Hernia meshes

Optomesh® STOMA - features

Optomesh® STOMA

Surgical mesh for parastomal hernia repair

Class IIB

PRODUCT CHARACTERISTICS 

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

The assortment list contains one mesh size (195 mm x 195 mm), but the dimensions may be modified by the doctor during implantation in order to adjust the shape to the individual patient’s anatomy.

Optomesh® STOMA does not contain any substances of allogenic or animal origin. The applied blue orienting lines along the product facilitate visibility and positioning the product in the operating field.

INDICATIONS

Optomesh® STOMA surgical meshes are intended for use during the surgical treatment of the causal or preventive occurrence of parastomal hernias. The most common indications for surgical treatment of hernias are: obstruction of intestinal passage, large hernia size, pain and discomfort while moving, chronic inflammatory changes around the stoma, entrapment episodes, and cosmetic considerations.

CONTRAINDICATIONS 

Optomesh® STOMA 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® STOMA product is also not recommended in the case of the patient’s allergy/sensitivity to the product material (polypropylene). 

Optomesh® STOMA 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® STOMA 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 unit packaging, product discolouration).

PRECAUTIONS

  1. Optomesh® STOMA 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® STOMA should only be used in non-infected wounds, and in conditions where it is possible to maintain strict surgical asepsis.
  4. Do not implant the Optomesh® STOMA surgical meshes after the expiration date.
  5. Optomesh® STOMA polypropylene surgical meshes are offered for sale only in a sterile version. The product cannot be re-sterilised.
  6. Product for single use only.
  7. It is not allowed to use a damaged, dirty or defective product (increased tightness of the knitted fabric at the funnel does not constitute a product defect).

FIXATION

For fixing the Optomesh® STOMA 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 use of the product may cause the following complications: exudation of blood or serous fluid, infections, pain, discomfort in the wound, haematomas, bruises, recurrence of hernias, intestinal growth, formation of fistulas, adhesions, intestinal obstruction, stoma prolapse/collapse, peristomal fistula, lack of mucocutaneous adhesion, occurrence of a peristomal abscess.

Diagnosed postoperative wound infections should be treated as soon as possible using available pharmacological methods. If severe and chronic infection is found, the possibility of partial resection of the infected tissue and/or the mesh should be considered. If no progress is made in the treatment of the infection, the need for complete removal of the implant should be considered. The use of surgical tackers and staplers can cause chronic pain due to compression of the nerves. These complications may cause a prolonged treatment process, chronic pain, recurrence of hernia, repeated surgical intervention or, in extreme cases, removal of the implant. 

The use of a non sterile, damaged device and its re-use may result in the above-mentioned complications or serious damage to the health and life of the patient.

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® STOMA should be stored:

  • in dark rooms at humidity 25-65%,
  • at temperature range 15-35oC,
  • 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.

Contact

TZMO SA
ul. Żółkiewskiego 20/26
87-100 Toruń
POLAND
Tel. +48 56 6123395

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