body implants, tissue expanders & facial implants · body implants, tissue expanders &...

Product Catalogue No 6 (October 2008)

Body Implants, Tissue Expanders & Facial Implants

Ref

No:

001

07Plastic and Reconstructive Surgery

Merrow Business Park, Guildford, Surrey GU4 7WAT: +44 (0)1483 456007 F: +44 (0)1483 456008

E: [email protected] W: www.eurosurgical.co.uk

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.

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.

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

Introduction

03 –

Glu

teal

Impl

ants

04 –

Tex

ture

d Si

licon

e Im

plan

ts

Gluteal implant placed in the retromuscular pocket in the so called subgluteal cellular space.

1) Incision of the skin

4) Implant

Gluteal Implants Gluteal Implants

2) Subcutaneous dissection

3) Muscle incision

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.

5) Gluteal medium6) Gluteal maximus7) Sciatic nerve

Gluteal Implants Gluteal Implants

Ref Vol

cm3 cm

A B

10910-200 200 10.6 3.7

10910-220 220 10.7 3.8

10910-240 240 10.9 3.9

10910-270 270 11.4 3.9

10910-300 300 11.7 4.0

10910-330 330 12.1 4.1

10910-360 360 12.3 2.8

Ref Vol

cm3 cm

A B C

13960-200 200 14.0 9.5 2.7

13960-250 250 14.5 9.8 3.1

13960-300 300 14.9 10.4 3.5

13960-350 350 15.2 10.9 3.8

13960-400 400 15.4 11.2 4.3

13960-450 450 15.8 11.7 4.5

13960-500 500 16.2 12.1 4.6

05 –

Glu

teal

Impl

ants

06 –

Glu

teal

Impl

ants

1) Single Projection Smooth Surface1) Low Projection Opaque Surface

OVAL BASE ROUND BASE

Ref Vol

cm3 cm

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

2) High Projection Opaque Surface

B C

A

A

A B

B C

07–

Calf

Impl

ants

08 –

Cal

f Im

plan

ts

CALF IMPLANT – SILICONE GEL – SMOOTH SURFACE

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.

Supplied sterile.

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

Incision in the skin1. Incision of the aponeurosis of the 2. medial gastrocnemius musclesImplant3. Inner popliteal sciatic nerve4. Soleus muscle5. Posterior muscle6. Tibiofibular7. Medial gastrocnemius muscle8.

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).

Calf Implants Calf Implants

Before using the product the surgeon should read the instructions for use contained in the packaging.

Fig 1.

Fig 2.

A B

Ref Vol

cm3 cm

A B C

10410-085 85 15.0 4.7 2.4

10410-140 140 19.7 5.4 2.5

10410-180 180 23.1 5.8 2.6

Ref Vol

cm3 cm

A 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.

1) Asymetrical Base

Designed to get closer to the anatomy of the area thus making the use of several implants unnecessary.

2) Symetrical Base

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.

A

A

B

C

B

C

09–

Pect

oral

Impl

ants

10 –

Pec

tora

l Im

plan

ts

PECTORAL IMPLANT – SILICONE GEL

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.

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.

This implant is presented for the right side and left side.

The incision is made in the auxiliary region, which should be wide enough (about 5cm) to allow the insertion of the implant (figure 1).

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).

Pectoral Implants Pectoral Implants

Fig 1. Incision 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.

11–

Pect

oral

Impl

ants

Pectoral Implants

12 –

Pec

tora

l Im

plan

ts

Ref Vol

cm3 cm

A B C

20130-190 D 190 14.7 10.7 2.4

20130-190 E 190 14.7 10.7 2.4

20130-230 D 230 16.0 12.0 2.7

20130-230 E 230 16.0 12.0 2.7

20130-300 D 300 16.9 12.7 2.9

20130-300 E 300 16.9 12.7 2.9

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.

IMPORTANT: Contains polyester reinforcement to help with insertion.

TEXTURED SURFACE

C

A

B

Pectoral Implants

Presented in smooth or textured surfaces as shown.

