Hot Topics Annual Meeting American Society for Aesthetic Plastic Surgery Aesthetic Surgery Education

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Hot Topics Annual MeetingAmerican Society for
Aesthetic Plastic SurgeryAesthetic Surgery
Education and Research FoundationMay 2003
Boston, MAV. Leroy Young, MDRobert Singer,
MDWilliam P. Adams, Jr. MDJoe Gryskiewicz, MD
Brian M. Kinney, MDRichard DAmico, MD
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Hot Topics Covered

• Topic Presenter
• EnzAid Rod Rohrich, MD
• Arnica Brian Kinney, MD
• Pain Pumps Mark Jewell, MD
• Radiance Miles Graivier, MD Dave Jansen, MD
• Clearlight and Relume Barry Di Bernardo, MD
• Legal Standards and Leroy Young, MD Working
  With the FDA
• Thermage Charles Hughes, MD
• Copper Peptides James Carraway, MD
• Wrinkle Relax Joe Gryskiewicz, MD
• Lipostabil Leroy Young, MD
• What We Thought Then
• What We Know Now Leroy Young, MD

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EnzAidR.J. Rohrich, MD

• Oral enzyme product is reported to produce
  accelerated wound healing in human skin

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Conclusion

• Oral supplementation accelerates wound healing
• HEALTHY patients
• Decrease inflammation

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Hot TopicsModerators Conclusion

• This is early data
• The initial studies are good
• More studies are necessary

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Arnica Montana
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Arnica Montana Conclusion

• Safety and efficacy are unproven
• ASERF has funded a well designed study to provide
  an answer
• Allergic reactions seem to be the most
  significant risk for short term use

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Hot TopicsModerators Conclusion

• The position of The American Society for
  Aesthetic Plastic Surgery is to be wary
• There is no good data

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Pain PumpsMark Jewell, MD

• Pain pumps are passive devices delivering local
  anesthetics postoperatively
• There are several manufacturers
• On-Q
• Stryker
• Sgarlatto
• Advanced Infusion

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Pain Pumps Summary

• Pain pumps are effective
• Safe
• Help avoid overnight stays
• May speed recovery
• High cost
• Generate phone calls
• Inconvenient for patients

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Hot TopicsModerators Conclusion

• The studies are good
• This could be helpful for some patients

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Radiance Regulatory Status Miles Gravier, MD
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Radiance

• Uniform calcium hydroxylapatite microspheres
• in sodium carboxymethyl-cellulose gel carrier

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Radiance Conclusions

• Appears to hold promise for long lasting soft
  tissue augmentation of lines, scars, depressions,
  and defects.
• Lip augmentation using Radiance has been
  successful, but with a relatively high rate of
  nodularity (10.5)
• Nodularity has responded nicely to treatment
• Massage / steroid injection / excision

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Hot TopicsModerators Conclusion

• This is early data
• The initial studies are good
• More studies are necessary
• Concern about long term inflammatory reactions
  and granulomas

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ClearLight and ReLumeBarry DiBernardo, MD
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The ClearLight Acne PhotoClearing System

• The Newest Approach in
• Acne Therapy

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Comparison to Other Therapies
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Full Face Studies Results

• 95.8 Responded to therapy (decrease
  gt 20)
• 74.3 Decrease in acne lesions gt 50
• 70.0 Median () decrease (group)
• 0 Adverse effect or discomfort

International Mulitcenter ClearLight Acne
Phototherapy Study, EADV Annual Conference
Munich 2002
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Hot TopicsModerators Conclusion

• The studies are good
• This could be very helpful
• especially for acne patients

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FDA Legal Standards

• Off label use of approved drug or device
• Use of unapproved drug or device

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Unapproved or Off-Label Use

• Restylane Unapproved
• Lipostabil Unapproved
• Mesotherapy Off-label
• Adatosil Off-label
• Botox Approved for glabellar wrinkles only

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Can Unapproved Drugsor Devices Ever Be Used
Legally?YES

• FDA Rules
• Personal use policy
• Compassionate use
• Clinical trials

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Off-Label Use Conclusion

• Get good informed consent
• Do not advertise
• Be very careful
• For questions contact Wally Pellerite at the
  FDA(301) 594-4692

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Hot TopicsModerators Conclusion

