Review article
Consensus statement of the Spanish Association of Urology on the use of meshes in pelvic organ prolapse
Consenso de la Asociación Española de Urología sobre el uso de mallas en la cirugía del prolapso de órganos pélvicos
L. Resel Folkersmaa, R. Vozmediano Chicharrob,
, R. González Lópezc, J. Jiménez Calvod, G. Escribano Patiñoe, G. Conde Santosf, M. Puyol Pallásg, J.L. Gago Ramosh, B. Madurga Patueli
Corresponding author
a Servicios de Urología del Hospital Universitario Clínico San Carlos, Madrid, Spain
b Hospital Regional Universitario de Málaga, Spain
c Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
d Complejo Hospitalario de Navarra, Spain
e Hospital Universitario Gregorio Marañó, Madrid, Spain
f Hospiten Rambla, Tenerife, Spain
g Hospital Fundación Sant Joan de Deu, Barcelona, Spain
h Hospital Universitario Germans Trias i Pujol y, Barcelona, Spain
i Coordinadora Nacional GUFFU de la AEU, Madrid, Spain
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Resel Folkersma, R. Vozmediano Chicharro, R. González López, J. Jiménez Calvo, G. Escribano Patiño, G. Conde Santos, M. Puyol Pallás, J.L. Gago Ramos, B. Madurga Patuel" "autores" => array:9 [ 0 => array:3 [ "nombre" => "L." "apellidos" => "Resel Folkersma" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:4 [ "nombre" => "R." "apellidos" => "Vozmediano Chicharro" "email" => array:1 [ 0 => "vozme@msn.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 2 => array:3 [ "nombre" => "R." "apellidos" => "González López" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "J." 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"apellidos" => "Madurga Patuel" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">i</span>" "identificador" => "aff0045" ] ] ] ] "afiliaciones" => array:9 [ 0 => array:3 [ "entidad" => "Servicios de Urología del Hospital Universitario Clínico San Carlos, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Hospital Regional Universitario de Málaga, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Complejo Hospitalario de Navarra, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Hospital Universitario Gregorio Marañó, Madrid, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Hospiten Rambla, Tenerife, Spain" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Hospital Fundación Sant Joan de Deu, Barcelona, Spain" "etiqueta" => "g" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Hospital Universitario Germans Trias i Pujol y, Barcelona, Spain" "etiqueta" => "h" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Coordinadora Nacional GUFFU de la AEU, Madrid, Spain" "etiqueta" => "i" "identificador" => "aff0045" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Consenso de la Asociación Española de Urología sobre el uso de mallas en la cirugía del prolapso de órganos pélvicos" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Although pelvic organ prolapse (POP) is a benign pathology, it can suppose a strong limitation in terms physical and social activities, psychological well-being, and overall quality of life. Women in the postmenopausal stage wish to maintain an active lifestyle and the ability to have sexual relations, and these factors will condition our way to manage this pathology.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">It is difficult to estimate the actual prevalence of POP due to the different classification systems used, and because there are few studies in comparison with urinary incontinence. It has been shown that both incidence and prevalence of POP increase with age and can vary from 5 to 40%, depending on its definition.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2–6</span></a> It is estimated that, in 2030, there will be approximately 63 million women with POP, but only 10-20% will seek medical evaluation for their condition.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The risk of a woman being submitted to POP-related surgery throughout her life varies from 6.3 to 19%, of which between 30 and 58% will require a second intervention for recurrent POP.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,9</span></a> In order to increase the success rate and decrease relapses, the use of implants emerged, and "mesh kits" were developed with the idea of facilitating surgery. However, their use did not provide the necessary basis for a correct training in complex pelvic surgery and led to many procedures being performed by inexperienced surgeons, increasing complication rates.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">In October 2008, the Food and Drug Administration (FDA) made the first notification, reporting rare but serious complications derived from the use of synthetic meshes in pelvic floor surgery.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> This generated a judicial flood of multiple claims in the United States (U.S.) and a major global controversy among the various specialists dealing with this pathology. Finally, in 2019, the FDA banned the sale and distribution of mesh for the surgical treatment of POP by the vaginal route in the United States, as manufacturers failed to demonstrate sufficient efficacy and safety of their products within the time limits established by law.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> These measures have produced a worldwide decrease in the use of mesh for the treatment of POP (some countries have even abandoned the use of mesh for the management of POP and urinary incontinence). In addition, it alarmed many women who had been successfully operated on, generating high costs for manufacturers and insurance companies.