C

A

B

Ref Vol

cm3 cm

A B C

10130-190 D 190 14.4 10.4 2.4

10130-190 E 190 14.4 10.4 2.4

10130-230 D 230 15.8 11.7 2.6

10130-230 E 230 15.8 11.7 2.6

10130-300 D 300 16.5 12.2 2.9

10130-300 E 300 16.5 12.2 2.9

SMOOTH SURFACE

Ref

I II

cm

A B C

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

Ref

I II

cm

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

Ref

I II

cm

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

Ref

I II

cm

A B C

20-025 20020-025 1 2.6 1.9 0.35

20-030 20020-030 2 3.1 2.3 0.41

20-032 20020-032 3 3.2 2.4 0.47

Facial Implants Facial Implants

13–

Faci

al Im

plan

ts

I) Smooth Surface II) Textured Surface

1) Chin Implant

2) Anatomical Malar

2) Anatomical Chin

A

B

C

B

A

C

A

C

B

14 –

Fac

ial I

mpl

ants

1) Malar

B C

A

CHIN IMPLANTS MALAR IMPLANTS

Ref

I II

cm

A B C

50-040 20050-040 1 4.0 0.8 0.2

50-055 20050-055 2 5.6 0.9 0.2

Ref Shore

I IIA

cm

A B C D

70-060 20070-06020 2.0 3.2

50 4.0 0.35

15–

Faci

al Im

plan

ts

I) Smooth Surface II) Textured Surface

1) Nasal Dorsum

2) “L” - shaped Nasal

A

C

B

B A

D C2) Ear

B C

A

16 –

Fac

ial I

mpl

ants

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.

C B

A

Ref

cm

A B C

60-013 1.30 0.35 7.0

Ref

cm

A B C

20080-053D 5.2 3.1 1.2

20080-053E 5.2 3.1 1.2


NASAL DORSUM EYELID SUSPENSOR AND EAR IMPLANT

17–

Faci

al Im

plan

ts

18 –

Fac

ial I

mpl

ants

Designed for prophylaxis of stenosis and cicatricial contractures.

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.

Made of medical-grade silicone elastomer it is recommended for all age groups and types of noses (black, Caucasian, oriental).

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.

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.

*Conceived by Dr José Lauro de Fonseca.

Ref

a b

mm

A B C

1170-018 1171-018 1 1.80 2.30 0.70

1170-019 1171-019 2 1.90 2.40 0.80

1170-020 1171-020 3 2.00 2.50 0.90

1170-021 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.


A A

C C

B B


NOSTRIL RETAINER NOSTRIL RETAINER

Silicone Block Silicone Block

19–

Silic

one

Bloc

k

20 –

Sili

cone

Blo

ck

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.

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

Presented with different degrees of hardness as described below.

2) Coloured – Double Consistency

Ref Shore

A cm

A B C D

1201-140 White10

14.0 1.5 4.5 1.250

1203-140 Pink10

14.0 1.5 4.5 1.250

3) Coloured – Single Consistency

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.Before using the product the physician should read the instructions for use contained in the packaging.

A C

B

A C

B

C B D

A

Ref Shore

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

1) Standard

SHEETS AND BLOCKS SHEETS AND BLOCKS

Hand Surgery Hand Surgery

21–

Han

d Su

rger

y

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.


22 –

Han

d Su

rger

y

Ref

I

cm

A B C D

2001-00 00 7.8 25.5 3.4 2.8

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

Ref

I

cm

A B C

2051-3 3 240.0 3.0 1.5

2051-4 4 240.0 4.0 2.0

2051-5 5 240.0 5.0 2.5

2051-6 6 240.0 6.0 3.0

Ref

I

cm

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

1) Oval Section1) Oval Section

2) Round Section

A

B

B

CB D

A

AC

PHALANGEAL JOINT TENDON SPACER

Silicone Scar Therapy Silicone Scar Therapy

23–

Silic

one

Scar

The

rapy

24 –

Sili

cone

Sca

r The

rapy

Silicone Gel for Scar Treatment

Medgel is a biocompatible medical-grade silicone gel.

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.

Intended for the prevention of hypertrophic scars, for treatment and control of old or recent scars resulting from surgery and keloid scars.

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).

Supplied non-sterile in individual or multiple packaging.

IMPORTANT: Not to be applied to open wounds, unsound tissue and on infected organs.

1) Plate

Ref QTD

cm

A B

1240-010 I1 10 10 1

1240-010 H 10 10 6

2) Strip

Ref QTD

cm

A B

1240-011 I1 30 2.0 1

1240-011 I2 30 2.0 2

1240-011 H 30 2.0 12


A

B

A

B

MEDGEL MEDGEL

25–

Silic

one

Scar

The

rapy

26 –

Sili

cone

Sca

r The

rapy

5) Inverted ‘T’

Ref QTD

cm

A B

1230-015 15 1

Note: Dimensions with approximate values.

