Obstetrics & Gynecology:
Perioperative Morbidity Using Transvaginal Mesh in Pelvic Organ Prolapse Repair
Altman, Daniel MD, PhD; Falconer, Christian MD, PhD; for the Nordic Transvaginal Mesh Group
From the Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden.
* For members of the Nordic Transvaginal Mesh Group, see the Appendix.
Corresponding author: Daniel Altman, MD, PhD, Department of Obstetrics and Gynecology, Danderyd Hospital, 182 88 Stockholm, Sweden; e-mail: email@example.com.
Dr. Altman has an educational advisory position for Gynecare Sweden AB. Dr. Falconer is a member of the Johnson & Johnson advisory board. The study was entirely funded by university-administered research funds but pretrial scientific meetings were sponsored by Gynecare Sweden AB.
OBJECTIVE: To describe the perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse.
METHODS: During a 6-month time period, 25 centers registered all surgical procedures using a commercially available mesh. The frequency and type of perioperative complications, during surgery and the associated hospital stay, were documented using a standardized protocol.
RESULTS: During the inclusion period, 248 women underwent transvaginal mesh surgery: anterior repair in 106 patients (43%), posterior repair in 71 (29%), combined anterior and posterior repair in 20 (8%), and total repair in 51 (21%). Mean age was 67.8 years (±10.3 standard deviation) and median parity was 2 (range 0–6). Surgery for prolapse recurrence was performed in 56% of the patients (n=140), and 91% (n=225) had undergone at least one previous pelvic floor surgical procedure. Serious complications occurred in 4.4% of patients (n=11) and were dominated by visceral injury (10 of 11 cases). One case of bleeding in excess of 1,000 mL occurred. Minor complications occurred in 14.5% of patients (n=36), and the majority were urinary tract infections, urinary retention, and postoperative fever. A multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications, odds ratio 2.8 (95% confidence interval 1.1–6.9). There were no other predictors of outcomes when assessing the association with age, parity, weight, previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy.
CONCLUSION: Perioperative serious complications are uncommon after transvaginal mesh procedures although particular care should be taken to detect visceral injury at the time of surgery.
LEVEL OF EVIDENCE: III
Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For many decades, suture repair techniques have been the primary choice of surgical treatment when indicated. Traditional surgical techniques are, however, frequently associated with unsatisfying anatomical recurrence rates.1,2
The notion of reinforcing pelvic floor defects using biomaterial implants is not an exclusively contemporary idea.3 Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success.4–8 It is plausible that inherently weak or damaged supportive tissues in the pelvic floor need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques.9–12 However, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years despite a lack of clinical safety data or compelling clinical evidence demonstrating that it improves outcomes compared with traditional suture techniques.13
It is likely that biomaterials need to be “anchored” in tissues not afflicted by the disease to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques that use a transobturator approach, passing the mesh through the arcus tendineus fascia pelvis or the sacrospinous ligaments through a transgluteal approach. Already commercially available implant materials are in need of patient safety documentation, but this is perhaps even more true when considering the surgical techniques by which these materials are placed in the body. Complication rates and perioperative morbidity using these surgical routes in pelvic organ prolapse surgery are generally unknown. The aim of the present study was to assess perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse using the PROLIFT (Gynecare, Somerville, NJ) system.
MATERIALS AND METHODS
After the introduction of transvaginal mesh, a multicenter study to describe the frequency and characteristics of perioperative complications associated with pelvic organ prolapse surgery using transvaginal mesh was initiated in October 2005. All participating gynecologists were experienced pelvic floor surgeons and had received pretrial hands-on training on the standardized transvaginal mesh techniques. Training included instructor-supervised procedures performed on live patients in operating room sessions. During a 6-month time period, all surgical procedures using transvaginal mesh were registered by the participating surgeons responsible for filling out a standardized safety protocol form. Trial forms were submitted to the clinical research unit at the Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden, where the data were assembled in a database accessible only to the responsible physician (D.A.). The study was performed at 25 centers: 12 in Sweden, two in Denmark, two in Norway, and nine in Finland.
The decision to operate on a patient using the transvaginal mesh system was left to the discretion of the operating surgeon, with no restrictions regarding primary or secondary procedures, recurrences, weight, parity, menopausal status, or age at surgery. The safety protocol registered perioperative complications and adverse events during the surgical procedure and its associated hospital stay. The protocol also provided background information on obstetric and gynecologic medical history and previous pelvic surgery.
For the purpose of this study, pelvic organ perforation (lower urinary tract or anorectal injury) and bleeding in excess of 1,000 mL were considered major complications, whereas other adverse events in relation to the hospital stay were considered minor complications.