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The FDA has the authority to question the use of vaginal mesh within the U.S., but not to regulate global medical practice. In 2012, FDA data were put in doubt by the Pelvic Surgeons Network, stating that vaginal mesh was an important tool in the surgical arsenal, which could be the best option in certain cases.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> The American Urogynecologic Society (AUGS) issued a similar statement in 2013, opposing any restrictions.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> The main scientific societies and associations have responded in this regard, with differing opinions and recommendations, so the controversy over its use still remains.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The Spanish Association of Urology (AEU for its initials in Spanish) has long been committed to this issue and, through the Working Group of Urodynamics, Functional Female Urology (GUFFU are its initials in Spanish), a commission of experts has been set up aiming to reach a consensus on the use of synthetic mesh in the surgical treatment of POP. A review of the most recent literature and documents published by the various scientific associations was carried out. Following an in-depth analysis, a consensus document with the conclusions has been issued, which is available on the AEU website and summarized below.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Impact of the use of meshes</span><p id="par0035" class="elsevierStylePara elsevierViewall">Surgery for stress urinary incontinence (SUI) has Burch colposuspension and/or suburethral sling implantation as reference techniques. However, this is not the case with POP surgery, which can be performed through multiple techniques and by diverse specialists. The vaginal route predominates in most countries (in almost 80% of patients), except for France, where the abdominal access (laparoscopic or open) is more common.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> One of the main issues is that there are no defined selection criteria, since the current guidelines provide only general recommendations regarding technique and surgical approach.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Since the 1950s, general surgery has used mesh placement for abdominal hernia repair, since it offers greater long-term efficacy when compared to the traditional techniques. In the 1970s, polypropylene (PP) meshes were used to correct POP by the abdominal approach, and in the 1990s these were placed through the vagina.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Synthetic meshes for suburethral slings and surgery for POP were approved by the FDA in 1996 and 2002, respectively (as a class II moderate-risk device).<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> This favored the increase in the use of transvaginal mesh, reaching its zenith in 2010, with more than 100 different implants, with the consequent appearance of specific adverse effects. It has been estimated that there are more than one million patients operated on with a transvaginal PP mesh in the U.S.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">In the United States, such complications are reported in the MAUDE database (Manufacturer and User Facility Device Experience Database).<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> More than 1000 complications occurred between 2005 and 2007, which is why the FDA issued the first notification of complications derived from the use of synthetic implants for the vaginal correction of POP and for the treatment of SUI in October 2008.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Between 2008 and 2010, 2874 additional complications were reported (1503 in POP and 1307 in SUI), and in July 2011 the FDA provided an updated communication about complications, but only associated with transvaginal repair of POP.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> This communication states that the abdominal approach has fewer adverse events and advocates safety measures. In 2014, the FDA recommended reclassifying devices from high-risk class II to class III (mesh manufacturers must have premarket approval, demonstrating their safety and effectiveness), and confirmed this fact in 2016.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">On February 2019, the FDA issued a document establishing the training and accreditation recommendations on pelvic floor surgery for surgeons and institutions. On April 2019, the FDA ordered all manufacturers of transvaginal surgical meshes for repair in the anterior compartment to stop selling and distributing all implants in the U.S. immediately.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> The communication was justified by the absence of data on the effectiveness and safety of the products provided by the manufacturers within the time limits established by law.</p><p id="par0060" class="elsevierStylePara elsevierViewall">All this has generated a great global impact, with consequences at all levels:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0065" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Medico-legal:</span> there are more than 160,000 litigation cases in the U.S that have cost more than four billion dollars. Patient associations have been created in several countries to raise awareness on surgical meshes, with their own websites and social networks.<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">20,21</span></a> In 2012, the first sentence was passed, which condemned the company and the doctor to pay $5 million to a patient who had received a transvaginal mesh implant (Avaulta Plus®) and required eight reinterventions.