Product Information Kit

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1 Ultrapro Comfort Plug TM Value Analysis Committee Kit I want a product that works with my technique My patients don t want to feel the mesh Minimize the amount of foreign material implanted Color sticky notes represent customer insights Third-party trademarks used herein are trademarks of their respective owners.

2 Table of Contents a and Codes (k) Clearance Letter Clinical Literature Brochures

3 a The first and only macroporous, partially absorbable mesh plug made from ULTRAPRO Partially Absorbable Lightweight Mesh ULTRAPRO Mesh provides long-term improvement in quality of life, with significant relief from movement limitations at 1-year postsurgery versus presurgery (P < 0.001) 1 The ULTRAPRO Portfolio offers low rates of recurrence (<2%) for a lasting repair, based on data from the IHMR and a multicentric German quality control study 1-3* ULTRAPRO Partially Absorbable Lightweight Mesh ULTRAPRO Hernia System ULTRAPRO Plug N= % recurrence-free at 1 year 1 N= % recurrence-free at 1 year 2 N= % recurrence-free at 1 year 3 * 0.7% recurrence rate 0.4% recurrence rate 1.4% recurrence rate * Data from a prospective, longitudinal study of 71 patients receiving open hernia repair with ULTRAPRO Plug from the IHMR. Two additional patient-reported recurrences could not be medically confirmed by a clinician Data from a prospective, longitudinal study of 151 patients receiving open hernia repair with ULTRAPRO Partially Absorbable Lightweight Mesh from the IHMR Data from a prospective, longitudinal study of 2792 patients receiving hernia repair with ULTRAPRO Hernia System from the IHMR s 1. Berrevoet F, Tollens T, Romanowski C, Jones P, McRoy L. Open macroporous partially absorbable flat mesh 12 month outcomes. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 2. Lorenz R, Koch A, Wiese M, Born H. Gilbert repair a new gold standard? First results of 2792 patients of a multicentric German quality control study. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL Doerhoff C, Lydon P, Hammond J, Romanowski C, Jones P. 12 month outcomes following open hernia repair with a partially absorbable plug and patch device. Abstract presented at the 36th Annual International Congress of the European Hernia Society; May 28-31, 2014; Edinburgh, Scotland. 3

4 Improved patient comfort without changing your technique Relies on familiar, easily reproducible plug & patch technique 1,2 No need to create a preperitoneal space Orientation markings aid placement, alignment, and fixation Large-pore, partially absorbable mesh promotes good tissue in-growth 3 * Leaves behind 65% less foreign material compared with heavier-weight mesh after partial absorption 4 *Evidence shown in an animal model. s 1. ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair. Ethicon Inc. 2. UPP Design Validation Results. UPP March Ethicon, Inc. 3. Klosterhalfen B. The ULTRAPRO Plug - a next generation device for hernia plug-repair. February Ethicon, Inc. 4. Hernia Mesh Sheet. April 29, Ethicon, Inc. 4

5 ULTRAPRO COMFORT PLUG is a sterile plug device made from ULTRAPRO Partially Absorbable Lightweight Mesh for open repair of groin hernias The device consists of a three-dimensional plug and a flat, preshaped onlay patch manufactured from nonabsorbable polypropylene monofilament and absorbable poliglecaprone 25 monofilament fibers. The structure of the plug contains ribs made from dyed (D&C Violet No. 2) polydioxanone polymer film 1 Trimmable filler and plug for a customized fit 1 Polydioxanone (PDS) ribs to ease placement 1 Offers appropriate strength with minimal foreign-body mass, for natural healing 2 Designed for excellent intraoperative handling 3 Relies on familiar surgical techniques 1,3 Rounded, soft conical tip and low profile in the abdomen-peritoneum designed to minimize foreign-body sensation The plug is composed of undyed ULTRAPRO Mesh. Dyed ribs are laminated to the plug mesh Ribs are made from dyed (D&C Violet No. 2) polydioxanone polymer film The onlay patch is a pre-shaped, dyed ULTRAPRO Mesh After absorption of the poliglecaprone 25 components, only the polypropylene mesh remains in the body, which is 65% less foreign material compared to heavyweight mesh after partial absorption. 4 The structure and size of this remaining mesh is designed to withstand the physiological forces of the abdominal wall 1 s 1. ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair. Ethicon Inc. 2. Klosterhalfen B. The ULTRAPRO Plug - a next generation device for hernia plug-repair. February Ethicon, Inc. 3. UPP Design Validation Results. UPP March Ethicon, Inc. 4. Hernia Mesh Sheet. April 29, Ethicon, Inc. 5

