Eurosurgical Silimed Brochure
Transcription
Eurosurgical Silimed Brochure
Plastic and Reconstructive Surgery Ref No: 00107 Body Implants, Tissue Expanders & Facial Implants Product Catalogue No 6 (October 2008) Introduction SILIMED, a company present in more than fifty countries of the five continents, has the largest line of products in the market, manufactured according to the highest standard of quality. They are all made with FDA-registered, medical-grade silicone. Contents Gluteal Implants 3–6 Calf Implants 7–8 Pectoral Implants 9 – 12 Facial Implants 13 – 18 Silicone Block 19 – 20 Hand Surgery 21 – 22 Silicone Scar Therapy 23 – 26 Tissue Expanders 27 – 38 Our manufacturing process is in strict compliance with the Good Manufacturing Practices determined by ANVISA and FDA, and our Quality Management System is certified according to the ISO 9001:2000, ISO 13485:2003 and ISO 13485:2003 standards (including the requirements from Canadá) and our products bear the CE mark. Every implant has its serial number, brand and size engraved which makes its identification possible at any time. The individual serial number allows our company to have control not only of the products sold, but also of all the material and techniques used during the manufacturing process. This characteristic reflects the seriousness and professionalism present in our company’s activities. Body Contour Implants Silimed offer the widest range of silicone implants for all areas of body contour surgery. With a long history of working with respected surgeons throughout the world on the development of implants for gluteal surgery, calf enhancement, pectoral implantation and facial surgery. The body contour implants offer a wide range of low-bleed shells, silicone shore and strengths to suit the variety of requirements and options of shell surface technology. Merrow Business Park, Guildford, Surrey GU4 7WA T: +44 (0)1483 456007 F: +44 (0)1483 456008 E: sales@eurosurgical.co.uk W: www.eurosurgical.co.uk Gluteal Implants Gluteal Implants Gluteal implant placed in the retromuscular pocket in the so called subgluteal cellular space. 4) Implant 1) Incision of the skin 5) Gluteal medium 6) Gluteal maximus 7) Sciatic nerve 2) Subcutaneous dissection Templates are available with the shape of the base of the gluteal implants. These templates are meant to help the surgeon in pre-surgery evaluation to select the implant that best suits each particular case. 04 – Textured Silicone Implants 03 – Gluteal Implants 3) Muscle incision Gluteal Implants Gluteal Implants OVAL BASE ROUND BASE 1) Low Projection Opaque Surface 1) Single Projection Smooth Surface A B C A Ref B Ref Vol cm3 cm A B Vol cm3 C cm A B 13960-200 200 14.0 9.5 2.7 10910-200 200 10.6 3.7 13960-250 250 14.5 9.8 3.1 10910-220 220 10.7 3.8 13960-300 300 14.9 10.4 3.5 10910-240 240 10.9 3.9 13960-350 350 15.2 10.9 3.8 10910-270 270 11.4 3.9 13960-400 400 15.4 11.2 4.3 10910-300 300 11.7 4.0 13960-450 450 15.8 11.7 4.5 10910-330 330 12.1 4.1 13960-500 500 16.2 12.1 4.6 10910-360 360 12.3 2.8 2) High Projection Opaque Surface A C Ref Vol cm3 cm 05 – Gluteal Implants A B C 13961-200 200 13.7 9.2 2.8 13961-250 250 14.0 9.5 3.5 13961-300 300 14.3 9.7 3.8 13961-350 350 14.9 10.4 4.2 13961-400 400 15.2 10.9 4.6 13961-450 450 15.4 11.2 4.7 13961-500 500 15.8 11.7 4.8 06 – Gluteal Implants B Calf Implants Calf Implants CALF IMPLANT – SILICONE GEL – SMOOTH SURFACE 1) Asymetrical Base SILIMED presents the widest range of calf implants