Transvaginal mesh implant for pelvic organ prolapse: Huaxi protocol

Abstract

With increasing age, pelvic organ prolapse (POP), due to its high incidence, has become a common disease that seriously affects patients’ quality of life and places a heavy economic burden on families and society. Transvaginal mesh (TVM) is a minimally invasive and effective treatment for POP, although its use remains controversial due to the potential risk of mesh‐related complications. The US Foods and Drugs Administration, along with authorities in England, Australia, New Zealand, and other countries, have banned the sale and distribution of commercial TVM kits designed for POP. The TVM procedure remains an option for POP treatment and still appeals to many surgeons and patients today in Asia and most European countries, which suggests that a considerable number of POP patients can benefit from its continued refinement. Here we introduce the Huaxi protocol of the TVM plant for the treatment of POP.

Graphical abstract

Keywords

pelvic floor reconstruction / pelvic organ prolapse / POP / transvaginal mesh / TVM

1 INTRODUCTION

The Gynecologic Urology/Continence Subspecialty Group of Huaxi was established in 2005 and is one of the earliest such groups in China. It is built upon a solid foundation in urodynamic studies and focuses on diseases including pelvic organ prolapse (POP), female stress urinary incontinence, vesicovaginal fistula, female urethral diverticulum, interstitial cystitis, neurogenic bladder, postoperative voiding dysfunction in pelvic floor surgery, and overactive bladder, among others. Led by Drs. Hong Shen and Deyi Luo, the team continuously conducts in‐depth clinical research, innovates surgical techniques, and has developed the “Transvaginal Repair of Apical Vesicovaginal Fistula”: the “Modified Latzko” procedure. Additionally, the “Vaginal Adventitia Reserved Technique” for transvaginal mesh (TVM), referred to as the “Blood Supply Reservation Technique,” was promoted for treating POP and the “Transvaginal Uterine Sling (TVUS)”: the “Natural Orifice Uterine Suspension,” was created for severe uterine prolapse. Furthermore, the “Modified Posterior Colporrhaphy” was pioneered for the treatment of vaginal laxity. Currently, the Gynecologic Urology/Continence Subspecialty Group of Huaxi has become the most standardized, systematically trained, resource‐rich, and influential subspecialty in China, ranking first in the volume of incontinence repair surgeries, pelvic floor reconstruction surgeries, and sacral nerve modulation surgeries nationwide. In 2023, with the establishment of the Pelvic Floor Disease Center, a new interdisciplinary approach combining urology, gynecology, and colorectal surgery was developed to study pelvic floor structures as a unified and interconnected whole, overcoming the limitations of single‐organ, single‐structure approaches and further advancing the subspecialty.

POP is the result of weakened support structures causing the abnormal descent of pelvic organs from their normal anatomical position. POP can be divided into anterior and posterior vaginal wall prolapse, as well as apical compartment/vaginal apex prolapse (apical vaginal vault [scar] prolapse, uterine [cervical] prolapse)[1,2]. POP itself is not a life‐threatening condition; however, it exerts a substantial influence on the lives, work, and psychological well‐being of patients, imposing a heavy economic burden on both families and society[1]. The reported prevalence of POP in developing countries ranges from 3.4% to 56.4%[3,4]. In China, the most recent epidemiological survey revealed that the morbidity of POP among adult women is approximately 9.6%. Cystocele is the most common type of POP, and its incidence increases with age[5]. Some of the clinical risk factors associated with POP are advanced age, vaginal childbirth, elevated parity, and obesity[2].

In moderate‐to‐severe POP patients or when patients decline conservative treatment, surgery is often necessary. Surgical methods can be categorized into obliterative and reconstructive approaches[6]. The vaginal obliterative approach, also known as colpocleisis, is an effective procedure for treating vaginal apex prolapse, with the advantages of less blood loss, a shorter operating time, and a low risk of recurrence, but the patient may no longer have sexual intercourse[7]. Otherwise, the reconstructive procedure preserves the patient's sex, but increases the possibility of POP recurrence[6]. Apical compartment prolapse can be divided into vaginal approaches, which include sacrospinous ligament fixation and uterosacral ligament suspension[8], and abdominal approaches, which include sacrocolpopexy (open, laparoscopic, and robotic) and laparoscopic lateral suspension (or robotically assisted)[9,10]. The surgical method for treating anterior and posterior vaginal prolapse is colporrhaphy, which can be performed with plication or augmentation[6]. Considering that POP resembles other fascial defects, mesh‐augmented repair using polypropylene has been introduced because of its effectiveness in correcting incisional hernias[11]. And over the past decades, as TVM for pelvic floor reconstruction has been used to treat POP, it has been widely practiced because of its minimal invasion and notable effectiveness[12]. However, in recent years, the relatively high incidence of mesh exposure with TVM has led to widespread concerns about its safety[13–15]. Responding to these concerns, the US Food and Drug Administration, England, and so on, banned the sale and distribution of commercial TVM kits designed for POP in April 2019[11,16]. Nevertheless, the TVM procedure remains an option for POP treatment and still appeals to many surgeons and patients today in Asia and most European countries, which suggests that a considerable number of POP patients can benefit from its continued refinement[11,17,18].