6 and Codes Code Size Shape How Supplied UPLUG401 Plug diameter: 40 mm Sterile, 1 per box Onlay mesh: 7 cm x 14 cm UPLUG403 Plug diameter: 40 mm Sterile, 3 per box Onlay mesh: 7 cm x 14 cm UPLUG406 Plug diameter: 40 mm Sterile, 6 per box Onlay mesh: 7 cm x 14 cm UPLUG551 Plug diameter: 55 mm Sterile, 1 per box Onlay mesh: 7 cm x 14 cm UPLUG553 Plug diameter: 55 mm Sterile, 3 per box Onlay mesh: 7 cm x 14 cm UPLUG556 Plug diameter: 55 mm Sterile, 6 per box Onlay mesh: 7 cm x 14 cm How supplied ULTRAPRO COMFORT PLUG is available in two sizes of plug (40 mm and 55 mm) with one size of onlay mesh (7 cm x 14 cm). ULTRAPRO COMFORT PLUG is supplied in boxes of one, three, or six devices. Each unit is sterile and individually wrapped in sterile packaging Indications for use 1 The ULTRAPRO COMFORT PLUG is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects For full Prescribing, see page 16 s 1. ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair. Ethicon Inc. 6

7 Product can be ordered direct through Johnson & Johnson Health Care Systems, Inc. (JJHCS) and through distributor channels Electronic ordering options Note: Placing orders electronically avoids minimum order fees for hospitals Order 360 : order360.jnjgateway.com For questions about your order, visit the website or call Global Healthcare Exchange: ghx.com For questions about your order, visit the website or call YOUR-GHX Electronic Data Interchange Call JJHCS EDI Help Line: Nonelectronic/Manual ordering options Call JJHCS at (option 1) between 8:30 a.m. and 8:00 p.m. eastern time, or fax your order to or For more information or product support, call ETHICON ( ) Customer support For product use assistance, clinical guidelines, service and repair, emergency assistance, copy of 510(k) clearance letter or complaints, please contact our Customer Support Center at customersupport@eesus.jnj.com or by calling ETHICON ( ). Our support center is staffed 24 hours a day, 7 days a week by qualified nurses to answer your product-related questions For complete product details, see. For more information, contact your local Ethicon representative or call ETHICON ( ) 7

8 Competitive Code Conversions ULTRAPRO COMFORT PLUG 40 mm codes Plug Mnfr Code # Description diameter QTY Category Mesh material Ethicon UPLUG401 ULTRAPRO COMFORT 40mm 1 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene Ethicon UPLUG403 ULTRAPRO COMFORT 40mm 3 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene Ethicon UPLUG406 ULTRAPRO COMFORT 40mm 6 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene 8

9 Competitive Codes - Comparable to 40mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material BARD PerFix Plug - Small 25mm 2 Non-Absorbable Polypropylene BARD PerFix Plug - Small 25mm 6 Non-Absorbable Polypropylene BARD PerFix Plug - Medium 33mm 2 Non-Absorbable Polypropylene BARD PerFix Plug - Medium 33mm 6 Non-Absorbable Polypropylene BARD PerFix Light Plug - Small 25mm 1 Non-Absorbable Polypropylene BARD PerFix Light Plug - Small 25mm 6 Non-Absorbable Polypropylene BARD PerFix Light Plug - Medium 33mm 1 Non-Absorbable Polypropylene BARD PerFix Light Plug - Medium 33mm 6 Non-Absorbable Polypropylene BARD PHASIX Plug and Patch - Small 25mm 1 Fully-resorbable Poly-4- Hydroxybutyrate (P4HB) BARD PHASIX Plug and Patch - Medium 33mm 1 Fully-resorbable Poly-4- Hydroxybutyrate (P4HB) 9

