Title: Hot Topics Annual Meeting American Society for Aesthetic Plastic Surgery Aesthetic Surgery Education
1Hot 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
2Hot 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
3EnzAidR.J. Rohrich, MD
- Oral enzyme product is reported to produce
accelerated wound healing in human skin
4Conclusion
- Oral supplementation accelerates wound healing
- HEALTHY patients
- Decrease inflammation
5Hot TopicsModerators Conclusion
- This is early data
- The initial studies are good
- More studies are necessary
6Arnica Montana
7Arnica 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
8Hot TopicsModerators Conclusion
- The position of The American Society for
Aesthetic Plastic Surgery is to be wary - There is no good data
9Pain PumpsMark Jewell, MD
- Pain pumps are passive devices delivering local
anesthetics postoperatively - There are several manufacturers
- On-Q
- Stryker
- Sgarlatto
- Advanced Infusion
10Pain Pumps Summary
- Pain pumps are effective
- Safe
- Help avoid overnight stays
- May speed recovery
- High cost
- Generate phone calls
- Inconvenient for patients
11Hot TopicsModerators Conclusion
- The studies are good
- This could be helpful for some patients
12Radiance Regulatory Status Miles Gravier, MD
13Radiance
- Uniform calcium hydroxylapatite microspheres
- in sodium carboxymethyl-cellulose gel carrier
14Radiance 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
15Hot TopicsModerators Conclusion
- This is early data
- The initial studies are good
- More studies are necessary
- Concern about long term inflammatory reactions
and granulomas
16ClearLight and ReLumeBarry DiBernardo, MD
17The ClearLight Acne PhotoClearing System
- The Newest Approach in
- Acne Therapy
18Comparison to Other Therapies
19Full 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
20Hot TopicsModerators Conclusion
- The studies are good
- This could be very helpful
- especially for acne patients
21FDA Legal Standards
- Off label use of approved drug or device
- Use of unapproved drug or device
22Unapproved or Off-Label Use
- Restylane Unapproved
- Lipostabil Unapproved
- Mesotherapy Off-label
- Adatosil Off-label
- Botox Approved for glabellar wrinkles only
23Can Unapproved Drugsor Devices Ever Be Used
Legally?YES
- FDA Rules
- Personal use policy
- Compassionate use
- Clinical trials
24Off-Label Use Conclusion
- Get good informed consent
- Do not advertise
- Be very careful
- For questions contact Wally Pellerite at the
FDA(301) 594-4692
25Hot TopicsModerators Conclusion
- Plastic Surgeons should not advertise off-label
use of products or medical devices
26ThermageCharles Hughes, MD
27Personal 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
28Multicenter Single Treatment Study
- Fitzpatrick Wrinkle Classification Score
- 83 showed at least one level of improvement
- 66 show measurable change in brow elevation
29Hot TopicsModerators Comment
- Thermage, a radiofrequency technology is
purported to tighten skin by contracting collagen
30Hot TopicsModerators Conclusion
- This is early data
- This initial study is flawed
- More studies are necessary
- and are currently in progress
31Copper Peptidesin a Skin Care Regimen
32Clinical 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
33Copper Summary
- Science for wound healing is good
- Science for skin improvement is weak
- Sales are strong (and repetitive)
- Very user friendly products
34Hot TopicsModerators Conclusion
- The extensive studies are good
- This could be helpful for some
- patients who are concerned
- about their skin care
35Wrinkle-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
37Clinical Study by two Independent investigators
- Extensive Inclusion and
- Exclusion Criteria
38Criticisms 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
39Summary
- 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
40Hot TopicsModerators Conclusion
- This is early data
- The initial studies are good
- More studies are necessary
- The effects are minor
41LipostabilV. Leroy Young, MD
42Lipostabil 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
43What 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)
44Rittes Results
45Lipostabil 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
46Hot TopicsModerators Conclusion
- The position of The American Society for
Aesthetic Plastic Surgery is to be wary - There is no good data
47What we thought then What we know now
V. Leroy Young, MD
48How to Decide What Worked and What Didnt
- Internet web sites
- Anecdotal reports
- Personal experience
- Widespread adoption/rejection
- Regulatory review/approval
- Peer-reviewed literature
49Previous 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
50What We Thought
- Gluteal augmentation
- Arnica and other homeopathics
- Gene chips and proteomics
- Thermage
- Ultrashape
- Hair growth
- Obesity control
51BOTOXHome Run (24 refs)
- Wrinkles
- Migraine headaches
- Hyperhidrosis
- Hemifacial spasm
- Torticollis
- Blepharospasm
52Intensed Pulsed Light (26 refs.)Uses
- Hair removal
- Vascular lesions
- Pigmented lesions
- Facial wrinkles
53Facial WrinklesIntense Pulsed Light
- Some changes in skin texture dermal thickness
- Overall not an effective treatment for wrinkles
54Hot TopicsModerators Conclusion
- The extensive studies are good
- This could be helpful for some patients who are
concerned about their skin care
55Power-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
56External Ultrasound-Assisted Liposuction Summary
- No objective proof of efficacy
57BlindnessInjectables (8 refs)
- Rare but well documented
- Related to
- Material injection
- Area injected
- Technique of injection
- Pretreatment
- Pre-existing disease
58Blindness and Injection
- Document vision before injection
- Get ophthalmologic consult immediately
- Usually irreversible
59Low 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
60RohrichLow 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.
61Hot TopicsModerators Conclusion
- The position of The American Society for
Aesthetic Plastic Surgery is to be wary - There is no good data
62Brava
- BRAVA claims to produce breast
- enlargement by wearing a suction device
63Downside of Brava
- Expensive 2,000
- Poor compliance
- Inconvenient
- Skin irritation
64Experience 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
65Hot TopicsModerators Comment
- BRAVA produces minimal results even with maximal
compliance - Compliance can be burdensome
66Will 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
67Hot 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
68Biochemistry 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
69Caloric 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
70Conclusion 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
71Hot TopicsModerators Conclusion
- The studies are good
- These are significant conclusions
- on Anti-Aging