The American Journal of Surgery 193 (2007) 697701

Clinical surgeryAmerican

Improved outcomes with the Prolene Hernia System mesh compared with the time-honored Lichtenstein onlay mesh repair for inguinal hernia repair
Samir S. Awad, M.D.*, Sasi Yallalampalli, B.A., Ahmad M. Srour, M.D., Charles F. Bellows, M.D., Daniel Albo, M.D., David H. Berger, M.D.
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Michael E. DeBakey Veterans Affairs Hospital, MED VAMC, OCL (112), RM 5A-344, 2002 Holcombe Blvd, Houston, TX 77401, USA Manuscript received June 2, 2006; revised manuscript August 30, 2006 Presented at the 30th Annual Meeting of the Association for VA Surgeons, Cincinnati, OH, May 9 11, 2006

Abstract Background: Inguinal hernia repairs are commonly performed operations. Recently, Neumayer et al examined the gold standard Lichtenstein onlay mesh repair (LMR) against laparoscopic inguinal hernia repair and showed that the recurrence rates are higher for laparoscopic mesh repairs when compared with the open onlay mesh repair (laparoscopic 10.1% versus open 4.9%). In 1998, the Prolene Hernia System (PHS) mesh, consisting of an onlay and an underlay patch attached with a connector, was introduced as an option for tension-free open repair of inguinal hernias combining the benets of a posterior and anterior repair from an open approach. Our objective was to evaluate the PHS mesh repair versus the LMR for inguinal hernias. We hypothesized that the recurrence rate of PHS mesh would be lower compared with the LMR with overall similar complication rates. Methods: PHS mesh hernia repairs performed from January 2003 to July 2005 and LMR repairs from January 2000 to July 2002 were included. Demographic data such as age, race, and gender as well as comorbid conditions such as chronic obstructive pulmonary disease, congestive heart failure, previous myocardial infarction, diabetes, hypertension, prostatism, and chronic cough were collected. Complications such as cord injury, seroma, hematoma, urinary retention, urinary tract infection, orchitis, and wound infection were recorded. Recurrences in each group were also recorded. A student t test and chi-square analysis were used for statistical analysis. Results: Six hundred twenty-two charts were reviewed during the 2 time periods (PHS mesh 321, LMR 302). The median follow-up for the study was 17 months. There was no signicant difference with regards to age, race, gender, or comorbidities between the 2 groups. Overall, there was a trend toward decreased complications in the PHS mesh group compared with the LMR group (PHS mesh 17%, LMR 23%, P .07), with a signicant difference in the hematoma/seroma rates (PHS mesh 6.9%, LMR 12.6%, P .015). Finally, there was a signicant decrease in the recurrence rate for the PHS mesh group when compared with the LMR group (PHS mesh 0.6%, LMR 2.7%, P .04). Conclusion: Our study shows, during a median follow-up of 17 months, improved outcomes by using the PHS mesh compared with the gold standard Lichtenstein onlay mesh for inguinal hernias with signicantly lower recurrence rates. Additionally, in the PHS mesh group, there was a trend toward decreased overall complication rates with signicantly less seroma/hematoma rates. Therefore, the PHS mesh repair may represent a superior alternative for the repair of inguinal hernias. 2007 Excerpta Medica Inc. All rights reserved.
Keywords: Inguinal hernia; Open; Laparoscopic; Anterior; Posterior; Mesh

Inguinal herniorraphy is an evolving surgical solution to an age-old problem. Since Bassini rst described repairing an inguinal hernia by suturing the conjoint tendon to the in* Corresponding author. Tel.: 713-794-7765; fax: 713-794-7352. E-mail address: sawad@bcm.tmc.edu

guinal ligament in 1889, the primary surgical objective has been to adequately cover the anatomic hole, termed the myopectineal orice by Henri Frauchad, through which the pathological hole, hernia, protrudes to prevent hernia recurrence. The initial Bassini repairs that were later modied by Halstead and McVay were performed under tension

0002-9610/07/$ see front matter 2007 Excerpta Medica Inc. All rights reserved. doi:10.1016/j.amjsurg.2006.08.087

