THE NEW SELF-GRIPPING MESH AND IT'S BENEFITS IN INGUINAL HERNIA REPAIR – REVIEW OF THE LITERATURE

Abstract

According to the guidelines of the European Hernia Society, the fixation devices like tacks, sutures and staples must be used with caution because these cause local trauma that may result in nerve injury and chronic pain23. The use of ProGrip™ self-gripping mesh in inguinal hernia repair, both open and laparoscopic technique, is rapid, safe, simple and cost-effective, providing low or no recurrence, low or no chronic pain and improved quality of life34. 8 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57 9Value analysis Committee 2013 - Product information kit of COVIDIEN -"ProGrip™ Laparoscopic Self- Fixating Mesh" , www.Covidien.com/Hernia 10Amid PK, Shalman AG, Lichtenstein IL., Open ?tension-free?repair of inguinal hernias: the Lichtenstein technique." Endosc., 2010; 24: 2958 - 2964; Brown C.N., Finch J.G., "Which mesh for hernia repair?", Ann R Coll Surg Engl., 2010; 92: 272 - 278 17 Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H, Bleichrodt R. "Chronic pain after mesh repair of inguinal hernia: a systematic review.", Am J Surg. 2007; 194:394-400 18 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57 19 O'Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers B, Horeyseck G. "Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair.", Br J Surg., 2005; 92:166-70 20 Alicia Mangram, MD, Olakunle F. Oguntodu, MD, MS, Francisco Rodriguez, MD, Roozbeh Rassadi, MD, Michael Haley, MD, Cynthia J. Shively, FNP-BC, RNFA, CNOR,James K. Dzandu, PhD, BSc, "Preperitoneal Surgery Using a Self-Adhesive Mesh for Inguinal Hernia Repair", JSLS, 2014; 18(4): 1-7 21 Koch CA, Greenlee SM, Larson DR, Harrington JR. Covidien sponsored study; Lissidini, G , Piccini, G, et al., "No tacks, no glue, no frustration during TAPP groin hernia repair with ProGrip™ and V-Loc™ 180.", HIS , 2012 FP-1740 27 Kingsnorth A., Nienhuijs S., Schule S., et al., " Preliminary Results of a Comparative Randomized Study: Benefit of Self - Gripping Parietex Progrip™ Mesh in Open Inguinal Hernia Repair", Hernia, 2010; vol 14 Supplement 28 Fumagalli Romario U., Puccetti F., Elmore U., Massaron S., Rosati R., " Self-gripping mesh versus staple fixation in laparoscopic inguinal hernia repair: a prospective comparision", Surg.

Headnote

ABSTRACT

THERE IS A CONTINUOUS DEBATE ABOUT WHAT TYPE OF MESHES ARE MORE SUITABLE TO BE USED IN INGUINAL HERNIA REPAIR. RECENTLY WAS INTRODUCED INTO CLINICAL PRACTICE A SELF - GRIPPING MESH WHO DOESN'T NEED ADDITIONAL FIXATION.

THE AIM OF THIS REVIEW IS TO EVALUATE THE FEATURES OF THIS SELF-GRIPPING MESH IN TERMS OF RECURRENCE RATE, DECREASED POSTOPERATIVE COMPLICATIONS AND IMPROVED QUALITY OF LIFE. RANDOMIZED TRIALS, PROSPECTIVE AND RETROSPECTIVE STUDIES, REVIEWS AND GUIDELINES PUBLISHED BETWEEN 2006 AND 2017 WERE ANALYZED IN TERMS OF RECURRENCE RATE, DECREASED POSTOPERATIVE COMPLICATIONS AND IMPROVED QUALITY OF LIFE.

THE USE OF SELF-GRIPPING MESH IN INGUINAL HERNIA REPAIR, BOTH OPEN AND LAPAROSCOPIC TEHNIQUE, IS RAPID, SAFE, SIMPLE AND COST - EFFECTIVE, PROVIDING LOW OR NO RECURRENCE, LOW CHRONIC PAIN AND IMPROVED QUALITY OF LIFE8.

KEY WORDS: SELF-GRIPPING MESH, INGUINAL HERNIA REPAIR, RECURRENCE RATE, POSTOPERATIVE COMPLICATIONS

INTRODUCTION

Inguinal hernia is the most common surgical pathology whose treatment consists in reduction and resection of the hernia sac and rearing the abdominal wall. From the end of 16th century till the end of 19th century the repair of the abdominal wall was done by closing the inguinal canal with different types of suture that joined the muscle and fascia components.