in the market, all designed by plastic surgeons. They are made of a low-bleed silicone elastomer envelope filled with biodesign high performance silicone gel, able to reproduce the soft tissues allowing a better suitability of the implant to the area involved. These implants are indicated to correct the unevenness or irregularities of the calf such as sequela of poliomyelitis, congenital malformation, neurological diseases, traumatisms and others. Although they have been designed to reparatory surgery they have been increasingly used in aesthetic surgery with excellent results. Designed to get closer to the anatomy of the area thus making the use of several implants unnecessary. B C A Ref Vol cm3 10410-085 Supplied sterile. 85 cm A B C 15.0 4.7 2.4 10410-140 140 19.7 5.4 2.5 10410-180 180 23.1 5.8 2.6 Presented in several types as described below. Calf implant placed below the aponeurosis of the medial gastrocnemius muscle (figure 1). A - Rear View / B – Side View Fig 1. IMPORTANT: Calf implants have a ‘small insertion pouch’ made of silicone attached to one of the ends of the base to help with insertion. To avoid damaging the implants do not use any sharp instruments (figure 2). Designed according to its name with a symmetrical base which allows the use of several implants at the same time in order to achieve the desired relief. B C A Ref A Vol cm3 B cm A Fig 2. Before using the product the surgeon should read the instructions for use contained in the packaging. B C 10400-012 12 6.2 2.1 1.6 10400-030 30 10.2 3.0 1.9 10400-070 70 15.7 3.3 2.5 10400-090 90 19.5 3.2 2.3 10400-095 95 19.4 4.9 1.7 10400-120 120 26.6 3.4 2.5 10400-140 140 26.2 4.4 2.5 Note 1: Dimensions and volumes with approximate values. 08 – Calf Implants 07– Calf Implants 1. Incision in the skin 2. Incision of the aponeurosis of the medial gastrocnemius muscles 3. Implant 4. Inner popliteal sciatic nerve 5. Soleus muscle 6. Posterior muscle 7. Tibiofibular 8. Medial gastrocnemius muscle 2) Symetrical Base Pectoral Implants Pectoral Implants PECTORAL IMPLANT – SILICONE GEL This implant is presented for the right side and left side. The SILIMED pectoral implant is made of a low-bleed silicone elastomer envelope and contains a definite volume of high performance biodesign silicone gel, whose shape, density and overall consistency have been developed to resemble the human tissue corresponding to application. The incision is made in the auxiliary region, which should be wide enough (about 5cm) to allow the insertion of the implant (figure 1). Indicated for reparatory surgery in cases of patients with deficiency in the pectoral region, such as congenital pectoral aplasia, due to its good results the pectoral implant has been increasingly used in aesthetic surgeries. Supplied sterile. The pocket is made under the pectoral muscle, undermining but without removing it from the minor pectoral muscle. The undermining should be interrupted 1cm or 2cm below the areola otherwise the implant will be positioned too low, which will result in a feminine appearance (figure 2). The pocket should be carefully inspected to verify the absence of remaining muscle fibres. Using long pincers, secure the polyester rim of the implant and introduce it into the pocket, positioning it between the two pectoral muscles and making sure that the angles of the implant are even with those of the muscle (figure 2). Fig 2. Undermining and Introduction Fig 3. Final Result Fig 4. Final Result Before using the product the physician should read the instructions for use contained in the packaging. 