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because of the direct approximation of tissue with resultant high recurrence rates reported to be between 5% and 21% [13]. In 1958, Usher et al [4] was the rst to perform inguinal herniorraphy by using prosthetic mesh, thereby eliminating the tension associated with tissue approximation. However, mesh repair did not gain widespread acceptance until Lichtenstein et al [5] coined the term tensionfree repair and advocated this approach in 1986. The Lichtenstein mesh repair (LMR) uses nonabsorbable sutures and a prosthetic at mesh screen to reinforce the inguinal canal oor. Since its introduction, the LMR has been the most widely performed groin hernia repair and is used as the standard to which newer techniques are compared [5,6]. The introduction of mesh for the repair of inguinal hernias signicantly decreased the recurrence rates observed with the tissue repairs. Understanding the inguinal canal anatomy, specically the myopectineal orice, which is composed of a lateral, medial, and femoral triangle, is paramount to the successful repair and prevention of hernia recurrence (Fig. 1). Currently, there are multiple tension-free techniques, which include the open anterior repair (onlay patch, plug and patch), open posterior repair (Stoppa-Rives technique; Kugel; CR Bard Inc, Murray Hill, NJ), combined posterior and anterior repair through an anterior approach (Prolene Hernia System [PHS]; Ethicon, Inc, Somerville, NJ), and the closed posterior approach (laparoscopic). Of these repairs, only the laparoscopic repair and the PHS mesh provide complete coverage of the myopectineal orice. During the 1990s, with advances in laparoscopic technology, the laparoscopic inguinal hernia repair was introduced with preliminary reports documenting recurrence rates, ranging from 3% to 10% [79]. Benets from this repair included less pain and quicker return to activity. A recent randomized controlled multicenter study by Neumayer et al [10] compared the LMR with the laparoscopic

repair and showed a higher recurrence rate of the laparoscopic repair when compared with the LMR (laparoscopic 10.1% versus open 4.9%). The complication rate was also higher in the laparoscopic group. Moreover, a steep learning curve was shown to achieve comparable recurrence rates [10]. The initial enthusiasm for this type of repair, specically for primary inguinal hernias has recently subsided because of the associated high cost, steep learning curve, more serious complications, and necessity for general anesthesia. In 1998, the PHS mesh, consisting of an onlay and an underlay patch attached with a connector, was introduced as an option for tension-free open repair of inguinal hernias. In theory, this repair combines the benets of a posterior and anterior repair from an open approach [11,12]. PHS mesh has been touted for the repair of direct, indirect, and femoral hernias with extremely low recurrence rates secondary to complete coverage of the myopectineal orice. The objective of this retrospective study was to compare the outcomes of the Lichtenstein method of hernia repair with that of the PHS mesh. We hypothesized that the recurrence rates with the PHS mesh repair would be lower than the LMR with similar complication rates and total operative times. Methods The medical records of consecutive patients undergoing elective open inguinal hernia repairs with mesh were reviewed. PHS mesh hernia repairs performed from January 2003 to July 2005 and LMRs from January 2000 to July 2002 were included. All repairs were performed under the supervision of 5 attending surgeons who were experienced in performing both techniques. All repairs were performed under general, regional, or local anesthesia. All patients received antibiotic prophylaxis with 1 preoperative dose of a rst generation cephalosporin or vancomycin if penicillin allergic. Lichtenstein mesh onlay repair The LMR was performed as previously described by Amid et al [13]. Briey, the inguinal canal was approached from an open anterior approach after dividing the skin, Scarpas fascia, and the external oblique aponuerosis. The cord was examined for an indirect sac, and any direct hernia was reduced and the oor was reinforced with a piece of at polypropylene mesh that was sewn to the conjoint tendon and the shelving edge of the inguinal ligament. The mesh was slit to accommodate the cord structures. The Prolene Hernia System mesh repair The PHS mesh repair was performed as described by Gilbet et al [14]. Again, the inguinal canal was approached from an anterior approach after dividing the skin, Scarpas fascia, and the external oblique aponeurosis. The cord was examined for an indirect sac. For indirect hernias, the hernia sac was inverted and a pocket created through the internal ring in the preperitoneal space by using a raytech sponge. The underlay of the PHS mesh was then deployed in the preperitoneal space. The overlay was secured by using 3 interrupted permanent sutures to the pubic tubercle, the

Fig. 1. Myopectenial orice of the inguinal canal showing the medial, lateral, and femoral triangles.

