Plastic Surgeon Herluf G. Lund Jr., MD, FACS From St. Louis Cosmetic Surgery

With four plastic surgeons and a medical spa, St. Louis Cosmetic Surgery has been around for more than 35 years.

Name: Dr. Herluf Gyde Lund, Jr.
Location: Chesterfield, MO
Website: stlcosmeticsurgery.com

As part of a large cosmetic practice in St. Louis that is one of the largest cosmetic breast surgery practices in the country, Dr. Lund has undoubtedly seen his share of patients and has stories to tell. In this inteview, Dr. Lund shares his clinics compensation structures for staff members, details different types of medical spa business models, and shares his thoughts on building a successful practice.

That's interesting: Dr. Lund chairs and serves on numerous committees for both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery and is a principle investigator in studies using the next generation, Cohesive Gel Implant. Every summer, Dr. Lund volunteers as the "camp doctor" for Camp Chippewa for Boys in Cass Lake, Minnesota.

What do you think physicians need to know about starting or running a medical spa?

Determine first if you really need a medical spa. If you just want to provide some products and skin care, then you may not need to add a great deal of staffing and services. You may be able to train your nursing staff to provide many of the treatments and the product manufacturers are usually very willing to help train you staff on how to market and sell their product lines. This does not require a big investment in inventory and office space and also lets you “try the water” first. Once you have made the decision to open a medical spa, then you need to decide what you want your medical spa to do. Once you have decided what you want to do, then you need to examine your patient practice mix and the surrounding competition to determine if the goals you have set are achievable given the environment you practice in. For example, there are essentially four types of medical spa models to choose from when setting up a medical spa...

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Interview: Brian K. Sidella, Founder Of Forever Young Medspa In South Florida

Brian K. Sidella, Owner and President Forever Young Medspa

Surviving and thriving in the cut-throat cosmetic industry of South Florida.

Brian Sidella, founder of Forever Young Medspa sat down with us to discuss how a non-physician running a medical spa competes with a host of physician run clinics in South Florida.

Name: Brian K. Sidella
Location: Cooper City, FL
Website: foreveryoungmedspa.us

Having now been in this business for almost 7 years, I’m still amazed at how this industry operates. Most of the players have a planned obsolescence strategy of about a 4 year life cycle and then most force you into a fork lift upgrade. As an example you could have begun 2004 with a Palomar Medilux, bought a Starlux 300 in 2005, a Starlux 500 in 2009 and now an Icon in 2012. Each of these systems represents a six figure investment. Whoever brings to market a field upgradable platform that will last a decade is going to dominate… as for the technology itself we have a pretty extensive suite from Palomar, Cynosure, Syneron, Edge & BTL. We use Palomar for IPL services and 1540 Fractional, Syneron for the Matrix, Cynosure for laser hair removal, Edge for HydraFacial M.D., Syneron for VelaShape & BTL for the Exilis...

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Dr. Daniel Kaufman, Discreet Plastic Surgery In Manhattan & Brooklyn

Daniel Kaufman MD stays busy with clinics in Manhattan's Upper East Side, the East Village, Brooklyn, and a location in Garden City, Long Island. 

Dr. Daniel Kaufman Plastic and Reconstructive Surgeon

Name: Daniel Kaufman, MD
Location: New York, NY
Website: DiscreetPlasticSurgery.com

Thats interesting:  He holds a Master of Science degree in Biomedical Engineering from the Polytechnic Institute of New York University. In fact, he helped create the program, just after completing his medical degree.

What is your professional approach to cosmetic medicine?

Training in plastic surgery, you learn about a wide variety of surgical procedures, cosmetic and reconstructive, that can be utilized in a multitude of medical situations. As a plastic surgeon facing difficult medical problems, I always

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Jeffrey W. Kronson, MD, of Gia Laser Aesthetic Center in Claremont CA

Dr. Jeffrey W. Kronson California Board Certified SurgeonTalking medical spas with Dr. Jeffrey Kronson of Gia Laser Aesthetic Center in Claremont, California.

Physician: Jeffrey W. Kronson, MD, FACS
Location: Claremont, CA
Website: http://www.gialaser.com

Profile:  Jeffrey W. Kronson, M.D., F.A.C.S. is the founder of both the Whittier Vascular Surgery Center and Gia Laser Aesthetic Center and a Past-Chair of the Department of Surgery at Presbyterian Intercommunity Hospital in Whittier, California. He currently practices at Methodist Hospital in Arcadia and Huntington Memorial Hospital in Pasadena. Dr. Kronson is Board-Certified by the American Board of Surgery in both general and vascular surgery and is a Fellow of The American College of Surgeons.

He currently serves as Medical Director at Gia Laser Aesthetic Center, which he founded in 2007.

How did you get started in cosmetic medicine?  

I had a large varicose vein practice where I was treating literally thousands of legs that were pathological but I had a real hard time with the cosmetic needs of the patients, usually for an insurance or financial reason. I opened the Medical Spa as a way to engage these clients in services that they requested, giving them different options and avenues. From there, it grew into the full complement of injectables (Botox and dermal fillers) IPL, body contouring, medical aesthetics and cosmeceuticals.

Now we have a full service Medical Spa. It is run by 5 full time employees, as I am there 2 days a week or by appointment. Our average patient is 30-65, educated, upper-middle class and often executive. Being just outside LA proper, we see our fair share of A-list celebs who don’t want the paparazzi chasing them. We offer complete privacy, complementary car service and a discreet, professional standard that is difficult to find elsewhere.

How do you select and manage your staff? Did you encounter any problems?

I have a full-time manager who screens candidates, we interview them then together and make a decision. We are part commission and part salary. Before I had the excellent woman that is currently working with me now, I had DISASTERS in finding supervisory personnel. I unfortunately ran into theft, deceit and dishonesty. Right now, that is a thing of the past.

It is also very difficult to find an RN who is as good clinically as she is selling retail. We also have finally found such a person but we need one more.

What laser technologies are you currently using?

We use Syneron EMax, Velashape and Lipolite. I bought these systems from the end of 2007 to the middle of 2009. The non-invasive Elos technology continues to give us superb results with no down time.

The new systems are interesting, less expensive as the economy has fallen, but all seem to require less individual treatments and fewer patient visits. It stands to follow that most are more invasive or ablative, though there is no long-term data that I am aware of on all these new ones out there.

