Michele Simone1, Emanuele Grasso1* and Valentina Cianci2
1Unit General surgery, Santa Maria Private Hospital via de Ferrarris 22 cap 70122 Bari, Italy
2Unit General Surgery Hospital Monopoli Bari, Italy
Received: 18 April, 2016; Accepted: 14 July, 2016; Published: 16 July, 2016
Emanuele Grasso, Unit General surgery, Santa Maria Private Hospital Via de Ferrarris, 22 cap 70122 Bari, Italy, E-mail:
Simone M, Grasso E, Cianci V (2016) Retrospective Study of 710 Patients Treated with 4ddome® Mesh: A New Chance for Open Inguinal Hernia Repair. J Surg Surgical Res 2(1): 043-047.10.17352/2455-2968.000030
© 2016 Simone M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Hernia; Dome; Inguinal hernia
Introduction: Although mesh techniques are used with increasing frequency, they are correlated to major long-term complications such as chronic inguinal pain (8.6%) and recurrence (1.6-8.6%). It is due to a non-development of an ideal mesh, which simultaneously ensures inguinal wall strength and a lower inflammatory foreign body reaction, which also seems to be correlated to the use of a non-absorbable mesh.
Materials and methods: They were retrospectively analyzed from January 2007 to June 2014, 710 patients (103 women with mean age of 62, (14.54%) and 607 men with mean age of 51.8, (85.45%) underwent a surgical groin hernia repair. In 96 patients (13.66%), we used the dome only and in 614 patients (86.36%), both the dome and the onlay mesh were used for inguinal hernia repair. In all cases, we used a 4DDome® mesh (dome, lay patch) for reconstruction. This prosthesis is made of 10% light polypropylene and 90% absorbable poly-L-Lactic Acid (PLLA).
Results: Mean operative time was 45 minutes (range: 20-70 minutes). There were no intraoperative complications. The majority of patients were discharged after a mean time of 12 hours (range: 12-72 hours). In 12 (1.81%) cases, there were a subcutaneous hematoma and a seroma in one case.
Fifty (7.2%) patients presented with incisional scar swelling. There were no wound infections. These minor complications resolved within 1 month.
Three (0.42%) patients had chronic inguinal pain (>3 months). Five (0.70%) recurrent hernias were observed.
Conclusion: In our study, we observed an adequate mesh tolerance: the majority of patients did not present chronic pain at 1 year, except in 0.42% of cases, with a low rate or recurrence of only 0.70%. Postoperative stay was reduced with an immediate return to physical activities. Consequently, according to our initial experience, absorbable meshes for inguinal hernia repair seem stand.
One of the first description of inguinal hernia was in an ancient egyptian medical text, the “Ebers Papyrus” dating to 1550 BC [1,2]. Since, the evolution of this disease has been chaotic until modern era.
It is interesting to note that for a common disease , a lot of different techniques have been proposed (open and laparoscopic approaches) using several devices (absorbable and non-absorbable) and different fixation procedures (stitches, fibrin glue, etc.) [3-5].
Although the use of mesh procedures is widespread all over the world, they are correlated with major long-term complications such as chronic inguinal pain (8.6-38.3%) [3,6,7] and recurrence (1.6-8.6%) . While recurrence could be prevented since it is most specifically due to technical mistakes (mesh dimension and position), chronic pain, save from nerves injury, is caused by a reaction to mesh implantation.
An ideal mesh should simultaneously ensure inguinal wall strength as well as a lower inflammatory body reaction.
The heavyweight polypropylene (PP) mesh is strong and is able to compensate for intra-abdominal pressure. However, it stimulates inflammatory reaction responsible for mesh shrinkage when scar tissue evolves [5,8].
This cell-mediated reaction due to a foreign body (i.e., mesh), which could persist for a long period, involves all inguinal groin structures (vessels, nerves, deferent duct). This leads to a lot of complications such as chronic pain, neuritis, paresthesia, testicular atrophy, infertility (these last two complications occur in animal models) [3,5].
Consequently, the reduction of non-absorbable materials should decrease the inflammatory response but it cannot, due to parietal strength, which is essential for hernia recurrence prevention.
Additionally, shrinkage seems to be correlated to the amount of non-absorbable materials.
