Surgical hernia mesh

ThinLight	MacroPore	MacroPore with orienting lines
Class IIB

ThinLight	MacroPore
60-85 g/m2	60-85 g/m2

PRODUCT CHARACTERISTICS 

Optomesh® non-resorbable surgical mesh products are knitted of transparent and blue monofilament polypropylene yarn using the knitting technique. They are designed for use in abdominal hernias.

The product is offered in two variants:

• MACROPORE – lightweight mesh with macro pores;
• THINLIGHT – thin lightweight mesh of standard pore size.

Optomesh® mesh implants are available in a full range of sizes. The products do not contain substances of allogenic and zoonotic origin.

The MACROPORE variant has blue orienting lines facilitating the visibility and to positioning of the product in the operating field.

INDICATIONS

Optomesh® surgical meshes are recommended for reconstructive procedures in order to strengthen places with soft tissue defect in the case of abdominal hernias i.e.:

• primary and recurrent,
• incisional hernias,
• inguinal and femoral hernias,
• umbilical hernias,
• with large gates.

Depending on the hernia type and the applied surgical method the right type of surgical mesh can be chosen as for the surgeon’s preferences, nature of reconstruction and applicable medical standards.

CONTRAINDICATIONS 

Optomesh® should not be used in infected wounds or susceptible to infection and in conditions where it is not possible to maintain strict surgical asepsis. The Optomesh® product is also not recommended in the case of the patient’s allergy/sensitivity to the product material (polypropylene). 

Optomesh® should not be used in children, women planning pregnancy, pregnant women, and where the process of physiological growth restricts the use of mesh products. It is not recommended to implant Optomesh® in direct contact with internal organs due to the possibility of causing adhesions, fistulas or intestinal obstruction. Do not use the product if there is doubt about its sterility (e.g. soaking, cracked / damaged paper-film packaging, product discolouration).

PRECAUTIONS

1. Optomesh® is designed for use by qualified and trained medical personnel.
2. In order to ensure strict surgical asepsis during the procedure, it is advisable to use special precautions (use of personal protective equipment, sterilisation of instruments, keeping high personal hygiene) and extraordinary attention while preparing the direct intervention site of the surgeon.
3. Optomesh® should only be used in non-infected wounds, and in conditions where it is possible to maintain strict surgical asepsis.
4. Avoid direct contact of the mesh with internal organs.
5. Do not implant the Optomesh® surgical meshes after the expiration date.
6. Optomesh® polypropylene surgical meshes are offered for sale only in a sterile version. The product cannot be re-sterilised.
7. Product for single use only.
8. Do not use the product if it is damaged, with structural defects or contaminated.

FIXATION

For fixing the Optomesh® mesh the use of surgical sutures, tackers (surgical screw-like tacks), tissue adhesive or staplers (surgical staples) is recommended. Absorbable fixing materials are also allowed. The size of the mesh and distance between the fixing places should be selected according to surgeon preferences, the nature of reconstruction and medical standards. It is allowed to cut the implant during a surgery to fit into the cavity. Using the fasteners the implant should be placed to closely adhere to the adjacent tissue. In order to prevent the recurrence of hernia, it is recommended to place the fixing elements at least approx. 1 cm from the edge of the product.

POSSIBLE COMPLICATIONS

The product application may cause the following complications: exudation of blood and serous fluid, infections, pain, discomfort in the wound, hematomas, bruises, recurrence of hernia, intestinal growth (formation of fistulas, adhesions, obstruction).

Diagnosed wound infections should be treated in the fastest possible way using available pharmacological methods. In case of severe and chronic infection, the possibility of partial resection of the infected tissue and/or the mesh should be considered. If there is no progress in the treatment of the infection, complete removal of the implant should be considered. The use of surgical tackers and staplers can cause chronic pain resulting from nerve compression. These complications can lead to a prolonged treatment process, chronic pain, hernia recurrence, repeated surgical interventions or, in extreme cases, implant removal.

The use of a product that is non sterile, damaged or re-used can lead to the above-mentioned complications or serious health damage and patient’s life threat.

STERILISATION PROCESS

Sterilisation is carried out by means of ethylene oxide (EO) in a validated process.

The product maintains its sterility within a specified validity period, kept only in the original packaging at maintaining appropriate storage conditions.

STORAGE CONDITIONS

Optomesh®  should be stored:

• in dark rooms at humidity 25 – 65%,
• at temperature range 15-35^oC,
• under conditions eliminating wetting and mechanical damage or chemical contamination,
• in the original unit packaging (box and direct packaging). Any mechanical damages to the packaging can expose the product to the loss of sterility.