**1. Introduction**

Arthure first described a method of fixating the prolapsed uterus to the sacral promontory in 1957 [1] and Lane introduced the concept of vaginal apex or uterine suspension to the sacral promontory using an intervening graft in 1962 [2]. The abdominal sacrocolpopexy (ASC) is the most durable repair for advanced pelvic organ prolapse (POP) and became the gold standard surgical treatment for apical vaginal defects, with long-term success rates of 78–100% [3–6]. Although ASC was established as the most durable operation, the morbidity associated with laparotomy limited its broad use especially in the elderly, obese or in women with significant medical comorbidities [5, 7]. In the last two decades, minimally invasive approaches have been widely accepted as an alternative option to ASC [8–10]. Laparoscopic sacrocolpopexy (LSC) was first reported in 1994 by Nezhat [11]. Robotic Assisted Sacrocolpopexy (RAS) was described a decade later by DiMarco [12] in 2004. Since the Food and Drug Administration (FDA) approval of the DaVinci Surgical system (Intuitive Surgical, Inc., Sunnyvale, CA) for gynecological operations in 2005, it has

become a fundamental part of the armamentarium in complex pelvic floor procedures [13].

Compared to the abdominal route, minimally invasive sacrocolpopexies are more costly and can be more time consuming in the inexperienced hands. Level I evidence from as early as 2012 supported LSC as the lower-risk option with improved anatomic and subjective outcomes, lower recurrence rates, less postoperative dyspareunia, less blood loss and faster recovery [4, 7, 14, 15]. Maher et al.'s randomized clinical trial demonstrated shorter hospital stay, earlier return to daily activity, improved anatomical outcomes, and less graft-related complications. There were also less re-interventions and related hospital costs, which ultimately outweighed longer operation times [15].

The limitation to wide acceptance of laparoscopic reconstructive pelvic surgery was the need for advanced surgical skill to dissect the pre-sacral space and suture mesh graft to the vagina and sacrum, which many surgeons found too arduous or time consuming to perform. Data shows that approximately 30 LSCs need to be performed to achieve an operation time comparable to an experienced surgeon, and about 60 are needed to obtain similar complication rates [7]. Long-term evidence across all surgical disciplines unequivocally shows that outcomes of high volume surgeons are superior, with lower complication rates [16, 17].

The number of women undergoing Pelvic Organ Prolapse (POP) procedures is estimated at 400,000 annually in the U.S. and an additional 260,000 for stress urinary incontinence (SUI) [18–20]. Over 50% of women over 65 years have some form of urinary incontinence. It is predicted that by 2030, about 20% of the U.S. population will be within this age group, increased from 13% in 2010 [21]. With aging demographics, the national burden related to pelvic floor disorders (PFD), decreased quality of life, and demand for pelvic floor surgeries is expected to increase. In 2010 there were 1,218,371 new pelvic floor-related patient visits in the U.S. [22]. The U.S. Census and NHANES data estimates that the number of women with PFD is expected to reach 43.8 million by 2050 [23]. With more cases of intraabdominally placed mesh for POP, and with robotic advancements, it is expected that there will be an increased number of complications such as lumbosacral osteomyelitis [20]. Mesh associated osteomyelitis has been reported in only a few cases, with none presenting up to a decade after mesh placement.

Prosthetic vaginal mesh for POP repairs was introduced in the 1990s, and became liberally used in the mid 2000s, aiming to replace long and complex intraabdominal procedures. In 2004 FDA approved vaginal meshes as POP repair kits. This resulted in standardization of surgical techniques across the U.S. and allowed for more robust research [24, 25]. Introduced by American Medical Systems (San Jose, CA), Apogee and Perigee systems were the first ready-to-use pelvic mesh repair kits commercially available in 2005 [24]. Shortly after they were followed by the most widely used Gynacare Ethicon's Prolift kits (Johnson and Johnson, Sommerville NJ) and many others such as C.R. Bard, Boston Scientific, Coloplast, and Cook Medical [24, 25]. Mesh kits were brought to the market relatively fast, and as the Gartner curve shows with most innovations, industry hype and corporate avarice lead to mass marketing, and drawbacks become clear when use of mesh became more widespread [26]. Between 2005 and 2010 in the U.S., J&J Ethicon's Gynacare division sold over \$1 Billion worth of female POP repair mesh products alone.