In our non-randomized study, we proposed to use a partially absorbable mesh, namely the 4DDome® mesh (Cousin Biotech) for inguinal hernia repair as it seems to offer the two characteristics of an ideal mesh (less foreign body with a lower inflammatory response).
Materials and Methods
They were retrospectively analyzed from January 2007 to June 2014, 710 patients (103 women with mean age of 62, 14.54%; 607 men with mean age of 51.8, 85.45%) underwent a surgical groin hernia repair in our surgical department.
It was explained to all patients the type of intervention and the material used with authorization to perform the procedure.
All operations were carried out by the same surgical team with experienced surgeons. Almost all total hernias were primary ones, except for 22 (3.098%) cases, which were recurrences, 10 cases after laparoscopic repair, and 12 cases after open techniques. All cases were operated on under spinal anaesthesia, and only unilateral hernias were treated.
Femoral hernias and emergency operations were excluded.
In 81 patients (11.55%), we used only the 4DDome® mesh for inguinal hernia repair and in 15 (2.11%) only the plug. In the other 614 patients (86.36%), onlay mesh and plug were used.
The 4DDome®. It is a prosthesis which consists of a cap, with a structure in the shape of dome made in the same way and the mesh material. They provide a patch onlay reinforcement, composed of 10% light polypropylene and 90% Poly-L-lactic acid (PLLA). PLLA is an absorbable synthetic polymer of amino acid lactate, immunologically inert.
All patients were submitted to antibiotic therapy post-operating with cephalosporin (cefotaxime).
After the operation, all patients were controlled with a clinical examination at discharge, 10 days, 1 month, and at 1 year.
The surgical technique consists in an arcuate skin incision on the inguinal site with successive dissection of subcutaneous tissues and fascia. We usually open the external oblique muscle fascia in order to dissect the spermatic cord and the cremaster muscle, and to identify the deferent duct. After identifying them, the hernia sac is dissected and repositioned into the abdominal cavity (through the inguinal ring if it is an indirect hernia). Sometimes, when the sac is too big, it is closed with a stitch at the base. Maintaining the sac deeply, the 4DDome® mesh is placed to close the defect and it is fixed by means of 3 or 4 absorbable sutures, which are stitched to the edge of the inguinal ring or to the wall of the defect if there is a direct hernia. Finally, the mesh is placed around the spermatic cord on the transversalis fascia and it is fixed by means of one absorbable suture stitched to the pubic tubercle.
The external oblique muscle fascia, the subcutaneous layer, and the skin are re-approximated using an absorbable running suture.
The mean operative time was 45 minutes (range: 20-70 minutes).
The majority of patients were discharged after a mean time of 12 hours (range: 12-72 hours).
In 12 cases (1.81%), there was a subcutaneous hematoma, which was treated conservatively in 8 cases. In 4 cases, it was necessary to perform surgery using site drainage and lavage. In one case, it was necessary to perform a laparotomy for a retroperitoneal bleeding due to an injury to left epigastric vessels. It was a nephropathic and cardiovascular patient presenting with cardiac transplantation and coagulation deficiency. In only one case (0.90%), a major persistent seroma was found in a patient who was surgically treated for prostate cancer. In 50 cases (7.2%), an incisional scar swelling was found with no wound infections.
In 27 cases (3,8%) of transitory hypoaesthesia solved in 30 days.
In 5 cases (0.70%) persistent hypoaesthesia and other 5 (0.70%) hyperaesthesia after three months and there is only one case (0.14%) of keloid skin.
These minor complications resolved spontaneously within one month. No problems were found at 1 year.
In 497 patients (70%), postoperative pain was present but disappeared after 10 days. Only in 25 cases (3.63%), postoperative pain disappeared within 3 months.
Three patients (0.42%) had chronic inguinal pain (> 3 months) with no functional limitation.
Only 5 (0.70%) recurrent hernias were observed. No infection was reported (Table 1).
The use of the mesh has become common for the majority of surgeons, and thanks to the development of new materials, fewer recurrences occur but there is no ideal outcome in all patients managed. In several studies, the incidence of chronic inguinal pain reaches 30% with 15% of recurrence [3,6] .