10 Competitive Codes - Comparable to 40mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material ATRIUM ProLite Ultra Mesh - 25mm 5 Non-Absorbable Polypropylene Self Forming Onlay ATRIUM ProLite Ultra Mesh - 32mm 5 Non-Absorbable Polypropylene Self Forming Onlay ATRIUM ProLite Ultra Mesh - 38mm 5 Non-Absorbable Polypropylene Self Forming Onlay ATRIUM ProLite Ultra Mesh - 25mm 5 Non-Absorbable Polypropylene Self Forming Keyhole Slit Onlay ATRIUM ProLite Ultra Mesh - 32mm 5 Non-Absorbable Polypropylene Self Forming Keyhole Slit Onlay ATRIUM ProLite Ultra Mesh - 38mm 5 Non-Absorbable Polypropylene Self Forming Keyhole Slit Onlay 10

11 Competitive Codes - Comparable to 40mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material ATRIUM ProLoop Mesh - 28mm 2 Non-Absorbable Polypropylene ProLoop with Onlay ATRIUM ProLoop Mesh - 39mm 2 Non-Absorbable Polypropylene ProLoop with Onlay ATRIUM ProLoop Mesh - 28mm 2 Non-Absorbable Polypropylene ProLoop with Keyhole Slit Onlay ATRIUM ProLoop Mesh - 39mm 2 Non-Absorbable Polypropylene ProLoop with Keyhole Slit Onlay ATRIUM ProLoop Mesh - 28mm 2 Non-Absorbable Polypropylene No Onlay ATRIUM ProLoop Mesh - 39mm 2 Non-Absorbable Polypropylene No Onlay GORE HP01 GORE BIO-A Hernia Plug Unknown 1 Fully resorbable Poly (glycolide: trimethylene carbonate) copolymer GORE HP02 GORE BIO-A Hernia Plug Unknown 1 Fully resorbable Poly (glycolide: trimethylene carbonate) copolymer) 11

12 ULTRAPRO COMFORT PLUG 55 mm codes Plug Mnfr Code # Description diameter QTY Category Mesh material Ethicon UPLUG551 ULTRAPRO COMFORT 55mm 1 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene Ethicon UPLUG553 ULTRAPRO COMFORT 55mm 3 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene Ethicon UPLUG556 ULTRAPRO COMFORT 55mm 6 Semi- Macroporous, PLUG Absorbable Thin Filament Polypropylene 12

13 Competitive Codes - Comparable to 55mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material BARD PerFix Plug - Large 41mm 2 Non-Absorbable Polypropylene BARD PerFix Plug - Large 41mm 6 Non-Absorbable Polypropylene BARD PerFix Plug X-Large 41mm 2 Non-Absorbable Polypropylene BARD PerFix Plug X-Large 41mm 6 Non-Absorbable Polypropylene BARD PerFix Light Plug - Large 41mm 1 Non-Absorbable Polypropylene BARD PerFix Light Plug - Large 41mm 6 Non-Absorbable Polypropylene BARD PerFix Light Plug X-Large 38mm 1 Non-Absorbable Polypropylene BARD PerFix Light Plug X-Large 38mm 6 Non-Absorbable Polypropylene BARD PHASIX Plug and Patch - Large 41mm 1 Fully resorbable Poly-4- Hydroxybutyrate (P4HB) BARD PHASIX Plug and Patch X-Large 38mm 1 Fully resorbable Poly-4- Hydroxybutyrate (P4HB) 13