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a></p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Industry:</span> in 2012, Johnson & Johnson® withdrew pelvic floor products from the market and Bard® eliminated the Avaulta® mesh in the U.S. In 2016, AMS® also withdrew all products. In 2019, following the latest FDA communication, Bard®, Coloplast® and Boston Scientific® ended up eliminating their products for transvaginal POP repair.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Scientific associations:</span> since 2011, there has been a global decline in the use of transvaginal meshes for POP repair, with a resurgence of traditional surgery, the use of autologous tissues and the employment of meshes in open or laparoscopic abdominal colposacropexy.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> In 2016, the use of mesh was five times lower than in 2007, with mesh procedures comprising 21% of those used ten years before.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a> United Kingdom, New Zealand and Australia<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a> have eliminated the use of mesh for surgical treatment of POP. Its use was also temporarily withdrawn in 2013 and 2014 in Japan and Scotland, respectively, but were subsequently reintroduced. This was possible after conducting a national study, analyzing the results and complications through a multicenter register, developing clinical guidelines, an appropriate accreditation and training program, and an informed consent describing the other surgical options and possible complications associated with the meshes.</p></li></ul></p><p id="par0080" class="elsevierStylePara elsevierViewall">The AUGS issued a statement in 2013 in which it "strongly opposes any restrictions by state or local medical organizations, healthcare systems, or insurance companies which ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders".<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the IUGA (International Urogynecological Association), the ICS and the NHS (National Institute for Health and Clinical Excellence) agree, although with some recommendations: to reduce the surface area of mesh used and to establish a certification system for surgeons.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">With regard to scientific societies in Spain, a debate on women's health was celebrated by the main representatives of the EUA, the Spanish Society of Gynecology and Obstetrics (SEGO) and the Ibero-American Society of Neurourology and Urogynecology (SINUG) in 2012.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a> This meeting documented, with regard to POP surgery, that the use of vaginal or abdominal implants is indicated and justified when it is performed by expert, well-trained surgeons; in those patients with severe, recurrent POP after previous surgery or when the risk of recurrence is detected or suspected in primary surgery. This should always be agreed with patients, evaluating the technical aspects, advantages and disadvantages, which should be reflected in the informed consent. Subsequently, various societies such as the European Association of Urology (EAU) and the European Urogynaecology Association (EUGA),<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> SINUG,<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">29</span></a> the International Federation of Gynecology and Obstetrics (FIGO),<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a> the Italian Association of Urology and Gynecology (AIUG),<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">31</span></a> the Spanish Agency of Medicines and medical Devices (AEMPS), have issued various documents regarding the surgical treatment of POP.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">32</span></a></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Evidence in the literature</span><p id="par0090" class="elsevierStylePara elsevierViewall">In general, the literature reflects that the use of meshes, compared to the use of native tissue, offers greater efficacy at the expense of new complications and a higher rate of surgical revisions.<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">33</span></a></p><p id="par0095" class="elsevierStylePara elsevierViewall">In the last review conducted by the Cochrane in 2016, on anterior POP surgery, 3332 surgeries from 33 randomized multicenter studies were included, comparing the use of native tissue with respect to mesh and demonstrated the following results<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">34</span></a>:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0100" class="elsevierStylePara elsevierViewall">Higher recurrence rates with native tissue: 32–45 vs. 13%.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0105" class="elsevierStylePara elsevierViewall">Higher need of repeat surgery due to recurrent POP after native tissue repair: 7 vs. 2%.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0110" class="elsevierStylePara elsevierViewall">Higher need of repeat surgery due to complications with the mesh (mainly due to exposure): 10 vs. 4-8%.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0115" class="elsevierStylePara elsevierViewall">No significant differences were observed in terms of dyspareunia or de novo SUI.</p></li></ul></p><p id="par0120" class="elsevierStylePara elsevierViewall">The multicenter, randomized PROSPECT study, conducted in the United Kingdom in 2017, involved 35 centers with 1348 patients and two years of follow-up. Three groups were compared in which native tissue, mesh or biological graft was used. There were no significant differences in terms of effectiveness of POP resolution, nor were there any differences in terms of serious complications or repeat procedures. However, it was shown that there was a 12% of exposure in patients undergoing surgery with mesh placement.