We have conducted extensive research on several aspects of female POP, including surgery selection, treatment effectiveness and safety maintenance. The guiding principle of our approach is to achieve excellent treatment outcomes for patients through rational, evidence‐based, precise, simple, easy‐to‐learn, and widely applicable surgical methods, to align with the requirements of high‐quality development in public hospitals. The use of TVM procedure for anterior, posterior, and total pelvic floor reconstruction remains the most common surgical option in our center because of its high success rate. However, consideration of the specific conditions of patients is necessary, as in young women who have apical compartment prolapse, laparoscopic lateral suspension or sacrocolpopexy is a suitable choice, and for recurrent POP after reconstructive surgery, colpocleisis should also be considered. Building on this foundation, we also pioneered a new uterine‐preserving technique called the TVUS procedure to address uterine prolapse in elderly patients.

In terms of effectiveness, we follow a dual reconstruction approach that takes into account both anatomical and functional factors. Mesh cutting is customized based on each patient's condition, by fixing the deep support to the sacrospinous ligament and elevating the cervix to accomplish level I reconstruction, ensuring that the mesh lies flat against the vaginal tissue to prevent mesh folding. For the safe maintenance of TVM, the full thickness of the vaginal mucosa is important for preventing mesh exposure. Because the adventitia of the vaginal wall is a layer composed of collagen, elastin, and adipose tissue containing blood vessels, lymphatics, and nerves, damage to this region is correlated with both vaginal wall stiffness and the occurrence of mesh exposure. Therefore, the “Blood Supply Reservation Technique” was used in our center to maintain the integrity of the vaginal wall via correct hydrodissection which was performed beneath the adventitia layer and full‐thickness vaginal wall cutting. The use of electrocautery during the procedure was avoided, and the vaginal wall was not trimmed. Maintaining the full thickness of the vaginal wall, along with its natural length and width, is beneficial for the reconstruction of the vaginal shape and optimal function.

2 ANTERIOR PROLAPSE

For cystocele patients, anterior TVM pelvic floor reconstruction is the mainstay of the procedure. The mesh was tailored to each patient, which involved trimming not only the main mesh body but also the superficial and deep support bands, as well as the adjusting body. The presence of the adjusting body not only helps maintain the cervix at a level above the ischial spines, thus restoring the full length of the vagina but also provides some cervical mobility, reducing discomfort during intercourse. Additionally, it facilitates the even distribution of the mesh, resulting in a discreet appearance of vaginal mesh placement (Figure 1).

Step 1: The surgery was performed under general anesthesia. For optimal exposure of the perineum, the patient was placed in a 10° Trendelenburg lithotomy position and then properly prepared.

Step 2: A hydrodissection was performed beneath the adventitia layer by inserting a single needle into the midline of the vaginal wall and 30–50 mL of normal saline was injected in forward, leftward, or rightward directions, making the vagina look like a swell without turning white.

Step 3: A vertical incision was made between the anterior fornix of the vagina and the neck of the bladder, extending ~5 cm into the anterior vaginal wall to reach the water sac. The water sac was carefully cut, creating a suitable space for the placement of the mesh, palpating toward the internal aspect of the obturator foramen and the ischial spines on both sides.

Step 4: Two incisions were made along the anteromedial edge of the obturator foramen at the urethral level, with an additional two incisions created 1 cm outward and 2 cm downward from the initial cut, serving as the second puncture points. The puncture needle was inserted from the aforementioned puncture points and the corresponding mesh straps were guided out of the body via the obturator foramen one by one, which was in proximity to the inner corner, and above the ischial spine.

Step 5: Modify the strap tension, trim the adjusting body of the mesh to fit the body, and ensure that the mesh is flat. A Prolene suture was used to secure the mesh at the cervix and bladder neck. After irrigation, the vaginal wall was sutured.

Step 6: Bring the cervix back to a higher position in the vagina, tighten the supporting straps of the anterior vaginal wall mesh again externally, adjust the tension appropriately, and trim excess supporting straps. Both a vaginal plug and a urethral catheter were inserted, and were removed within 48 h. All patients received intravenous antibiotics for a duration of 48 h after surgery.

3 POSTERIOR PROLAPSE

TVM pelvic floor reconstruction was chosen for rectal prolapse patients. Like the anterior mesh, the mesh was cut based on each patient's condition. Depending on the condition of the patient, it may be necessary to perform partial cervical amputation at the same time or to reconstruct of the anterior pelvic deep branch (Figure 2).