Afterwards the additional reinforcement of the posterior wall with different types of mesh started. Initially meshes were biological (autologous and heterologous) and metal thread. Due to development of biochemical and biotechnological industries, the meshes based on polymers were introduced into practice.

Nowadays, there is a continuous debate about what type of meshes are more suitable to be used in repairing the inguinal defect.

Recently was introduced into practice a self-gripping mesh for repairing inguinal hernia defect that doesn't need additional fixation.

The aim of this review is to evaluate the features of this self-gripping mesh in terms of recurrence rate, decreased postoperative complications and improved quality of life.

MATERIAL AND METHOD

Two randomized trials, two guidelines, one consensus development conference, four reviews, six prospective and seven retrospective studies, published between 2006 and 2017, were analyzed in terms of recurrence rate, postoperative complications and quality of life.

RESULTS AND DISCUSSIONS

There are many studies comparing different types of meshes used in open or laparoscopic inguinal hernia repair. The new self-gripping mesh introduced into clinical practice was evaluated in literature in terms of recurrence rate, decreased chronic pain and improved quality of life.

Self - gripping mesh

In 2008 Covidien launched ProGrip™ mesh, a self-adhesive prosthetic material used in repairing inguinal hernia both open and laparoscopic technique.

It is made of polyethylene terephthalate and has absorbable micro-grips made of monofilament polylactic acid. It is lightweight, isoelastic, macroporous knitted monofilament polypropylene mesh, hydrophilic, with absorbable micro-grips that provide self - adhesive fixation during the first months after implantation.

The weight of the mesh before the absorption of the micro-grips is 82 g/m2 and after the absorption is 49 g/m2.The pore size is 1.8 x 1.8 mm. There are 36 micro-grips per cm, cub-shaped 1 mm atraumatic prominences, with an absorption time more than 18 months9.

The mesh is for left or right side, flat, plug or anatomical, and has different dimensions and shapes.

The laparoscopic self - gripping mesh has a fast absorbing film on the posterior side made of 70% collagen and 30% glycerol, and the time of dissolution is less than one day.

Recurrence rate

ProGrip™ mesh is a new device that combines mesh and fixation device, which eliminates the need for additional glue, tacks or sutures.

The gold standard treatment for inguinal hernias is tension - free repair because of lower recurrence rates and improved quality of life10. The introduction of meshes decrease recurrence rate of less than 5% 11. So, the rate of recurrence using self - gripping mesh was questionable.

Among the factors that influence the recurrence rate of inguinal hernia are type of mesh used, mesh location and migration, extent of mesh overlap, fixation devices and failure to close the parietal defect, as seen in an article published in 201512 Also, the pore size is another factor that may affect the recurrence rate, because larger pore allow a greater ingrowth, increase the pliability and functionality of the mesh13.

Thanks to thousands of absorbable micro-grips that adhere immediate to entire environment tissue about 0.5 mm below the lower rim of the mesh14 and provide strong fixation and strength incorporation at five days after implantation, there is no need for additional fixation with glue, tacks or suture15 comparing with other unfixed meshes.

For a low recurrence rate the features of the mesh used in laparoscopic inguinal hernia repair, according to the recommendations from the International Hernia Society and the European Association for Endoscopic Surgery, must be: monofilament, minimum dimensions of 10x15 cm, minimum pore size of 1.0 - 1.5 mm and minimum tensile strength in all directions more than 16 N/cm2.16, conditions respected by the ProGrip™ mesh.

Postoperative complications

The rate of chronic groin pain after inguinal hernia repair ranges from 11% to 40%17. Although pain may be eliminated by identification and preservation of inguinal groin nerves, other authors have studied the meshes18. The use of lightweight polypropylene mesh is associated with less postoperative pain19 and low foreign body sensation.

The fixation devices lead to many postoperative complications, including vascular injury, nerve damage, seroma, hematoma, testicular problems, urinary retention, wound infection and chronic groin pain. The self - gripping mesh eliminates the complication risk, increased operation time and expense and low rates of recurrence20.