10 – Pectoral Implants 09– Pectoral Implants Fig 1. Incision Pectoral Implants Pectoral Implants SMOOTH SURFACE TEXTURED SURFACE A A B B C C Ref Ref Vol cm cm 3 10130-190 D 190 Vol cm3 A B C 14.4 10.4 2.4 cm A B C 20130-190 D 190 14.7 10.7 2.4 10130-190 E 190 14.4 10.4 2.4 20130-190 E 190 14.7 10.7 2.4 10130-230 D 230 15.8 11.7 2.6 20130-230 D 230 16.0 12.0 2.7 10130-230 E 230 15.8 11.7 2.6 20130-230 E 230 16.0 12.0 2.7 10130-300 D 300 16.5 12.2 2.9 20130-300 D 300 16.9 12.7 2.9 10130-300 E 300 16.5 12.2 2.9 20130-300 E 300 16.9 12.7 2.9 Presented in smooth or textured surfaces as shown. Note 1: Dimensions and volumes with approximate values. Note 2: D = right, E = left Templates are available with the shape of the base of the pectoral implants. These templates are meant to help the surgeon in pre-surgery evaluation to select the implant that best suits each particular case. 12 – Pectoral Implants 11– Pectoral Implants IMPORTANT: Contains polyester reinforcement to help with insertion. Facial Implants Facial Implants CHIN IMPLANTS MALAR IMPLANTS I) Smooth Surface II) Textured Surface 1) Malar 1) Chin Implant A B B C C Ref A cm Ref I II A B C cm 20-025 20020-025 1 2.6 1.9 0.35 A B C 20-030 20020-030 2 3.1 2.3 0.41 20-032 20020-032 3 3.2 2.4 0.47 I II 10-035 20010-035 1 3.5 1.6 0.7 10-045 20010-045 2 4.5 1.7 0.8 10-050 20010-050 3 4.8 1.7 0.8 10-055 20010-055 4 5.3 1.8 0.8 10-075 20010-075 5 7.5 1.9 0.8 2) Anatomical Malar A 2) Anatomical Chin C B B Ref cm A Ref 13– Facial Implants cm I II A B C 15-060 20015-060 1 6.1 1.4 0.6 15-065 20015-065 2 6.4 1.5 0.7 15-080 20015-080 3 7.9 1.5 0.8 I II A B C 25-40D 20025-40D 1 2.0 4.0 0.42 25-40E 20025-40E 1 2.0 4.0 0.42 25-45D 20025-45D 2 2.3 4.3 0.42 25-45E 20025-45E 2 2.3 4.3 0.42 25-50D 20025-50D 3 2.5 5.0 0.45 25-50E 20025-50E 3 2.5 5.0 0.45 14 – Facial Implants C Facial Implants Facial Implants NASAL DORSUM EYELID SUSPENSOR AND EAR IMPLANT I) Smooth Surface II) Textured Surface 1) Eyelid Suspensor Implant This implant is made of soft silicone elastomer, reinforced at the fixation with the eyelid. It is indicated in cases of “Severe Palpebral Ptosis”, when the capacity of the eyelid elevator muscle is diminished. 1) Nasal Dorsum C B A A Ref cm I II 50-040 20050-040 50-055 20050-055 A B C 1 4.0 0.8 0.2 2 5.6 0.9 0.2 Ref cm 60-013 2) “L” - shaped Nasal B B C A B C 1.30 0.35 7.0 A 2) Ear D C A Shore I II 70-060 20070-060 A 20 50 B cm A B 2.0 C D C Ref cm 3.2 4.0 A B C 20080-053D 5.2 3.1 1.2 20080-053E 5.2 3.1 1.2 0.35 16 – Facial Implants 15– Facial Implants Ref Facial Implants Facial Implants NOSTRIL RETAINER NOSTRIL RETAINER It has a functional anatomic format and can be sectioned by adjusting the length according to requirements. The nostril retainer helps to hold the septum in a vertical position, allows for nasal breathing immediately after the operation without blocking the flow of air, is painless and non-traumatic, easy to clean and sterilise, erases the memory of ectopic cartilage and maintains constant results. Supplied sterile in individual packaging. 