SERAMESH® delivery programme Version 11/2019
Instructions for use SERAMESH®/SERATOM®/SERATIM®/SERASIS®/SERATEX®/SERAGYN® Version 2020-05 – CE090017
The risks that may be encountered even with the correct use of the product are given in the Instructions for Use.
Two separate components for an individual adaptation
In the laparoscopic procedure, the overly wide opening between the two sides of the diaphragm is narrowed with appropriately placed sutures. To reinforce the muscle tissue, the two components of the SERAMESH® PA DRUM implant are placed circumferentially around the new opening. The pliable mesh consists of two parts, which each has a semi-circular cut-out. These two mesh components are inserted one after the other into the body with their cut-outs individually positioned tighter or more loosely around the oesophagus.
Strong but gentle
The semi-circular cut-outs of the two mesh components have a reinforced edging. This means that the area where the greatest stability is required is strengthened by not one but three layers of mesh. At the same time, the edging technique envelops the edges of the mesh, ensuring that no rigid/hard thread ends protrude into this sensitive area.
SERAMESH® PA DRUM is a partially absorbable mesh with an initial mass per unit area of approx. 85 g/m², which reduces to approx. 28 g/m² following partial absorption. Thus, there is a sufficiently firm mesh augmentation at the beginning, while only about 1/3 of the original material remains in the body after 90 – 120 days. However, this partial absorption does not change the construction of the mesh: the mesh remains supple and sufficiently strong to stabilise the defect.
Well thought-out details
Each mesh has two sides: a rough and a smooth. The rough side should be applied to the diaphragm, as the experience of our development partner shows that this side adheres better/more easily. For easy recognition of the rough side during surgery, the two mesh components have been furnished with small rectangular tabs. If the mesh components are positioned as shown in the diagram, the rough side automatically comes to rest against the diaphragm.
After closure of the hiatus with sutures, the V-shaped mesh component is inserted behind the oesophagus (retro-oesophageal, see diagram) with the orientation tab lateral and pointing upwards to the left (anatomically speaking, to the right). Thanks to its hydrophilic surface, the mesh adheres to the diaphragm by itself and is fixed in place with tissue glue. The U-shaped implant is then brought into position in front of the oesophagus (see diagram) with the orientation tab lateral and pointing downwards to the right (anatomically speaking, to the left). The two parts of the mesh then overlap. The U-shaped implant is also glued into place. The pore size and the nature of its surface give SERAMESH® PA DRUM exceptional adhesive properties, so that no additional suturing is required.
Safety and security for the patient
SERAMESH® PA DRUM reinforces the tissues right where it is needed. It is available in two sizes, so that all common defects – even intrathoracic stomachs – can be treated safely and securely.