Composite mesh

Parietex™ optimized composite mesh

<p>Parietex™ optimized composite mesh is intended for the reinforcement of abdominal wall soft tissues where a weakness exists.</p>

Ordering information

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Indications, Safety, and WarningsParietex™ optimized composite mesh is intended for the reinforcement of abdominal wall soft tissues where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.Warning

Parietex™ optimized composite mesh is not designed for “bridging” repair technique with the mesh placed in an “inlay” position. The “inlay” repair technique is defined as cutting mesh to the size of the defect, positioning the mesh in the abdominal wall defect and then suturing the edges of the mesh to the edges of the defect. In any case, every effort should be made to close the defect.

Parietex™ optimized composite mesh is not designed for repair of parastomal hernias.

Parietex™ optimized composite mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

The mesh should be used in the form in which it is provided without being cut.

Parietex™ optimized composite mesh with open skirt: Do not use by laparoscopic approach. The device is designed for placement by open surgery only.

Parietex™ optimized composite mesh with open skirt: Ensure that no tissue is trapped between the device and the abdominal wall to avoid bowel entrapment

Adverse effectsThe possible complications associated with the use of Parietex™ optimized composite mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, fistula formation, adhesions, infection, inflammation, acute and chronic pain, bowel obstruction, extrusion/erosion, and/or allergic reactions to the components of the product.

Parietex™ optimized composite mesh with open skirt: Other possible complications inherent to the surgical procedure may occur, including but not limited to: trocar site herniation and organ injury.

The incidence and severity of complications may depend on numerous factors, including but not limited to the type and size of the defect, the mesh fixation, the surgical technique and patient-related factors (e.g., comorbidities). A thorough assessment of each patient’s medical history and condition should be made to determine the suitability for implantation of this device. The treatment of complications may require one or more revision surgeries, that may not necessarily resolve the complications and may pose risks of subsequent complications.

Being a permanent implant designed to integrate into tissues, significant dissection may be required in case it needs to be removed, in part or in whole. It is important that patients are given complete information regarding possible complications.

Contraindications

As Parietex™ optimized composite mesh will not stretch enough to accommodate growth, its use is not appropriate in patients in a period of growth or pregnancy.

Any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of Parietex™ optimized composite mesh is not appropriate in an infected or contaminated site. Furthermore, this product should be used with the understanding that infection may require removal of the mesh.

Please refer to the instructions for use for complete contraindication and risk information.

Frequently asked questions

The mesh should be used in the form in which it is provided without being cut.

Parietex™ optimized composite mesh should be hydrated in its original blister before being handled. This is carried out by immersing it completely in a sterile saline solution for several seconds to ensure its conformability and flexibility.

Yes, sutures are necessary. The technique used to anchor the mesh (suture and/or tack) is left up to the surgeon.

Ordering information

With preplaced sutures

Item number	Diameter (cm)	Shape	Units per box
PCO9FX	9	Circular	1
PCO12FX	12	Circular	1
PCO15FX	15	Circular	1
PCO20FX	20	Circular	1
PCO1510FX	15 × 10	Rectangular	1
PCO2015FX	20 × 15	Rectangular	1
PCO2520FX	25 × 20	Rectangular	1
PCO3020FX	30 × 20	Rectangular	1

Without preplaced sutures

Item number	Diameter (cm)	Shape	Units per box
PCO9X	9	Circular	1
PCO12X	12	Circular	1
PCO15X	15	Circular	1
PCO20X	20	Circular	1
PCO1510X	15 × 10	Rectangular	1
PCO2015X	20 × 15	Rectangular	1
PCO2520X	25 × 20	Rectangular	1
PCO3020X	30 × 20	Rectangular	1

With open skirt

Item number	Diameter (cm)	Shape	Units per box
PCO1510OSX	15 × 10	Rectangular	1
PCO2015OSX	20 × 15	Rectangular	1
PCO2520OSX	25 × 20	Rectangular	1
PCO3020OSX	30 × 20	Rectangular	1
PCO8OSX	37 × 28	Circular	1

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† Based on preclinical animal and benchtop studies. Animal Preclinical data and benchtop studies are not necessarily indicative of human clinical performance. Minimization of visceral adhesions are indirectly assessed in clinical data by the low rates of adhesion complications.

1. Based on internal test report 1003CR053, Comparative study of textile tear and suture strength: Parietex™ optimized composite vs. Parietex™ composite. April 2011.

2. Based on internal test report 108515, Evaluation of the local tissue effects and tissue attachment minimization in a rat caecal adhesion model — BioMatech (NAMSA). February 2011.

3. Based on internal test report 162750, Evaluating local tissue effects, tissue integration and minimizing tissue attachment performance of Symbotex™ composite mesh vs. Parietex™ optimized composite mesh. May 2013.

4. Based on internal report, Club Hernie registry extraction Parietex™ optimized composite mesh (Medtronic). November 2020.

Parietex™ optimized composite mesh

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