During a 6-month period, 248 women underwent surgery using the transvaginal mesh system. Patient characteristics are presented in Table 1. The majority of patients underwent secondary surgery because of prolapse of a previously operated pelvic compartment, and more than 90% of the patients had undergone at least one previous pelvic floor surgical procedure (Table 1).
All patients underwent a standardized procedure performed by senior surgeons. All participating surgeons received hands-on training using transvaginal mesh techniques before initiation of the study. The compartment-specific surgical techniques have previously been described in detail.14 The uniformly sized and shaped polypropylene mesh is passed through the arcus tendineus fascia pelvis using four extension arms in the anterior vaginal compartment (Fig. 1). In the posterior compartment, the mesh is placed through a transgluteal approach, and the two extension arms are fixated to the sacrospinous ligament. (Fig. 2).
Data on perioperative complications are presented as frequencies (%). A risk analysis of major complications was performed using a backwards multivariable logistic regression model assessing the impact of age, parity, weight, perioperative antibiotics, prior pelvic floor surgery, prior hysterectomy, and concurrent surgical procedures. Results from the risk analysis are presented as odds ratios (ORs) with 95% confidence intervals (CIs). All analyses were performed with Statistica software, version 7 (Statistica, Tulsa, OK).
The study was approved by the Stockholm Regional Board of Ethics at Karolinska Institutet, Stockholm, Sweden. The transvaginal mesh manufacturing company had no influence over study aim, study design, execution of the study, or analysis and interpretation of data. The corresponding author performed all analyses of the data and had full control and access to all information regarding the manuscript content, drafted the paper, and had the final responsibility for the decision to submit for publication.
Patient characteristics and surgical data are presented in Table 1. Anterior repair was performed in 106 of the 248 patients (43%), posterior repair in 71 patients (29%), combined anterior and posterior repair in 20 patients (8%), and total repair in 51 patients (21%) (Table 1). Concomitant surgical procedures were performed in 58 patients (24%): 21 vaginal hysterectomies, 27 posterior colporrhaphies, seven tension-free vaginal tape (TVT) or transobturator tension-free tape procedures, five sacrospinal fixations, three vaginal wall repairs using other mesh, one posterior intravaginal sling plasty, one vaginal enterocele obliteration, one bilateral salpingo-oophorectomy, and two cervix amputations.
General anesthesia was used in 49 patients, spinal anesthesia in 162 patients, epidural in 11 patients, combined spinal and epidural in 12 patients, and local anesthesia alone in three patients (information on anesthesia is missing for 11 patients). Perioperative antibiotics was administered in 235 subjects (95%), four patients did not receive any antibiotics, and information was missing in the remaining nine patients.
The overall rate of serious complications was 4.4% (95% CI 2.5–7.8) (11 of 248 patients) and was dominated by visceral injury (Table 2). Minor complications occurred in 14.5% (95% CI 10.7–19.4) (n=36) and were dominated by urinary tract infections, urinary retention, and postoperative fever (Table 2). Detailed complication rates and perioperative morbidity for the various surgical procedures are shown in Table 2.
The multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications (OR 2.8, 95% CI 1.1–6.9) (Table 3). We found no other predictors of outcomes when assessing the association with age (by year), parity (by number of childbirths), weight (by kilograms), previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy (Table 3).
When evaluating safety aspects of biomaterial implants in pelvic floor surgery, emphasis is usually placed on the morbidity associated with specific biomaterials,15,16 with relatively little attention paid to the actual surgical techniques. The present study focuses on immediate morbidity caused by the surgical technique rather than mid- to long-term complications such as rejection, erosion, and infections, typically ascribed to the biomaterials themselves.
We found that serious complications occurred in 4.4% of our cases using the described transvaginal mesh system. Although we consider the rate of serious complications relatively low, particular care should be taken to detect visceral injury at the time of surgery, considering that visceral injury accounted for 10 of the 11 cases of serious complications. A similar rate of serious intraoperative complications (3.6%) was reported in a recent series of 148 patients using an alternative transvaginal mesh system.17 Even though the transvaginal mesh systems are diverse and data not completely comparable because of the inherent differences in surgical techniques, visceral injury constituted the most common serious complication also in this study, occurring in 4 of 148 (2.7%) cases.17
Close to 15% of our patients experienced what we characterized as minor complications. Although not life threatening, such complications may have considerable impact on quality of life and daily function. Prospective studies extending beyond the operative hospital stay are therefore needed to clarify how minor complications attributed to the surgical procedure, such as groin pain, buttock pain, defecation difficulties, urinary urgencies, and bladder-emptying difficulties, progress over time. Not surprisingly, a transvaginal mesh procedure performed in concurrence with other pelvic floor surgery was associated with an increased risk for minor complications compared with isolated transvaginal mesh procedures. We found no other predictors of major or minor morbidity in patient characteristics or surgical history.
