PROCEED Surgical Mesh Discussion Guide

Transcription

1 PROCEED Surgical Mesh Discussion Guide Create an IPOM mesh optimized for strength and performance Color sticky note represents customer insight.

2 Table of Contents Click on the question below to jump to the page. Product Materials What is PROCEED Surgical Mesh? Which materials are used to make PROCEED Mesh? What are the roles of the different sides of the mesh? What is the purpose of the PDS film? How does ORC work? What happens to PROCEED Mesh once it is implanted? How does peritoneal healing occur? How does temperature affect PROCEED Mesh? What are the physical specifications of the mesh? How should the mesh be oriented? Usage and Procedure Information In which procedures is PROCEED Mesh used? Is there a recommended direction that the mesh should be placed? Are there any techniques to assist in orienting the mesh? Are there any techniques to help position and secure the mesh during laparoscopic repair? How should PROCEED Mesh be fixated to the abdominal wall? Do you need to use nonabsorbable sutures for positioning and fixating the mesh? How should PROCEED Mesh be handled? Can you sew two pieces of PROCEED Mesh together? Can the device be used in a bloody field? Can PROCEED Mesh be used in infected cases? Key Messages What are the key marketing messages for PROCEED Mesh? Does this fit with the macroporous partially absorbable mesh (MPPAM) philosophy? Ordering Information What are the ordering codes, sizes, and shapes? Through which distribution channels can customers order the device? Is the product available on contract, independent, or through GPOs? Can the device be returned? What is the shelf life?

3 PRODUCT MATERIALS USAGE & PROCEDURE INFORMATION KEY MESSAGES ORDERING INFORMATION Product Materials Q: What is PROCEED Surgical Mesh? A: A macroporous, partially absorbable, tissue-separating mesh that can be used for open and laparoscopic intra-abdominal ventral hernia repair 1 Q: Which materials are used to make PROCEED Mesh? A: Four layers from parietal to visceral side 1 : 1. PDS (polydioxanone) Suture polymer film 2. PROLENE Soft Polypropylene Mesh 3. PDS (polydioxanone) Suture polymer film 4. Oxidized regenerated cellulose (ORC) knitted fabric Q: What are the roles of the different sides of the mesh? A: The nonabsorbable polypropylene mesh side (parietal, as indicated by the blue stripes) allows for tissue ingrowth, while the ORC side (visceral) provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during wound healing, to minimize tissue attachment to the mesh. 1 Q: What is the purpose of the PDS film? A: The PDS film creates a flexible, secure bond between the polypropylene mesh and ORC. It is absorbed within 6 months. 1 Q: How does ORC work? A: ORC is a plant-based material that forms a continuous gel, physically separating the mesh from underlying viscera. ORC is broken down by hydrolysis into carbon dioxide and water, and absorbed within 4 weeks. Minimal visceral attachment has been demonstrated in animal studies that show reduction in the extent and severity of adhesions to the mesh. 1,2* Q: What happens to PROCEED Mesh once it is implanted? A: At the following approximate time periods 1-3* Day 1: The ORC forms a continuous gel that physically separates the mesh from visceral surfaces By Day 28: The ORC is almost completely absorbed, and the PDS film is in the process of breaking down By Day 119: The ORC is completely absorbed, PDS absorption is nearly complete, and the remaining polypropylene mesh is surrounded by fibroblasts Q: How does peritoneal healing occur? A: Publications on this subject indicate that on 2,4,5 Day 3: Mesothelial cells begin to cover the wound surface and mesh Day 5: Fibroblast ingrowth of the mesh is apparent; macrophages are present Day 7: Mesothelial layer becomes completely reconstituted; entire mesh covered by early neoperitoneum Day 14: Mesh filaments completely integrated with abdominal wall; mesh covered by mature neoperitoneum Q: How does temperature affect PROCEED Mesh? A: The IFU states that it should be stored at or below 25 C 1 Q: What are the physical specifications of the mesh? A: Pore size (pre-absorption) 6 = Vertical: 3.5 mm; horizontal: 2.5 mm Average filament size 7 = 3.5 mil (polypropylene) Weight (post-absorption) 7,8 = 44 g/m 2 Mullen burst strength (post-absorption) 7,8 = 98 psi Parietal Side Visceral Side PDS Suture polymer film PROLENE Soft Mesh PDS Suture polymer film Oxidized regenerated cellulose (ORC) Q: How should the mesh be oriented? A: The blue stripes can be oriented in any direction, as long as the side with the blue stripes is placed adjacent to those tissues where tissue ingrowth is desired. 1,6,9 *Based on animal studies

