Mesh fracture as a cause for recurrence in laparoscopic Sugarbaker parastomal hernia repair: a case series

Introduction

Parastomal hernia is common, with a reported incidence of up to 44% (1). Patients with parastomal hernia are often bothered by pain, intestinal obstruction, poor cosmesis or leakage due to difficult fitting of the stoma appliance. Consequently, operative repair of parastomal hernia is requested by a substantial part of the patients (2,3).

Independent of surgical technique, parastomal hernia repair carries a high risk of postoperative complications, including risk of bowel perforation, surgical site infection, bowel obstruction and chronic pain (4-6).

Several operative techniques have been described for parastomal hernia repair, including laparoscopic repair using the Sugarbaker technique, in which an intraperitoneal onlay mesh causes a lateral position of the bowel adherent to the abdominal wall (7). Mesh repair of ventral abdominal wall hernias—including parastomal hernias—is advantageous, as the incidence of hernia recurrence is significantly decreased compared to suture repair (7-11). Thus, mesh repair has become routine in parastomal hernia repair. This presents the surgeon with the dilemma of balancing the advantages in mesh repair with the substantial risk of complications.

Mesh fracture is a rare cause of recurrence after ventral abdominal wall hernia repair, and this adverse event has not previously been reported on following parastomal hernia repair (12-14).

In the current study, we report seven cases of mesh fracture in patients undergoing laparoscopic Sugarbaker parastomal hernia repair using an identical specific synthetic composite mesh. We present the following article in accordance with the AME Case Series Checklist (available at http://dx.doi.org/10.21037/ls-20-116).

Methods

This was a retrospective case series aiming at reporting on patients with intraoperative verification of mesh fracture after previous laparoscopic parastomal hernia repair in our institution. Patients included in the study underwent primary laparoscopic surgery with the Sugarbaker technique for a parastomal hernia at the Digestive Disease Center at Bispebjerg Hospital, University of Copenhagen, Denmark between October 2014 and May 2016. This center has regional function for treatment of parastomal hernias serving a background population of 1.8 million. Patients undergoing a keyhole mesh repair were excluded.

All patients were operated on using a modified laparoscopic Sugarbaker technique with a 20 cm Parietex^TM Composite Parastomal Mesh (Medtronic, MN, USA) designed for the Sugarbaker technique. This mesh is composed of a 3D monofilament polyester textile with a central band of translucent 2D monofilament polyester textile, which is intended to cover the bowel forming the stoma. The visceral side of the mesh is covered with an absorbable, hydrophilic film made of collagen and glycerol, designed to limit the formation of adhesions to the mesh. On the parietal side, only the 2D band is covered with the collagen film, whereas the rest of the surface is polyester to enhance tissue integration. The mesh was fixated with permanent Bard CapSure™ tackers (Bard Davol, RI, USA) and non-absorbable subcutaneous transfascial sutures. Suture closure of the defect was not conducted.

Preoperative data on patient demography included age, gender, body mass index (BMI), comorbidities, American Society of Anesthesiologists (ASA) score, indication for index surgery and type of stoma. We also collected data regarding primary hernia surgery including hernia defect size, postoperative complications, length of stay, time from primary hernia surgery to diagnosis of recurrence and time to recurrence surgery.

The current paper specifically describes those patients who subsequently were operated on for parastomal hernia recurrence and had verification of a mesh fracture at laparoscopy. End of follow-up was August 2020.

The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). According to Danish law, no informed consent is required from patients anonymously reported on, and thus, individual consent was waived for the present study. The Danish Data Protection Agency (ref. BFH-2016-071) and the Danish Patient Safety Authority (ref. 3-3013-1848/1) approved the study.

Results

A total of 41 patients underwent laparoscopic modified Sugarbaker repair of a parastomal hernia during the inclusion period.

