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

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


1
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
2
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

3
EnzAidR.J. Rohrich, MD
  • Oral enzyme product is reported to produce
    accelerated wound healing in human skin

4
Conclusion
  • Oral supplementation accelerates wound healing
  • HEALTHY patients
  • Decrease inflammation

5
Hot TopicsModerators Conclusion
  • This is early data
  • The initial studies are good
  • More studies are necessary

6
Arnica Montana
7
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

8
Hot TopicsModerators Conclusion
  • The position of The American Society for
    Aesthetic Plastic Surgery is to be wary
  • There is no good data

9
Pain PumpsMark Jewell, MD
  • Pain pumps are passive devices delivering local
    anesthetics postoperatively
  • There are several manufacturers
  • On-Q
  • Stryker
  • Sgarlatto
  • Advanced Infusion

10
Pain Pumps Summary
  • Pain pumps are effective
  • Safe
  • Help avoid overnight stays
  • May speed recovery
  • High cost
  • Generate phone calls
  • Inconvenient for patients

11
Hot TopicsModerators Conclusion
  • The studies are good
  • This could be helpful for some patients

12
Radiance Regulatory Status Miles Gravier, MD
13
Radiance
  • Uniform calcium hydroxylapatite microspheres
  • in sodium carboxymethyl-cellulose gel carrier

14
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

15
Hot TopicsModerators Conclusion
  • This is early data
  • The initial studies are good
  • More studies are necessary
  • Concern about long term inflammatory reactions
    and granulomas

16
ClearLight and ReLumeBarry DiBernardo, MD
17
The ClearLight Acne PhotoClearing System
  • The Newest Approach in
  • Acne Therapy

18
Comparison to Other Therapies
19
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
20
Hot TopicsModerators Conclusion
  • The studies are good
  • This could be very helpful
  • especially for acne patients

21
FDA Legal Standards
  • Off label use of approved drug or device
  • Use of unapproved drug or device

22
Unapproved or Off-Label Use
  • Restylane Unapproved
  • Lipostabil Unapproved
  • Mesotherapy Off-label
  • Adatosil Off-label
  • Botox Approved for glabellar wrinkles only

23
Can Unapproved Drugsor Devices Ever Be Used
Legally?YES
  • FDA Rules
  • Personal use policy
  • Compassionate use
  • Clinical trials

24
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

25
Hot TopicsModerators Conclusion
  • Plastic Surgeons should not advertise off-label
    use of products or medical devices

26
ThermageCharles Hughes, MD
27
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

28
Multicenter Single Treatment Study
  • Fitzpatrick Wrinkle Classification Score
  • 83 showed at least one level of improvement
  • 66 show measurable change in brow elevation

29
Hot TopicsModerators Comment
  • Thermage, a radiofrequency technology is
    purported to tighten skin by contracting collagen

30
Hot TopicsModerators Conclusion
  • This is early data
  • This initial study is flawed
  • More studies are necessary
  • and are currently in progress

31
Copper Peptidesin a Skin Care Regimen
  • James H. Carraway, MD

32
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

33
Copper Summary
  • Science for wound healing is good
  • Science for skin improvement is weak
  • Sales are strong (and repetitive)
  • Very user friendly products

34
Hot TopicsModerators Conclusion
  • The extensive studies are good
  • This could be helpful for some
  • patients who are concerned
  • about their skin care

35
Wrinkle-Relax (Faux-Tox)
Joe Gryskiewicz, MD
36
  • Topical
  • Relaxes muscles
  • Reduces catecholamine release which inhibits
    intensity of muscle contraction
  • Reduces depth and size of fine wrinkles lines

37
Clinical Study by two Independent investigators
  • Extensive Inclusion and
  • Exclusion Criteria

38
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

39
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

40
Hot TopicsModerators Conclusion
  • This is early data
  • The initial studies are good
  • More studies are necessary
  • The effects are minor

41
LipostabilV. Leroy Young, MD
42
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

43
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)

44
Rittes Results
45
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

46
Hot TopicsModerators Conclusion
  • The position of The American Society for
    Aesthetic Plastic Surgery is to be wary
  • There is no good data

47
What we thought then What we know now
V. Leroy Young, MD
48
How to Decide What Worked and What Didnt
  • Internet web sites
  • Anecdotal reports
  • Personal experience
  • Widespread adoption/rejection
  • Regulatory review/approval
  • Peer-reviewed literature

49
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

50
What We Thought
  • Gluteal augmentation
  • Arnica and other homeopathics
  • Gene chips and proteomics
  • Thermage
  • Ultrashape
  • Hair growth
  • Obesity control

51
BOTOXHome Run (24 refs)
  • Wrinkles
  • Migraine headaches
  • Hyperhidrosis
  • Hemifacial spasm
  • Torticollis
  • Blepharospasm

52
Intensed Pulsed Light (26 refs.)Uses
  • Hair removal
  • Vascular lesions
  • Pigmented lesions
  • Facial wrinkles

53
Facial WrinklesIntense Pulsed Light
  • Some changes in skin texture dermal thickness
  • Overall not an effective treatment for wrinkles

54
Hot TopicsModerators Conclusion
  • The extensive studies are good
  • This could be helpful for some patients who are
    concerned about their skin care

55
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

56
External Ultrasound-Assisted Liposuction Summary
  • No objective proof of efficacy

57
BlindnessInjectables (8 refs)
  • Rare but well documented
  • Related to
  • Material injection
  • Area injected
  • Technique of injection
  • Pretreatment
  • Pre-existing disease

58
Blindness and Injection
  • Document vision before injection
  • Get ophthalmologic consult immediately
  • Usually irreversible

59
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

60
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.

61
Hot TopicsModerators Conclusion
  • The position of The American Society for
    Aesthetic Plastic Surgery is to be wary
  • There is no good data

62
Brava
  • BRAVA claims to produce breast
  • enlargement by wearing a suction device

63
Downside of Brava
  • Expensive 2,000
  • Poor compliance
  • Inconvenient
  • Skin irritation

64
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

65
Hot TopicsModerators Comment
  • BRAVA produces minimal results even with maximal
    compliance
  • Compliance can be burdensome

66
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

67
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

68
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

69
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

70
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

71
Hot TopicsModerators Conclusion
  • The studies are good
  • These are significant conclusions
  • on Anti-Aging
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