If there was such a product that clearly was faster, non-invasive and gave outstanding results, we would certainly entertain the idea of purchasing it.

What marketing strategies have you found effective for your clinic? 

  • Social media (FB), the internet, many marketing sites.
  • Clipper coupon ads
  • Some print
  • Glossy postcards
  • Word of mouth, specials and invertising still the best.

What treatment/s generate the most revenue?

Lipolite and laser in general are most profitable as there are no disposables.

Any parting advice for other docs starting or running medical spas?

 Know everything. If there is a “rogue” RN operating outside the boundaries of your practices and policies, you will be meeting an attorney sooner rather than later;.

Doing this job well is a FULL-TIME commitment. It is far different to add a laser to an MD’s practice than to open a free-standing Medical Spa in addition to a busy practice. Learn finance. Hire people you trust. Know what you don’t know and hire someone to know it.

This interview is part of a series of interviews of physicians running medical spas, laser clinics and cosmetic surgery centers. If you'd like to be interviewed, just contact us.

Interview: Stephen Weber MD, PhD of Lone Tree Plastic Surgery

Sitting down with Dr. Stephen Weber of Lone Tree Facial Plastic & Cosmetic Surgery Center outside of Denver, Colorado.

Physician: Stephen Weber MD, PhD
Location: Lone Tree, CO
Website: http://www.lonetreefacial.com

That's interesting: Dr. Weber has participated in the "Face to Face" program where local plastic surgeons donate their services to the victims of domestic violence and has participated in the annual humanitarian mission surgical trips providing free care to medically isolated, indigent patients.

Profile: I am a double board-certified Facial Plastic and Reconstructive Surgeon practicing at Lone Tree Facial Plastic & Cosmetic Surgery Center in the Denver metro area. My practice involves all aspects of facial cosmetic surgery including facelift, browlift, blepharoplasty, rhinoplasty, otoplasty, facial implants, facial resurfacing and scar revision. Our office also provides comprehensive treatments for facial aging including Botox and Dysport to reduce facial wrinkles, dermal fillers to minimize facial lines and folds as well as fractional laser (Fraxel and MiXto) resurfacing.

Can you tell us a little bit about you and how you got started in cosmetic medicine?

I became a Facial Plastic & Reconstructive Surgeon by a very circuitous route. In medical school, I planned to become an Infectious Disease specialist and even obtained a Ph.D. in Immunology and Microbiology in pursuit of that goal. However, my first rotation after successfully defending my thesis was in head and neck surgery. I knew that first day that I wanted to become an Otolaryngologist (Head & Neck Surgeon, ENT). During my residency training in Otolaryngology and Head & Neck Surgery I realized that my goals of performing a diversity of procedures in a technically demanding sub-specialty made Facial Plastic Surgery a very well suited specialty. I trained as Dr. Shan Baker’s fellow in Facial Plastic Surgery at the University of Michigan and then entered practice.

Can you tell us more about your clinic and the services available? 

My practice is a single specialty clinic. We have two plastic surgeons here at the practice, myself and Dr. Rick Schaler who is my partner and practice owner. We have eight other staff including one nurse, five estheticians, one front desk staff member and a billing manager. We offer the full range of facial reconstructive and cosmetic surgery. Our office has a fully functional operating room in which we perform all of our cosmetic procedures under IV sedation. On the medical spa side, we offer all of the available injectable treatments including Botox, Dysport, Xeomin, Restylane, Perlane, Juvederm, Radiesse and Sculptra. We perform laser services including Fraxel and MiXto (fractional CO2) resurfacing, vascular laser and laser hair removal treatments. We also perform a full complement of facial peels and facial treatments. Our patient population comes from the surrounding suburbs of Lone Tree, Highlands Ranch, Littleton, Parker as well as Denver proper.

How are you dealing with staff in your clinic?

Fortunately, we have not had the need to fire staff. The reason for this is that we’re very careful with the hiring process. The communication between members of our office is very clear. When we set out to hire a new member of the office we have a clear, articulated goal regarding our needs and the type of person we want to hire. Everybody in the office has a chance to veto a potential new member of the office staff. Each member of the office also has the opportunity to veto that potential candidate. We tend to hire from a pool of people already familiar to the office or from strong referrals from friends of the practice. We have avoided print advertising of open positions of late as this always leads to a huge response with relatively low yield of the type of candidate that we need.

For the front desk staff, compensation is hourly. For procedure or treatment oriented members of the office, including physicians, compensation is heavily weighted toward production. This is the most fair compensation method and encourages productivity. The formula is simple, clearly articulated and fair. Employees are paid a percentage of net collections. An employee can review their production at the end of each month, if requested. I review my own production at the end of every pay period and encourage the rest of our staff to do the same.

What laser technologies are you using now? How do you decide on new purchases?

We perform laser treatments including Fraxel and MiXto (fractional CO2) resurfacing, vascular laser and laser hair removal treatment. In terms of new purchases, laser companies really need to show us a substantial improvement in results before we will purchase new technology. We are marketed to by phone, mail, email and at conferences. I am interested in new radiofrequency technologies but I think the jury is still out and we’re holding out on making that purchase.

How do you market your clinic?

In terms of social media, we market on Facebook , Twitter, as well as LinkedIn. We’re trying to determine whether Pinterest can be leveraged with pre- and post-op photos and other images. We use social media to communicate with current and prospective patients with informational posts and product samples/ give-aways. Our email list of current patients is our most valuable marketing tool. Providing current patients with updates that they can forward to friends is invaluable. We also put on open houses and seminars that allow us to provide education, meet new patients and learn more about our current clients.

In the pay-per-click arena, we use Google AdWords with a relatively conservative budget. That has drawn a lot of traffic to our website and helped generate surgical cases. We have been testing the waters of direct mail and print advertising. Direct mail has had moderate result. Print advertising has been disappointing. We do not currently take part in Groupon, Living Social or any other daily deal sites. The main reason for this is cost and questionable ability to develop lasting relationships with users of these services.

What are the most coveted treatments/services in your practice? Have you tried removing some of your services?