• Plastic Surgeons should not advertise off-label
  use of products or medical devices

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ThermageCharles Hughes, MD
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Personal Experience50 Patients /12 months

• Easy to use - good computer feedback
• 90 of patients saw improvement
• 75 had positive comments from friends or
  relatives with no knowledge of the procedure

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Multicenter Single Treatment Study

• Fitzpatrick Wrinkle Classification Score
• 83 showed at least one level of improvement
• 66 show measurable change in brow elevation

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Hot TopicsModerators Comment

• Thermage, a radiofrequency technology is
  purported to tighten skin by contracting collagen

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Hot TopicsModerators Conclusion

• This is early data
• This initial study is flawed
• More studies are necessary
• and are currently in progress

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Copper Peptidesin a Skin Care Regimen

• James H. Carraway, MD

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Clinical Uses

• Copper peptides can improve healing after
  chemical peels, laser, and dermabrasion
• Suggested uses are for improving texture and fine
  lines in the skin
• May be used in conjunction with Retin-A and
  sunscreens

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Copper Summary

• Science for wound healing is good
• Science for skin improvement is weak
• Sales are strong (and repetitive)
• Very user friendly products

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Hot TopicsModerators Conclusion

• The extensive studies are good
• This could be helpful for some
• patients who are concerned
• about their skin care

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Wrinkle-Relax (Faux-Tox)
Joe Gryskiewicz, MD
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• Topical
• Relaxes muscles
• Reduces catecholamine release which inhibits
  intensity of muscle contraction
• Reduces depth and size of fine wrinkles lines

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Clinical Study by two Independent investigators

• Extensive Inclusion and
• Exclusion Criteria

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Criticisms of Study Design

• No control this means a group of untreated
  subjects was not used as a comparison
• Scans e.g. Primus is preferable
• Mold results may vary throughout the day
• Statistical significance of subjective
  questionnaire absent

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Summary

• Wrinkle relax works
• No loss of natural expression
• Since it relaxes, not paralyzes, doesnt relax as
  much as Botox
• If you can live with 75 of your patients being
  happy, then add it to your practice
• Dont forget the 25 who paid 75 and experienced
  slight or no change

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Hot TopicsModerators Conclusion

• This is early data
• The initial studies are good
• More studies are necessary
• The effects are minor

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LipostabilV. Leroy Young, MD
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Lipostabil Background

• Publication by Brazilian dermatologist Patricia
  Guedes Rittes in 2001 for eyelid fat deposits
• Subsequent lay press Harpers Bazaar
• Numerous internet sites
• ASAPS position statement

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What is Lipostabil?

• Phosphatidylcholine (lecithin)
• Most abundant phospholipid in animals and in 50
  of mass
• Key building block of membrane bilayers
• Principal phospholipid in plasma
• Zwitterionic phospholipid. It has an ionic and a
  lipophillic end (surfactant)

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Rittes Results
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Lipostabil Conclusions

• Lipostabil is phosphatidylcholine, a zwitterionic
  phospholipid
• Theoretical reasons to suspect phosphatidylcholine
  might affect fat
• Conclusive proof is lacking
• Scientifically valid and approved studies are
  needed

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Hot TopicsModerators Conclusion

• The position of The American Society for
  Aesthetic Plastic Surgery is to be wary
• There is no good data

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What we thought then What we know now
V. Leroy Young, MD
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How to Decide What Worked and What Didnt

• Internet web sites
• Anecdotal reports
• Personal experience
• Widespread adoption/rejection
• Regulatory review/approval
• Peer-reviewed literature

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Previous Hot Topics Presentations

• Peer-reviewed
• Topic publication
• Botox alternatives 24
• Injectables/Implantables (already covered) 12
• Tissue sealants/Glues 7
• Intense pulsed light 26
• Microdermabrasion 9
• Power-assisted liposuction 4
• External UAL 9
• Blindness and injectables 8
• Arnica Montana cosmetic surgery 68
• Low level laser liposuction 2
• Electromagnetic fields wound healing 9
• Resorbably fixation devices 10
• Brava 2
• Laser leg vein therapy 10
• Chemical peel 10
• Cohesive gel breast implants 3
• Anti-aging hormone replacement 157