ProGrip™ mesh provides a modern alternative to mesh fixation complications in both open and laparoscopic inguinal hernia treatment. Its features eliminate possible fixation devices complications with no increase in recurrence rate21.

Due to absorption of 40% of the mesh weight, the sensation of foreign body decrease22.

According to the guidelines of the European Hernia Society, the fixation devices like tacks, sutures and staples must be used with caution because these cause local trauma that may result in nerve injury and chronic pain23.

Thanks to its features, the micro-grips of the ProGripTM mesh provides an uniform atraumatic fixation on the entire surface and can decrease the recurrence rate and chronic pain24. Once the micro-grips are absorbed, only the macroporous part, made of polyester, remains at the site, having strong incorporation to environment tissue.

Koch et al. reported that self-gripping mesh was not associated with an increased recurrence rate, postoperative complications or increased cost, but with an improved quality of life with low chronic pain25.

An article published in 2012 sponsored by Covidien, a retrospective study on 169 patients with inguinal hernia treated laparoscopic with ProGrip-™ mesh, reported that the mesh is safe and cost - effective, with a recurrence rate of 1.78% , 98.8% of patients had no or low to mild pain and less complication than traditional meshes as seen in table 126.

In a comparative randomized study that evaluates the advantages of ProGrip™ mesh, published by Kingsnorth A. et all in 2010, the preliminary results were reduced operating time low postoperative pain and improved quality of life. The conclusion was that this device makes the inguinal hernia repair simple, fast and economical27.

In an article comparing self-gripping mesh and staple fixation, a prospective study on 96 patients treated laparoscopic for inguinal hernia, from which 49 patients with ProGrip™ mesh and 46 patients with mesh and staple fixation, the authors reported that the use of mesh with atraumatic fixation may be associated with reduced risk of vascular and nerve injury or chronic pain and improved quality of life. Also the procedure decrease tissue trauma and its cost are relatively low28.

Another article published in 2015 that followed at least one year 91 patients with inguinal hernia treated laparoscopic with ProGrip™ mesh concluded that this type of mesh can be safely used, with no recurrence, no chronic pain and improved quality of life29.

CONCLUSIONS

Thanks to its features, ProGrip™ mesh: provide a low or no chronic pain comparing the fixation with tacks, glue or sutures30; has a recurrence rate decreased or similar to other prosthetic materials; provide a good preservation of cord and nerve structures31; is faster than other fixation devices32; is easy to applied; reduce the costs associated with other fixation devices, pain therapy and operation time33.

The use of ProGrip™ self-gripping mesh in inguinal hernia repair, both open and laparoscopic technique, is rapid, safe, simple and cost-effective, providing low or no recurrence, low or no chronic pain and improved quality of life34.

Footnote

8 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

9Value analysis Committee 2013 - Product information kit of COVIDIEN -"ProGrip™ Laparoscopic Self- Fixating Mesh" , www.Covidien.com/Hernia

10Amid PK, Shalman AG, Lichtenstein IL., Open ?tension-free?repair of inguinal hernias: the Lichtenstein technique." Eur J Surg. 1996;162:447-453

11 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

12 Arita A.N. et al, "Laparoscopic repair reduces incidence of surgical site infection for all ventral hernias", Surg. Endosc, 2015; 7:1769-1780

13 Arnab Majumder, et al. "Cell-coating affects tissue integration of synthetic and biologic eshes: comparative analysis of the onlay and underlay mesh positioning in rats", Surg. Endosc., 2016; 30:4445 - 4453

14 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

15 Bresnahan E., Bates A., Wu A., Reiner M. ans Jacob B " The use of self - gripping (Progrip TM) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study", Surg. Endosc., 2015; 29: 2690-2696

16 Bittner R. et all, "Update of guidelines on laparoscopic (TAPP) treatement of inguinal hernia (International Endohernia Society)", Official Jurnal of the Society of American Gastrointestinal and Endoscopic Surgeons, 2015; 289 - 321; Bittner R. et all, " Lightweight mesh and noninvasive fixation: an effective concept for preventuin of chronic pain with laparoscopic hernia repair (TAPP)", Surg. Endosc., 2010; 24: 2958 - 2964; Brown C.N., Finch J.G., "Which mesh for hernia repair?", Ann R Coll Surg Engl., 2010; 92: 272 - 278