14 Competitive Codes - Comparable to 55mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material ATRIUM ProLite Ultra Mesh 44mm 5 Non-Absorbable Polypropylene Self Forming Onlay ATRIUM ProLite Ultra Mesh 44mm 5 Non-Absorbable Polypropylene Self Forming Keyhole Slit Onlay ATRIUM ProLoop Mesh 48mm 2 Non-Absorbable Polypropylene ProLoop with Onlay ATRIUM ProLoop Mesh 50mm 2 Non-Absorbable Polypropylene ProLoop with Onlay ATRIUM ProLoop Mesh 48mm 2 Non-Absorbable Polypropylene ProLoop with Keyhole Slit Onlay ATRIUM ProLoop Mesh 50mm 2 Non-Absorbable Polypropylene ProLoop with Keyhole Slit Onlay ATRIUM ProLoop Mesh - No Onlay 48mm 2 Non-Absorbable Polypropylene ATRIUM ProLoop Mesh - No Onlay 50mm 2 Non-Absorbable Polypropylene 14

15 Competitive Codes - Comparable to 55mm ULTRAPRO COMFORT PLUG Plug Mnfr Code # Description diameter QTY Category Mesh material COVIDIEN PNP6X3 Parietex Plug and Patch System 65mm (flat) 3 Non-Absorbable Polyester 6.5cm round plug COVIDIEN PNP8X3 Parietex Plug and Patch System 80mm (flat) 3 Non-Absorbable Polyester 8cm round plug 15

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18 for use DESCRIPTION ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair en For indirect inguinal hernia repair, a high dissection of the neck of the hernia sac can be performed allowing the Plug to expand. Surgical manipulation may be used to facilitate deployment. For direct inguinal hernia repair, the defect is circumscribed at its base and the content is fully may be used to facilitate the deployment. the femoral vessels and nerves. ADVERSE REACTIONS Potential adverse reactions with device implantation are those typically associated with surgically STERILITY The device is sterilized by Ethylene Oxide. Do not resterilize. Do not use if package is opened or damaged. Discard open, unused product. STORAGE Store at or below 30 C. Do not use after expiry date. TRACEABILITY The Plug is composed of an undyed ULTRAPRO Partially Absorbable Lightweight Mesh. Dyed ribs are laminated to the Plug mesh. Ribs are made from dyed (D&C Violet No. 2) polydioxanone The onlay patch is a pre-shaped, dyed ULTRAPRO Mesh. The ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable Onlay patch No ) is identical to the material used for dyed/undyed PROLENE Polypropylene Suture. copolymer is identical to the material used for MONOCRYL (poliglecaprone 25) Suture. After absorption of the poliglecaprone 25 components, only the polypropylene mesh remains. The structure and size of this remaining mesh is designed to withstand the physiological forces of the abdominal wall. INDICATIONS Plug { reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. APPLICATION layer can be cut or trimmed. outer layer ribs accommodate the cord structures. Adequate overlap needs to be considered to cover the defect on all sides. The onlay mesh should be positioned tension- and fold-free with the longer side parallel Adequate onlay patch fixation, e.g., with sutures, is required to minimize postoperative complications and recurrence. be maintained. The tails created to accommodate the cord structures must be brought together ACTIONS/PERFORMANCE and following wound healing. When implanted subcutaneously in animals, the poliglecaprone 25 copolymer and the The device elicits a transient mild to moderate foreign body reaction. In an animal study, the not potentiate infections. CONTRAINDICATIONS The device must be separated from the abdominal cavity by peritoneum. WARNINGS If this product is used in patients with the potential for growth or tissue expansion (such as infants or children or women who may become pregnant), the surgeon should be aware that the device Users should be familiar with open surgical procedures and techniques involving non-absorbable meshes. Do not use if package is opened or damaged. Reuse of this device (or portions of this device) may create a risk of product degradation and cross-contamination, which may lead to infection or transmission of bloodborne pathogens to patients and users. PRECAUTIONS In inguinal hernia repair, the device should always be used as a whole, i.e., Plug plus onlay patch. subsequent infection may require removal of the device. In order to minimize the risk of hernia recurrence, the following precautions should be observed: Care should be taken to avoid intra-operative damaging of the device, e.g., with sharp instruments or thermal devices. The onlay patch should adequately overlap the defect on all sides. must be maintained. to clearly identify the device that was implanted. CAUTION Federal (U.S.A.) Law restricts this device to sale by or on the order of a licensed healthcare practitioner. SYMBOLS USED ON LABELING Do not reuse Do not resterilize Use By Year and Month Sterile. Method of sterilization: Ethylene Oxide Recommended storage conditions: below 30 C (86 F) product meets the essential requirements of Medical Directive 93/42/EEC. See Catalogue number Manufacturer Batch number Do not use if the product sterilization barrier or its packaging is compromised. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed healthcare practitioner. 06/ Ethicon, Inc