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">35</span></a></p><p id="par0125" class="elsevierStylePara elsevierViewall">Another multicenter study, conducted in France in 2018, compared the use of mesh in laparoscopic surgery and transvaginal surgery, finding no differences in terms of effectiveness, but observing fewer Clavien III grade complications in the laparoscopic procedures (0.8 vs. 8.6%) and less dyspareunia (14 vs. 30%).<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">36</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">The latter and other studies demonstrated that the incidence of exposure is lower in hands of expert surgeons.<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">37</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">In 2017, a consensus document prepared by a panel of experts from the EUA and EUGA was published in the European Urology, setting out benchmarks for the use of implants in the treatment of SUI and POP.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">28</span></a> This document describes the factors that influence the effectiveness and safety of the various surgical techniques with meshes:<ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">•</span><p id="par0140" class="elsevierStylePara elsevierViewall">Indication according to contemporary guidelines.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">•</span><p id="par0145" class="elsevierStylePara elsevierViewall">Surgeon experience.</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">•</span><p id="par0150" class="elsevierStylePara elsevierViewall">The characteristics of the material employed: it is recommended that it be polypropylene, monofilament, macropore (greater than 75 microns) and as biocompatible as possible.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">•</span><p id="par0155" class="elsevierStylePara elsevierViewall">The area of material used: less area for SUI than for POP.</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">•</span><p id="par0160" class="elsevierStylePara elsevierViewall">Route of implantation: transvaginal vs. transabdominal.</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">•</span><p id="par0165" class="elsevierStylePara elsevierViewall">Patient characteristics: pelvic inflammatory disease, obesity, smoking.</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">•</span><p id="par0170" class="elsevierStylePara elsevierViewall">Associated procedures, such as simultaneous hysterectomy.</p></li></ul></p><p id="par0175" class="elsevierStylePara elsevierViewall">They also list a number of recommendations for the use of implants in POP surgery:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">•</span><p id="par0180" class="elsevierStylePara elsevierViewall">Proper patient selection.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">•</span><p id="par0185" class="elsevierStylePara elsevierViewall">Implantation of mesh should only be considered in complex, carefully selected cases, after failed primary repair surgery and with the least amount of mesh possible.</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">•</span><p id="par0190" class="elsevierStylePara elsevierViewall">Introduction of a certification system for surgeons dedicated to this pathology.</p></li></ul></p><p id="par0195" class="elsevierStylePara elsevierViewall">In the numerous studies present in the literature, with respect to these synthetic materials, there are other very important aspects to consider, such as the weight of the mesh and its biocompatibility. It has been proven that lightweight meshes are better. They are classified as ultra-light (below 35 g/m<span class="elsevierStyleSup">2</span>), light (35−70 g/m<span class="elsevierStyleSup">2</span>), standard (70-140 g/m<span class="elsevierStyleSup">2</span>) and heavy (above 140 g/m<span class="elsevierStyleSup">2</span>), which shows that not all meshes available on the market are the same in terms of weight and design.<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">38</span></a> Regarding biocompatibility, the impact of the mesh on vaginal smooth muscle structure is important. A study on primates showed that the meshes with better incorporation to the tissue, with a higher proportion of muscle fibers and less inflammatory tissue, are those that meet the recommended characteristics.<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">39</span></a></p><p id="par0200" class="elsevierStylePara elsevierViewall">Although we know that there is not an ideal mesh, it has been shown that hand made slings have a significantly higher percentage of exposure compared to commercial kits (14.6 vs. 1.6%).<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">40</span></a></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Conclusions</span><p id="par0205" class="elsevierStylePara elsevierViewall">With this document, the AEU presents the current perspective on the use of transvaginal implants, in the form of meshes, in POP surgery:<ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">1</span><p id="par0210" class="elsevierStylePara elsevierViewall">The objective of surgical procedures for treatment of POP, is to relieve symptoms, improve or preserve function, prevent actions that alter other pelvic floor compartments, and improve quality of life.