Recently, the Food and Drug Administration published major complications following hernia repair. According to this review, which included 252 events, the polypropylene mesh had more mechanical failures (80 vs. 14%; p<0.05), the biomaterial mesh had more reactions (57 vs. 7%; p<0.05), the PTFE/PP mesh had more infections (75 vs. 41%; p=0.07). As a result, specific mesh materials are related to specific complications .
In the recent past, the polypropylene (Prolene®) mesh was regarded as a “gold standard” in groin hernia repair . Now, it is a subject of controversy because of fears concerning the long-term effects of their implantation.
As a matter of fact, in contrast to the strength of the inguinal wall, the mesh is responsible for a major foreign body inflammatory response. It appears with macrophage infiltration and proliferation, foreign body giant cell reaction, transient edema, angiogenesis conducive to mesh adherence to surrounding spermatic cord structures (vessels and nerves). This reaction could well persist for a long time. It is responsible for nerve injury and infertility in an experimental animal study [11-14].
In addition, inflammatory reaction is accountable for the well-known PP shrinkage when scar tissue evolves. The latter acts as 20% of the original mesh size . Shrinkage is one of the causes of recurrence since mesh surface decreases and does not cover the defect.
Technical mistakes with inadequate mesh dimension and position represent other causes of recurrence.
On the other hand, it is not possible to prevent or reduce the amount of PP because of an increased risk of recurrence due to a significant loss in tensile strength as shown by Klosterhalfen.
Additionally, it is difficult to place a light mesh in situ.
Hence, it is very difficult to find the adequate balance between inguinal wall strength and a lower inflammatory body reaction.
The importance of material selection was demonstrated in the study by Weyhe where the surgical approach to hernia results in an independent prognostic factor for clinical outcome. In addition, mesh construction and composition (pore size and filament structure) appeared to be more important determinants of foreign body reaction than absolute material reduction of 1 gram or more per implant [14,15] .
In their study, Champault et al., have demonstrated that chronic pain is not correlated to the surgical techniques. In fact, its incidence is the same in laparoscopic approaches and in Liechtenstein procedures (17.9% vs. 20.7%) while the comparison between Beta-D glucan-coated mesh and PP shows a lower incidence of chronic pain in the first (4.8%) vs. PP mesh (26.5%) [11,16].
To improve biocompatibility and safety, a large variety of newly developed meshes have been introduced on the marketplace. Nowadays, a lot of composite meshes are available. They combine absorbable components (polyglactin, poliglecaprone 25, PLLA) with standard PP. They present different scaffolds.
The aim of our study is to prevent two major complications, which have been described previously, using a new composite 4DDome® mesh (Cousin Biotech). We infer that these devices offer the best mesh quality: good tolerance thanks to absorbable PPLA (less inflammatory response) and a good inguinal wall strength.
The 4DDome® mesh is a prosthesis which consists of a plug, with a dome-shaped structure made in the same manner and material as the mesh. They provide a reinforcement onlay patch, composed of 10% light polypropylene and 90% Poly-L-Lactic Acid (PLLA) [17-19,]. PLLA is an absorbable synthetic polymer of amino acid lactate, immunologically inert (Figure 1). It is used in several medical products such as stitches and screws. It is also used to repair broken bones. It increases dermal thickness by causing a local reaction, leading to an increase in collagen deposits. It is eventually degraded and undergoes resorption.
- (1930) The Edwin Smith Surgical Papyrus (University of Chicago Press: University of Chicago.
- Reinhold Scholl, Der Papyrus Ebers (2002) Die größte Buchrolle zur Heilkunde Altägyptens (Schriften aus der Universitätsbibliothek 7), Leipzig.
- Parthasarathy M, Reid V, Pyne L, Groot-Wassink T (2015) Are we recording postoperative complications correctly? Comparison of NHS Hospital Episode Statistics with the American College of Surgeons National Surgical Quality Improvement Program. BMJ Qual Saf 2015-003932v1 .
- Hope WW (2015) Commentary on "Medium-Term Recurrence and Quality of Life Assessment Using the Hernia-Specific Carolinas Comfort Scale Following Laparoscopic Inguinal Hernia Repair": Asking the Right Questions-Evaluating Outcomes in Hernia Repair. J Laparoendosc Adv Surg Tech A 25: 481 .