Direct and aggressive marketing by large corporation sales-representatives to inadequately trained in pelvic reconstructive surgery ObGyns and general Urologists led to inappropriate procedures. Often after a minimal "training course" and/or cadaver lab, many physicians became "mesh repair specialists" advertised by the product manufacturer. Regretfully, repairs for prophylactic reasons or due to peer

*From Open to Minimally Invasive: The Sacrocolpopexy DOI: http://dx.doi.org/10.5772/intechopen.101308*

pressure, and use of mesh simply to boost revenue from anterior-posterior repairs became common. Increased complication rates and reports of significant patient morbidity became evident. Bleeding (0–3%), visceral injury (1–4%), urinary infection (0–19%), graft erosion (0–30%), and fistula formation (1%) led to FDA review of Urogynecologic mesh products [19, 27]. There was a five-fold increased complication rate from 2005 to 2007 compared to the previous three years [19]. From October 2008 to 2011, surgical mesh outcomes were scrutinized, revealing an additional 2874 reports of adverse events with POP mesh repairs, and 1371 with stress urinary incontinence (SUI) repairs, resulting in the FDA advisory warning: "complications of POP repairs with mesh are not rare and may be difficult to treat" [19].

The most frequently reported issues were urinary tract infections (UTI), urinary retention, mesh erosion, dyspareunia, bleeding, and organ perforation. More than half of women with erosion from non-absorbable synthetic mesh required surgical removal [19, 28–30]. There were seven reported deaths from POP repairs [19]. The FDA conducted a scientific literature review from 1996 to 2011, which showed that symptomatic results or quality of life were not improved with use of mesh versus the traditional native repair [31]. In light of this, the FDA reclassified mesh for transvaginal repair from Class II to Class III "High Risk", which required manufacturers to submit premarket approval applications [19]. In 2012, J&J Ethicon and C.R. Bard were first to voluntarily remove their POP mesh kits from the markets due to increased litigation and diminishing profits [18, 32]. Ethicon's Gynemesh and Coloplast's Restorelle are still in use, although with a future still uncertain [19].

Women are exposed to lawsuit advertisements in various media focused on complications of surgical mesh, and presented with tragic, yet often, anecdotal stories [26, 33, 34]. While acknowledging these warnings, many organizations have missed the opportunity to proactively confront the vaginal mesh debate. Instead of gathering surgeons and industry together to improve the use of mesh, initiate protocols for selecting optimal surgical candidates, and standardize recommendations for surgeon credentialing, pelvic mesh kit manufacturers have succumbed to the bans and quickly settled ensuing tort case law suits. The biggest companies such as Johnson & Johnson moved towards more lucrative "new" non-surgical treatment options such as anti-incontinence vaginal inserts and pessaries. Treatments became focused on pelvic floor muscle strengthening with adjunctive therapies, vaginal cones, kegel chairs, laser vaginal rejuvenation and electrical muscle stimulation devices whose benefits are often difficult to substantiate [35, 36]. From vaginal pessaries first described in 1550 BC [20], the market has expanded to include vaginal rings, self-powered wireless urinary incontinence sensors for disposable diapers [37], and intra-vaginal inserts. Adult diapers has become the next multi-billion dollar industry as they were aggressively advertised and fast out-paced infant diaper sales in the U.S. [35]. In 2012, the North American market for adult incontinence pads and diapers sold 11 billion units worth \$4.42 billion [38]. Major personal care brands such as Depend, Poise, and Tena are aimed to remove the social stigmatism around incontinence, with advertisement campaigns and product launches targeting the boomer generation [38]. Young athletes and celebrities are used in late-night advertisements to influence women of all ages [31, 33, 34, 38].

