UNDERSTANDING BOTOX® COSMETIC FACIAL TREATMENTS

I can drive a car. I can change a flat and add oil or windshield wiper fluid when the light tells me to, but I’m not a mechanic and don’t understand motors and transmissions. Patients often have a similar experience when it comes to their BOTOX® Cosmetic treatments. They like the results but don’t have a good understanding of how it works and how it can be used. My intention here is to present information that will make practical sense to patients so that they can maximize their experience with a BOTOX® Cosmetic treatment.

The bacteria Clostridium botulinum produces a toxin that causes the illness called botulism. It is characterized by muscle weakness which can effect breathing, swallowing, speaking and seeing. Large muscle movement of the arms and legs can also become involved. Botulinum toxin Type A is highly purified and used in small amounts for cosmetic purposes. The chemical name for BOTOX® Cosmetic is Onabotulinumtoxin A.

The toxin blocks the release of acetylcholine at the neuromuscular junction between a nerve fiber and a muscle fiber so that the muscle contraction is weakened or reduced. This temporary blockage and reduction of muscular contraction on average lasts 3 – 4 months. It is this decreased action of the treated muscle and its subsequent relaxation that produces the effect seen. Treated muscles have less movement and dynamic wrinkles soften or disappear.

There are several very important things to know about BOTOX® Cosmetic before an initial treatment. First of all, BOTOX® and BOTOX® Cosmetic are both Onabotulinumtoxin A, but they are used differently. BOTOX® is used for medical purposes such as migraine, large muscle spasm, cervical dystonia and bladder dysfunction. BOTOX® Cosmetic is used for cosmetic treatments. The difference is not in the product but in the number of units used for treatments. Hundreds of units of BOTOX® can be used for medical issues, while a much smaller number of units are used for cosmetic treatments. There have been reports of botulism and deaths occurring after medical BOTOX® treatments. However, these serious adverse effects have not been reported with BOTOX® Cosmetic treatments.

Another thing to understand about all neurotoxins including BOTOX® Cosmetic is that there is an albumin component in the products. People who are allergic to egg white may have an allergic reaction to that component. In addition, it is important to understand that the albumin component is derived from human plasma donors. The albumin from these donors has been highly purified, and there has been no report of transmission of any viral illness.

Of course there are minor transient adverse effects that can happen with any treatment which can include bruises, redness, swelling and soreness. Some other adverse events reported after BOTOX® Cosmetic treatments include transient headache, flu-like symptoms and numbness in the area of injection.

So you understand how it works, read about the risks and are ready to try BOTOX® Cosmetic. Let me go over several things to think about before a treatment.

If you are prone to bruising, you may want to pre-treat with arnica for several days beforehand. Arnica is a homeopathic medication that can be purchased in a drug store or health food store and helps decrease the incidence of bruising. Also you may not want to take medications that promote bleeding for several days before a treatment such as aspirin, ibuprofen or naproxyn. Make sure your injector knows if you are taking a prescribed blood thinner, but do not stop the medication. If a bruise does develop from a treatment, bromelain may help it resolve faster. Bromelain is an enzyme found in pineapple, comes in pill form and can be found in health food stores.

Another thing to think about is the timing of a treatment. It can take up to two weeks for a treatment to take full effect. If you have an event coming up that you want to look refreshed for, give yourself enough time for any bruising that might occur to resolve, for the full effect to happen and for any touch up that might need to be done.

I would like to go over how BOTOX® Cosmetic is used and placed to create the look you are trying to achieve. The main areas of the face that BOTOX® Cosmetic is used are the glabella (the area between your eyebrows that are associated with frowning or looking angry), the forehead (the area above your eyebrows that have lines running horizontally across) and the crow’s feet (the area lateral to your eyes that form when you smile). Less often treated areas include the bunny lines (the lines that form around your nose), the perioral lines (the lines that form above the upper lip also called smokers lines) and the platysma bands (the ropey vertical muscles running down the neck from the chin to the top of the chest). Other lesser injected areas include under the nose for the horseshoe line that can occur under the nose, the sides of the mouth for the down turned corners that can appear and under the eye to give it a more rounded appearance.

The muscles of the glabella are called depressor muscles. In other words, when they contract they bring your eyebrows together and down forming the frown or angry look and the associated vertical lines (the 1s,11s,111s) that can appear between your eyebrows. The muscles that raise your eyebrows are called elevator muscles. When they contract, they bring your eyebrows up and open the area around your eyes, but they also form the horizontal lines on the forehead. The depressor and elevator muscles work together to create your facial expressions. If you want to open your eyes and look less angry, weaken the depressors and leave the elevators alone. This causes a relative stronger effect from the elevators and raises the eyebrows. However, if the horizontal lines on your forehead are the bigger concern, you must weaken the depressor muscles as well as the elevator muscles. Weakening only the elevator muscles will allow the depressors to be relatively stronger and lower your brow making you look like you are scowling. These two muscle groups must be balanced to give a natural relaxed effect a patient wants.