19 510(k) Clearance Letter Clinical Literature 510(k) Clearance Letter 19

20 510(k) Clearance Letter Clinical Literature 510(k) Clearance Letter 20

21 510(k) Clearance Letter Clinical Literature 510(k) Clearance Letter 21

22 510(k) Clearance Letter Clinical Literature Clinical Literature Gilbert Repair a New Gold Standard? First Results of 2792 Patients of a Multicentric German Quality Control Study Ralph Lorenz MD, Andreas Koch MD, Martin Wiese, Henry Born MD for the working group In collaboration with AN- Institute for quality management in the operative medicine Otto-von-Guericke-Universität Magdeburg 26 ambulatory Hernia centers in Germany Location of Participating Hernia centers Arnsberg Bad Aibling Berlin 3 x Cottbus Dortmund 2 x Fürstenfeldbruck Jena Kelkheim Krefeld Lampertheim Leipzig 2 x Meißen München 2 x Münster Neumünster Neustadt/Coburg Nürnberg Pforzheim Tübingen Wahlstedt Weimar Online project since 2009 Pilot phase for 2 years 16 hernia centres in Germany now joining 26 hernia centers in Germany criteria: pain and recurrence only Hernia surgery with 3-D-meshes Follow up after 4, 12 and 52 weeks (examination) Independent patient questionaire with Carolina Comfort Scale after 4, 12 and 52 weeks EHS Classification and using UHS as Tailored approach. The highest rate (for Gilbert Repair selected cases) are large size mostly direct or combined hernias. The rate of intraoperative and postoperative complications is very low intraoperative complications Follow up after 4,12,and 52 weeks (Recurrence rate) postoperative complications Number of Hernia Procedures in different Hernia centers per year 2009/2010/2011/ Follow up after 4,12,and 52 weeks (Patients satisfaction with Carolina Comfort Scale) ASA Classification Day cases Ultrapro Hernia System = UHS size M = round 7,5cm L = round 10 cm OVAL = 10 x12 cm with retromuscular mesh part (colour rings) Conclusion: Gilbert repair using the partly absorbable Ultrapro Hernia System combines a simple and safe open access with a secure posterior mesh placement The Gilbert Repair is usable in most of all groin hernias as well in recurrent cases, in our study it was mostly used in large size direct or combined hernias With 3 available sizes of the UHS there is a possibility for a tailored concept adapted on the size of the hernia A high rate of day cases is possible The rate of intra- and postoperative complications is very low The recurrence rate after 1 year is very low The patient satisfaction is very high Our results are comparable with other current comparative studies (1),(2),(3) Literature (1) Persson K, Rimback G, Dalenback J The Lichtenstein Perfix Plug and Prolene Hernia System techniques for inguinal hernia repair Long time follow up of a RCT Hernia (2012) 16 (suppl.1) : (2) Tsirline T, Colavit P,Belyansky I et al. Ultrapro Hernia System versus conventional Lichtenstein repair for inguinal hernia system: results from the multinational registry Presentation New York 5th Hernia Congress (3) Tollens T. et al Ultrapro Hernia System: Toward an ideal solution? Surg Techn Intern (2011) Authors Ralph Lorenz MD, 3CHIRURGEN Klosterstrasse 34/35, D Berlin, lorenz@3chirurgen.de Andreas Koch MD, FACS, Chirurgische Praxis Cottbus, Thiem Strasse 112, D Cottbus Martin G. Wiese, GesundheitsZentrum Kelkheim Frankenallee 1, D Kelkheim Henry Born MD, Medizinisches Zentrum Leipzig-Lausen, Zschochersche Allee 68, D Leipzig 22

