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4DDome

Semi-resorbable parietal reinforcement implant

Partially resorbable plug & patch system for open treatment of inguinal hernias.

4DDome is a partially resorbable plug & patch implant for open inguinal hernia repair. The system combines a PP/PLLA composite dome to fill the hernial canal with an anterior mesh for superficial reinforcement of the inguinal region. The objective is tension-free repair with a limited amount of permanent material.

Composition: composite macroporous monofilament mesh in polypropylene (PP) and poly-L-lactic acid (PLLA)

4DDome et fer
More information Instructions for use

Clinical benefits

Partially resorbable PP/PLLA composite implant: reduces the amount of permanent material compared to conventional plugs

  • Plug & patch concept: the combination of the dome and anterior reinforcement allows tension-free repair of the hernial canal and inguinal region
  • Standardized and reproducible technique: clear positioning of the dome in the hernial ring and flat coverage by the patch
  • Low migration tendency: the dome concept and the surface of the anterior implant stabilize the reconstruction
  • Different sizes: adaptation to the defect diameter and patient anatomy
  • Compatible with already established plug & patch techniques.

4DDome consists of a PP/PLLA composite dome (plug) and a flat implant (patch), both partially resorbable. The dome is positioned in the hernial neck to reinforce the deep ring, while the anterior implant reinforces the inguinal region at the surface. The PLLA provides additional stability during the healing phase, then is progressively resorbed; a lightweight polypropylene mesh remains that provides long-term mechanical “safety” to prevent recurrence.

4DDome is specifically indicated for open repair of inguinal hernias (and, in certain cases, femoral hernias) using a plug & patch technique. The dome is positioned in the hernial neck while the flat anterior implant reinforces the inguinal region extraperitoneally. The system is particularly intended for centers where the plug technique is well established and where a partially resorbable alternative to fully permanent plugs is desired.

With 4DDome, the dome is introduced and centered in the hernial neck, before placement of the flat reinforcement on the anterior inguinal region. The dome diameter is selected according to that of the hernial ring; the flat reinforcement can be adjusted by cutting to obtain sufficient overlap. Fixation is generally performed by sutures or staples, in accordance with established plug & patch techniques.

4DDome has been the subject of several clinical studies and a long history of use in open inguinal hernia surgery. Prospective series and randomized trials versus other plug systems show good results in terms of recurrence rate, complications, and chronic pain. The combination of a partially resorbable PP/PLLA composite and a plug & patch technique is described as a safe and effective option for elective inguinal hernia repair. Registry data from Club Hernie confirm these results in routine practice.[1–5]

[1] Leroy JL et al. Hernia. 2006;10(5):401‑408.
[2] Mutter D et al. Surg Technol Int. 2010;19:105‑110.
[3] Mutter D et al. Hernia. 2012;16(5):561‑566.
[4] Simone M et al. J Surg Surgical Res. 2016;2(1):43‑47.
[5] Club Hernie Registry – comparative study 4DDome® vs competing prostheses, 2023.

Material: partially resorbable PP/PLLA composite (PLLA portion resorbable, PP permanent)

  • Structure: dome (plug) for intracanal reinforcement (up to 90% resorbable) + flat mesh (patch) for extraperitoneal coverage of the inguinal region (up to 75% resorbable)
  • Design: macro-porous mesh with shape memory for reproducible plug & patch positioning
  • Application: open repair of inguinal hernias (and certain femoral hernias) using plug & patch technique
  • Sizes: different dome diameters and associated mesh dimensions to adapt to the hernial ring diameter and anatomy.

Resources

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Retrospective Study of 710 Patients Treated with 4DDome® Mesh: A New Chance for Open Inguinal Hernia Repair

Expanded Clinical Experience with 4DDome® Composite Prosthesis In Elective Open Inguinal Herniorrhaphy

Expanded Clinical Experience with 4DDome® Composite Prosthesis In Elective Open Inguinal Herniorrhaphy

4DDOME – Product Sheet – French

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4DDome is a class III medical device, manufactured by COUSIN BIOTECH S.A.S. Its CE conformity assessment was performed by the notified body DQS MED (CE0297). The quality system of COUSIN BIOTECH S.A.S has been certified compliant with the requirements of ISO 13485 standard.

Recommendations for use: Carefully read the labeling, instructions for use, and surgical technique before any intervention.

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