Of concern for a lot of female patients is the effect of the brow dropping. If you have a heavy brow, heavy upper eyelids or eyebrows that sit below the orbital rim, you will notice any weakening of the forehead elevator muscles. A typical comment from someone who experiences that effect will be that they have to lift their eyebrow to apply their upper eye shadow.

The muscle around the eye is circular. Weakening the lateral side of this muscle (the side of the eye near the ear) will soften the lines formed when smiling. There is no effect on the eyelids. Softening these lines is another way to highlight the eye area. This area is very vascular and an injection bruise is not uncommon in this area.

Allergan wants patients to understand how many units are being used in a treatment area. Was the amount injected adequate to make a change in the treatment area? Were more units needed to produce the desired effect? Was a different treatment pattern needed? An injector should have this information in a record that can be reviewed prior to a subsequent treatment.

The number of units that are typically injected in a given area differ. Allergan recommends 20 units of BOTOX® Cosmetic in the glabellar area. They also recommend 24 units total for treating crow’s feet. Some patients may need more or less units for these areas. There is no FDA approval for using BOTOX® Cosmetic in the forehead only because no formal study has been done. However, it is a commonly treated area, and the number of units used varies per patient.

After a treatment, patients are advised to remain upright for 4 hours while BOTOX® Cosmetic is being absorbed into the muscle. Facial expressions such as smiling, raising your eyebrows and frowning may help the product find the active muscle if done within the first 30 minutes. Patients are advised not to do any exercise or have any strong sun or tanning bed exposure for 24 hours. Also the injection area should not be compressed or massaged.

As the BOTOX® Cosmetic treatment starts to take effect, there are several things to look for. Any asymmetry in a facial expression that starts to show up should be addressed and touched up. The most common area that might require a touch up is the forehead. If the lateral sides of the forehead still have movement when the central area of the forehead doesn’t, you may see a peaking of the lateral eyebrows that does not look natural. I call this having Spock eyes after the character from Star Trek. This is an easy touch up fix.

After two weeks if you are still having a significant amount of movement in a treated area, it should be looked at. It may be that the area was undertreated or that the injections were not placed correctly. Also patients can develop an antibody to a protein component of BOTOX® Cosmetic which may result in a blunted response to a treatment.

I hope I’ve given you some practical information and better understanding about BOTOX® Cosmetic and a treatment experience with it. Please contact me at Willo MediSpa if you would like more information or further explanation. I can be reached by email at customerservice@willomedispa.com, by phone at 602-296-4477 or by stopping by the office at 201 E. Monterey Way, Phoenix, AZ 85012.

Written By:
Dr. Nello Rossi – Willo MediSpa

Phone: (602) 296-4477
Email: CustomerService@WilloMediSpa.com
Website: https://www.willomedispa.com/

Office Hours

Sunday – Monday: Closed
Tuesday: 4pm – 6pm
Wednesday – Friday: 12pm – 6pm
Saturday: 12pm – 4pm

BE AWARE OF COUNTERFEIT BOTOX® COSMETIC

Be Aware of Counterfeit Botox® Cosmetic

Counterfeit Botox® Cosmetic can have dangerous side effects, be sure to know what to look for.

Central Phoenix, AZ

Beware of counterfeit and adulterated BOTOX® Cosmetic. Unfortunately, there are medical offices and injectors who are using counterfeit BOTOX® Cosmetic. It is not uncommon for offices to get faxes, solicitation emails and phone calls from people trying to represent themselves as certified sellers of different aesthetic supplies at reduced rates.

On August 4, 2015, two Canadians were sentenced for distributing counterfeit, misbranded and adulterated BOTOX® Cosmetic into the United States. This case was investigated by the FDA’s Office of Criminal Investigations. One defendant received a sentence of 24 months of imprisonment, and the other received a sentence of 3 months. They operated a wholesale drug distribution business selling non-FDA approved BOTOX® Cosmetic sourced from Turkey to U.S. doctors. Besides being illegal to use in the United States, the BOTOX® Cosmetic was not stored or shipped refrigerated, had counterfeit exterior packaging and manufacturing lot numbers on the cartons did not match the lot numbers on the drug vials inside the cartons.

On that same day, Philippe Schaison, President of Allergan Medical Aesthetics, issued a letter to Arizona Aesthetic Health Care Partners. He stated that illegally imported or counterfeit BOTOX® Cosmetic posed a significant risk to patient safety because the quality and safety of the drug is unknown and cannot be guaranteed. Because of this safety issue, the Arizona Legislature passed Arizona House Bill 2322 that became effective July 3, 2015, making it a felony offense to manufacture, sell or distribute misbranded drugs in Arizona. A drug is misbranded if it is not approved by the FDA or is obtained outside the licensed supply chain regulated by the FDA, the Board of Pharmacy, or the Department of Health Services.