The first decade of the twenty-first century was also a time of fast-paced technological advancement. With increased equipment availability and acceptance within the surgical community of DaVinci robotic surgical systems in mid 2000s, the use of robotic technology made LSC a more accessible procedure. These advancements permitted precise and intuitive movements, allowing suturing of mesh to the vagina with relative ease for more practitioners [3, 7, 39, 40]. Improved ergonomics and the three-dimensional viewing of the robotic system provided better visualization of tissue planes and vasculature near the sacral promontory, allowing for faster

dissection and overall safer procedures with less blood loss and better outcomes [3]. Robotic wristed instruments improved dexterity, requiring fewer cases to gain surgical competence, and became more attractive in a wider number of surgical theaters [7, 39, 40]. There is paucity of data comparing patient outcomes between laparoscopic and robotic assisted sacrocolpopexies (RAS). The randomized controlled ACCESS trial demonstrated that RAS are more costly than LSCs (\$19,616 vs. \$11,573, p < 0.001) [3, 7] with no difference in procedure time (225 vs. 246 min p = 0.110), anatomical outcomes, pelvic floor function, or quality of life [3, 7].

While vaginal mesh complications are extensively researched and publicized, research data of intra-abdominally placed mesh for pelvic floor repairs issues are obscure [8, 40, 41]. Descriptions of mesh problems associated with placement by endoscopic procedures are even more rare. Available data pertains to the risks that are mostly those specific to laparoscopy, use of general anesthesia, pneumoperitoneum and prolonged Trendelenburg positioning [42, 43]. Complications of vaginal POP repairs with mesh are widely reported, however, what is attributable to poor technique versus mesh itself is debatable. Published data from self-proclaimed "mesh removal experts" confirm this. Margulies et al. (a vocal critic of vaginal mesh and a prominent plaintiff expert), identified mesh folding at the time of mesh excision surgery in 69% of patients who had their mesh removed due to dyspareunia [44]. During Crosby's surgeries for mesh removal, he also found that mesh to be folded or had significant tension in 70% of his patients [45].

Cho et al. performed a large case review to compare LSC to the traditional open procedure. There were no significant intraoperative complications other than a 1.08% risk of blood transfusion, and a low rate of postoperative complications (8% constipation, 4% lower abdominal discomfort, 5% urge incontinence, 4% vaginal spotting, and less than 3% for all other complications) [43]. Meticulous mesh placement and improved visualization resulted in good long-term outcomes (0% relapse rate at 1 year) [20]. 98.8% of women were satisfied with their surgical outcome, with no reports of sexual dysfunction [43]. Altogether, these results show that the minimally invasive approach has better outcomes comparable to the abdominal approach, and is also significantly safer and more efficient [46]. In view of medico-legal climate and with politically prevailing negative opinions of vaginal mesh, abdominally placed mesh via minimally invasive surgery for POP is safe, durable, and currently the best option. As in any mesh/implant surgery, patient selection, surgical field sterility, avoidance of excessive electrocautery, clear planes of dissection, meticulous hemostasis and proper mesh placement are of the uttermost importance [44, 45].

With the vaginal mesh industry on hold, many prominent pelvic surgeons reverted to intra-abdominal repairs. The options range from the classic sacrocolpopexy in which the vaginal cuff after hysterectomy is affixed to the anterior longitudinal ligament (ALL) with permanent sutures and Y-shaped mesh graft [9, 47], to uteropexy to preserve fertility [47]. These repairs can be done with sutures, with or without mesh graft [9, 47]. Variants of the repair include sacral cervicocolpopexy, now the most commonly utilized by FPMRS specialists in the U.S., in which preservation of the cervical stump during hysterectomy facilitates suturing of the vaginal apex to ligaments [10]. This procedure is easier and safer, reduces operating times, and decreases the risk of mesh complications five fold [10]. Other options are sacrocolpoperineopexy [10] or modification of anterior or posterior rectopexy [48]. The choice of the procedure depends on patient site-specific defects and the comfort of the operating surgeon. There is also colpopectopexy, a modification of the apical vaginal suspension where the lateral aspects of the illiopectineal ligaments are used for unilateral or bilateral fixation of prolapsing vagina, which gained some hold first in Europe and later in the.