</p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">2</span><p id="par0215" class="elsevierStylePara elsevierViewall">POP surgery must be considered a complex surgery, which should be performed by surgeons with sufficient experience and, in the future, accredited, in order to be able to assume these treatments with energy and obligation of the necessary means and knowledge. The surgeon treating this pathology must act with diligence, in time and place, according to the state of science (lex artis, or set of generally accepted medical practice) and aiming to obtain the best results, minimizing risks and complications.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">3</span><p id="par0220" class="elsevierStylePara elsevierViewall">Patients must be informed about the various medical and surgical treatments, be aware of the advantages, risks and complications of the different techniques and surgical approaches, from surgery with native tissues to surgery with the use of implants.</p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">4</span><p id="par0225" class="elsevierStylePara elsevierViewall">Regarding the surgical option of transvaginal implant, it should be evaluated and should not be ruled out if it is thought to be indicated. Transvaginal implants will be indicated in complex cases, as primary surgery when there is high suspicion of surgical failure, and in those with recurrent POP.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">5</span><p id="par0230" class="elsevierStylePara elsevierViewall">Commitment to developing, together with other scientific societies, a clinical guide to the diagnosis and treatment of POP with evident selection criteria to indicate the most appropriate surgical technique for each patient.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">6</span><p id="par0235" class="elsevierStylePara elsevierViewall">Commitment to creating a National Register documenting the type of implant used, the surgical procedure, the effectiveness and complications observed.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">7</span><p id="par0240" class="elsevierStylePara elsevierViewall">Promote specific training of surgeons in these techniques, both theoretical and practical. Achieving expert skill is a crucial objective in order to ensure success and avoid complications in these procedures.</p></li></ul></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Final proposal of the AEU</span><p id="par0245" class="elsevierStylePara elsevierViewall">The AEU proposes the following initiatives:<ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">1</span><p id="par0250" class="elsevierStylePara elsevierViewall">Create a clinical practice guideline to assist on the diagnosis and treatment of POP, with clear selection criteria to indicate the most appropriate surgical technique, objectively define results and complications, and establish follow-up protocols.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">2</span><p id="par0255" class="elsevierStylePara elsevierViewall">To create a National Register documenting the implants used, the type of surgical procedure, the effectiveness and the complications observed.</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">3</span><p id="par0260" class="elsevierStylePara elsevierViewall">To create an Informed Consent detailing the risks inherent in the use of implants in the treatment of pelvic floor pathologies, the conservative procedures and the various surgical techniques available.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> It is necessary and advisable to involve the patient in decision making.</p></li><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">4</span><p id="par0265" class="elsevierStylePara elsevierViewall">The development of a specific training program by the scientific societies to achieve training in the surgery of the different types of pelvic floor disorders.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p></li><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">5</span><p id="par0270" class="elsevierStylePara elsevierViewall">To promote the creation of a consensus document gathering the opinions of the different national and international scientific associations.</p></li></ul></p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres1397254" "titulo" => "Abstract" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Objective" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Acquisition of data/evidence" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Results/evidence from the literature" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusions" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "AEU Proposal" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1280286" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1397255" "titulo" => "Resumen" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "abst0035" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0040" "titulo" => "Objetivo" ] 2 => array:2 [ "identificador" => "abst0045" "titulo" => "Adquisición de datos/evidencia" ] 3 => array:2 [ "identificador" => "abst0050" "titulo" => "Resultados/evidencia de la literatura" ] 4 => array:2 [ "identificador" => "abst0055" "titulo" => "Conclusiones" ] 5 => array:2 [ "identificador" => "abst0060" "titulo" => "Propuesta AEU" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1280287" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Impact of the use of meshes" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Evidence in the literature" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Conclusions" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Final proposal of the AEU" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2020-04-14" "fechaAceptado" => "2020-04-15" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1280286" "palabras" => array:4 [ 0 => "Mesh" 1 => "Transvaginal mesh" 2 => "Pelvic organ prolapse" 3 => "Consensus document" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1280287" "palabras" => array:4 [ 0 => "Mallas" 1 => "Mallas transvaginales" 2 => "Prolapso de órganos pélvicos" 3 => "Documento de consenso" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Recently the Food and Drug Administration has banned the use of transvaginal meshes for the surgical treatment of pelvic organ prolapse (POP) in the United States. This has caused a worldwide impact on the management of pelvic floor pathology by different specialists.