17– Facial Implants Provided in two versions; one simple (a) and another option with lateral fixation patches (b) which may be used during the first post-surgery phase to prevent the displacement of the product and with a white dot to indicate the correct positioning as described below. Before using the product the physician should read the instructions for use contained in the packaging. B B A A *Conceived by Dr José Lauro de Fonseca. Ref mm a b A B C 1170-018 1171-018 1170-019 1171-019 1 1.80 2.30 0.70 2 1.90 2.40 0.80 1170-020 1170-021 1171-020 3 2.00 2.50 0.90 1171-021 4 2.10 2.60 1.00 1170-022 1171-022 5 2.20 2.70 1.05 1170-023 1171-023 6 2.30 2.80 1.10 1170-024 1171-024 7 2.40 2.90 1.20 1170-025 1171-025 8 2.50 3.00 1.30 1170-026 1171-026 9 2.60 3.10 1.40 1170-027 1171-027 10 2.70 3.20 1.50 1170-028 1171-028 11 2.80 3.30 1.60 1170-029 1171-029 12 2.90 3.40 1.70 1170-030 1171-030 13 3.00 3.50 1.80 Note: Dimensions with approximate values. 18 – Facial Implants Made of medical-grade silicone elastomer it is recommended for all age groups and types of noses (black, Caucasian, oriental). C It is indicated for septoplasty surgeries and on rhinoplasty primary surgeries (unilateral labial fissures). It assists in the correct positioning of the anatomic structures committed located between them and the nostril septum and permits the normal growth of the facies and the nose. C Designed for prophylaxis of stenosis and cicatricial contractures. Silicone Block Silicone Block SHEETS AND BLOCKS SHEETS AND BLOCKS The silicone block is meant to substitute or augment soft or cartilaginous tissues such as the chin and nose. Being moldable it is designed for carving any type of solid implant. 2) Coloured – Double Consistency It is made of a silicone elastomer which is homogenous, pure or reinforced, translucent, colourless or pigmented. It has a smooth surface and is vulcanised to obtain the desired or specified degree of hardness. Supplied non-sterile A C B D Ref Shore Presented with different degrees of hardness as described below. A 1) Standard B C 1203-140 Pink 10 50 10 50 B C D 14.0 1.5 4.5 1.2 14.0 1.5 4.5 1.2 3) Coloured – Single Consistency Ref Shore A 19– Silicone Block White A cm A B C 1200-010 Super Soft 12 12.0 7.0 1.5 1200-030 Soft 25 12.0 7.0 1.5 1200-050 Medium 50 12.0 7.0 1.5 1200-080 Hard 70 12.0 7.0 1.5 Before using the product the physician should read the instructions for use contained in the packaging. B A C Ref Shore A cm A B C 1202-140 White 50 14.0 6.0 1.2 1204-140 Pink 50 14.0 6.0 1.2 Note: Dimensions with approximate values. 20 – Silicone Block A 1201-140 cm Hand Surgery Hand Surgery PHALANGEAL JOINT TENDON SPACER Made of silicone elastomer. It is indicated in arthroplasty surgeries for implant of the metacarpal-phalangeal, proximal interphalangeal and distal interphalangeal joints. Made of silicone elastomer. This is a passive shaper for temporary use, meant to reconstitute the tendons of the hand in cases of tendinous adherences and scars, absence of the sheath or rupture of the tendon. Supplied Sterile. 1) Oval Section 1) Oval Section C C D B B A Ref A cm Ref I cm I 2001-00 00 A B C 2051-3 3 240.0 3.0 1.5 2051-4 4 240.0 4.0 2.0 A B C D 2051-5 5 240.0 5.0 2.5 7.8 25.5 3.4 2.8 2051-6 6 240.0 6.0 3.0 2001-0 0 9.5 29.5 4.3 3.3 2001-1 1 11.5 32.1 5.5 4.8 2001-2 2 11.8 36.8 5.9 5.2 2001-3 3 12.8 42.6 6.6 5.4 2001-4 4 13.8 49.6 6.9 5.9 2001-5 5 14.7 54.1 8.2 6.3 2001-6 6 15.1 61.3 8.4 6.4 2001-7 7 15.9 67.4 9.7 6.6 2) Round Section B A Ref 21– Hand Surgery I Before using the product the physician should read the instructions for use contained in the packaging. A B 2052-2 2 300.0 2.0 2052-3 3 300.0 3.0 2052-4 4 300.0 4.0 2052-5 5 300.0 5.0 2052-6 6 300.0 6.0 2052-7 7 300.0 7.0 22 – Hand Surgery cm Silicone Scar Therapy Silicone Scar Therapy MEDGEL MEDGEL Silicone Gel