17 Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H, Bleichrodt R. "Chronic pain after mesh repair of inguinal hernia: a systematic review.", Am J Surg. 2007; 194:394-400

18 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

19 O'Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers B, Horeyseck G. "Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair.", Br J Surg., 2005; 92:166-70

20 Alicia Mangram, MD, Olakunle F. Oguntodu, MD, MS, Francisco Rodriguez, MD, Roozbeh Rassadi, MD, Michael Haley, MD, Cynthia J. Shively, FNP-BC, RNFA, CNOR,James K. Dzandu, PhD, BSc, "Preperitoneal Surgery Using a Self-Adhesive Mesh for Inguinal Hernia Repair", JSLS, 2014; 18(4): 1-7

21 Koch CA, Greenlee SM, Larson DR, Harrington JR. " Randomizedprospective study of totally extraperitoneal inguinal hernia repair: fixation versus no fixation of mesh. ", JSLS,. 2006;10:457-460

22 Covidien Internal Test Report TEX033-a. Data on File (October 2012), www.Covidien.com/Hernia

23 Miserez M. et all, "Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients", Hernia, 2014; 18: 151-163

24 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

25 Koch CA, Greenlee SM, Larson DR, Harrington JR. " Randomizedprospective study of totally extraperitoneal inguinal hernia repair: fixation versus no fixation of mesh. ", JSLS,. 2006;10:457-460

26 Birk, D. " Self-gripping mesh in laparoscopic inguinal hernia repair. Technique and clinical outcome of 96 operations.", HIS , 2012 P-1654. Covidien sponsored study; Lissidini, G , Piccini, G, et al., "No tacks, no glue, no frustration during TAPP groin hernia repair with ProGrip™ and V-Loc™ 180.", HIS , 2012 FP-1740

27 Kingsnorth A., Nienhuijs S., Schule S., et al., " Preliminary Results of a Comparative Randomized Study: Benefit of Self - Gripping Parietex Progrip™ Mesh in Open Inguinal Hernia Repair", Hernia, 2010; vol 14 Supplement

28 Fumagalli Romario U., Puccetti F., Elmore U., Massaron S., Rosati R., " Self-gripping mesh versus staple fixation in laparoscopic inguinal hernia repair: a prospective comparision", Surg. Endose., 2013; 27: 1798-1802

29 Bresnahan E., Bates A., Wu A., Reiner M. ans Jacob B " The use of self - gripping (Progrip TM) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study", Surg. Endose., 2015; 29: 2690-2696

30 Birk, D. " Self-gripping mesh in laparoscopic inguinal hernia repair. Technique and clinical outcome of 96 operations.", HIS , 2012 P-1654. Covidien sponsored study; Laxa, B, Jacob, B., "An ongoing prospective study evaluating self-gripping mesh (Parietex ProGrip™) without additional fixation during laparosocpic total extraperitoneal (TEP) inguinal hernia repair: initial analysis.", HIS, 2012 P1620. Covidien sponsored study

31 Kolbe, T, Hollinsky, C, Walter, I, Joachim, A, R ? icke T., " Influence of a new self-gripping hernia mesh on male fertility in a rat model.", Surgical Endoscopy, 2010; 24: 455-461

32 Lissidini, G , Piccini, G, et al., "No tacks, no glue, no frustration during TAPP groin hernia repair with ProGrip™ and V-Loc™ 180.", HIS , 2012 FP-1740

33 Edwards, C. "Self-fixating mesh is safe and feasible for laparoscopic inguinal hernia repair.", Surgical Endoscopy and Other Interventional Techniques. Conference: 2011 Scientific Session of the Society of American Gastrointestinal and Endoscopic Surgeons, SAGES San Antonio, TX United States, (30.03.2011 - 02.04.2011). 25: S324

34 Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

References

REFERENCES

1. Value analysis Committee 2013 - Product information kit of COVIDIEN -"ProGrip™ Laparoscopic SelfFixating Mesh" , www.Covidien.com/Hernia

2. Amid PK, Shalman AG, Lichtenstein IL., " Open "tension-free"repair of inguinal hernias: the Lichtenstein technique." Eur J Surg. 1996;162:447-453.