Of these, seven (17%) patients (four females) were diagnosed with hernia recurrence median 29 months (range, 20–63 months) after the primary hernia surgery. The recurrence repair occurred median 32 months (range, 20–67 months) after primary hernia surgery. None of these seven patients had complications during the postoperative stay after their primary hernia surgery, however three of the patients were operated on as an emergency case due to bowel obstruction through the fractured mesh, though there was no need for bowel resection.

All patients with diagnosed hernia recurrence had a colostomy due to previous colorectal malignancy (n=3) or benign disease (n=4). Demographic data are given in Table 1.

Table 1 Demographic data for patients with mesh fracture after parastomal hernia repair
Full table

In all seven patients, the mesh fracture occurred in the transition zone between the 2D and 3D zones of the mesh. The mesh fracture defect sizes varied between 2.0 cm × 2.0 cm and 4.0 cm × 4.0 cm. Figure 1 demonstrates the intraoperative presentation of the mesh fracture in three of the cases.

Figure 1 Three cases of central mesh fracture diagnosed during surgery for recurrence of parastomal hernia.

During surgery for recurrence, the following findings were made in each case:

• Herniation of small bowel through a circular central fracture of the mesh. The herniated bowel was vital and easily repositioned. Additional fracture along the bowel forming the stoma.
• Central 4 cm × 4 cm mesh fracture. Adhesions between omentum and mesh.
• Central 3 cm × 3 cm mesh fracture at the site, where the stoma forming intestine passed through the fascia. Adhesions between omentum and mesh.
• Central 4 cm × 4 cm mesh fracture with herniation of small bowel and omentum. Adhesions between omentum and mesh.
• Central 2 cm × 2 cm mesh fracture causing herniation of small bowel.
• Mesh fracture with herniation of mesentery. Severe adhesions between omentum and mesh.
• Central 3 cm × 5 cm mesh fracture causing small bowel herniation. Several adhesions between small bowel, omentum and mesh.

All seven patients operated on for hernia recurrence had an uneventful recovery and were discharged 3 to 9 days after recurrent repair (Table 2).

Table 2 Primary and recurrence surgery data
Full table

Discussion

We report seven cases of mesh fracture after laparoscopic parastomal modified Sugarbaker mesh repair, in which all patients developed recurrence within 36 months after the primary stoma construction.

The hernia repair was done using a Parietex^TM Composite Parastomal Mesh for Sugarbaker repair, which is a monofilament polyester mesh. A previous study of 36 patients undergoing open incisional hernia repair using a monofilament lightweight polyester mesh reported a 22%-recurrence rate, and seven of these eight recurrences (88%) were due to mesh fracture (13). The incidence of mesh fracture in that study was not reported. In the present series, suture repair was not performed before placement of the mesh. Using the modified Sugarbaker technique thus creates a bridged repair at the fascial defect of the stoma, which is not supported by anterior aponeurotic tissue. This is in parallel with the description of Žuvela et al. that incomplete closure of the anterior fascial layer was associated with fracture of a polypropylene mesh in three patients having previously undergone retromuscular mesh repair of a ventral hernia (14). Hypothetically, closure of the defect may have reduced the forces of tension on the mesh, however if mesh fracture was avoidable with defect closure remains unknown. In addition, the current findings suggest a relative weakness of the Parietex^TM Composite Parastomal Mesh for Sugarbaker repair at the junction between the 2D and 3D zones, which may cause fracture years after the primary hernia repair.

Previous studies have found similarly high recurrence rates after parastomal hernia repair, even with different types of meshes. In a recent study including 38 patients undergoing recurrent parastomal hernia repair, a biological mesh had been used in 50% of the patients, and a collagen mesh in the remaining 50% (15). Similarly, a study including 50 consecutive patients undergoing open keyhole surgery using a polypropylene mesh showed a 26% recurrence rate (16). This underlines the difficult nature of parastomal hernia repair regardless of technique and mesh type.

The intraoperative findings did not offer a clear explanation as to why the mesh fracture happened. In addition to the bridged repair of the hernia defect, most patients were obese, which has previously been associated with mesh fracture after incisional hernia repair (14). The intraperitoneal placement of the mesh might play a role as well, seeing that the mesh is unprotected in the abdominal cavity, and as such possibly subject to more wear and tear by intraabdominal organs and the tack fixation.