The sun and dry air in Denver are the reason why people flock to this area. However, they wreak havoc on facial skin. As a result the demand for lasers and peels here is tremendous. On a volume basis, Fraxel skin resurfacing and Botox are the most common services in our office. However, the fixed cost associated with these services is significant. From a revenue perspective, surgery provides the greatest revenue and greatest profit for the practice. About 75% of our cases are elective in nature. We have not dropped any procedures recently. When I joined the practice, I introduced Sculptra facial injections and Radiesse hand rejuvenation and we’ve seen high demand for these treatments. 

What have you learned about practicing cosmetic medicine?

I’ve developed a thicker skin and learned not to take things personally. In the past, when a patient booked surgery with a competitor I assumed that I had erred in some way or not provided excellent photos of patient results or …. I’m noticing today more and more patients that will meet multiple surgeons and come back to book surgery with me. When I’ve asked why, the answers that patients provide are incredibly vague. It really is a gut feeling that people have that you are or are not the surgeon that will provide what they’re looking for. All we can do is provide as much information and education, quality photos of surgery results, a top notch facility and a warm, caring environment to convince patients that we’re the right team for them.

Any last thoughts on advice for your physician colleagues in the cosmetic industry?

I would urge physicians, especially in the plastic surgery realm, to compete by providing exceptional service. With Groupon and other daily deal sites, there is increasing pressure to compete on cost. Some of these deals will temporarily drive patients into the practice. However, few are likely to be loyal patients when the practice down the road runs an even cheaper deal. The daily deal trend has provided consumers with cheap (not necessarily quality) services. However, this has come at the expense of sustainability for practices that jumped in without doing enough research. The bottom line is that daily deals will lead to a spike in volume composed of largely price-oriented patients. Further, the deal seeking crowd is unlikely to see the value in your services. Continuing to drive down prices when our costs are fixed is not only unsustainable but diverts your attention from providing services, such as surgery, that are the profit engine for the practice. When you offer services at cost, you CANNOT "make it up on volume."

This interview is part of a series of interviews of physicians running medical spas, laser clinics and cosmetic surgery centers. If you'd like to be interviewed, just contact us.

Interview: Anthony Youn, MD, FACS

Medspa MD's interview with Dr. Anthony Youn, MD, FACS, a plastic surgeon and author practicing in Michigan.

Physician: Dr. Anthony Youn, MD, FACS
Location:
Troy, Michigan
Website:
www.dryoun.com
That's interesting: Dr. Youn has been named one of the top three plastic surgeons in the United States by askmen.com and the only Michigan plastic surgeon named as a Top Doctor by U.S. News and World Report.

Profile: I am a board-certified plastic surgeon in private practice in Troy, Michigan. I am a member of the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery, and an Assistant Professor of Surgery at Oakland University / William Beaumont School of Medicine.

Can you tell us a little bit about your background and how you got started as a plastic surgeon?

My first taste of plastic surgery was when I underwent major reconstructive surgery to my jaw in the summer between high school and college.  Prior to this surgery, my mandible was so large it was twice the size of Jay Leno’s and dubbed “Jawzilla.” At the time I hoped that this surgery would transform me, a skinny Asian American nerd with no nerve, no game, and no clue, into an Adonis: A ladies’ man.  Unfortunately, this surgery started a four-year dating drought, and didn’t really teach me that changing your appearance could change your life until much, much later.

My real introduction to plastic surgery came in the form of an eight-month-old boy who was mauled by a raccoon. His face was literally eaten off. The moment I saw the plastic surgeon make plans to reconstruct this poor child’s face, I was hooked. I describe this scene in great detail in my book.

I completed my plastic surgery residency at Michigan State University in Grand Rapids, a fellowship in aesthetic plastic surgery in Beverly Hills, and stared my private practice in Metro Detroit.

Can you tell us more about your practice and how it's organized?

Youn Plastic Surgery, PLLC is a private practice plastic surgery clinic. I have six employees: a receptionist, a patient coordinator/scheduler, a medical assistant, two aestheticians, a nurse injector, and myself. The office inhabits 4000 sq feet on the 12th floor of the tallest high rise building in Metro Detroit. We offer a full range of surgical and non-surgical plastic surgery treatments, including laser treatments, injections, cosmetic and reconstructive plastic surgery.

Staff compensation is often a question for docs. How do you handle that?

All of my employees are paid hourly, with no pre-set incentives or commission. Full time employees get full benefits, including health insurance, 401K, and profit-sharing. I work with a practice management company to help with payroll and other employment issues.

What are your thoughts about the IPL and cosmetic lasers that youre using in your clinic?

Due to my frequent media appearances, I often have new technology come through my office, usually for limited periods of time. I frequently present the newest laser and light-based technology for several television programs, and have partnered with various companies who supply them to me on a trial basis. That being said, I also own several ‘workhorse’ devices that are used on a daily basis.  I have the Cynosure Cynergy laser, which combines pulse dye and Nd-YAG lasers in one, and the Syneron eLight with Refirme, hair removal, and skin rejuvenation treatment heads. My office also uses the Dermosonic device for the temporary reduction of cellulite and a microdermabrasion machine as well.

Sound's like you're fortunate in that you're really busy which leads to the next question: How are you marketing your practice?

I’m fortunate that the only advertising I purchase is the maintenance of my three websites:dryoun.com, celebcosmeticsurgery.com, and institchesbook.com.  I’m often featured in local and national media, which has given me a significant amount of exposure. In the past I’ve used many sources of advertising, including newspapers, local magazines, internet SEO, local TV and radio, all with varying results. I find that internal advertising using Constant Contact (email software) has been our most effective means of getting the word out. The yellow pages is the one media source I recommend other providers not waste their money on.

I recently went on a book tour to promote my book which included articles in several magazines and newspapers, including Plastic Surgery Practice and Plastic Surgery News.  This exposure has been really valuable for my practice.

What treatments or services are most profitable for you?

No question, Surgery. The vast majority of the profits of my practice come from surgery. Although approximately 25-30% of the gross practice revenue stems from non-surgical treatments, approximately 60-70% of this revenue goes to supply costs, like Botox vials, Restylane syringes, and laser maintenance costs. 

Plastic surgeons, like all doctors in cosmetic medicine, usually have some interesting patient stories to tell. Do you have one that really stands out?