U.S. [49] (Case 2). Advancements in MIS, robotics and laparoscopy continue with the fast pacing introduction of better visualization systems, artificial intelligence, machine learning, computer enhanced surgery and integration of imaging studies into the live surgical field.

Complications of Minimally Invasive Surgery (MIS) with mesh for POP, diagnostic modalities, findings and management protocols are under-publicized. In 2011, Smith and Davila proposed a vaginal approach on how to manage small versus large mesh exposures, mesh contractions and infection, and also recommended preventative strategies [50]. However, reports are still lacking on how to manage infected mesh deep in the sacral region. Our three cases demonstrate that laparoscopic and robotic approaches to intra-abdominal mesh complications are feasible and can be utilized in a safe, efficient, and effective manner in the proper surgical setting. The described cases attempt to shed light on delayed onset osteomyelitis of the lumbosacral vertebrae, one of the rarely reported, but morbid complications of sacrocolpopexy. Its presentation, complications, and complexity of the intraoperative field are reviewed. As the use of permanent sutures and mesh implants in the vicinity of ligaments and bone increases, potential for osteomyelitis will increase. FPMRS surgeons applying mesh to the intra-peritoneal cavity must be extra vigilant in timely recognition and treatment of this once rare condition [14, 27].

A literature search showed that there is no case report of delayed onset osteomyelitis presenting up to a decade after mesh placement. We present three cases of osteomyelitis including presentation, diagnosis and management from a tertiary academic referral center. Patients presented between 1 and 10 years after mesh colpopexy procedure. Three different mesh materials were utilized during the initial POP repair procedures: Restorelle Y, Gynamesh and Gore-tex mesh.

The first case demonstrates failed expectant management followed by surgical intervention on a medically compromised patient, whereas the two subsequent cases describe elective surgical repairs undertaken after several prior failed mesh removal attempts. All cases were successfully managed by a multidisciplinary surgical team, completely resecting infected meshs utilizing DaVinci Xi Robotic System.

Case 1: Chronic urinary tract infection and back pain, vaginal malodorous discharge and pulmonary embolism.

74yo white female with a history of 4th degree uterovaginal prolapse who underwent DaVinci assisted laparoscopic sacral colpopexy and laparoscopic supracervical hysterectomy (LSC/LSH/BSO) with Restorelle Y polypropylene mesh (Coloplast) in 2015. Eightheen months after surgery the patient presented to a local emergency room with lower back and abdominal pain. She was diagnosed with UTI and discharged home on oral antibiotics. She presented 1 month later to our institution with fever and a history of chronic UTI, worsening back pain and generalized weakness. She was admitted by for intravenous antibiotics with presumptive diagnosis of pyelonephritis complicated by urosepsis. During her workup it was discovered that she also had a pulmonary embolism and was treated accordingly.

Computed Tomography (CT) scan showed hyper-enhancement of the lumbar sacral joints L5 to S1, with Magnetic Resonance Imaging (MRI) noted a welldefined enhancing fistulous tract from the lumbosacral region to the vaginal space consistent with discitis and osteomyelitis (**Figure 1A** and **B**). The patient's mental status was slightly impaired either due to age, delirium from nicotine withdrawal, or current medical condition. She was a heavy lifetime smoker with history of chronic obstructive pulmonary disease (COPD), a non-compliant patient and poor historian. Her pulmonary embolus was treated, she was kept on IV antibiotics for the discitis, the fever subsided, and the patient condition was stabilized. She then developed a new onset of malodorous vaginal discharge. Patient's family reported a

**Figure 1.** *(A and B) MRI showing discitis and osteomyelitis.*

history of prior POP mesh repair. Urogynecologic and Spine surgeons were consulted at that time and vaginal examination showed apical abscess with copious foul discharge.