4 PRODUCT MATERIALS USAGE AND PROCEDURE INFORMATION KEY MESSAGES ORDERING INFORMATION Usage and Procedure Information Q: In which procedures is PROCEED Surgical Mesh used? A: PROCEED Mesh can be used for open or laparoscopic intraperitoneal/intra-abdominal ventral hernia repair. 1 Q: Is there a recommended direction that the mesh should be placed? A: Correct surface orientation is critical for PROCEED Mesh to function as intended. The polypropylene mesh side (side with the blue stripes) should be placed adjacent to those tissues where tissue ingrowth is desired. The other surface, the ORC side, should be placed adjacent to those tissues where minimal tissue attachment is desired (i.e., visceral surfaces). 1 The polypropylene side, which has the blue stripes, should be placed adjacent to tissues where tissue ingrowth is desired. Q: Are there any techniques to assist in orienting the mesh? A: The surgeon can write and make markings on the mesh. The surgeon can also cut a notch out of the mesh and draw on the body where the notch should be, ensuring there is adequate overlay. Q: Are there any techniques to help position and secure the mesh during laparoscopic repair? A: Some surgeons roll it up on both sides like a scroll before inserting through the trocar. Please refer to the PROCEED Scroll Technique document for detailed instructions. Q: How should PROCEED Mesh be fixated to the abdominal wall? A: To avoid dislodging, crinkling or curling of the edges, adequate mesh fixation is required to minimize post-operative complications and recurrence. The fixation technique, method and products used should follow the current standard of care. Careful attention to fixation and spacing will help prevent excessive tension or disruption between the mesh materials and connective tissue. It is recommended that points of fixation be placed 6.5 mm to 12.5 mm (1/4" to 1/2") apart, at a distance approximately 6.5 mm (1/4") from the edge of the mesh. 1 Q: Do you need to use nonabsorbable sutures for positioning and fixating the mesh? A: It is surgeon preference what suture to use. Q: How should PROCEED Mesh be handled? A: Follow the Instructions for Use, including 1 : Mesh should be shaped using sharp cutting instrumentation and in such a way that sufficient overlap of the fascial defect on all sides is achieved When cutting or shaping, use caution to avoid damaging the mesh. Do not use mesh if edges appear frayed or separated Do not soak or stretch the mesh Safety and effectiveness of PROCEED Mesh in combination with solutions other than saline (such as peritoneal instillates, and/or medications) have not been studied Q: Can you sew two pieces of PROCEED Mesh together? A: Suturing mesh together can create a weak area that may lead to a recurrent hernia. Q: Can the device be used in a bloody field? A: PROCEED Mesh has an ORC component that should not be used in the presence of uncontrolled and/or active bleeding, as fibrinous exudates may increase the chance of adhesion formation. As in any surgical procedure, hemostasis should be verified prior to closing the patient. In addition, if hemostasis is not achieved on the abdominal wall prior to placing the mesh, it will be very difficult to achieve it after placing the mesh. As fibrin is an early component of adhesions, most investigators in the area of adhesions believe that blood should be meticulously cleared from the abdomen if adhesions are to be minimized. 1 Q: Can PROCEED Mesh be used in infected cases? A: In animal studies, PROCEED Mesh did not potentiate infections. However, it is recommended that the device not be used following planned intraoperative or accidental opening of the gastrointestinal tract. If the mesh is used in a contaminated field, contamination of the mesh may lead to infection that may require removal of the mesh. 1