3. Mahmoud Abo Amra, "Outcome of Lichtenstein inguinal hernioplasty with self gripping polyester mesh", International Journal of Multidisciplinary Research and Development , 2017; 4(8):50-57

4. Arita A.N. et al, "Laparoscopic repair reduces incidence of surgical site infection for all ventral hernias", Surg. Endosc, 2015; 7:1769-1780

5. Arnab Majumder, et al. "Cell-coating affects tissue integration of synthetic and biologic eshes: comparative analysis of the onlay and underlay mesh positioning in rats", Surg. Endosc., 2016; 30:4445 - 4453

6. Bresnahan E., Bates A., Wu A., Reiner M. ans Jacob B " The use of self - gripping (Progrip TM) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and longterm outcomes study", Surg. Endosc., 2015; 29: 2690-2696

7. Bittner R. et all, "Update of guidelines on laparoscopic (TAPP) treatement of inguinal hernia (International Endohernia Society)", Official Jurnal of the Society of American Gastrointestinal and Endoscopic Surgeons, 2015;289 - 321

8. Bittner R. et all, " Lightweight mesh and noninvasive fixation: an effective concept for preventuin of chronic pain with laparoscopic hernia repair (TAPP)", Surg. Endosc., 2010; 24: 2958 - 2964

9. Brown C.N., Finch J.G., "Which mesh for hernia repair?", Ann R Coll Surg Engl., 2010; 92: 272 - 278

10. Nienhuijs S, Staal E, Strobbe L, Rosman C, Groenewoud H, Bleichrodt R "Chronic pain after mesh repair of inguinal hernia: a systematic review.", Am J Surg. 2007; 194:394-400

11. O'Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers B, Horeyseck G. "Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair.", Br J Surg, 2005; 92:166-70.

12. Alicia Mangram, MD, Olakunle F. Oguntodu, MD, MS, Francisco Rodriguez, MD, Roozbeh Rassadi, MD, Michael Haley, MD, Cynthia J. Shively, FNP-BC, RNFA, CNOR,James K. Dzandu, PhD, BSc, "Preperitoneal Surgery Using a Self-Adhesive Mesh for Inguinal Hernia Repair", JSLS, 2014; 18(4): 1-7

13. Koch CA, Greenlee SM, Larson DR, Harrington JR. " Randomizedprospective study of totally extraperitoneal inguinal hernia repair: fixation versus no fixation of mesh. ", JSLS,. 2006;10:457-460.

14. Covidien Internal Test Report TEX033-a. Data on File (October 2012), www.Covidien.com/Hernia

15. Miserez M. et all, "Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients", Hernia, 2014; 18: 151-163

16. Birk, D. " Self-gripping mesh in laparoscopic inguinal hernia repair. Technique and clinical outcome of 96 operations.", HIS , 2012 P-1654. Covidien sponsored study.

17. Lissidini, G , Piccini, G, et al., "No tacks, no glue, no frustration during TAPP groin hernia repair with ProGrip™ and V-Loc™ 180.", HIS , 2012 FP-1740.

18. Kingsnorth A., Nienhuijs S., Schule S., et al., " Preliminary Results of a Comparative Randomized Study: Benefit of Self - Gripping Parietex ProgripTM Mesh in Open Inguinal Hernia Repair", Hernia, 2010; vol 14 Supplement

19. Fumagalli Romario U., Puccetti F., Elmore U., Massaron S., Rosati R., " Self-gripping mesh versus staple fixation in laparoscopic inguinal hernia repair: a prospective comparision", Surg. Endosc., 2013; 27: 1798-1802

20. Laxa, B, Jacob, B., "An ongoing prospective study evaluating self-gripping mesh (Parietex ProGrip™) without additional fixation during laparosocpic total extraperitoneal (TEP) inguinal hernia repair: initial analysis.", HIS, 2012 P1620. Covidien sponsored study.

21. Kolbe, T, Hollinsky, C, Walter, I, Joachim, A, R ? icke T., " Influence of a new self-gripping hernia mesh on male fertility in a rat model.", Surgical Endoscopy, 2010; 24: 455-461.

22.Edwards, C. "Self-fixating mesh is safe and feasible for laparoscopic inguinal hernia repair.", Surgical Endoscopy and Other Interventional Techniques. Conference: 2011 Scientific Session of the Society of American Gastrointestinal and Endoscopic Surgeons, SAGES San Antonio, TX United States, (30.03.2011 - 02.04.2011). 25: S324.