Guidelines for Injector in Aesthetic Medicine

Updated 3/2017-- all links (except to my own posts) removed as many no longer active. 

There is a great article in the “throw-away” MedEsthetics magazine (July/August 2011 issue) written by Padriac B. Deighan, MBA, JD, PhD.  You can read the entire article here (pp 16-20; online issue).   If you employ any practice extenders in your office or run a medical day spa, you will find the article useful.

Deighan categorizes injectables in three ways:  botulinum toxins, dermal fillers, and sclerotherapy.

Botulinum toxins are prescription only drugs which are available to physician offices and via pharmacies, but not directly to non-physicians.  In other words, a registered nurse can inject neurotoxins under physician supervision, but cannot acquire them.

Botulinum toxin injection is considered a medical procedure which should only be provided in a medical setting by a trained and licensed provider (ie physician, registered nurse, nurse practitioner or physician assistant). 

Deighan notes that a medical spa is a medical setting ONLY if it is owned by a physician.  He recommends against Botox parties in patient’s homes, even though a physician can legally provide this service in that setting.

……

Injectable dermal fillers are not prescription drugs, but are medical devices

As such, they are delivered pursuant to the practice of medicine and all state and federal guidelines.  This is a distinction without difference because, although they are not prescriptive, medical devices – as categorized by the United States Food and Drug Administration (FDA) – can only be utilized in a medical facility and delivered to patients by an appropriate medical provider.

Non-medical day spas or even medical day spas without physician supervision should not be injecting dermal fillers.

……

Moving on to sclerotherapy used most commonly to treat leg veins but also other areas.  Sclerotherapy is the introduction of a foreign substance into the lumen of the vein to cause thrombosis and subsequent fibrosis.  The injected solution falls into three types:  Chemical Irritants (glycerin, polyiodinated Iodine), Hypertonic solutions (Hypertonic-saline 11.7%, Hypertonic-glucose), and Detergent sclerosants (Sodium morrhuate, Sodium tetradecyl sulfate, 0.25% -3%, Ethanolamine oleate, and Polidocanol foam, 0.5-5% ).

Deighan states that saline is not considered a medical device or product, but the others are and therefore are subject to medical practice guidelines for the particular state and must be delivered in a medical setting.

…….

Please go read the article for his take  on CMAs (certified medical assistants) and cosmetic medical procedures.  Here’s part of it:

Recently, many CMAs have wrongfully asserted that they are allowed to inject and, therefore, have been injecting botulinum toxins, dermal fillers and sclerosants.  CMAs are marginally trained, non-medical personnel………

It will also be a huge problem in any professional negligence claim, because there will be no coverage for such a loss.  An insurance carrier will not provide a defense or indemnity for any claim related to these procedures. …….

He extends this same stand to “certified” technicians. 

For example, some “certified laser technicians” and their employers incorrectly believe that the designation “certified” elevated their stature and allows them to perform medical services.  Certified Laser Technician, Certified Medical Esthetician, and Medical Esthetician are not categories of medical providers. ……..

Related posts:

Medical Spa Regulations (March 26, 2009)

Medical Lasers and the Law (March 25, 2009)

Dysport or Botox for Crow’s Feet?

Updated 3/2017-- photos and all links (except to my own posts) removed as many no longer active. 

A new study published online in Archives of Facial Plastic Surgery suggests Dysport (abobotulinumtoxinA) is better for treating Crow’s feet than Botox (onabotulinumtoxinA).

Let’s look at the study which only had 90 patients, all older than 18 years of age (mean age 54½, 77 women), were enrolled in a randomized, double-blind, split-face study.

The authors include this history of both products:

….in 2002, the FDA approved Botox Cosmetic (onabotulinumtoxinA) (Allergan Inc, Irvine, California) for the treatment of corrugator-mediated glabellar lines.

Concurrently, another botulinum toxin type A product manufactured by Medicis Aesthetics (Scottsdale, Arizona), Dysport (abobotulinumtoxinA), had been used in other countries since 1991. It was approved for cosmetic use in Europe in 2001, before being approved by the FDA in April 2009 for the treatment of moderate-to-severe glabellar lines.