for Scar Treatment 1) Plate Medgel is a biocompatible medical-grade silicone gel. B A Ref Intended for the prevention of hypertrophic scars, for treatment and control of old or recent scars resulting from surgery and keloid scars. cm A Medgel comes in the following models: Plates for wide or widespread scars (eg burns) Strips for linear scars (eg abdominoplasty, reduction mammoplasty; Caesarean births and cardiac surgery) Discs for areolar scars (eg breast reduction or augmentation and removal of cysts) Inverted ‘T’ for mammary reductions (eg reduction mammoplasty) Gel for uncovered areas (eg hands, face, neck) and areas not accessible by the medgel plate (eg behind the ear). 23– Silicone Scar Therapy Before using the product the physician should read the instructions for use contained in the packaging. B 1240-010 I1 10 10 1 1240-010 H 10 10 6 2) Strip B A Ref QTD cm Supplied non-sterile in individual or multiple packaging. IMPORTANT: Not to be applied to open wounds, unsound tissue and on infected organs. QTD 1240-011 I1 A B 30 2.0 1 1240-011 I2 30 2.0 2 1240-011 H 30 2.0 12 24 – Silicone Scar Therapy Its easiness of use offers comfort to the patient when it is in contact with the skin. It is permeable to water vapour, impermeable to micro-organisms, its elasticity enables free joint movement and it is non-antigenic and essentially non-toxic. Silicone Scar Therapy Silicone Scar Therapy MEDGEL MEDGEL 3) Strip 5) Inverted ‘T’ B B A A Ref QTD Ref QTD cm 1240-016 I1 cm A B 10 5 1 4) Disc 1240-013 I2 A B 34 9.5 2 6) Gel A Ref B cm QTD cm A A 1230-015 B 1240-012 I2 7 2 1240-012 H 7 12 15 B 1 Note: Dimensions with approximate values. 26 – Silicone Scar Therapy Ref 25– Silicone Scar Therapy QTD Tissue Expanders Tissue Expanders Made of a chemically and mechanically resistant smooth or textured surface silicone elastomer envelope. The indications are multiple, from mammary reconstruction to the correction of burn sequelae, baldness surgery, facial tumours and scars in general. Provided in two types; expander for slow expansion with different valves and intraoperative expander for fast expansion during surgery with luer. 1) Round Valve The references of the expanders are formed by the association of the codes of the desired components with the nominal volume. Ex: 250ml rectangular expander with adult and child valve - ref 810-250-3 or auricular 16ml expander child valve – ref 841-016-1. When the part has a specific differentiated used for the left and right side, at the end of the reference add the letter E (left) or D (right). Ex: 40ml auricular expander – left side/child valve – ref 841-040 E1. Some expanders are delivered with two or more valves. Notwithstanding the above we must stress that expanders are single use devices that must be discarded after use together with the valves that have not been used. Adult base diameter: 34mm Child base diameter: 22mm Note 2: Both have a resistant radiopaque stainless steel disc to prevent the needle from trespassing. The needle must be introduced all the way to the bottom perpendicular to the valve. Note 3: Take care not to damage the tip of the needle while introducing it as this could turn it into a hook, leaving an opening in the septum thus resulting in the reflux of the injected liquid. Supplied sterile. Before using the product the surgeon should read the instructions for use contained in the packaging. 