The same type of mesh was used in all patients that had mesh fracture, indicating that this mesh type may be unsuitable for parastomal hernia repair. Previous data from our center showed initial promising results using this mesh, but the observation was limited by a relatively short median follow-up of 12 months (0–59 months) (17). In the present study, recurrence was diagnosed between 20 and 63 months after primary hernia surgery, indicating that a degenerative process in the mesh may play a role in mesh fracture, and warranting a very long follow-up in patients undergoing laparoscopic parastomal hernia repair.

As stated above, several factors may contribute to mesh fracture. It is unclear whether the fracture was due to failure of the polyester material, or a failure in the design. Considering that all fractures occurred in the same area of the mesh (i.e., the junction between the 2D and 3D zones), it seems likely to be a failure due to design rather than material.

As a consequence of our findings, the Parietex^TM Composite Parastomal Mesh for laparoscopic Sugarbaker parastomal hernia repair was withdrawn from the world market.

Only patients with verified mesh fracture in the study period was included, and not the entire population of patients undergoing parastomal hernia repair in the same period, which limits the study. However, since no diagnostic tool other than laparoscopy can accurately verify mesh fracture, the true incidence of mesh fracture would most likely be understated. Preoperative CT scan in a specialized hernia protocol was performed on all patients included in this study, and did not reveal any mesh fractures. Thus, to accurately assess the full scope of the problem, all patients with recurrent parastomal hernia after previous mesh repair would have to undergo laparoscopic surgery, which was not feasible.

The current study underlines the importance of post-marketing surveillance after introduction of new mesh products on the international market. Most notably, in 2016 the manufacturer Ethicon withdrew the Physiomesh®, which was a large-pore lightweight polypropylene mesh intended for laparoscopic incisional hernia repair. This action was taken following data from a Polish randomized study that was terminated at interim analysis, and unpublished data from both the German and the Danish Hernia databases. These registry studies suggested significantly higher risks of recurrence following the use of Physiomesh® compared to other available mesh types (18). Data from the respective databases were later published confirming the preliminary results (19,20).

Surgeons worldwide play a crucial role in detecting unreliable or even unsafe medical devices. In Denmark, surgical treatment of parastomal hernia has been centralized to five centers. Patients are treated and operated on by a dedicated team of hernia surgeons, all specializing in parastomal hernia repair. This ensures a relatively high volume of procedures performed by few surgeons. Centralization also ensures that all patients undergoing surgery at our center are re-referred when complications including hernia recurrence are suspected. These factors—in combination with a national prospective hernia registry (19)—are of paramount importance, when it comes to post-marketing surveillance of medical devices. In light of this, we believe our findings warrant further investigation into mesh fracture as a reason for recurrence in parastomal hernia repair.

In conclusion, we report seven cases of mesh fracture as reason for recurrence after laparoscopic parastomal hernia repair, using a monofilamentous composite polyester mesh. Consideration should be given to prioritizing centralization of these surgical procedures and close long-term monitoring on a national level of surgical techniques and implants in a constant effort to optimize safety and quality after parastomal hernia repair.

Acknowledgments

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the Guest Editor (Jacob Rosenberg) for the series “Hernia Surgery” published in Laparoscopic Surgery. The article has undergone external peer review.

Reporting Checklist: The authors have completed the AME Case Series Checklist. Available at http://dx.doi.org/10.21037/ls-20-116

Data Sharing Statement: Available at http://dx.doi.org/10.21037/ls-20-116

Peer Review File: Available at http://dx.doi.org/10.21037/ls-20-116

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/ls-20-116). The series “Hernia Surgery” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). According to Danish law, no informed consent is required from patients anonymously reported on, and thus, individual consent was waived for the present study. The Danish Data Protection Agency (ref. BFH-2016-071) and the Danish Patient Safety Authority (ref. 3-3013-1848/1) approved the study.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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