Today, the cosmetic applications for onabotulinumtoxinA and abobotulinumtoxinA have expanded to the treatment of hyperfunctional lines related to the orbicularis oculi, frontalis, transverse nasalis, and depressor anguli oris, among other muscle groups.

The 90 patients were seen and treated between December 2009 to August 2010. To be included in the study, the men (n=13) and women (n=77) had to have moderate to severe lateral orbital rhytids at maximal contraction and NOT had botulinum neuromodulator treatment to the crow's feet within the prior 6 months.

Other exclusion criteria included: prior face-lift, brow-lift, or blepharoplasty; prior periocular laser or chemical resurfacing; prior adverse reaction associated with botulinum neuromodulator; or a history of degenerative neuromuscular diseases.

Each of the 90 participants were photographed prior to treatment and during each subsequent follow-up visit (posttreatment days 2, 4, 6, and 30).

A standard 5-view photographic series was taken for each patient at rest and at maximal contraction.

Patients and investigator separately assessed the crow’s feet at rest and at maximal contraction on each side, according to a validated 5-point photographic scale (0, no wrinkles; 1, very fine lines; 2, fine lines; 3, moderate wrinkles; and 4, severe wrinkles). This assessment was done prior to treatment and at each follow-up visit.

The treatment consisted of 10 U of Botox on one side of the face while the contralateral side received 30 U of Dysport with treatment sides of the face being randomized by computer-aided software. The recommended dosage ratio of Dysport to Botox varies from 5:1 to 3:1. The article sites the reason for this dosage “recent studies and the clinical experience of the senior investigator point to a 3:1 ratio as being optimal.”

Sixty-seven percent of patients preferred the side treated with Dysport, while 33% of patients chose the side treated with Botox. This difference was statistically significant (P = .002).

On post-treatment day 30, the investigator-assessed efficacy score at maximal contraction averaged 2.60 for the Dysport-treated side of the face and 2.33 for the Botox-treated side (P=0.01).

However, two other secondary end points, investigator and patient assessments of resting lateral orbital rhytids, did not achieve statistical significance (P = .42 and P = .28, respectively).

I would say this is a start in determining which might be better, but it needs to be remembered that this is a very small study and has not been duplicated.

REFERENCE

An Internally Controlled, Double-blind Comparison of the Efficacy of OnabotulinumtoxinA and AbobotulinumtoxinA; Kartik D. Nettar, Kenneth C. Y. Yu, Sumit Bapna, John Boscardin, Corey S. Maas; Arch Facial Plast Surg. 2011;Published online June 20, 2011. doi:10.1001/archfacial.2011.37

Using Botox for Hyperhidrosis

 Updated 3/2017-- all links (except to my own posts) removed as many are no longer active and it was easier than checking each one.

A few months ago a friend asked me about using Botox for her axillary hyperhidrois.  I had not ventured into this use of Botox (no patients referred or ask for it), but have been intrigued by it.  

A few weeks after our discussion which included me suggesting she ask her Dermatologist about the treatment as I felt this would be easier for her to get her insurance to cover the cost, I had the opportunity to use some “leftover” Botox on her.  This meant she would only get approximately half the suggested units, but she jumped at it.

Before treatment in addition to using antiperspirant, she would wear a T-shirt under her scrub top.  Often she would add protective “pads” to prevent ruining her good clothing.  Since she has been able to forgo the “pads” and the t-shirts.   It hasn’t been long enough to know if the reduced dose will reduce the longevity of the treatment.

Botulinum toxin (Botox) treatment temporarily blocks the nerves that trigger the sweat glands. The FDA approved Botox for axillary (underarm) hyperhidrosis in 2004.

The recommended dosage of Botox solution is 50 Units per axilla per treatment.  This is divided into injects approximately 1.5 – 2 cm apart.  (photo credit)

The pain my friend experienced seemed to be minimal, but topical creams could be used.

Improvements in sweating are typically seen within two to four days. The benefit usually lasts four to six months. Then, the treatment needs to be repeated.

