Images of the ProGrip™ advanced self-gripping polypropylene mesh product and in-use.

ADG2015

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ProGrip™ advanced self-gripping polypropylene mesh is made for use in ventral hernia repair using either laparoscopic or robotic-assisted surgical techniques.

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Indications, Safety, and WarningsIndicationsProGrip™ advanced self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissues where weakness exists. It is indicated for use in the extraperitoneal space during ventral hernia repair procedures, utilizing either conventional laparoscopic or robotic-assisted surgical techniques.Contraindications

As ProGrip™ advanced self-gripping polypropylene 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 ProGrip™ advanced self-gripping polypropylene 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.

The collagen-based film is not intended to minimize tissue attachment, and thus this product cannot be used intraperitoneally.

Warnings

Do not use the device past the labeled expiration date.

The device is provided in 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.

Only open the packaging when ready to place the mesh. Handle the mesh using clean, sterile gloves and instruments.

ProGrip™ advanced self-gripping polypropylene mesh is not designed for “bridging” repair technique. Every effort should be made to close the defect. The safety and efficacy of the mesh have not been established when the mesh is used in a case in which the defect is not closed.

ProGrip™ advanced self-gripping polypropylene mesh is not designed for repair of parastomal hernias.

ProGrip™ advanced self-gripping polypropylene mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

ProGrip™ advanced self-gripping polypropylene mesh is not intended for repair of chest wall defects.

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.

When implanting in a preperitoneal site, the mesh shall be placed with the grips towards the muscle/ fascia with the mesh completely covered with peritoneum. The self-gripping side of the mesh can be differentiated from the continuous collagen-based film side visually or through tactile feel.

The safety and effectiveness of the mesh positioned in the onlay space have not been established.

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

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

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.

The placement of the mesh should ensure necessary overlap beyond the margins of the defect according to the surgeon’s judgment and practice.

Do not force the mesh through the trocar. Inappropriate insertion may lead to textile and/or grips damage.

If the mesh is trimmed, the marking may no longer be centered and lose its functions.

The package contains a desiccant. The desiccant is neither intended to be used in combination with the device nor during the surgery.

Unused product, explant, and packaging may be a potential biohazard. Handle and dispose them with the necessary precautionary measures in accordance with accepted medical practices and with applicable local, state, and federal laws and regulations on disposal of packaging and medical waste. Unused portions of the mesh should be discarded. If unused mesh has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard mesh with care to prevent risk of transmission of viral and other infection

ADG2015

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Not what you're looking for?

United States

Customer Care Team

ADG2015

progrip-advanced-mesh-2015-corner-fold-prod