28 – Tissue Expanders 27 – Tissue Expanders Presented in several types as described below. Tissue Expanders Tissue Expanders 2) Cone Shaped Valve 5) Locating the Valve Contains a ceramic cuvet to prevent the needle from trespassing. e. Marking the exact place for the injection f. Insert the needle, checking whether it completely passes the septum 11mm/base 3) Assembly Sequence 6) Luer Lock Cut tube at required length without passing the mark. This luer accompanies intraoperative expanders and some expanders for slow expansion as an external valve. Fit the tube connected to the expander into the free end of the connection until it meets the tube. 4) Incorporated Magnetic Valve for Slow Expansion – ref XXXX9 29 – Tissue Expanders a. Silicone septum b. Envelope reinforcement to prevent folds c. Magnetic disc with stabiliser d. Magnetic finder There are different templates available with the base format of the expanders. These templates are meant to help the surgeon make the pre-surgery evaluation and select the expander that best adapts to each case. 30 – Tissue Expanders Dome diameter: diameter 22mm Tissue Expanders Tissue Expanders SMOOTH SMOOTH 1) Rectangle / Smooth / Remote Valve 2) Round / Smooth / Remote Port A C C B A B Ref Ref cm I 31– Tissue Expanders 810-030 30 I A B C A B C 800-050 50 6.2 3.6 2.5 5.1 2.5 800-100 100 7.9 2.8 810-050 50 3.8 3.8 3.8 800-200 200 9.6 4.1 810-100 100 4.6 6.0 5.3 800-300 300 10.6 5.0 800-400 400 11.2 5.5 810-105 105 4.1 8.7 3.3 810-160 160 5.1 11.0 3.8 800-500 500 12.2 6.2 810-200 200 5.0 6.0 7.0 800-600 600 13.2 6.5 810-205 205 5.5 9.5 4.0 800-700 700 15.0 6.1 810-250 250 5.9 9.6 5.0 800-800 800 15.2 6.4 810-320 320 6.2 14.1 4.7 800-900 900 15.2 7.6 810-400 400 5.5 13.6 5.6 800-1000 1000 15.3 8.4 810-500 500 6.9 15.8 5.1 810-600 600 5.0 18.0 7.0 810-640 640 8.0 18.0 5.0 810-700 700 5.0 28.0 5.0 810-720 720 7.3 15.2 6.3 810-800 800 8.7 18.5 5.7 810-1000 1000 8.0 20.2 7.0 32 – Tissue Expanders cm Tissue Expanders Tissue Expanders SMOOTH SMOOTH 3) Cresent / Smooth / Remote Valve 5) Calf / Smooth / Remote Valve C B A A Ref B cm I C A B C 820-012 12 5.1 2.1 2.1 820-025 25 6 2.7 2.6 820-050 50 6.8 3.5 3.3 I A B C 145 19.2 5.3 2.6 185 22.9 5.7 2.6 Ref cm 820-100 100 8.1 4.3 3.5 880-145 820-150 150 8.7 4.6 4.1 880-185 820-200 200 9.3 4.9 4.7 820-300 300 10.1 5.6 5.8 820-400 400 11.4 6.2 6.5 820-700 700 13.4 7.8 8.8 6) Ear / Smooth / Remote Valve C B A Ref I 33 – Tissue Expanders A B C 841-016 16 6.2 1.6 1.1 841-040 40 6.5 2.2 2.6 841-055 55 7 2.5 3.2 34 – Tissue Expanders cm Tissue Expanders Tissue Expanders SMOOTH SMOOTH 7) Spherical / Smooth / Remote Port 8) Elipitical / Smooth / Remote Port A Ref B cm 35 – Tissue Expanders I A B C C Ref 741-003 03 1.7 741-005 05 2.2 I 741-008 08 2.5 881-010 741-012 12 2.8 741-016 16 3 741-018 18 3.3 741-020 20 3.4 741-030 30 3.8 741-060 60 4.8 cm 10 A B C 6.1 2.1 1.8 36 – Tissue Expanders A Tissue Expanders Tissue Expanders SMOOTH SMOOTH 9) Ovoid / Smooth / Remote Port 11) Syndactyli / Smooth / Remote Port B B A Ref A cm I A B 861-021 21 2.7 4.2 861-025 25 2.9 4.6 10) Longitudinally Curved / Smooth / Remote Valve C A B C 851-001 1 1 1 0.3 741-005 2 2 1 0.3 741-008 3 3 1 0.3 741-012 4 4 1 0.3 741-016 5 5 1 0.3 B Ref Vol ml I 20830-220 37 – Tissue Expanders cm I 220 cm A B C 10.0 4.0 4.5 20830-480 480 20.7 5.0 4.8 20830-520 520 16.0 5.0 6.0 38 – Tissue Expanders A Ref Product Catalogue No 6 (October 2008) Eurosurgical, Merrow Business Park, Guildford, Surrey, GU4 7WA T: +44 (0)1483 456007 F: +44 (0)1483 456008 E: sales@eurosurgical.co.uk W: www.eurosurgical.co.uk