Inguinal hernia repair using a synthetic long-term resorbable mesh: results from a 3-year prospective safety and performance study

Abstract

Purpose

Conventional meshes for hernia repair and abdominal wall reinforcement are usually made from polypropylene, polyester or other synthetic plastic materials known to promote foreign body reactions and a state of chronic inflammation that may lead to long-term complications. A novel approach is to use long-term resorbable implants like TIGR ^® Matrix Surgical Mesh. Preclinical studies have shown that this mesh maintains mechanical integrity beyond the point in time where newly formed tissue is capable of carrying the abdominal loads.

Methods

This was a first-in-man, prospective, pilot study performed during 2009, at two sites in Sweden. Forty patients with primary inguinal hernias were enrolled for Lichtenstein repair using TIGR ^® Matrix Surgical Mesh. The primary endpoint was safety as assessed by monitoring the incidence of adverse events and serious adverse events (SAEs) both related and unrelated to the mesh. The secondary endpoint was pain or discomfort. Visual Analogue Scale (VAS) 0–10 and Inguinal Pain Questionnaire were used for scoring pain and discomfort. Included patients have been followed for 36 months using ultrasound in combination with clinical examination.

Results

All patients followed a normal early postoperative course. After 12 months no SAEs were reported. None of the patients with an isolated lateral inguinal hernia (LIH) had developed a recurrence but 4 (44 %) with medial and 4 (33 %) with combined hernias had recurred at 36-month follow-up. After 3-year follow-up none of the patients with LIH reported pain in the VAS-form and none of those patients could feel the sensation of a mesh in their groin. In the total study population 5 (16 %) patients experienced chronic pain in the form of mild sporadic pain and 3 (9.7 %) patients could feel the sensation of a mesh in their groin.

Conclusion

The use of a synthetic long-term resorbable mesh (TIGR ^® Matrix Surgical Mesh) in Lichtenstein repair was found to be safe, without recurrences, and promising regarding pain/discomfort at 3-year follow-up in patients with LIH. However, patients with medial and combined inguinal hernias had high recurrence rates.