23 Table of Contents 510(k) Clearance Letter Clinical Literature Clinical Literature 23

24 510(k) Clearance Letter Clinical Literature Clinical Literature 12 Month Outcomes Following Open Hernia Repair with a Partially Absorbable Plug and Patch Carl Doerhoff¹, Peter Lydon², Jeffrey Hammond³, Christine Romanowski ³ Pete Jones³ 1 Surgicare of Missouri, 1705 Christy Drive, Suite 215, Jefferson City, Missouri ² Eastern Massachusetts Surgery Center, 100 Morse Street, Norwood, MA ³ Clinical Development & Medical Affairs, ETHICON Surgical Care, Johnson & Johnson Global Surgery Group Background: The popularity of the plug and patch technique for hernia repair stems from the ease of performing this surgical procedure. A two-component, partially absorbable device was developed primarily for groin hernias to fill or reinforce hernia defects and to provide support during wound healing. Methods: The International Hernia Mesh Registry, a prospective multi-center registry collects data on hernia mesh products. Patients complete Carolinas Comfort Scale (CCS), validated QOL questionnaire specific to herniorrhaphy at baseline and 1, 6, 12 and 24 months postoperatively. Symptomatic patient is defined as one providing a response of >1 to any CCS question. Patients who underwent open herniorrhaphy with a partially absorbable plug and patch device (ULTRPRO Plug, Ethicon, Somerville, NJ) and completed up to 12 months postoperative follow-up were included. McNemar tests were used to compare symptomatic events. Results: 92 patients enrolled across 7 centers with 12 month data available for 71 patients. Mean age 57.6 years (15.2 SD)) and mean BMI kg/m² (3.9 SD). Hernia types: 90.2% inguinal; 8.7% umbilical; 1.1% femoral, 94.6% were primary repairs. Fixation methods: 97.8% sutures; 1.1 % sutures and glue; 1.1% none. Anesthesia utilized; 57.6% general, 42.4% local. Most procedures (78.3%) were < 1 hour long and median duration in hospital; 0.0 (0.0, 3.0) nights. Preoperatively, incidence of patient reported symptomatic pain (56.5%) decreased (7.5%) p<0.001; symptomatic movement limitations (35.9%) decreased (4.5%) p < at 12 months postoperatively, respectively. Most common adverse event was seroma, 7.6 % patients. There were 4 patient reported recurrences; 1 medically confirmed, 1 confirmed as not a recurrence and 2 yet to be confirmed, due to patients not returning for assessment. Conclusion: These results indicate that inguinal hernia repair with this plug and patch is associated with significant improvement compared to baseline in pain and movement limitations at 12 months postoperatively. 24

25 Brochures Brochures ULTRAPRO COMFORT PLUG Partially Absorbable Hernia Repair The first and only macroporous, partially absorbable mesh plug for open inguinal hernia repair New technology without the need to learn a new technique Trimmable filler and plug for a customized fit 1 Polydioxanone (PDS) ribs to ease placement 1,2A Offers appropriate strength with minimal foreign body mass, for natural healing 1,2B Designed for excellent intraoperative handling 2A Relies on familiar surgical techniques 1,2A Macroporous, partially absorbable mesh allows for excellent tissue in-growth* 2B 65% less foreign material versus heavyweight mesh after partial absorption 2C Rounded, soft conical tip, and low profile in abdomen-peritoneum designed to minimize foreign body sensation 3 25

26 For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert Ethicon US, LLC. All rights reserved