Long-Term, Prospective, Multicenter Study of Poly-4-hydroxybutyrate (P4HB) Mesh
A 5-year clinical study by Dr. Roth on the long-term outcomes of bioresorbable Phasix™ Mesh.
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Complex, high-risk hernia cases? No problem.
See how patient quality of life improves post-ventral hernia repair with P4HB—even after 5 years.
Fill out the form below to access the clinical study on Phasix™ Mesh 60-month outcomes.
Download clinical summary
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See why surgeons are talking about Phasix™ Mesh.
"The ability to utilize materials that will be resorbed and still provide us with the result that we want is going to push this methodology and product forward."
–Dr. Alan Thornton* on Phasix™ Mesh and the future of hernia repair.
Supported by 5-year clinical data and proven outcomes.4
Fill out the form below to access this evaluation of clinical and quality of life outcomes summary on P4HB. Get in on the latest hernia repair technology in under 1 minute to advance your hernia repair practice.
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The only hernia scaffold produced through fermentation rather than chemical synthesis.
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See what hernia leaders are saying about Phasix™ Mesh
"Having something like Phasix™ Mesh that I can tell them is as strong but that will ultimately absorb and go away, gives them a huge amount of comfort and confidence."
– Dr. Joe E. Johnson
"I think the ability to utilize materials that will be resorbed and still provide us with the result that we want is going to push this methodology and product forward."
– Dr. Alan Thornton*
"It's challenging some of the things we've always thought about hernia repair. The fact that this mesh is resorbable is important."
– Dr. William Hope*
oriegjioer
Let's have a conversation
Improved healing from the start for better patient care.
Phasix™ Bioresorbable Mesh has the repair strength of a synthetic mesh along with the remodeling characteristics of a biologic graft.
- Degrades within 12 to 18 months
- Over 185,000 implants globally
- More than 35 clinical studies
- More than 950 patients studied
- Supported by 5-year data
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Dr. Joe E. Johnson
Clinic
"Using Phasix has been a huge benefit for me. It's easy to handle in the operating room, it doesn't curl, doesn't de-laminate. Just as strong, if not stronger than synthetic. And then goes away."
Dr. Steven DeMeester
Clinic
"I've had no problems with mesh infection or erosion. I've been very pleased with the handling properties."
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Store Tab
360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation.
360° rotation knob is effectively sized
360° rotation knob is effectively sized
360° rotation knob is effectively sized
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Patients are asking for an absorbable mesh option. Do you have one?
See the benefits of adding bioabsorbable Phasix™ Mesh to your practice—the mesh revolutionizing hernia repair. Access the latest study now.
Download now
REFERENCES
*Paid BD consultant and real Phasix™ Mesh prescriber.
Indications Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists, in patients undergoing abdominal, plastic, and reconstructive surgery in ventral hernia repair and other abdominal fascial defect procedures. Contraindications 1. Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required. Warnings 1. Phasix™ Mesh must not be put in direct contact with the bowel or viscera. 2. The use of any mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh. 3. The manufacture of this device involves exposure to certain antibiotics (as specified in the package insert). The safety and product use for patients with hypersensitivities to these antibiotics is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. 4. The safety and effectiveness of Phasix™ Mesh in the following applications has not been evaluated or established: a. Pregnant or breastfeeding women b. Pediatric use c. Neural and cardiovascular tissue. 5. 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. 6. 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. 7. The mesh is supplied sterile. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black. 8. This mesh has been designed for single use only. Reuse, reprocessing, resterilization, 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 mesh may lead to injury, illness, or death of the patient or end user. 9. If unused Phasix™ Mesh has been in contact with instruments or supplies used on a patient or contaminated with body fluids, handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations to prevent risk of transmission of viral infections. 10. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach. 11. This mesh is not for the use of treatment of stress urinary incontinence. 12. Phasix™ Mesh has not been studied for use in breast reconstructive surgeries. Precautions 1. Please read all instructions prior to use. 2. Only physicians qualified in the appropriate surgical techniques should use this mesh. Users should be familiar with mesh strength and size requirements. Improper selection, placement, positioning, and fixation of the mesh can cause subsequent undesirable results. 3. Clinical data in accordance with EU MDR has not been established for laparoscopic/robotic procedures. 4. The safety and effectiveness of Phasix™ Mesh in the proximity of existing or excised cancer has not been established. Adverse Reactions In preclinical testing, Phasix™ Mesh elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the mesh was resorbed. Possible complications may include, but are not limited to infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect. Please consult product package insert for more detailed safety information and instructions for use.
BD-89934 (5/23)
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