As a plastic surgeon, I often encounter patients whom I suspect suffer from Body Dymorphic Disorder, or BDD. Typically, I encourage them to seek counseling and avoid plastic surgery. Unfortunately, most BDD patients don’t believe they have the disorder and refuse to see a therapist. I remember a patient I’ll call “Jane.”

Jane was a librarian in her mid-forties who consulted me for eyelid surgery. It didn’t take long for me to diagnose her with BDD.

“So what would you like to talk about today?” I asked her.

“Don’t act like you don’t know, Dr. Youn. I see you staring at my eyes.  Just like everyone who comes into the library. They pretend to read books or go through the card catalogue, but the moment I look away they stare at me. I catch them doing it all the time. I need you to fix my hideous eyes.”

“What’s wrong with them?  I think they look fine.”

“Don’t patronize me. You know what’s wrong with them! I’ll pay you five thousand dollar cash to fix them. I hear you’re the best. I want you to make them perfect.”

I spent an hour trying to convince Jane that she didn’t need surgery and that she should seek professional counseling instead. She wouldn’t listen.  She became increasingly agitated. Finally she said if I didn’t operate on her, she would take a scalpel and perform the surgery on herself in my office right then! 

Cue creepy horror film music here.

I would never operate on Jane, who clearly seemed mentally imbalanced. But I wanted to say no to her as tactfully as possible. I pulled out my trump card. When things get ugly, I go to the one excuse that always defuses a situation, guaranteed to reject a patient for surgery without making her upset. 

Sadly, it’s the same excuse countless women used on me during high school and college.

“Jane, it’s not you, it’s me. I’m not ready to do your surgery. I don’t think I’m a skilled enough surgeon to make you happy.

“Really?”

“Yes. Jane, I’m not good enough for you.”

Don’t laugh. She bought it.    

Any final words of advice for other physicians running their own clinic?

I think the best advice I can give is this: When you are done with work, do things you enjoy.  As physicians, we are accustomed to delayed gratification. It’s always a challenge for us to find balance in our lives. I currently split my time between my family, my work, and writing. We’ve each undergone over 23 years of schooling to become practicing physicians, and now is the time to enjoy the fruits of our labor. Find moments of happiness in your work and at home. I think the turtle in Kung Fu Panda said it best, “Today is the present, and that’s why it’s a gift.”

About: Dr. Youn is the author of a plastic surgery tell-all, In Stitches, recently published by Simon and Schuster and  a regular contributor to CNN.com, MSNBC.com, and USA Today.  Dr. Youn has been featured on the Rachael Ray Show, Good Morning America, the Dr. Oz Show, the CBS Early Show, and many others.

Dr. Youn has authored or co-authored several papers and scientific manuscripts on plastic surgery, including such procedures as the Volumetric Facelift and Facial Reshaping. In addition, throughout his career he has conducted scientific research on a variety of topics, extending from cosmetic surgery, to laser treatments, to reconstructive trauma surgery, to HIV medications.  He is a member of the Editorial Advisory Board for Plastic Surgery Practice Magazine and has lectured throughout the country.

This interview is part of a series of interviews of physicians running medical spas, laser clinics and cosmetic surgery centers. If you'd like to be interviewed, just contact us.

Can Nurse Practitioners Offer Botox?

Can nurse practitioners offer botox and fillers?

Guest Post By Carolyn Buppert, NP, JD

Can Nurse Practitioners offer Botox, Restylane, Juvederm and other cosmetic treatments on their own?

The answer to this question is going to be state-specific. Here are the steps to follow:

  1. Read your state's Nurse Practice Act section on scope of practice for nurse practitioners to answer these questions: What acts require physician collaboration or supervision? How is collaboration or supervision defined? (Boards of Nursing in the United States: State-by-State Web Links)
     
  2. Go to your state's Board of Medicine Websites and search for any policies on provision of botulinum toxin (Botox®). Note that botulinum toxin is a prescription medication, so a prescription or order for the medication must be written and someone must administer the drug. If your state has policies on botulinum toxin, note the requirements for prescription and administration. Some states consider administration of botulinum toxin a medical act, and some states consider it to be within the scope of a registered nurse. Prescribing is always a medical act.
     
  3. If you live in a state that requires no physician collaboration when nurse practitioners prescribe, then as long as the Board of Medicine has no requirements with respect to botulinum toxin, you are free to proceed with your practice idea. If your state requires physician collaboration in order for nurse practitioners to prescribe, then you'll need to line up a collaborator. In most states, the collaborator does not need be on site, but in some states, the collaborator must practice at the site with specified frequency. Follow the rules as they relate to any prescribing.

About: Carolyn Buppert, NP, JD is an attorney practicing in Bethesda, Maryland.


Xeomin vs. Botox vs. Dysport

Botox & Dysport now have a new contender in the cosmetic space... Xeomin.

About Xeomin: (pronouced ZEE-oh-min) from Merz Pharma GmbH & Co KGaA

Download the Xeomin Report PDF

Botox, Dysport and Xeomin have a lot in common, but they also have some important differences. Unlike both Botox and Dysport, Xeomin does not need to be refrigerated before it's reconstituted (see below). This should be an advantage during distribution. What's more, Xeomin has no additives — just botulinum toxin type A. This may lessen a patient's likelihood of developing antibodies.

Supposedly, Xeomin is more like Botox than Dysport. It takes about one week for the full effects of Xeomin injections to be realized, and once this occurs the results last from three to six months. Dysport, Xeomin and Botox should not be used interchangeably.

Also, since Xeomin is approved only for cervical dystonia and blepharospasm in adults who have had previous treatments with onabotulinumtoxinA (Botox), any use for wrinkles and crows feet is going to be off label. This, along with the fact that Botox pretty much owns this space will probably mean that Xeomin will have a hard slog finding a huge audience. It may be worth trying thought to see if you just like it that much better. (Anyone who's already tried it, please leave a comment and let us know what you think.)

Storage

Unopened vials of XEOMIN® (incobotulinumtoxinA) can be stored at room temperature 20 to 25°C (68 to 77° F), in a refrigerator at 2 to 8°C (36 to 46°F), or a freezer at -20 to -10°C ( 4 to 14°F) for up to 36 months. Do not use after the expiration date on the vial. Reconstituted XEOMIN® (incobotulinumtoxinA) should be stored in a refrigerator at 2 to 8°C (36 to 46°F) and administered within 24 hours.

