheskie rekomendatsii. Nederzhanie mochi. Pod red. GR Kasiana, ZK Gadzhieva, AV Zaitseva. 2020 (in Russian)].Пушкарь Д.Ю., Касян Г.Р. Отдаленные результаты использования свободной синтетической петли в лечении недержания мочи у женщин (восьмилетние результаты). Урология. 2010;2:32 [Pushkar' DIu, Kasian GR. Otdalennye rezul'taty ispol'zovaniia svobodnoi sinteticheskoi petli v lechenii nederzhaniia mochi u zhenshchin (vos'miletnie rezul'taty). Urologiia. 2010;2:32 (in Russian)].Ellington DR, Richter HE. Indications, contraindications, and complications of mesh in surgical treatment of pelvic organ prolapse. Clin Obstet Gynecol. 2013;56(2):276-88.Milani AL, Vollebregt A, Roovers JP, Withagen M. The use of mesh in vaginal prolapse. Ned Tijdschr Geneeskd. 2013;157(31):A6324.American Urogynecologic Society’s Guidelines Development Committee. Guidelines for providing privileges and credentials to physicians for transvaginal placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2012;18(4):194-7.Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: Retraction. Female Pelvic Med Reconstr Surg. 2020;26(5):349.Kelly EC, Winick-Ng J, Welk B. Surgeon Experience and Complications of Transvaginal Prolapse Mesh. Obstet Gynecol. 2016;128(1):65-72.Deng T, Liao B, Luo D, et al. Risk factors for mesh erosion after female pelvic floor reconstructive surgery: a systematic review and meta-analysis. BJU Int. 2016;117(2):323-43.Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;2(2):CD012079.Nilsson CG, Palva K, Aarnio R, et al. Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013;24(8):1265-9.Liapis A, Bakas P, Creatsas G. Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: Efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(11):1509-12.