   

REFERENCES

Botox Website:  Severe Underarm Sweating

Medscape has a video by Marina Peredo, MD on the Treatment of Hyperhidrosis With Botox

Dr. William Hall has a nice Youtube video:  BOTOX for Excessive Sweating/Hyperhidrosis Procedure.

Hyperhidrosis: A Review of Current Management; Atkins, Joanne L.; Butler, Peter E. M.; Plastic & Reconstructive Surgery. 110(1):222-228, July 2002

Use of A Grid To Simplify Botulinum Toxin Injection for Axillary Hyperhidrosis; Lam, David G. K.; Choudhary, S.; Plastic & Reconstructive Surgery. 112(6):1741-1742, November 2003.

Use of a Grid to Simplify Botulinum Toxin Injection for Axillary Hyperhidrosis; Kavanagh, Gina M.; Plastic & Reconstructive Surgery. 117(1):317, January 2006.

Botulinum Toxin A for Axillary Hyperhidrosis (Excessive Sweating); Marc Heckmann, M.D., Andrés O. Ceballos-Baumann, M.D., and Gerd Plewig, M.D.; N Engl J Med 2001; 344:488-493

Using Botox in Combination with Other Treatments

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. 

Recently I read and completed a nice CME article on Medscape (first reference below).  It focused on the consensus panel’s (second reference, from first article and not read by me) recommendations. 

As Botox and Dysport are used more often, it is becoming more common for them to be used in combination with other treatments (ie Laser resurfacing, fillers, and surgery).  It was nice to see a consensus regarding how to approach multimodal treatment with BoNTA. 

Treatment Recommendations

Botox+ Injectable fillers

BoNTA and injectable fillers can be administered the same day or separate days. However, it may be preferable to inject the first agent, wait until effects are clinically evident, and then follow up with second agent as needed.

Upper face: Typical to inject BoNTA first.
Mid and lower face: Typical to inject filler first.

Botox + Ablative laser resurfacing

Inject BoNTA several days prior to the ablative procedure and wait until BoNTA effects are clinically evident.

Botox + Nonablative lasers/chemical peels

Nonablative procedure first. Inject BoNTA 10-15 minutes after nonablative procedure.

Botox + Surgery

Avoid injecting BoNTA on day of surgery. Follow-up BoNTA injections can continue beginning 3 months after surgery.

REFERENCE

Aesthetic Treatment With Neurotoxins: Options and Individualized Treatment: Practical Use of Botulinum NeurotoxinA in Aesthetic Practice; Medscape article,   06/18/2010;  Michael A.C. Kane, MD

Kane M, Donofrio L, Ascher B, et al. Expanding the use of neurotoxins in facial aesthetics: a consensus panel's assessment and recommendations. J Drugs Dermatol. 2010;9;7-22.

More on Allergan Botox Suits

Updated 3/2017 -- all links removed as many no longer active. and it was easier than checking each one.

A year ago the FDA required Allergan to add a black box warning Botox and a Risk Evaluation and Mitigation Strategy (REMS)  to it’s safety labels for all botulinum toxin products.  The agency took the action because of two main reasons. 

In February, I wrote about the lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.

Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. In March, Orange County Registar ran this article by Colin Stewart:  Allergan wins Botox death trial.

Yesterday Katherine Hobson, WSJ Blog, wrote an article:  Allergan Now Batting .500 in Botox Lawsuits

Yesterday an Oklahoma jury awarded $15 million to a woman who claimed she experienced pain and other problems after receiving the shots, reports the Orange County Register. (The O.C. is Allergan’s home base.) Though the jury ruled for Allergan on a product liability claim, it found the company was negligent in its off-label promotion of the drug, plaintiff’s attorney Ray Chester tells the Health Blog.

The Orange County Register article by Colin Stewart:  Jury blames Botox

An Oklahoma jury Tuesday reached a $15 million negligent-damage verdict against the maker of Botox in the case of a 47-year-old woman who suffered years of pain after getting the wrinkle-smoothing injections.

The suit was filed against Irvine-based Allergan by Dr. Sharla Helton, an obstetrician and gynecologist in Oklahoma who fell ill and eventually lost her job after getting the injections in 2006.

