Macrolane Breast Enhancement

Mr Adrian Richards

Consultant Plastic Surgeon

Aurora Clinics

UK

www.aurora-clinics.co.uk

)Procedures in millions(

0.0

4.0

8.0

12.0

6.0

10.0

2.01.0M1.1M

1.9M

9.5M

1997

2006

Shift Towards Non-Invasive ProceduresShift Towards Non-Invasive Procedures

Non- Invasive ProceduresInvasive Procedures

0.0

4.0

8.0

12.0)Procedures in millions(

6.0

10.0

2.0

1997 2006

Growth Rate = 118%CAGR = 7.4%

Growth Rate = 747%CAGR = 27.1%

Source: The American Society for Aesthetic Plastic Surgery, March 2007

Non-invasive procedures account for majority of growth Non-invasive procedures = 83% of market

Cosmetic EnhancementCosmetic Enhancement

Patients who want Patients who want improvement in body improvement in body shape but shape but don’tdon’t want want

surgerysurgery

Surgical ProceduresSurgical Procedures

MINTEL Report 2007MINTEL Report 2007

Key findings

• Body shaping is outpacing market growth in the surgical segment

• Less invasive surgical techniques are driving growth and taking away the fear associated with surgery

• Patient fear of cosmetic surgery going wrong still presents a powerful obstacle to surgery

How Women Perceive MACROLANE´s Advantages

• No hospital stay

• Less invasive

• Short recovery period with no time off from work

• A natural material in the body that is absorbed over time

• A look that is natural and unique for each woman, tailored to their own appearance

Source: TDA/Q-Med focus groups in Rio de Janeiro and Madrid, 2006

What is Macrolane?

• Macrolane is a NASHATM gel for volume restoration and contouring of body surfaces

• CE-approved

• Developed from non-animal stabilized hyaluronic acid (NASHATM)

How is Macrolane different?

• Macrolane VRF is a thicker gel used for body aesthetics rather than facial aesthetics and therefore creates greater volume with a slower absorption

• Stabilized using the NASHATM patented technology specifically for use in Body Aesthetics

• Longer residence time than natural HA

• Biocompatible and safe

• Specifically developed for volume restoration and contouring of body surfaces, including breast shaping

NASHATM Safety Profile

• Pure and minimally modified by stabilization, the long implant lifetime does not cause tissue incompatibility– No rejection problems

• Side effects and post-treatment complications are rare, and generally mild and transient resolving within a couple of weeks

• Patients injected with NASHATM gel have not demonstrated any allergic responses to the implants– as assessed by analysis of blood samples or skin patch tests

• Used successfully in facial aesthetics for over 10 years– Nearly 10 million procedures world-wide

NASHANASHATM Research and Research and

DocumentationDocumentation NASHATMPapers

Olenius M, Aesth Plast Surg 1998 Narins R et al, Dermatol Surgery 2003 Carruthers A et al, Dermatol Surg 2005 Wang F et al, Arch Dermatol 2007

Macrolane Papers

Per Heden, poster, AAWC Monaco 2007 Inami F, et al J Plastic Surg 2006 Tengvar et al, poster, IMCAS 2008

Extensive Experience of Breast Augmentation with Stabilized Hyaluronic Acid of non-animal origin

(NASHA™)

Inami F, Handa T and Handa K

Journal: Journal of Plastic Surgery (full citation: Inami F, Handa T and Handa K. Mammoplasty with fillers. J Plastic Surg 2006;49: 1335–41.)

Number of patients: 1100

Average volume: 35 mL per breast

Cannula used: 18 G, 12 cm cannula with lateral holes

Breast Augmentation with Stabilized Hyaluronic Breast Augmentation with Stabilized Hyaluronic Acid Gel of non-animal origin: Visualisation of Acid Gel of non-animal origin: Visualisation of

tissue behind the Implantstissue behind the Implants

Objective:

To investigate the feasibility of monitoring breast tissue behind implanted HA gel, using mammography

Conclusion:

The presence of Macrolane in the breast does not compromise the detection, diagnosis or management of breast disease

Magnus Tengvar, Per Heden, Michael Olenius. Poster presented at IMCAS, January 2008

Patient Selection

• Breast volume

• Skin quality

• Ptosis– Grade 1– Grade 2– Grade 3

Body-tailored Product Concept

Patient ProfilePatient Profile

Age18 – 24 years

Small under-developed breasts

Developmental asymmetry

30 – 45 yearsPost pregnancyWeight lossAging change

Grade 2 Ptosis Right Grade 1 Left

Grade 3 Ptosis

Macrolane VRF Product RangeMacrolane VRF Product Range

MACROLANE VRF 30 MACROLANE VRF 2010 & 20 ml plastic syringe 10& 20 ml plastic syringeTerminally sterilize Terminally sterilize20 mg/ml HA 20mg/ml HA12G cannula or larger size 12G cannula or larger sizeMedium restoration power Lower restoration power

Syringe Volumes

• 10 & 20 ml• 12G blunt cannula

Dosage and Administration

• Recommended maximum volume per treatment site is 100 ml (per treatment session)

• No experience to date of more than 240ml injected at one treatment session

• No overcorrection - treated area can be massaged

• Treatment time 45 minutes

Macrolane VRF

Treatment Procedure

Breast Volume Restoration

• 19 patients

• Screening mammography and ultrasound

• Initial 100 -120mls per breast

• Optional touch up 20 ml at 4 wks for asymmetry or unevenness

• Injection anterior to the pectoralis major muscle but posterior to the mammary gland

Pre-treatment Precautions

• Procedure can be carried out in a minor operations room

• Normal precautions as for similar minor surgical treatments should be observed

• Aspirin and non-steroidal anti-inflammatory drugs may increase risk of bruising or bleeding at injection sites

• A pre-treatment of oral antibiotics is recommended

Markings and Equipment

Photos provided by Mr Chris Inglefield of London Bridge Plastic Surgery Clinic, London, UK

Incision is made with a No 11 blade or using a

12g needle

Inject Macrolane VRF using a 16g blunt

cannula

Deposit product when withdrawing

Photos provided by Mr Chris Inglefield of London Bridge Plastic Surgery Clinic, London, UK

Before treatment 100cc Immediately after

Before treatment

Immediately post treatment

3 months follow up

Pre Treatment Post 100cc @ side

Pre Treatment Post 100cc @ side

Pre Treatment Post 100cc @ side

Side Effects

• Pain 10-14 days

• Firmness 14 days

• Bruising rare

• Fever and malaise

Longevity

• 50% present at 12 months

• 80:20 rule– 80% need top up at 12 months– 20% at 18 months

Summary

• Suitable for patients who would not consider surgery

• Generally well tolerated

• Patient satisfaction high

• Long term follow up and further studies required

Thank You

Mr Adrian Richards

Consultant Plastic Surgeon

www.aurora-clinics.co.uk