Monofilament mesh

Parietene™ flat sheet mesh

<p>Parietene™ monofilament polypropylene flat sheet mesh is indicated for abdominal wall hernia repair by open or laparoscopic approach.</p>

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Indications, Safety, and WarningsIndicationsParietene™ flat sheet mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repair.Contraindications

As Parietene™ flat sheet mesh will not stretch 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 Parietene™ flat sheet mesh is not appropriate in an infected or contaminated site. Furthermore, these products should be used with the understanding that infection may require removal of the mesh.

Possible complications

The possible complications associated with the use of Parietene™ flat sheet mesh are those typically associated with surgically implantable mesh: acute and chronic pain, allergic reactions to the components of the product, extrusion/erosion, hematoma, infection, inflammation, recurrence and/or seroma.

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.

Any adverse event or serious incident that occurs in relation to the device should be reported to the manufacturer and/or the competent authority of the country in which the patient is established, as applicable per local, federal or national laws and regulations.

Warnings

Do not use the device past the labeled expiration date.

The device is provided in a double sterile packaging. Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if the package is open or damaged or if the integrity of the packaging appears compromised.

Open the last packaging only for the placement of the mesh and handle the mesh using clean sterile gloves and instruments.

The 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.

The mesh is not designed for repair of parastomal hernias.

The mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

For women planning future pregnancies, the surgeon should be aware that this product will not stretch enough as the patient grows.

Do not place the mesh in direct contact with the viscera. Direct contact with the viscera may lead to risks of adhesions, fistula formation and bowel obstruction. Do not implant the mesh in an intraperitoneal position.

The placement of the mesh should assure necessary overlap beyond the margins of the defect, according to surgeon’s practice. When possible, a minimum of 5 cm overlap over the edges of the defect is recommended for ventral hernia repair.

The mesh should not be overly stretched when it is being put in place in order to maintain the elasticity and the porosity of the reinforcement. A moderate and equal tension should be applied in all directions for fixation in order to account for wound shrinkage during the healing process.

Ensure that the mesh is adequately fixated. To avoid injury, exercise caution if fixating the device in the presence of nerves or vessels.

Do not force the mesh through the trocar. Inappropriate insertion may lead to textile damage.

Unused product, explant and packaging may be a potential biohazard. Handle and dispose of them with the necessary precautionary measures in accordance with accepted medical practices and with applicable local, federal or national laws and regulations on disposal of packaging and medical waste.

Features

Parietene™ flat sheet mesh brings the strength of a heavyweight to open and laparoscopic hernia repairs with the following features and benefits:

Low recurrence rate of 0.6% at 1-year follow-up^‡,1
Macroporous structure with multidirectional elasticity³
May be trimmed to size as required^§,4
Able to be introduced through a trocar^◊,1,2,5
Compatible with most suture types on the market^1,6,7

Ordering information

Item number	Size (cm)	Units per box
PP0611X3	11 x 6	3
PP1510X3	15 x 10	3
PP1515	15 x 15	1
PP3030	30 x 30	1

Resources

Parietene™ Flat Sheet Mesh Information Sheet (open in new window)

View to learn more about the features and benefits of Parietene Flat Sheet mesh

PRODUCT PDF 4 MB

Parietene™ flat sheet mesh

Features

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Parietene™ flat sheet mesh

Features

Ordering information

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Customer Care Team