S. Awad et al. / The American Journal of Surgery 193 (2007) 697701 Table 1 Baseline characteristics of the patients LMR PHS (n 302) (n 321) Characteristic Age (y) 59.5 Race (%) White 73.5 Black 24.2 Asian 0.3 Multiracial 1.7 Other 0.3 Hernia (%) Unilateral 91.1 Bilateral 8.9 Primary 95.7 Recurrent 4.3 Coexisting conditions (%) Urinary outlet obstruction 22.2 Severe chronic obstructive pulmonary disease 12.3 Chronic cough 2.6 Smoking 19.9 Congestive heart failure 5.3 Prior myocardial infarction 6.6 Hypertension 51.3 Diabetes 11.6 Alcohol consumption 2 drinks/day 15.9 ASA class (%) I 3.3 II 37.7 III 42.1 IV 4.0 Unknown (%) 12.9 58.5 74.1 23.7 0.3 0.3 1.6 89.1 10.9 96.3 3.7 19.9 9.7 3.4 21.4 3.1 7.2 55.5 12.5 12.1 3.7 32.7 39.3 4.7 19.6

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documented. Patients were followed until hernia recurrence or last clinic visit. Recurrences in each group were recorded. Data are presented as mean standard error of the mean. Univariate comparisons were made by using an unpaired Student t test and chi-square analysis. The recurrence-free interval was analyzed with Kaplan-Meier curves. P values of less than .05 were regarded as signicant. Results Six hundred twenty-two charts were reviewed during the 2 time periods (PHS mesh 321, LMR 302). The median follow-up was 20 months. Table 1 lists the demographic characteristics of the LMR and PHS mesh patients. The 2 groups were comparable in age, race, and type of hernia. Furthermore, there was no signicant difference in the comorbidities between the 2 groups. The majority of hernias repaired were primary and unilateral in both groups. Table 2 shows the type of anesthesia used, operative times, early and late postoperative complications, and the recurrence rates for each type of mesh repair. A higher percentage of the repairs were performed under regional anesthesia in the LMR compared to the PHS mesh group. In contrast, more repairs were performed under local anesthesia in the PHS mesh group. There was no signicant difference in the operative time needed to complete both types of repair (PHS mesh 90.6 1.6 minutes, LMR 89.5 1.7 minutes, P not signicant). This did not vary with the type of hernia encountered. Overall, there was a trend toward decreased complications in the PHS mesh group compared with the LMR group (PHS mesh 17%, LMR 23%, P .07), with a signicant difference in the hemaTable 2 Characteristics of the repair procedures, postoperative complications, follow-up, and recurrences rate Variable Type of anesthesia (%) General Regional Local, with or without sedation Operation time (min) Intraoperative complications (%) Problems related to anesthesia Injury to spermatic-cord structure Injury to vessel Peritoneal defect over mesh at closure Immediate postoperative complications (%) Urinary retention Urinary tract infection Hematoma or seroma Orchitis Wound infection Neuralgia or other pain Long-term complications (%) Hematoma or seroma Orchitis or other testicular problems Infection Neuralgia or other pain Recurrence rate (%) * P .05. LMR (n 302) 58.3 40.1 2.0 89.5 1.7 1.3 0.0 0.0 PHS (n 321) 61.1 30.8 8.1 90.6 1.6 0.6 0.3 0.9

conjoint tendon, and the shelving edge of the inguinal ligament. A lateral slit was made in the mesh to accommodate the cord structures and to recreate the internal ring. The extended portion of the overlay was placed under the external oblique aponeurosis laterally. For direct hernias, the attenuated transversalis fascia of the oor of the inguinal canal was opened and the hernia sac and contents reduced. Similarly, a pocket in the preperitoneal space was created with placement of a raytech sponge. The underlay of the PHS mesh was then deployed into this space through the oor. The overlay was then sutured to the pubic tubercle, conjoint tendon, and the shelving edge of the inguinal ligament as described above. The extended portion of the overlay was placed under external oblique laterally. Demographic data such as age, race, and gender as well as comorbid conditions such as chronic obstructive pulmonary disease, congestive heart failure, previous myocardial infarction, diabetes, hypertension, prostatism, and chronic cough were collected. The type of anesthesia and the American Society of Anesthesiologists classication for each patient were recorded. Information about the side and type (direct, indirect, pantaloon) of each hernia was collected. Operative times (skin incision to skin closure) were recorded for each repair. Intraoperative complications including iatrogenic vessel and nerve injury and as well as anesthesia related complication were recorded. Any postoperative complications such as cord injury, seroma, hematoma, urinary retention, urinary tract infection, orchitis, or wound infection were

3.0 0.3 12.6 0.7 2.0 4.3 0.7 0.7 0.3 3.3 2.6

2.2 0.3 6.9* 1.2 2.8 2.2* 0.9 0.0 0.0 1.6* 0.6*

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Fig. 2. Kaplan-Meier curves showing percentage of patients free of recurrence over time. LMR Lichtenstein mesh repair; PHS Prolene Hernia System mesh repair.