Diagnosis of a lumbosacral-peritoneal-vaginal fistula tract with mesh erosion was made. Despite 2 weeks of intravenous (IV) broad-spectrum antibiotic therapy, there was lack of improvement in pain, copious daily drainage increased and lumbosacral osteomyelitis worsened. Patient had developed local neurological deficits in the lower extremities compromising her ability to stand up and she could no longer walk. Spine surgical intervention became urgent and despite serious medical comorbidities, in consultation with General surgery and Urogynecology, it was determined that surgical removal of the infected mesh, fistula resection, abscess evacuation, and bone debridement could no longer be further delayed.

Intra-operatively, a vaginal fistulous connection was identified when a probe was passed through the vagina and was visible intra-abdominally to the pre-sacral lumbar bone space (**Figure 2A**). Using DaVinci assisted laparoscopy, adhesions were freed of the involved bowel, and the infected mesh was removed and abscess drained (**Figure 2B**). The bladder and ureter were dissected with illuminated stents in place. Bone debridement was performed and osteopromotive materials were grafted onto the L4 to S1 posterior lumbar region by Spine and Vascular Surgeon, who dissected and patch repaired the left common iliac vein in the process to completely remove mesh from the lumbosacral area. Total operating time of 180 min. The patient was kept on IV antibiotics and anticoagulation for 6 weeks postoperatively while recovering at a nursing facility. She was home in 6 weeks time living independently. Unfortunately she was a heavy smoker with poor hygiene and severe COPD that succumbed to pulmonary complications about 9 months later, albeit unrelated to her surgery.

Case 2: Pelvic pain with persistant right groin/inguinal skin draining sinus tract. History of four failed fistula repairs, ventral and inguinal hernia.

A 70 year-old white female presenting with a right groin/inguinal draining sinus tract and ventral hernia complaining of pelvic and abdominal pain. She had a history of a total abdominal hysterectomy and an open colpopectopexy with Gore-Tex mesh performed in 2005. Subsequently, over the past 5 years she underwent multiple partial mesh revisions and three failed open peritoneo-cutaneous fistula tract

*From Open to Minimally Invasive: The Sacrocolpopexy DOI: http://dx.doi.org/10.5772/intechopen.101308*

#### **Figure 2.**

*(A) Probe in fistula canal tracking to ischiopubic bone and iliopectineal ligament (laparoscopic view) and (B) mesh removed from vaginal cuff.*

repairs. After numerous second opinions, the patient was referred to our center. The patient presented in 2019 with complaints of abdominal, pelvic pain and chronic persistent groin discharge requiring several pads per day, compromising her daily activities. In the few months prior she also developed a painful lower abdominal bulge. Based on physical examination and CT scan, the patient was diagnosed with an eight-centimeter incarcerated ventral hernia (**Figure 3A**) with a patent fistulous tract from the groin to the upper vagina and intraperitoneal space, draining proximal to the bladder (**Figure 3B**).

Elective robotic repair of the incarcerated ventral hernia and mesh resection with fistula repair was performed. Upon laparoscopic entry, extensive adhesions were noted with loops of small bowel in the hernia sac. A right ureteral lighted stent was inserted illuminating the area of the bladder that was involved in the hernia sac. Under direct laparoscopic and cystoscopic guidance a blunt probe was inserted into the right groin sinus tract opening, mapping the fistula tract to the right pubic bone and right iliopectineal ligament immediately adjunct to bladder and right upper vagina.

The ventral and inguinal hernias were reduced and the fistula tract was dissected noting Gore-Tex mesh and suture material adherent to the inner aspect of the iliopubic bone, its periosteum, bladder and vagina (**Figure 3C**). There was a defect found in the right pubic bone approximately three-centimeter in size with granuloma tissue formation on the mesh that was also involving bone (**Figure 3D**). Bone debridement was performed and cultures showed heavy growth of Serratia Marcescens (SM), pathognomonic to nosocomial infections [51].