- Stoikes N, Webb D, Powell B, Voeller G (2013) Preliminary report of a sutureless onlay technique for incisional hernia repair using fibrin glue alone for mesh fixation. Am Surg 79: 1177-1780 .
- Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H, et al. (2007) Chronic pain after mesh repair of inguinal hernia: a systematic review. Am J Surg 194: 394-400 .
- Beldi G, Haupt N, Ipaktchi R, Wagner M, Candinas D (2008) Postoperative hypoesthesia and pain: qualitative assessment after open and laparoscopic inguinal hernia repair. Surg Endosc 22: 129-133 .
- Zhong C, Wu B, Yang Z, Deng X, Kang J, et al. (2013) A meta-analysis comparing lightweight meshes with heavyweight meshes in Lichtenstein inguinal hernia repair. Surg Innov 20: 24-31 .
- Schumpelick V (2001) does every hernia demand a mesh repair? A critical review. Hernia 5: 5-8.
- Nyhus LM (2000) Ubiquitous use of prosthetic mesh in inguinal hernia repair: the dilemma. Hernia 4: 184-186 .
- Kumar S, Wilson RG, Nixon Sj, Macintyre IM (2002) Chronic pain after laparoscopic and open mesh repair of groin hernia. Br J Surg 89: 1476-1479 .
- LeBlanc KA (2001) Complications associated with the plug and patch method of inguinal herniorraphy. Hernia 5:135-138 .
- Bischoff JM, Aasvang EK, Kehlet H, Werner MU (2012) Does nerve identification during open inguinal herniorrhaphy reduce the risk of nerve damage and persistent pain? Hernia 16: 573-577 .
- Stula I, Družijanić N, Sapunar A, Perko Z, Bošnjak N, et al. (2014) Antisperm antibodies and testicular blood flow after inguinal hernia mesh repair. Surg Endosc 28: 3413-3420 .
- Hansen NL, Ciritsis A, Otto J, Busch D, Kuhl CK, et al. (2015) Utility of Magnetic Resonance Imaging to Monitor Surgical Meshes: Correlating Imaging and Clinical Outcome of Patients Undergoing Inguinal Hernia Repair. Invest Radiol 50: 436-442 .
- Garcia-Urena MA, Ruiz VV, Diaz Godoy A (2007) difference in PP shrinkage depending on mesh position in an experimental study. The Am J Surg 193: 538-542 .
- Mutter D, Callari C, D Agostino J, Cahill RA, Forgione A, et al. (2010) Expanded clinical experience with 4DDome(R) composite prosthesis in elective open inguinal herniorrhaphy. Surg Technol Int 19: 105-110 .
- Mutter D, Champault G, Binot D, Vix M, Leroy J, et al. (2012) PerFix™ plug versus 4DDOME(®) implants for inguinal hernia repair: prospective multicentric randomised controlled trial. Hernia 16: 561-566 .
- Tanaka K, Mutter D, Inoue H, Lindner V, Bouras G, et al. (2007) in vivo evaluation of a new composite mesh ( 10 % polypropylene\ 90 % poly-L-lactic acid) for hernia inguinal repair. J Mater Sci Mater Med 18: 991-999.
- Nicholson S (1986) inguinal Hernia repair using local anesthesia. Ann Coll Siug Engl 68: 53-54 .
- Jacob DA, Schug-Pass C, Sommerer F, Tannapfel A, Lippert H, et al. (2012) Arch Surg. Comparison of a lightweight polypropylene mesh (Optilene® LP) and a large-pore knitted PTFE mesh (GORE® INFINIT® mesh)--Biocompatibility in a standardized endoscopic extra peritoneal hernia model. 397: 283-289.
- Awad SS, Yallampalli S, Srour AM, Bellows CF, Albo D, et al. (2007) Improved outcomes with the Prolene Hernia System mesh compared with the time-honored Lichtenstein onlay mesh repair for inguinal hernia repair. Am J Surg 193: 697-701 .
- Kolbe T, Hollinsky C, Walter I, Joachim A, Rülicke T (2010) Influence of a new self-gripping hernia mesh on male fertility in a rat model. Surg Endosc 24: 455-461 .