toma/seroma rates (PHS mesh 6.9%, LMR 12.6%, P .015), as well as the neuralgia or other pain rates (PHS mesh 2.2%, LMR 4.3%, P .04). There were no mortalities in either group. Finally, 8 patients (2.7%) in the LMR group had recurrence, in comparison with 2 patients (0.6%) in the PHS mesh repair group showing a signicant decrease in the recurrence rate for the PHS mesh group compared with the LMR group (PHS mesh 0.6%, LMR 2.7%, P .03). Figure 2 shows the recurrence-free interval for each repair. Comments The repair of a simple inguinal hernia or a complicated recurrent hernia is no longer just the sewing together of a defect in the musculature. Present-day hernia operations require that the surgeon more fully understand the functional anatomy and pathophysiology of the abdominal wall and groin. The ideal inguinal hernia repair should provide effective coverage of the myopectineal orice, have the lowest possible recurrence rate, have minimal operative and postoperative discomfort, and allow rapid return to normal activities. Furthermore, it should be cost effective and ideally should be applicable to most types of hernias encountered [15]. This study aimed to compare the current gold standard Lichtenstein onlay mesh with the PHS mesh for the open repair of inguinal hernias from an anterior approach. Multiple studies have examined the on-lay mesh repair and have shown that this repair has a very low learning curve and can be readily performed by using local or regional anesthesia in patients who are deemed high risk for general anesthesia. Results from 3,019 repairs from 5 sites have shown a 0.5% recurrence rate and an overall 0.6% infection rate [6]. A meta-analysis of 17 trials reported by the European Hernia Trialists Collaboration showed that mesh repairs have lower recurrence rates and less long-term pain when compared with nonmesh repairs [16]. Recently, Nuemayer et al [10], in their study with a 2-year follow-up, showed recurrence rates of 4.9% in patients who had the LMR. Given the reproducible results from the various studies, the LMR is considered the standard against which other repairs should be compared.

In an attempt to improve on the LMR, Gilbert [11] developed an approach to the preperitoneal space through the internal ring and led to the development of the PHS mesh. The PHS mesh, consisting of an underlay patch, an overlay patch, and a joining connector, has potential benets over the traditional LMR and laparoscopic repairs and thus would be expected to have lower recurrence rates. The PHS mesh provides complete coverage of the entire myopectineal orice through the underlay placed in the preperitoneal space, which protects the medial and femoral triangles, and the overlay, which protects the lateral triangle of the myopectineal orice. The connecter maintains the mesh in position either through the internal ring for indirect hernias or through the transversalis fascia for direct hernias decreasing the likelihood of mesh migration. In contrast to laparoscopic preperitoneal repairs, the underlay of the PHS mesh is not xed to the surrounding structures, allowing for greater exibility of the underlay to contour to the abdominal wall in a tension-free manner [17]. Preliminary reports of the PHS mesh repair have shown extremely low recurrence rates, ease of placement, less postoperative pain, and equivalent operative times to the LMR [12,14,18 22]. Our results from this study of 622 patients showed a lower hernia recurrence rate in the PHS mesh group (0.6%) when compared with the LMR group (2.7%) after a median follow-up of 20 months. Both groups had very similar baseline characteristics and preoperative comorbidities. Our recurrence rate for the LMR group was lower than that reported by Neumayer et al [10] but is within the range of other previous reports [6,16]. The recurrence rate for the PHS mesh group corroborates the recurrence rates reported by Gilbert et al [14]. Recently, a clinical trial of 300 patients evaluating the Lichtenstein and PHS mesh methods showed no recurrences in the PHS mesh group and 1 residual femoral hernia in the open mesh repair group [22]. In our series, in both groups, approximately 40% of the patients were repaired under local or regional anesthesia avoiding the need for general anesthesia, a requirement for laparoscopic repair. More repairs were done under local anesthesia in the PHS mesh group. This was also shown by Farrakha et al [20]. The rates for the use of local and regional anesthesia is similar to those previously reported [10,18]. Overall, there was a trend towards decreased complication rates occurring during the intraoperative, immediate postoperative, and long-term time periods in the PHS mesh group when compared with the LMR group as shown in Table 2. Specically, the hematomas/seromas as well as neuralgia were signicantly lower in the PHS mesh versus the LMR group. Although postoperative pain and return to activity were not measured in this study, several reports have shown superior outcomes in these regards when using the PHS mesh repair versus the Lichtenstein method. One study showed that patients undergoing inguinal hernia repair with PHS mesh had signicantly less postoperative pain and returned to normal activity sooner than patients repaired with the Lichtenstein patch [12]. Huang et al [19] showed decreased neuralgia with the PHS mesh repair when compared with the plug and patch technique. Other studies by Kingsnorth et al [12] and Veronen et al [22] have also shown decreased chronic pain after the PHS mesh repair.