Indications & Usage

Cervical Dystonia: XEOMIN (incobotulinumtoxinA) is indicated for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients.

Blepharospasm: XEOMIN (incobotulinumtoxinA) is indicated for the treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox).

Complications

Like other botulinum products, Xeomin must carry a black box warning regarding a rare risk for spreading outside of the injection site. If this occurs, life-threatening swallowing and breathing problems may result. This has not been seen in people receiving neurotoxins for cosmetic reasons or to treat blepharospams. It has mainly occurred among children treated off-label for cerebral palsy-related muscle spasms.

Adverse Reactions

Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).

Blepharospasm: The most common adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).

Drug Interactions

Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Cost

The costs are expected to be similar to Botox. I checked over on Medical Spa RX and they don't seem to be carrying it as of now so you won't be able get a deal on it the way you can with Rx's Botox Group Buy Program.

Have you got any intention of trying something besides Botox or Dysport? Does Xeomin have a chance in your clinic? Would you try it on a few patients to see if you like it?

Texas Law & Botox Regulation

Eveidently, and this surprises me, if you're in Texas, anyone can inject Botox, Restylane, orJuvederm if they're 'delegated to' by a clincian.

Is this why the individuals and websites that were leading the do-it-yourself Botox injections hailed from Texas?

Hopefully, Texas will get it's act together and finally pass some sensible regulation around Botox and injectables. Undoubtedly there are individuals who have been injecting safely and will be affected by this but it's just not a good idea to have anyone able to inject.

via WFAA.com

Last year, actress Dana Delaney opened up publicly in Prevention magazine about getting a botched Botox job that caused one eye to droop. She said the wrinkle fighting toxin was improperly injected into a nerve.

Botox and other injectable treatments are controlled substances. Only someone with a medical license can order them. That has many surprised to hear there are no rules about who can inject them. In medical spas across Texas, just about anyone can wield the needle.

“As long as I’m the one purchasing it, right now I can delegate to whoever I want to,” said Dr. Lori Stetler, a Dallas dermatologist.

Stetler applauds efforts to make the lucrative anti-aging industry safer for patients.

Friday, the Texas Medical Board will consider changing who can be delegated to perform “cosmetic procedures” that use “prescription medications.” That includes Botox and a host of other wrinkle fillers, including Restylane and Perlane.

Among the considerations is limiting who can give injections to doctors, nurses or physician assistants. Training is also an issue. Currently, no experience is required.

“There’s no set or approved curriculum or licensure or anything for that,” said Stetler, who says patients can unknowingly find themselves in unqualified and inexperienced hands.

She hopes potential state-wide changes will improve the safety profile of all anti-aging clinics.

“I like the idea that they are looking into and hopefully will get rid of some of those people who are harming the public,” she said.

Friday will be the medical board’s first discussion. Action is unlikely. If the board eventually changes the regulations, anyone who breaks the rules could face punishment or potentially lose their medical license.

"Action is unlikely?" What is going on in Texas? Why would the Texas Medical Board be unlikely to take action and follow almost every other state on this issue? Who are the doctors arguing against this?

By this reasoning it should be possible for Texas physicians to run 'Do It Yourself Botox Course' and teach patients how to inject themselves...

Botox: Allergans (Still) Big Seller

Every successful cosmetic clinic that I know of is a big consumer of Botox by necessity. Medspas, derms, clinics and in many places dentists offer Botox and move a lot of it.

Here's a really good artitlce on how Allergan has positioned Botox to be a really stable source of income over the long term.

Via CNN Money

Alergans Survival Strategy: Botox Everlasting

Most big, mainstream pharma companies are desperately working to develop new expensive drugs and filing lawsuits to extend patents on old ones. But to dodge that deadline, Allergan is using another strategy; let’s call it the “stay small and make weird products” approach.

The company behind Botox, the “face-lift in a bottle,” is itself aging rather gracefully. Net sales increased by 13.3%, to roughly $1.3 billion, in the first quarter of 2011 compared with the same period last year, and the company has given analysts no reason to think it won’t put together a string of good quarters.

That’s because Allergan’s product portfolio is looking first class: “We believe Allergan has one of the most compelling growth profiles in specialty pharma,” a May report by Piper Jaffray analysts David Amsellem and Michael Dinerman said. But pharma companies need more than a good growth strategy, says Ken Cacciatore, an analyst with Cowen Group. They should also develop new products and have plans to keep the patent rights for the ones that they already have. “That’s really the holy grail of pharmaceuticals,” he says, “and Allergan has it.”

The holy grail

A huge part of Allergan’s patent-cliff immunity is its blockbuster Botox, which has helped the company evade the patent problems facing others in the industry in two ways: First, Allergan has continued to discover new applications for it. “Really, Botox is a Russian doll,” says Allergan CEO David Pyott, because Allergan keeps discovering new uses stacked inside the original treatment.

Second, Botox is also a special pharmaceutical because of the way it’s made. “It’s going to be very difficult for anyone to get a truly substitutable product through the FDA,” says Cacciatore.

That’s because Botox is something called a biologic, which means it isn’t man-made. Instead, Botox is created by making a solution that contains trace concentrations of the deadly botulinum toxin. Botox works in both the medical and cosmetic arenas by temporarily paralyzing targeted muscles. For example, Botox injections into the eye muscles can help patients suffering from a condition called strabismus, in which their eyes are misaligned. In a more vain vein, cosmetic Botox reduces the appearance of wrinkles in the forehead by numbing facial muscles so that they can’t contract to form creases.

Allergan and doctors have found muscle paralysis can be useful in other places: Allergan plans on getting Botox approved to treat patients with neurogenic detrusor overactivity, or overactive bladders, this year. Last year Botox was approved to treat chronic migraines, which is one of Allergan’s most promising markets, according to Ben Andrew, an analyst from William Blair & Co. Botox has the potential to be the first treatment of its kind in that space, he says, because it’s preventive: “Every other FDA-approved product is used in response.”

Botox’s success as a treatment for chronic migraines could surprise the market, according to Gary Nachman, a senior analyst in specialty pharmaceuticals with Susquehanna Financial Group: “You’re looking at a potentially huge blockbuster that people are really not giving them full credit for.”