6) Gel

Ref QTD

cm

A B

1240-013 I2 34 9.5 2

3) Strip

Ref QTD

cm

A B

1240-016 I1 10 5 1

4) Disc

Ref QTD

cm

A B

1240-012 I2 7 2

1240-012 H 7 12

A

B

A

B

B

A

Silicone Scar Therapy Silicone Scar Therapy

MEDGEL MEDGEL

1) Round Valve

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.

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.

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.

Supplied sterile.

Presented in several types as described below.

Tissue Expanders Tissue Expanders

Before using the product the surgeon should read the instructions for use contained in the packaging.

Adult base diameter: 34mm

Child base diameter: 22mm

27 –

Tis

sue

Expa

nder

s

28 –

Tis

sue

Expa

nder

s

5) Locating the Valve

e. Marking the exact place for the injection

f. Insert the needle, checking whether it completely passes the septum

6) Luer Lock

This luer accompanies intraoperative expanders and some expanders for slow expansion as an external valve.

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.

29 –

Tis

sue

Expa

nder

s

30 –

Tis

sue

Expa

nder

s

2) Cone Shaped Valve

Contains a ceramic cuvet to prevent the needle from trespassing.

Dome diameter: 11mm/base diameter 22mm

3) Assembly Sequence

Cut tube at required length without passing the mark.

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

Silicone septuma. Envelope reinforcement to b. prevent foldsMagnetic disc with stabiliserc. Magnetic finderd.



SMOOTH SMOOTH

31–

Tiss

ue E

xpan

ders

2) Round / Smooth / Remote Port

CB

32 –

Tis

sue

Expa

nder

s

Ref

I

cm

A B C

800-050 50 6.2 3.6

800-100 100 7.9 2.8

800-200 200 9.6 4.1

800-300 300 10.6 5.0

800-400 400 11.2 5.5

800-500 500 12.2 6.2

800-600 600 13.2 6.5

800-700 700 15.0 6.1

800-800 800 15.2 6.4

800-900 900 15.2 7.6

800-1000 1000 15.3 8.4

A

1) Rectangle / Smooth / Remote Valve

A

B

Ref

I

cm

A B C

810-030 30 2.5 5.1 2.5

810-050 50 3.8 3.8 3.8

810-100 100 4.6 6.0 5.3

810-105 105 4.1 8.7 3.3

810-160 160 5.1 11.0 3.8

810-200 200 5.0 6.0 7.0

810-205 205 5.5 9.5 4.0

810-250 250 5.9 9.6 5.0

810-320 320 6.2 14.1 4.7

810-400 400 5.5 13.6 5.6

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

C

33 –

Tis

sue

Expa

nder

s

5) Calf / Smooth / Remote Valve

6) Ear / Smooth / Remote Valve

B

A

C

CB

34 –

Tis

sue

Expa

nder

s

Ref

I

cm

A B C

880-145 145 19.2 5.3 2.6

880-185 185 22.9 5.7 2.6

Ref

I

cm

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

A

3) Cresent / Smooth / Remote Valve

Ref

I

cm

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

820-100 100 8.1 4.3 3.5

820-150 150 8.7 4.6 4.1

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

A

BC


SMOOTH SMOOTH

35 –

Tis

sue

Expa

nder

s

7) Spherical / Smooth / Remote Port

Ref

I

cm

A B C

741-003 03 1.7

741-005 05 2.2

741-008 08 2.5

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

Ref

I

cm

A B C

881-010 10 6.1 2.1 1.8

8) Elipitical / Smooth / Remote Port

B C

36 –

Tis

sue

Expa

nder

s

AA


SMOOTH SMOOTH

37 –

Tis

sue

Expa

nder

s

11) Syndactyli / Smooth / Remote Port

A

B

Ref

I

cm

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

9) Ovoid / Smooth / Remote Port

A

38 –

Tis

sue

Expa

nder

s

Ref

I

cm

A B

861-021 21 2.7 4.2

861-025 25 2.9 4.6

B


SMOOTH SMOOTH

10) Longitudinally Curved / Smooth / Remote Valve

Ref Vol

I

ml cm

A B C

20830-220 220 10.0 4.0 4.5

20830-480 480 20.7 5.0 4.8

20830-520 520 16.0 5.0 6.0

C

A B

Eurosurgical, Merrow Business Park, Guildford, Surrey, GU4 7WA

T: +44 (0)1483 456007 F: +44 (0)1483 456008

E: [email protected] W: www.eurosurgical.co.uk

Product Catalogue No 6 (October 2008)

body implants, tissue expanders & facial implants · body implants, tissue expanders &...

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