She blamed Botox for double vision, breathing difficulty and years of continual pains in her arms, hands and feet.

The article states “wrinkle-smoothing injections” were done, doesn’t specifically tell us why Dr Helton had Botox injections, but leaves us to assume it was facial expression lines.  Botox can be used safely, but should be done by a trained physician.  I would not recommend the DIY trend.

Related posts:
Excess Sweating  (April 20, 2009)
BOTOX -- Black Box Warning (May 7, 2009)
Neurotoxins: Dysport and Botox (January 6, 2010)
Black Market Botox  (January 27, 2010)
Botox Gets Bad Press (February 10, 2010)
Botox for Upper Extremity Spasticity 9March 17, 2010)

Botox for Upper Extremity Spasticity

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

Until recently, the therapeutic use of non-cosmetic BOTOX (onabotulinumtoxinA) for adult upper extremity spasticity was considered off-label use. Last week, the U.S. Food and Drug Administration (FDA) approved Botox to treat spasticity in the upper extremity flexor muscles in adults.

Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis. Spasticity is defined as

“a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyper-excitability of the stretch reflex as one component of the upper motor neuron syndrome.”

Spasticity often creates problems with mobility, self-care, and function. The spastic muscles can become stiff. Associated joints can be affected by lack decreased range-of-motion with contractures forming.

Botox works by temporarily blocking the connections between nerves and muscles, resulting in a temporary paralysis of the spastic muscle. Advantages of using Botox to treat muscle spasm include the ability to target specific muscles which when successful allows reduction of other systemic medications (ie Zanaflex, Baclofen, Dantrium).

Botox does not take the place of conservative measures, such as positioning, stretching and exercise in spasticity management. These measures remain essential.

Botox can decrease the dosage or use of oral antispastic medications which often provide only limited effects with short duration and frequent unwanted systemic side effects, such as weakness, sedation and dry mouth.

Botox has a Black Box Warning that states the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

The most common adverse reactions to Botox reported by patients with upper limb spasticity were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms.

Botox has not been shown to be safe and effective treatment for other upper limb muscles, spasticity in the legs, or for treatment of fixed contracture – a condition that affects range of motion. Treatment with Botox is not intended to substitute for physical therapy or other rehabilitative care.

REFERENCES
FDA News Release

Botulinum toxin type A in the treatment of upper extremity spasticity: A randomized, double-blind, placebo-controlled trial; NEUROLOGY 1996;46:1306; D. M. Simpson, MD, D. N. Alexander, MD, C. F. O'Brien, MD, M. Tagliati, MD, A. S. Aswad, MS, J. M. Leon, PhD, J. Gibson, MD, J. M. Mordaunt, MS and E. P. Monaghan, PhD

Botulinum Toxin in Poststroke Spasticity; Clin Med Res. 2007 June; 5(2): 132–138; Suheda Ozcakir, MD and Koncuy Sivrioglu, MD

Botox Gets Bad Press

Updated 3/2017-- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

BOTOX has been getting a lot of bad press recently. First, the potential use of black market Botox in terroristic activity. Now it is the focus of a lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.

Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. The trial began two weeks ago. I have looked for updates, but found none.  [update below]

BOTOX is most commonly known for it’s cosmetic uses in wrinkle reduction, but is approved by the FDA for treatment of cervical dystonia, strabismus, blepharospasm, primary axillary hyperhidrosis, and glabellar wrinkles. It is also used "off label" for a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, traumatic brain injury, cerebral palsy, achalasia, and various dystonias.

The treatments in cerebral palsy are used to decrease muscle spasms. A multidisciplinary panel systematically reviewed relevant literature from 1966 to July 2008 and published their recommendations in the Journal Neurology:

For localized/segmental spasticity, botulinum toxin type A is established as an effective treatment to reduce spasticity in the upper and lower extremities. There is conflicting evidence regarding functional improvement. Botulinum toxin type A was found to be generally safe in children with cerebral palsy; however, the Food and Drug Administration is presently investigating isolated cases of generalized weakness resulting in poor outcomes.