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In theory, inguinal hernia repair with the PHS mesh should require more operation time because of the greater amount of dissection needed when compared with the LMR technique. However, in concordance with prior reports [14,20], the average time of the mesh repair was not statistically different between the PHS mesh and LMR groups. The mean operative time in this study for either method was higher than in other reports and may be related to the hernia repairs being performed in a teaching institution. Mean repair times for the PHS mesh have ranged from 27 to 65 minutes [20,21]. This study has several limitations including that it was a retrospective review in a predominantly male patient population with a median follow-up of 20 months. Nevertheless, to date, this study is the largest comparison of the PHS mesh repair to the LMR in a well-matched patient series and suggests improved outcomes for the PHS mesh with respect to recurrence and complications. In summary, the PHS mesh method for inguinal hernia repair was associated with a lower recurrence rate as well as fewer complications when compared with the Lichtenstein onlay mesh repair technique. These low recurrence rates may stem from the complete coverage of the myopectineal orice and exibility of the PHS mesh. Further prospective research is needed to rigorously evaluate the comparative advantages of PHS mesh repair in relation to other repair methods. References
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[6] Shulman AG, Amid PK, Lichtenstein IL. The safety of mesh repair for primary inguinal hernias: results of 3019 operations from ve diverse surgical sources. Am Surg 1992;58:2557. [7] Liem MSL, van der Graaf Y, van Steensel CJ, et al. Comparison of conventional anterior surgery and laparoscopic surgery for inguinalhernia repair. N Engl J Med 1997;336:15417. [8] Fitzgibbons RJ Jr, Camps J, Cornet DA, et al. Laparoscopic inguinal herniorrhapy: results of a multicenter trial. Ann Surg 1995;221:313. [9] McCormack K, Scott NW, Go PM, et al. EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003;(1): CD001785. [10] Neumayer L, Giobbie-Hurder A, Jonasson O, et al. Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 2004;350: 1819 27. [11] Gilbert AI. Sutureless repair of inguinal hernia. Am J Surg 1992;163: 3315. [12] Kingsnorth AN, Wright D, Porter CS, Robertson G. Prolene Hernia System compared with Lichtenstein patch: a randomised double blind study of short-term and medium-term outcomes in primary inguinal hernia repair. Hernia 2002;6:1139. [13] Amid PK. Lichtenstein open tension-free hernioplasty. Woodbury, CT: Cin-Med, 1997 (video) (ACS CC-1869). [14] Gilbert AI, Young J, Graham MF, et al. Combined anterior and posterior inguinal hernia repair: intermediate recurrence rates with three groups of surgeons. Hernia 2004;8:2037. [15] Awad SS, Fagan SP. Current approaches to inguinal hernia repair. Am J Surg 2004;188(suppl):9S16. [16] EU Hernia Trialists Collaboration. Repair of groin hernias with synthetic mesh: meta analysis of randomised controlled trials. Ann Surg 2002;26:1472 80. [17] Awad SS, Bruckner B, Itani KMF, et al. Transperitoneal view of the PROLENE Hernia System Open Mesh Repair. Int Surg 2005;90(suppl): S63 6. [18] Mayagoitia JC. Inguinal hernioplasty with the Prolene Hernia System. Hernia 2004;8:64 6. [19] Huang CS, Huang CC, Lien HH. Prolene hernia system compared with mesh plug technique: a prospective study of short- to mid-term outcomes in primary groin hernia repair. Hernia 2005;9:16771. [20] Farrakha M, Shyam V, Bebars GA, et al. Ambulatory inguinal hernia repair with prolene hernia system (PHS). Hernia 2006;10:2 6. [21] Murphy JW. Use of the prolene hernia system for inguinal hernia repair: retrospective, comparative time analysis versus other inguinal hernia repair systems. Am Surg 2001;67:919 23. [22] Vironen J, Nieminen J, Eklund A, Paavolainen P. Randomized clinical trial of Lichtenstein patch or Prolene Hernia System for inguinal hernia repair. Br J Surg 2006;93:339.