This product can expose you to Rifampin and Minocycline HCL, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
An umbilical hernia repair solution designed for ventral, incisional, umbilical and epigastric hernia repair as well as trocar site closure, with an absorbable barrier featuring Sepra® technology.
With over 1.5 million implanted globally,
the patch is designed for open hernia repair, combining permanent polypropylene mesh with a resorbable hydrogel barrier based on Sepra® Technology.
Ideal for herniation into a trocar site, along with Richter’s hernias. The smallest Ventralex™ ST Hernia Patch allows for an intraabdominal, tension-free repair with no transfascial suturing.
4.3 cm, 6.4 cm, and 8 cm sizes available
Supports long-term hernia repair with low risk of recurrence.
With over 40 years in hernia repair monofilament polypropylene mesh allows for tissue ingrowth leading to a strong repair
Demonstrated strong and durable results
Polydioxanone (PDO) monofilament is unique in its flexibility and tensile strength, facilitating patch insertion and placement. Preclinical testing has demonstrated that absorption via hydrolysis is essentially complete in 6-8 months.4
Pocket and strap facilitate placement, positioning and lateral fixation. SorbaFlex™ Memory Technology is contained within a knitted polypropylene mesh tube.
Posterior layer of the hernia patch
The Sepramesh™ IP Composite layer of Ventralex™ ST incorporates a hydrogel barrier based on Sepra® Technology, an extensively studied barrier that has been used clinically since 2006. It provides visceral protection during the critical healing period and then resorbs within 30 days.
Bioresorbable PGA fibers reinforce the integrity of the hydrogel barrier by binding it to the polypropylene mesh.
120-Day Comparative Analysis of Adhesion Grade and Quantity, Mesh Contraction, and Tissue Response to a Novel Omega-3 Fatty Acid Bioresorbable Barrier Macroporous Mesh After Intraperitoneal Placement.
The Ventralex™ ST Hernia Patch Advantage
Clinical Summary “Ventralex™ ST Hernia Patch Repair for Small Umbilical Hernia Safety and Effectiveness Outcomes” (Journal of Abdominal Wall Surgery, 2023)6
488 adult patients underwent primary umbilical hernia repair using the Ventralex™ ST Hernia Patch between 2014–2018.
Highlights
“Umbilical hernia repair using a Ventralex™ ST hernia patch placed in the preperitoneal space showed acceptable results in terms of recurrence and re‑operations.”
“The hernia recurrence rate was 2.5% during long‑term follow‑up, with low major complication and surgical site infection rates.”
“Ventralex™ ST hernia patch repair demonstrated safe and effective outcomes for small primary umbilical hernias.”
Ventralex™ ST Hernia Patch Compared to Parietex™ Ventral Patch
Parietex™ Ventral Patch is porcine based mesh, and at 4 weeks, the collagen film is totally degraded. It has two removal handles composed of colored tubes and yarns and four flaps (one at each corner of the device) made up of bidimensional monofilament polyester. It also has two dyed PGLA poly (glycolide-co-L-lactide) expanders. The PGLA component is completely absorbed prior to one year. 7,8
Ventralex™ ST’s hydrogel barrier based on Sepra® Technology swells over 60% more than Parietex™ Composite barrier.9
Additionally uncoated monofilament polypropylene allows for the majority of tissue ingrowth and strength to occur within the first two weeks after placement of a composite hernia prosthesis.
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INDICATIONS.
The Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.
CONTRAINDICATIONS.
Do not use this mesh in infants, children, or pregnant women, whereby future growth may be compromised by the use of such mesh materials. 2. The use of this mesh has not been studied in breastfeeding or pregnant women. 3. Do not use this mesh for the reconstruction of cardiovascular defects. 4. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.
WARNINGS.
The use of any permanent mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh. 2. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require the removal of the mesh. 3. If the unused mesh has been in contact with instruments or supplies used on a patient or contaminated with bodily fluids, discard with care to prevent the risk of transmission of viral infections. 4. To prevent recurrences when repairing hernias, the mesh should be sized with appropriate overlap for the size and location of the defect, taking into consideration any additional clinical factors applicable to the patient. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. 5. This mesh is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. 6. This mesh has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the mesh and may lead to mesh failure which may result in injury to the patient. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the mesh and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. 7. This mesh should be used once the exterior foil pouch has been opened. Do not store for later use. Unused portions of the mesh should be discarded. 8. Ensure proper orientation; the bioresorbable coated side of the mesh should be oriented against the bowel or sensitive organs. Do not place the polypropylene side against the bowel. There may be a possibility for adhesion formation when the mesh is placed in direct contact with the bowel or viscera. 9. Do not cut or reshape any portion of the Ventralex™ ST Hernia Patch, except for the polypropylene positioning strap, as this could impact its effectiveness. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include but are not limited to, bowel or skin perforation and infection. 10. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may potentially compromise the SorbaFlex™ PDO monofilament. 11. To ensure a strong repair, the mesh should be secured with tacks or sutures through the polypropylene mesh straps or positioning pocket. 12. Excess positioning strap material above the fixation line must be cut off and discarded to eliminate excess material from remaining in the body. 13. When used to repair deficiencies caused by trocars, the mesh should be used under endoscopic guidance or direct visualization. 14. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach. 15. This mesh is not for the use of treatment of stress urinary incontinence.
PRECAUTIONS.
Please read all instructions prior to use. 2. Only physicians qualified in the appropriate surgical techniques should use this mesh. 3. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament during fixation. 4. The safety and effectiveness of Ventralex™ ST Hernia Patch has not been evaluated in clinical studies in the presence of malignancies in the abdominopelvic cavity.
ADVERSE REACTIONS.
Possible complications may include, but are not limited to, seroma, adhesions, hematomas, pain (including chronic pain), inflammation, infection, foreign body reaction, fibrosis, erythema, implant migration and/or erosion, extrusion, fistula formation, allergic reaction, and recurrence of the hernia or soft tissue defect. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult package insert for more detailed safety information and instructions for use.