Product diversity

Allergan is unique, says Lavin, because it has positioned itself well in three distinct sectors: ophthalmology, obesity, and cosmetics, all of which target the aging, sedentary population of U.S. consumers. “I think of aging and obesity as two areas I’d like to invest in,” he says.

Allergan can develop in seemingly strange sectors because of its relatively small size. It has a market cap of about $25 billion, compared with, say, J&J (JNJ, Fortune 500) and Novartis (NVS), which have market caps of $183 billion and $145 billion, respectively. “A company like Allergan still has a small enough base revenue that incremental hundreds of millions matter,” says Cacciatore. “Large pharma companies have consolidated themselves into a box where they need incremental billions.”

Allergan’s growth strategy allows it to invest in niche markets heavily enough to be a persistent threat to much larger companies. It’s a phenomenon that CEO David Pyott enjoys: “I remember years ago when I was relatively new at this job, and people said, ‘Do you really think you can compete against Pfizer in ophthalmology?’ We’d just smile and say, ‘We love taking market share from those guys.’ ”

Method to the madness

Allergan’s portfolio looks bizarre at first glance, but there is a pattern to much of its drug development.

Take Latisse, for example. Allergan researchers noticed that patients using its glaucoma treatment Lumigan were also growing longer lashes. The company then conjured up a medical condition, hypotrichosis, or inadequate eyelashes, to pair with its newly made drug. Allergan essentially created the market for Latisse, which was approved by the FDA in 2008. The company expects to make over $500 million from Latisse — again, a drug it had already invented and released as Lumigan.

Latisse is just one example of how Allergan aims to keep improving its own technology to discover new drugs, renew patents for existing ones, and find new uses for both. Pyott says he has overseen the growth of the company’s research and development budget from $80 million when he joined 10 years ago to $800 million this year. That’s about 16% of total sales that Allergan plows back into R&D.

Dysport hasn't really made a huge difference and for most medspas or clinics it's certainly still playing second-fiddle. )I'd be interested if anyone has information they could add as a comment as to exactly where Dysport sits as a percentage of market share right now.)

Managing Patient Expectations Part 2 - Botox Training MD

Read Managing Patient Expectations Part 1

Managing patient expectations is a learned skill but one that you have to master in order to run a competitive and profitable cosmetic practice.

Be aware of is patients who are complaining about previous providers. It's a potential indicator that this client might be a difficult client to deal with.

Clearly if someone is continually bashing another doctor (provided that the didn't do something that caused obvious harm) and they're angry with that doctors and his staff, that's going to put me on guard.

Now, there are situations where a patient's anger is appropriate.

I have a patient right now, that for years, went to another provider, and when she came to me and told me that she's switching providers, I did become a little alarmed right out of the bat. But once I got to know her my misgivings were removed. She had been going to this other physician for years and years and years, and she was upset with him because of the treatment she received for the previous several injections... but she attributed it to the front desk since the clinic had became very busy and impersonal. So I think you have to look at each patient individually. She was legitimate with her complaint and we have a great relationship but there are others.. If a patient is very, very angry, and constantly bashing a former provider and complaining about results you need to be aware, because you could be the next one on their hit list.

I think it's important to take as much time as you can so that you're comfortable and the client's comfortable. To simply make a decision that you're not going to treat that patient and you are now wasting your time, sitting in that room with the patient is the bad approach because then the patient's gonna be angry.

As far as I know, I've never sent anybody out of the office angry because I declined the treatment.

I really make the decision very rapidly as to whether I'm going to treat them or not. I think with time you develop that. I know within the first minute or so if I'm going to treat or won't, but I spend the same amount of time sometimes for both of them - the person I'm going to treat versus the person I'm not going to treat -  because to make that person angry is not what I want to do for a number of obvious reasons.

Often, I can convert them into doing something else that's realistic or telling their friends that's I'm genuine person.  I listen to exactly what they want and I try to understand what they want to have done. Sometimes it's a very small,small correction they're asking for and I don't think I can alleviate it... a very tiny line that I can barely see. So I listen to them, I give them a mirror, I have them point it to me. I try to totally understand what they are pointing up. And most of the time, I can see what it is they want me to correct.

However, if I don't think I can correct it and I think that it's unrealistic, I don't tell them: "That's unrealistic", I explain to them the limitations of the product and the scientific discussion. This product is made for this procedure, not unfortunately for what you want to have done and what you want to have done, I'm unable to correct this in the way that you're asking for.

Some patien'ts don't accept that and will respond with..  "But you're a plastic surgeon or you're an aesthetic physician, this is what you do." So then you have to educate them more with, "Unfortunately we don't have all the tools available". (The 'no magic wand' defense.)

So, even if you've decided that you're not going to treat a specific patient, I think it's really important to spend time with them, see what they want you to do and have them leave happy.

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Marc S. Scheiner MD

Dr. Marc S. Scheiner completed his undergraduate studies at the University of Delaware, and received his medical degree at the University of Texas. Following his residency at the University of Florida, he practiced family medicine in the small town of Elkton, Maryland during the 1990’s. During that time, Dr. Scheiner was forced to refer patients from rural Cecil County to Baltimore or Delaware for plastic surgical procedures. His interest in this type of surgery and his desire to provide these services for the local community led him to begin plastic surgery training.

Dr. Scheiner was accepted at the Nassau University Medical Center in 1999, where he entered the General Surgery Program. Following the completion of his general surgery residency, he began training with the oldest and largest plastic surgical group in the United States, the Long Island Plastic Surgical Group in New York.

In June of 2004, Dr. Scheiner completed his plastic surgical training and moved back to Cecil County to open the O’Leigh Aesthetic Surgery Center, LLC, filling a much needed gap in locally provided plastic surgical care.

In 2006, Dr. Scheiner, along with several other local physicians, began construction of a new medical facility in Elkton, Maryland. This building, in addition to being Dr. Scheiner’s new office, houses Cecil County’s first ambulatory surgery center, the Upper Bay Surgery Center. Upper Bay Surgery Center offers ambulatory surgical procedures in a private, comfortable, and safe environment.

Dr. Scheiner has lived in Cecil County since 1984 and currently resides in North East with his wife and three children.