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What We Thought

• Gluteal augmentation
• Arnica and other homeopathics
• Gene chips and proteomics
• Thermage
• Ultrashape
• Hair growth
• Obesity control

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BOTOXHome Run (24 refs)

• Wrinkles
• Migraine headaches
• Hyperhidrosis
• Hemifacial spasm
• Torticollis
• Blepharospasm

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Intensed Pulsed Light (26 refs.)Uses

• Hair removal
• Vascular lesions
• Pigmented lesions
• Facial wrinkles

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Facial WrinklesIntense Pulsed Light

• Some changes in skin texture dermal thickness
• Overall not an effective treatment for wrinkles

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Hot TopicsModerators Conclusion

• The extensive studies are good
• This could be helpful for some patients who are
  concerned about their skin care

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Power-assisted Liposuction (PAL)4 refs. -- Large
Personal Experience

• 10 Reasons Why I Like PAL
• Working in fibrous areas redos are easier
• Less fatiguing
• Refine difficult areas/lumps by machining them
  down
• Useful for superficial liposuction
• Multiple cannula options allow small incisions
• Use in curved areas with remote access
• Very efficient for harvesting fat for injection
• No burns or nerve injuries
• Minimal noise, nuisance hassle
• Affordable

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External Ultrasound-Assisted Liposuction Summary

• No objective proof of efficacy

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BlindnessInjectables (8 refs)

• Rare but well documented
• Related to
• Material injection
• Area injected
• Technique of injection
• Pretreatment
• Pre-existing disease

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Blindness and Injection

• Document vision before injection
• Get ophthalmologic consult immediately
• Usually irreversible

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Low Level LaserLiposuction 1 ref.

• Neira reported pretreatment of fat with 635 um
  low level laser caused transient pores in fat
  cell membranes which permitted fat to pass from
  inside the cell to outside
• Claimed easier removal and better results

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RohrichLow Level Laser

• Detailed study in animals with no evidence of
  efficacy.
• My personal use shows no objective evidence of
  efficacy.
• I dont think this works.

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Hot TopicsModerators Conclusion

• The position of The American Society for
  Aesthetic Plastic Surgery is to be wary
• There is no good data

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Brava

• BRAVA claims to produce breast
• enlargement by wearing a suction device

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Downside of Brava

• Expensive 2,000
• Poor compliance
• Inconvenient
• Skin irritation

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Experience with Brava

• Produces less than 1 cup size increase in women
  who can comply
• For patient who doesnt want implants doesnt
  want much enlargement
• Unhappy patients can be a problem

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Hot TopicsModerators Comment

• BRAVA produces minimal results even with maximal
  compliance
• Compliance can be burdensome

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Will Gel Implants Return To Market?

• McGhan Mentor have core studies using FDA
  guidelines for PMA approval
• The time frame should be Fall 2003 or Spring 2004

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Hot TopicsModerators Conclusion

• The studies are good
• In October, 2003, an FDA Advisory panel voted 9
  to 6 to allow silicone implants to be marketed
  and distributed for cosmetic breast enlargement
• Final decision by the FDA pending

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Biochemistry of Aging

• Aging is a complex process that primarily
  involves oxidative damage to DNA, protein, and
  lipids
• Aging is associated with altered patterns of gene
  expression and decreased protein turnover
• Obesity is a major accelerator of aging
• Caloric restriction is the only intervention
  consistently shown to increase longevity and
  reverse the changes associated with aging

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Caloric Restriction (CR)Anti-Aging

• CR of 30 or gt is the only thing shown to
  consistently significantly extend lifespan
• CR delays or prevents degenerative diseases
  osteoarthritis, cardiovascular, and neurological,
  Type II diabetes mellitus
• CR works in all models evaluated from yeast to
  mammals
• 15-year results from the NIA primate study
  suggest
• it works in monkeys
• The biosphere experiment suggests it works in
• humans

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Conclusion CR Mimics

• The physiology chemistry of hunger and satiety
  are being defined
• Compounds which mimic CR are currently in testing
  and in the foreseeable future safe drugs should
  be available that will enable appetite control
  and selective burning of fat
• CR net effect thinner, more healthy people who
  live longer

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Hot TopicsModerators Conclusion

• The studies are good
• These are significant conclusions
• on Anti-Aging