Compared with posterior repair, anterior repair was associated with a longer operating time, greater blood loss, and more frequent complications despite similar patient characteristics. This may be attributed to the higher proportion of patients undergoing repeat surgery of the anterior compartment when compared with the posterior compartment, and subsequently, more difficult dissections. However, this may also reflect actual differences in surgical anatomy. Anterior vaginal dissections may be associated with excessive bleeding, requiring heightened attention due to injury to vascular structures such as the veins of Santorini. Also, the passage of four supportive arms of the anterior mesh, compared with two in the posterior procedure, could negatively influence surgical characteristics. The prolonged length of stay for patients after an anterior, compared with a posterior, repair may be associated with the higher complication rate associated with anterior transvaginal mesh. The overall length of stay in the present study was similar to what previously has been reported from Sweden in recent years when evaluating pelvic reconstructive surgery, both with and without mesh.18,19
When interpreting our data, a number of study traits needs consideration. First, the majority of procedures were performed because of prolapse recurrence in a previously operated vaginal compartment. This may cause subsequent difficulties with scar tissue and fibrosis in the surgical area and may have affected our complication rate negatively. Second, although the participating gynecologists were all experienced pelvic floor surgeons, this series represents the first experience with a new surgical technique. It is possible that the complication rate may decrease because many procedures were performed in the beginning of the learning curve. Finally, a surgical procedure may be universally accepted when the magnitude of its benefits outweighs the risks. To decide whether transvaginal mesh procedures are beneficial in comparison with traditional suture techniques, prospective comparative studies are necessary.
Our study is strengthened by the large scale multicenter design, the standardized surgical procedure, and the pretrial hands-on training required for all participating surgeons. In this first prospective description of surgical complications associated with the transvaginal mesh, we decided to prioritize the ability to generalize our findings to a broad population through the wide range of patients included. We recognize that our sample size may not suffice for detection of rare surgical complications. This is, however, difficult to achieve in a clinical setting in a reasonable amount of time, and future studies using a retrospective, or register-based, design may comprise larger study populations able to describe also infrequent complications. A further limitation of the present study is the possibility of selection bias, caused by the open and unrestricted inclusion, influencing our results. Considering the large numbers of previous pelvic floor surgeries performed in this group of patients and the fact that the majority of transvaginal mesh operations were performed because of recurrences, one may argue that, if any, selection was toward more complicated patients and subsequently more difficult procedures.
Much of the current knowledge of biomaterial in vivo characteristics in pelvic floor surgery derive from research on suburethral sling procedures, such as the TVT.18,19 It is, however, important to consider the different anatomical conditions associated with pelvic organ prolapse surgery. Compared with suburethral tapes, biomaterials used at pelvic organ prolapse repair increase the biomaterial load considerably because of the increased size of the mesh. This may increase the risk for adverse tissue reactions and biomaterial-associated complications. Although the polypropylene compound used for TVT and transvaginal mesh is identical, other characteristics, such as elasticity and pore size, differ. One should, therefore, not assume that the biomaterial properties are the same for the two procedures, and results from incontinence surgery may not be directly applicable to pelvic organ prolapse surgery. Caution is advised until large-scale long-term prospective safety studies describing biocompatibility are available.
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This study was made possible through the cooperation and collective efforts of the Nordic Transvaginal Mesh Group:
Sweden: Daniel Altman, Stockholm; Bo Anzén, Stockholm; Lena Clementsson, Kristiansstad; Christian Falconer, Stockholm; Folke Flam, Stockholm; Jonas Gunnarsson, Göteborg; Björn Holm, örebro; Kenneth Krohn, Norrköping; Gregor Larson, Västerås; P-G Larsson, Skövde; Paula Löwenadler, Ystad; Mazoumeh Rezapour, Uppsala; Gunilla Tegerstedt, Stockholm; Vasiliki Tsaknakis, Halmstad; and Jan Zetterström, Stockholm.
Denmark: Susanne Axelsen, Skejby; Karl Möller Bek, Skejby; and Jens Prien Larsen, Nyköbing Falster.
Finland: Pentti Heinonen, Tampere; Reijo Hiltunen, Seinajoki; Penti Kiilholma, Turku; Teuvo Takala, Lahti; Kirsi Rinne, Koupio; Hans Unnerus, Lojo; and Tapio Väyrynen, Jorvi.
Norway: Marie Ellstrøm Engh, Aakershus; Nils Eriksson, St. Olav; Kolbjörn Kasin, Kongsberg; and Sigurd Kulseng Hansen, Asker Baerum.
© 2007 The American College of Obstetricians and Gynecologists