5 PRODUCT MATERIALS USAGE AND PROCEDURE INFORMATION KEY MESSAGES ORDERING INFORMATION Key Messages Q: What are the key marketing messages for PROCEED Surgical Mesh? A: Trusted by surgeons for over 10 years A: Optimized for strength and performance PROCEED Mesh gives surgeons the reassurance of strong tissue incorporation 2,10 * A: Macroporous design and partially absorbable tissue-separating barrier are designed to support safe and comfortable healing 2,11-13 In a study from the International Hernia Mesh Registry (IHMR), patients receiving open hernia repair with PROCEED Mesh reported significant improvement in pain and movement limitations from baseline at 12 months postsurgery 11 Results from a laparoscopic ventral hernia repair study showed low rates of complications (infection, 0%; pain, 4.7%) and hernia recurrence (5.7%) at 2-year follow-up 13 Q: Does this fit with the macroporous partially absorbable mesh (MPPAM) philosophy? A: Yes MP (macroporous) pore size (pre-absorption) 6 = Vertical: 3.5 mm; horizontal: 2.5 mm PA (partially absorbable) PDS (polydioxanone) Suture polymer film is fully absorbed in 6 months, and ORC is fully absorbed within 4 weeks 1 M (mesh) made from permanent PROLENE Soft Polypropylene Mesh 1 *Shown in a preclinical study Data from a prospective, longitudinal study of 82 patients receiving open hernia repair using PROCEED Mesh from the IHMR; 95.1% ventral hernias, 4.9% umbilical hernias; mesh placement: preperitoneal (n=40), intraperitoneal (n=40), retrorectus (n=1), onlay (n=1) Data from a multicenter prospective observational cohort study of 210 patients undergoing primary laparoscopic ventral hernia repair (n=97) or incisional hernia repair using intra-abdominal placement of PROCEED Mesh

6 PRODUCT MATERIALS USAGE AND PROCEDURE INFORMATION KEY MESSAGES ORDERING INFORMATION Ordering Information Q. What are the ordering codes, sizes, and shapes? Ordering Code Mesh Size Shape How Supplied PCDB1 5 cm x 10 cm Rectangle Sterile, 1 per box PCDR1 7.5 cm x 15 cm Rectangle Sterile, 1 per box PCDN1 10 cm x 15 cm Oval Sterile, 1 per box PCDM1 15 cm x 15 cm Square Sterile, 1 per box PCDD1 10 cm x 20 cm Rectangle Sterile, 1 per box PCDG1 15 cm x 20 cm Oval Sterile, 1 per box PCDH1 20 cm x 25 cm Oval Sterile, 1 per box PCDJ1 20 cm x 30 cm Rectangle Sterile, 1 per box PCDT1 26 cm x 34 cm Oval Sterile, 1 per box PCDW1 25 cm x 35.5 cm Rectangle Sterile, 1 per box PCDL cm x 30.5 cm Square Sterile, 1 per box Q. Through which distribution channels can customers order the device? A: Through distributors or direct (country dependent) Q. Is the product available on contract, independent, or through GPOs? A: Yes (individual country dependent) Q. Can the device be returned? A: No Q. What is the shelf life? A: 2 years References 1. PROCEED Surgical Mesh. Instructions for Use. Ethicon Inc. 2. Hutchinson RW, Chagnon M, Divilio LT. Preclinical Abdominal Adhesion Studies With PROCEED* Surgical Mesh. Ethicon, Inc. 3. Ellerbrock K. NG TSM / PROCEED Surgical Mesh. PD 06/0124. Ethicon, Inc. 4. dizerega GS, Campeau JD. Peritoneal repair and post-surgical adhesion formation. Hum Reprod Update. 2001;7: Shapiro L, Holste JL, Muench T, dizerega G. Rapid reperitonealization and wound healing in a preclinical model of abdominal trauma repair with a composite mesh. Int J Surg. 2015;22: Cooper S. Pore size measurement. March 17, Ethicon, Inc. 7. Mesh Spec Sheet - R&D Mesh Database - Rev 6. April 29, Ethicon, Inc. 8. Vailhe E. Mesh Competitor Testing, Version 1. AST July 21, Ethicon, Inc. 9. Deeken CR, Thompson DM Jr, Castile RM, Lake SP. Biaxial analysis of synthetic scaolds for hernia repair demonstrates variability in mechanical anisotropy, non-linearity and hysteresis. J Mech Behav Biomed Mater. 2014;38: Holste JL. Are Meshes with Lightweight Construction Strong Enough? Int Surg. 2005;90 (suppl 3):S10S Berrevoet F, Murdoch J, Jones P, et al. Open hernia repair surgery using a tissue-separating flat mesh (TSM) 12 month patient reported outcomes from the International Hernia Mesh Registry (IHMR). Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 12. Klosterhalfen B1, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices Jan;2(1): Berrevoet F, Tollens T, Berwouts L, et al. A Belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Acta Chirurgica Belgica. 2014;114: Ethicon US, LLC. All rights reserved