Recommendations: For localized/segmental spasticity that warrants treatment, botulinum toxin type A should be offered as an effective and generally safe treatment (Level A).

Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes temporary muscle paralysis. A Botox “black box” warning was ordered by the FDA in May 2009 due to reports that the effects of the toxin may spread from the area of injection to other areas of the body causing serious adverse problems. This label requirement is required on Botox and Botox Cosmetic (botulinum toxin type A); Myobloc (botulinum toxin type B); and a new FDA-approved product, Dysport (abobotulinumtoxinA).

When the botulinum toxin spreads beyond the area injected the toxin can cause symptoms similar to those of botulism. These symptoms include unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids

According to AboutLawSuits.com Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug.

 

REFERENCES

LA Times

Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review); NEUROLOGY 2010;74:336-343

 

***March 3, 2010 Update

Yesterday, Orange County Registar ran this article by Colin Stewart:  Allergan wins Botox death trial. 

By a 10-2 vote, jurors decided Tuesday that Botox-maker Allergan was not responsible for the death of a young cerebral palsy patient who died in 2007 after Botox injections.

Black Market Botox

Updated 3/2017-- photos and all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

Earlier today I listened to NPR’s broadcast of the Diane Rehm show:  Implications of a Global Black Market for Botox (link removed 3/2017 -- no longer active).  The guests were

Col. Randall Larsen, executive director of the bi-partisan, Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism and the founding director of The Institute for Homeland Security (2000-2003)

Marina Voronova-Abrams, biosecurity or biothreat reduction expert, formerly based in Central Asia and Russia, now works for the nonprofit environmental group Global Green

Dr. Tina Alster, clinical professor of dermatology at Georgetown University Medical Center and the Director of the Washington Institute of Dermatologic Laser Surgery.

Kenneth Coleman, a Senior Fellow, for the Chemical & Biological Weapons Nonproliferation Program (CBWNP) of the James Martin Center for Nonproliferation Studies at the Monterey Institute of International Studies

In full disclosure, Diane Rehm begin by mentioning the use of Botox for her own vocal spasmotic dystonia.  Very interesting show.  

The reason for the show was the Washington Post article by Joby Warrick  “Officials fear toxic ingredient in Botox could become terrorist tool” posted Monday, January 25, 2010.

….Obtaining the most lethal strain of the bacterium might have posed a significant hurdle for would-be terrorists in the recent past. But today, the prospect of tapping into the multibillion-dollar market for anti-wrinkle drugs has spawned an underground network of suppliers and distributors who do most of their transactions online, the researchers found. Customers don't need prescriptions or identification, other than a shipping address………..

So lethal is the undiluted toxin that at least three countries -- the United States, the then-intact Soviet Union and Iraq -- explored its possible use as a possible biological or chemical weapon. All three gave up on the idea, partly because botulinum toxin degrades quickly when exposed to heat, making it poorly suited for delivery by missile or bomb

Having taken a few courses on Disaster Preparedness, it is always pointed out botulinum toxin is not a great toxin for mass destruction as it would be difficult to weaponize the bacteria as noted above and here.

Botulinum toxin is the most poisonous substance known.  A single gram of crystalline toxin, evenly dispersed and inhaled, would kill more than 1 million people, although technical factors would make such dissemination difficult. The basis of the phenomenal potency of botulinum toxin is enzymatic; the toxin is a zinc proteinase that cleaves 1 or more of the fusion proteins by which neuronal vesicles release acetylcholine into the neuromuscular junction.

BOTOX is currently licensed for treatment of cervical dystonia, strabismus, blepharospasm,  primary axillary hyperhidrosis, and glabellar wrinkles.  It is also used "off label" for a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, traumatic brain injury, cerebral palsy, achalasia, and various dystonias.

REFERENCES

Botulinum Toxin as a Biological Weapon;  JAMA. 2001;285:1059-1070 (consensus statement)

Bogus Botox® (botulinum toxin type A) Suspected in Botulism Outbreak; Medpage Today, November 30, 2004; Jeff Minerd

Caution About a Bioterror Attack on the U.S. Milk Supply; June 2005; Marguerite Rigoglioso