Botox vs Dysport: A Comparison

By plastic surgeon, Marc Sheiner MD

What's the difference between Botox and Dysport?

The following discussion will explore Dysport and Botox Cosmetic in the United States, stressing the differences and the similarities between them. The discussion will begin with the similarities between Dysport and Botox.

Both of these roducts, Botox and Dysport, are neurotoxins. Specifically, they're type A Botulinum toxins that are Citicholine release inhibitors. Both therefore block the Citicholine release and prevent the communication between the nerve and the muscle, temporarily immobilizing muscles that produce wrinkles. Both are similarly FDA approved for the temporary improvement in the appearance of moderate to severe glabellar lines associated with Procerus and Corrugator muscle activity, i.e. the frown lines. Both are supplied in vials, and the fine powder requiring reconstitution with saline and both are injected in the facial muscles with a 30 gauge needle. In addition, both are also used off label to treat crow's feet and forehead lines or the lip line, essentially anywhere a rhytid or a wrinkle is present.

It has been reported that Dysport has a quicker onset, that is, people notice the effect of Dysport in 1-2 days as opposed to 4-7 days with Botox. Also, it is commonly reported that Dysport diffuses over a wider area than does Botox. This make some importance when treating areas around the eyes and that you can use a smaller amount of Dysport and alleviate potential complication such as ptosis (sagging or drooping of the eyelid). There are also some reports that people state that Dysport is less painful although this is not proven in any scientific literature. In addition, there are reports that Dysport may actually last a bit longer than Botox. Typically, Botox remains effective for 3-4 months and some reports say that Dysport may act a bit longer, 4-5 months.

Now for the differences among the 2 products. (Some of the differences are scientifically proven while others are anecdotal references.)

To begin with, Botox is supplied by the manufacturer Allergan in 150 unit vials. Typically the 100 unit vial is supplied for $525. Dysport is supplied by Medicis in 300 and 500 unit vials. The 300 unit vial typically goes for $475. So if the Botox and the Dysport vials are divided by units, one can see that 1 unit of Botox costs $5.25 with 1 unit of Dysport costs $1.50. However, the difference does not equate to a cheaper product if you will because you actually require more Dysport to obtain the same results with Botox. And we will discuss that in a moment.

The Botox is used in a fashion exactly the same as Dysport. However 1 unit of Botox does not equal 1 unit of Dysport. Typically, anywhere from 2.5-3 or even 4:1 ratios of Dysport to Botox is effective. So, that is to say that you may require 2.5 or 4 units of Dysport to obtain the same result as you would with 1 unit of Botox. For example, the glabella is typically treated with 5 injections of Botox, 4 units in each site and that's a total of 20 units. With Dysport, you actually use 10 units in 5 sites for a total of 50 units. Another difference is the reconstitution.

Reconstitution simply means the product needs to be dissolved in normal saline. There are many ways to do this. I typically apply 2.5 cc's of normal saline to a 100 unit vial of Botox, which will give you 4 units of Botox per 0.1 ml of fluid.

With Dysport, you place 1.5 cc's of normal saline into the 300 unit vial and that would equate to 10 units of Dysport per 0.05 mL or cc's of fluid.

Those are some of the similarities and differences. I would now like to discuss some of the questions that typically are asked by clients when they are deciding whether to use the Botox or Dysport.

One common thing that I hear often is one of the products is better than the other. I explain to them that basically both are the exact same product aside from some molecular differences. And I explain that some report subtle differences regarding quicker onset, but in my experience both products produce the same results and last essentially the same amount of time.

Another question I often hear is one of the products associate with more complications than the other product. And I tell them no, that both of the products are associated with the exact same side effects profile. You can obtain bruising, swelling, redness, ptosis from both of the products. However, Dysport is a relatively new product in the United States and Botox has been used for a greater length of time so the exact safety profile of Dysport has not been illustrated to date.

Another question I sometimes hear is why should I choose Botox over Dysport? If I'm asked that question, I don't make the decision for the person. I will occasionally help them along by explaining to them that I personally use on family members and what product most clients use. I tell them that they both predicatively improve wrinkles and in my office they're both the same price. You'll read a lot of information that Dysport is cheaper.  And of course if you do the math, 7:01 in the beginning you'll see cheaper per unit but you need to use more units. Still, when you do it that way, Dysport does come out to be more affordable. However, I offer them both at the same price after discussion, explaining to them that both of them have the same side effect profile and produce the same results.

And if you present them with that information and then say one is more expensive than the other, most people obviously choose the cheaper one so I just keep it in the office as an added product you know, cause some people  do actually prefer one product over the other, that's why I keep it in my office.

So, in conclusion, although there are subtle molecular differences between Botox and Dysport, both are injected exactly the same way, both have the exact same indications, that is the treatment of facial wrinkles or rhytids and both require reconstitution with normal saline. In addition, both have the similar side effect profiles and both, in my practice are similar in price. Although as mentioned, some practitioners will offer Dysport at a decreased cost. Also, some clinicians do report a quicker onset and a longer duration of action of Dysport but presently, this does not appear to be clinically significant.

In my opinion, again, I offer a choice because some people prefer it and other people actually like to try new products. My vote goes to Botox cause of it's long safety record and the fact that it's on the market for such a long time and I have predictable results with the product. However, I do think it's an added product for all aesthetic practices.

About: Marc Scheiner MD is the primary instructor for the online botox training course for clinicians at BotoxTrainingMD.com and is the owner of O'leigh Aesthetic Surgery Center in Elkton, Maryland.

Allergan Shifting Headache Sales Reps to Botox

Allergan sales forces previously working on GlaxoSmithKline headache drugs Imitrex and Amerge as part of a co-promotion will be reassigned to Botox, in support of the drug's new headache indication.

The move,  confirmed by a company spokesperson,  gives Allergan a jump start with headache specialists, since the GSK co-promotion deal was “a very good way for Allergan to learn the headache market,” Allergan CEO David Pyott told the Journal. Crystal Muilenburg, a spokesperson for Allergan, says that sales forces will initially target neurologists, pain, and headache specialists, to train them on Botox's “injection protocol and dosing regimen.” Muilenburg declined to estimate the number of reps that will support the headache indication, which received an FDA green light on October 15. GSK drugs Imitrex and Amerge have lost patent protection.