Step 1: The patient was placed in a 10° Trendelenburg lithotomy position under general anesthesia and then properly prepared (i.e., skin preparation and catheterization).

Step 2: After confirming the position of the vaginal fornix, 30–50 mL of normal saline was injected into each side of the rectovaginal space to form water sacs.

Step 3: A full‐thickness incision was made in the posterior vaginal wall between the hymen edge and the top of the vagina, with an incision length of approximately 5 cm. The water sac on both sides was separated along the vaginal wall, extending posteriorly and downward until reaching the ischial spines, and the sacrospinous ligaments were accurately identified.

Step 4: On both sides of the anus, small incisions were made 3 cm outward and 3 cm downward. A puncture needle was inserted through the sacrospinous ligaments from the abovementioned puncture points, guided by fingers, and the mesh support straps used for the posterior pelvis were removed from the body. The proximal end of the mesh was secured to the cervix with Size 4 sutures, and after rinsing, the vaginal wall was sutured.

Step 5: Return the cervix to a higher position within the vagina, readjust the tension on the external vaginal mesh support straps, ensuring proper tightness, and trim any surplus mesh straps.

4 APICAL COMPARTMENT/VAGINAL APEX PROLAPSE

4.1 Anteroposterior TVM

For uterine prolapse, posterior reconstruction is highly necessary, especially for patients with a short anterior wall, because it provides strong support. Additionally, posterior reconstruction can elevate the posterior vaginal wall, bringing the upper segments of the anterior and posterior walls closer together, which helps patients achieve better sensation of sexual function. The advantages of posterior reconstruction also include safer puncture, with no concerns about the bladder or ureters, and the posterior mesh needs to cover only the upper 1/3 of the posterior vaginal wall, making the procedure simpler. Therefore, for patients with uterine prolapse, both anterior and posterior pelvic reconstructions should be performed simultaneously. The specific surgical steps are the same as those for the anterior procedure.

4.2 TVUS

We proposed a new technique called TVUS to address uterine prolapse in elderly patients. This technique involves the suspension of the uterus to the abdominal wall by threading a prosthetic strip through the uterine cavity. It successfully restores suspensory support and ensures that the vagina remains aligned with its normal midline axis. The indications for the TVUS procedure were elderly patients (aged > 65 years) with advanced uterine prolapse (POP‐Q stage ≥ III), who did not present with any gynecological malignancy or pathology. In our initial experience involving 46 patients, the objective success rate and subjective success rate were 100% and 98%, respectively, at the 12‐month follow‐up. No serious complications were reported. Notably, no bladder injuries, intestinal injury, pelvic inflammatory disease, mesh exposure, or abnormal uterine bleeding were observed during follow‐ups. The main steps of this technique are described as follows (Figure 3):

Step 1: After anesthetization, the patient was placed in the lithotomy position. Subsequently, the surgical area was disinfected with povidone‐iodine, after which the bladder was emptied with a urinary catheter.

Step 2: The laparoscope was placed on the umbilicus following the establishment of the pneumoperitoneum.

Step 3: A customized needle was then introduced into the uterine cavity to create a passage from the cervix to the anterior abdominal wall by piercing the fundus of the uterus and abdominal wall under laparoscopic observation.

Step 4: Then, a prosthesis strip was placed in the created passage after removing the needle.

Step 5: The ends of the strip were fixed to the cervix and the anterior rectus sheath, following the adjustment of the uterus to the correct position.

Step 6: Finally, the skin incision was closed in layers using absorbable sutures.

5 BRIEF SUMMARY

Although concerns about postoperative mesh complications have significantly impacted the use of TVM in many countries, its minimal invasiveness and advantages in the treatment of POP are still very apparent, making it a popular treatment option for POP in Asia and most European countries. Therefore, avoiding mesh exposure is one of the main challenges in the application of TVM. Our center has significantly reduced the incidence of mesh exposure, even approaching zero exposure, by using the “Blood Supply Reservation Technique.” TVM is still the primary method of surgical treatment for POP patients at our center. At the same time, we have innovatively developed a surgical approach called TVUS for the treatment of severe uterine prolapse through a natural cavity. This approach eliminates the need for further harm to pelvic support structures and reduces the psychological distress associated with a hysterectomy. For the surgical treatment of female POP patients, surgeons should consider the specific conditions of the patients and their needs, adopt the most suitable treatment methods, and develop rational plans to improve the patients’ quality of life while safeguarding their maximum interest. Scientific perioperative management and proper surgical procedures are not only guarantees of efficacy but also the primary means to reduce postoperative complications. Increasing attention to various surgical procedures, conducting extensive professional learning and exchanges, enhancing training, improving surgical skills, and actively engaging in scientific research are all aimed at providing higher‐quality services to patients.

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