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Objective</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">To achieve a consensus on the use of meshes in the surgical treatment of POPs.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Acquisition of data/evidence</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">A Committee of experts of the Spanish Association of Urology (AEU) was organized to review the literature and analyze the safety and efficacy of the use of polypropylene meshes in POP surgery.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Results/evidence from the literature</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The evidence reflects that the use of meshes, compared to the use of native tissues, offers better efficacy at the expense of new complications and a higher rate of surgical reviews, these being minor in the hands of expert surgeons.</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusions</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">POP surgery must be performed by experienced surgeons, properly trained and in referral centres. The patient should receive correct information about the different treatment options. Transvaginal meshes should only be indicated in complex cases and in recurrences after POP surgery.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">AEU Proposal</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Creation of a clinical guideline and a national registry for long-term evaluation. Preparation of an Informed Consent available to all professionals and patients, as well as a specific training plan to achieve better training in complex pelvic floor surgery.</p></span>" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Objective" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Acquisition of data/evidence" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Results/evidence from the literature" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusions" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "AEU Proposal" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Introducción</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Recientemente la Food and Drug Administration ha prohibido el uso de mallas transvaginales para el tratamiento quirúrgico de los prolapsos de órganos pélvicos (POP) en Estados Unidos. Esto ha suscitado una repercusión a nivel mundial en el manejo de la patología del suelo pélvico por parte de los diferentes especialistas.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Objetivo</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Lograr un consenso sobre el uso de mallas en el tratamiento quirúrgico de los POP.</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Adquisición de datos/evidencia</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Se organizó un Comité de expertos de la Asociación Española de Urología (AEU) para una revisión de la literatura y analizar la seguridad y eficacia del uso de mallas de polipropileno en la cirugía de los POP.</p></span> <span id="abst0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Resultados/evidencia de la literatura</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">La evidencia refleja que el uso de mallas, comparado con el uso de tejidos nativos, ofrece una mejor eficacia a expensas de nuevas complicaciones y una mayor tasa de revisiones quirúrgicas, siendo estas menores en manos de cirujanos expertos.</p></span> <span id="abst0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Conclusiones</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">La cirugía del POP debe ser realizada por cirujanos con experiencia, adecuadamente formados y en centros de referencia. El paciente debe recibir una información correcta acerca de las diferentes opciones de tratamiento. Las mallas transvaginales sólo deben indicarse en casos complejos y en recidivas tras cirugía del POP.</p></span> <span id="abst0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Propuesta AEU</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Creación de una guía clínica y de un registro nacional para la evaluación a largo plazo. Elaboración de un Consentimiento Informado a disposición de todos los profesionales y pacientes. Así como un plan de formación específico para conseguir una mejor capacitación en la cirugía compleja del suelo pélvico.</p></span>" "secciones" => array:6 [ 0 => array:2 [ "identificador" => "abst0035" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0040" "titulo" => "Objetivo" ] 2 => array:2 [ "identificador" => "abst0045" "titulo" => "Adquisición de datos/evidencia" ] 3 => array:2 [ "identificador" => "abst0050" "titulo" => "Resultados/evidencia de la literatura" ] 4 => array:2 [ "identificador" => "abst0055" "titulo" => "Conclusiones" ] 5 => array:2 [ "identificador" => "abst0060" "titulo" => "Propuesta AEU" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Resel Folkersma L, Vozmediano Chicharro R, González López R, Jiménez Calvo J, Escribano Patiño G, Conde Santos G, et al. 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| Year/Month | Html | Total | |
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