#### **Figure 3.**

*(A) Outside view of pelvic bulge, (B) laparoscopic view of the hernia after bowel loops reduction, (C) probe in fistula canal tracking to ischiopubic bone and iliopectineal ligament and (D) old Gortex suture material removed from bone defect.*

The cutaneoperitoneal tract and vesicovaginal defects were resected and repaired. Cystoscopy with hydrodissection and lighted ureteral stents assured bladder and right ureter integrity. The pubic bone defect was irrigated with antibiotic solution and packed with bone wax. The ventral and right inguinal hernia was repaired creating myofascial advancement flaps. A wound vacuum was applied at a pressure of 125 mmHg (**Figure 4**). Total operating time of 75 min. She was discharged after 24 h.

**Figure 4.** *Wound vacuum at a pressure of 125 mmHg.*

#### *From Open to Minimally Invasive: The Sacrocolpopexy DOI: http://dx.doi.org/10.5772/intechopen.101308*

Case 3: Pelvic pain, vaginal bleeding, dyspareunia, and chronic vaginal discharge.

52 year-old white female with a history of two prior cesarean sections and DaVinci LSC with Gynecare Y mesh and total laparoscopic hysterectomy (TLH) in 2012 complicated by vaginal apex mesh erosion which caused recurrent vaginal bleeding, dyspareunia and chronic UTI. She had two separate vaginal mesh revisions in 2017 that were further complicated by acute post-surgical intra-abdominal bleeding requiring return to the OR for bladder hematoma evacuation and blood transfusion. The patient presented 2 years later in 2019 complaining of chronic malodorous vaginal discharge, dyspareunia, post-coital bleeding and severe pelvic pain. Vaginal examination revealed copious foul-smelling discharge originating from a necrotic upper vagina with discolored vaginal mesh and pus.

Cultures of the discharge were collected, resulting in heavy growth of Group B Streptococcus and Bacteroides Ovatus. CT scan showed an intra-peritoneal pelvic abscess extending from the presacral space to the upper vagina. Although CT did not identify discitis, an MRI was recommended for evaluation of osteomyelitis that could not be ruled out due to swelling. Since the complications of mesh significantly impacted her quality of life and led to loss of consortium, the patient elected for mesh removal.

Upon laparoscopic evaluation, multiple loops of small bowel were adherent to the pelvic sidewall, occluding the anterior and posterior cul-de-sacs (**Figure 5A**). Frozen pelvis was encountered with dense adhesions of the recto-sigmoid with non-visualization of the sacral promontory. Extensive enterolysis was performed to gain access to the eroded and infected vaginal mesh and pelvic abscess (**Figure 5B**). Multiple loops of the small bowel and rectosigmoid colon were freed from the mesh, presacral space, vagina, bladder and ureter.

Laparoscopic access to the infected Gynecare mesh allowed for evacuation of the intra-abdominal abscess. Once the infected graft was removed, upper vaginectomy and drainage of the pelvic abscess were performed (**Figure 5C**). The anterior longitudinal ligament appeared to be inflamed but not grossly infected. All old fixation sutures were cut and removed.

Early and aggressive intervention in this case prevented progression of upper necrotizing vaginal abscess ascending on the mesh and braided suture (Ethibond)

#### **Figure 5.**

*(A) Dissection of rectosigmoid colon off vaginal cuff/mesh complex, (B) mesh exposed, (C) vaginal cuff with eroded mesh dissected off the pelvic promontory and (D) vaginal cuff closure in layers utilizing the DaVinci Robot.*

"ladder" into the anterior longitudinal ligament and periostium of the sacral and lumbar vertebra. DaVinci Xi Robotic system was utilized for the resection of peritoneo-vaginal fistulous tract, entire mesh, upper vaginectomy, and cuff closure (**Figure 5D**).

Integrity of the bladder and rectum were confirmed by cystoscopy and proctosigmoidoscopy. The patient was discharged home 6 hours later and remains asymptomatic for over 1 year.