A key challenge that we started addressing immediately upon FDA approval is reimbursement,” said Muilenburg. “As with many new drugs, reimbursement is not widely established for Botox in this new therapeutic category.”

Physicians or patients looking for information on reimbursement can visit a dedicated website, call 1-800-44-BOTOX (option 4), or locate a Botox reimbursement business manager for “on-site education, training, and support,” according to the website. Physicians can also sign up to receive forthcoming treatment records and case studies on the headache indication, as they become available.

Allergan paid $600 million to settle Justice Department charges of off-label marketing in September, and pled guilty to marketing Botox off-label for conditions including headache. As part of the settlement, Allergan was forced to drop a First Amendment lawsuit challenging FDA policy on the exchange of “truthful scientific and medical information,” a spokesperson reported at the time. The pending approval in September of Botox for an ailment that previously existed as an off-label use sparked rumors about a relationship between Allergan's lawsuit and FDA's approval of the headache indication, rumors which Muilenburg quelled: “The FDA granted approval of Botox for the treatment of chronic migraine patients based on two phase III pivotal trials, and on its own merit,” she said. “The two actions are completely separate matters.”

Botox's headache indication, specifically, is for the prophylaxis of headaches in adult patients with chronic migraines. GCI Health has been awarded the PR account for the indication. Muilenburg declined to reveal other agency partners for the headache indication launch.

Allergan Starts Trials for Hair-Growth Treatment

Botox maker Allergan is about to launch clinical trials of a hair-growth treatment similar to its drug Latisse, which stimulates the growth of eyelashes.

The Phase 1 trial, scheduled to start this month, will focus on the safety of two formulations of bimatoprost, which is the active ingredient in Latisse.

This phase of the trials will include a total of about 28 patients — men with moderate male-pattern baldness and women with moderate female-pattern hair loss.

The FDA approved Latisse as a treatment for eyelashes, with a warning that it can cause hair growth on other parts of the body that come in contact with the drug.  Some doctors have already tried using Latisse as an “off-label” treatment for hair loss.

Hair-restoration expert Dr. Alan Bauman of Boca Raton, Fla., reported “modest hair growth” among patients who have been applying Latisse daily to their scalp.

Irvine-based Allergan might want more impressive results than that in order to make its hoped-for baldness remedy more commercially successful.

Bauman predicted that “Allergan will likely test a stronger concentration for the use on the scalp than the 0.03% bimatoprost found in Latisse.”

If Phase One (safety) trials are successful and Phase Two and Three trials (efficacy) are eventually completed, bimatoprost could become the third FDA-approved drug for the treatment of baldness in men and only the second FDA-approved drug for women with hereditary hair thinning or female pattern baldness,” Bauman said. Those conditions affect an estimated 60 million-100 million Americans, he said.

The clinical trial will be run out of Tempe, Ariz.  It is scheduled to be completed in February.

Injecting Botox As A 'Medical Esthetician'

It seems that there are medical spas that are having non-medical staff performing medical treatments... In this case, Botox injections.

Here's a comment that someone posted on the comment thread from the post: Medical Assistants Can Not Inject Botox.

As a medical aesthetician I have injected under a physician's supervision for nearly eight years. That is the concept of a med spa? Medical Aesthetic procedures delivered under a physician's supervision. I have more often seen patients injured by laser treatments. In fact, in a decade of working in spas that offered Botox, I've never seen serious side effect. I've seen one temporarily droopy brow, once, injected by a "diamond" injector physician.
AestheticInjector

@Aesthetic Injector
You may have been doing this. Your supervising physician may know that you're doing this... but this is not legal in the US (or Canada or Euroope as far as I know).

First: There is no such licensee as a 'Medical Aesthetician'. If you're an esthetician working in a medical spa, you're an esthetician working in a medical spa. You have no expanded scope of practice or licensure about what medical treatments you can perform. Your esthetican license allows you to perform certain treatments... none of which allow you to break the dermis. You have no licensure that allows you  to perform injections. In this case there is no difference between an esthetician and the front desk staff (or anyone off the street).

Second; you equate what you're doing directly with a physician. In this you're correct. You are indeed performing medicine.

However, your supervising physician can not extend his or her license to allow you to perform Botox injections. It does not matter if the physician knows about it. It does not matter if the physician trained you to do it. It does not matter if the physician tells you to do it. The fact that it's relatively easy and that you've been doing it (even successfully) is irrelevent. Your physician can not 'expand' the treatments that you're licensed to perform. Injecting Botox is not one of them. There is no legal difference between what you're doing inside of this 'medical spa' and what you would be doing if you were injecting Botox in a motel room somewhere, other than the physician that's allowing you to do this is on the chopping block too.

Third; If you have any issue at all, you are not going to be covered by any malpractice carrier. You (and your supervising physician) are performing entirely without any net or recourse. Your supervising physician is probably in deeper water since his or her medical license is also at risk.

You mention that you've seen 'diamond' injectors who's Botox treatments have resulted in drooping around the eye. This is a known potential complication with Botox. So, if a diamond level physician who's squirting Botox day and night can have a complication, what are the odd that you could run into any sort of complication?

If you ever perform a treatment with a negative outcome that results in any investigation, you'll be found to be performing medicine without a license, without malpractice coverage, and without a chance of any good outcome.

So, what's going to happen?

Truthfully, I don't know, but here's a probable outcome based on experience.

Something is going to go wrong; you're going to have a complication, a patient is going to be unhappy, a staff member is going to be fired but has a grudge... something will happen. It always does at some point. It may even be unrelated.

Someone is going to point out that this clinic is operating outside of both legal and ethical guidelines, and then it's going to get ugly. If it involves a patient or civil suit it's going to be even uglier. These things have a way of cascading out of control.

If you disagree, I'd truly love to hear your arguments.

Anyone else want to weigh in on this?

FDA Approves Botox as Migraine Preventive

Federal health authorities on Friday approved Botox injections for the prevention of chronic migraines in adults, an advance experts described as "modest."

In a statement, the Food and Drug Administration recommended Botox be injected approximately every three months around the head and neck to dull future headache symptoms.

The drug -- whose generic name is onabotulinumtoxinA -- has not been shown to work against migraines that occur 14 days or fewer per month, nor has it been shown to work for other forms of headache, said the statement.

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