What does this mean for patients? First of all, be cautious if the cost of your BOTOX® Cosmetic per unit is suspiciously lower than the average cost in your area. Could a decreased cost per unit be the result of the provider purchasing their supplies from an illegal source at a lower cost to them? Remember most offices charge by the unit and your treatment cost should be the cost per unit times the number of units used. Secondly, check the reputation of the office or injector you are using. If there have been complaints about poor results, could it be that a knock-off product is being used rather than authentic BOTOX® Cosmetic or just bad technique by the injector? An office or injector that uses illegally obtained BOTOX® Cosmetic risks being criminally prosecuted by the FDA Office of Criminal Investigations. Thirdly, ask to see the BOTOX® Cosmetic vial. Only authentic BOTOX® Cosmetic vials have a sophisticated hologram image that states “Allergan”. The BOTOX® Cosmetic carton will also indicate if the product is packaged for use in the United States by a U.S. License Number (1145) located on the box side panel as well as on the product vial.

Patients who suspect that they are or were being treated with illegal BOTOX® Cosmetic can anonymously report their concerns to www.authenticbotoxcosmetic.com or to the FDA Office of Criminal Investigations (OCI) by calling 1-800-551-3989, or visiting the OCI Website.

In my practice here at Willo MediSpa, I only purchase and use aesthetic products that come directly from their respective manufacturers. The BOTOX® Cosmetic I use is purchased from and supplied by Allergan. The vials are shipped overnight via FedEx Express packaged in a Styrofoam container with dry ice to keep the temperature controlled. In the office, the product is kept in a freezer until it is reconstituted with bacteriostatic saline for patient use.

Also, I regularly show new patients how BOTOX® Cosmetic is packaged, the vial it comes in and what it looks like before being reconstituted to make it injectable. I find that this information gives patients some extra understanding and reassurement about their treatment.

Please contact me if you have any questions concerning BOTOX® Cosmetic by email at customerservice@willomedispa.com, by phone at 602-296-4477 or stop by the office at 201 E. Monterey Way, Phoenix, AZ 85012.

Written By:
Dr. Nello Rossi – Willo MediSpa

Phone: (602) 296-4477
Email: CustomerService@WilloMediSpa.com
Website: https://www.willomedispa.com/

Office Hours

Sunday – Monday: Closed
Tuesday: 4pm – 6pm
Wednesday – Friday: 12pm – 6pm
Saturday: 12pm – 4pm

Is Botox^® Cosmetic Safe?

Is BOTOX^® Cosmetic Safe?

Dr. Nello Rossi in Phoenix, AZ discusses the history and risks of BOTOX^® and BOTOX^® Cosmetic, and whether it is safe to use.

Phoenix, AZ

I have a patient who wants to have a BOTOX^® Cosmetic treatment but is afraid. She has read the internet and has seen many comments of adverse side effects from botulinum toxin type A treatments. My first response to her was of course BOTOX^® Cosmetic is safe. In one form or another it has been used for over 25 years and has a sterling track record.

After I thought about my anticipated response to her, I realized that I had never really researched any articles about botulinum toxin type A nor read any of the blogs that related patients’ bad experiences after a treatment. So I decided to do my homework. Here is what I found. Please note that in this discussion, I am focusing on BOTOX^® Cosmetic which is used in aesthetic treatments. The number of units used for BOTOX^® Cosmetic treatments is far less than the number of units used in medical therapies with BOTOX^®.

Botulinum toxin type A is the active component in BOTOX^® and BOTOX^® Cosmetic. BOTOX^® was FDA approved in 1989 for medical therapeutic use for strabismus and blepharospasm. The Drs. Carruthers in Canada were treating patients using botulinum toxin type A for these conditions in their practice and realized that there was an effect on wrinkles besides helping reduce the muscle contractions associated with the conditions. This lead to the FDA approving BOTOX^® Cosmetic in 2002 for the treatment of wrinkles known as the glabellar lines (frown lines between the eyebrows).

Since being FDA approved, BOTOX^® has been used for more and more medical conditions. BOTOX^® Cosmetic’s use is also growing. In 2008, it was reported that world-wide there were 3 million botulinum toxin type A treatments a year⁴, and that up to that time there had been 15 million treatments⁶. In 2013, there were over 3.5 million U.S. patients² who received 6.3 million botulinum toxin type A treatments¹.

In 2002, there was a case brought against Allergan from a woman who claimed that after a BOTOX^® treatment for a then off-label use for migraines she developed unbearable migraine, fatigue, neck weakness and difficulties breathing and swallowing for four months. She lost her case against Allergan, but the company admitted that the product insert stated that BOTOX^® had unknown risks as an anti-wrinkle treatment in doses higher than 20 units and acknowledged that the drug could spread to other areas of the body³. Allergan’s clinical studies had shown a potential link to headaches, pain, flu-like symptoms and respiratory problems³.

In 2005 a case of a death after a treatment with a BOTOX^® -lidocaine mixture was reported for a woman being injected for chronic neck and back pain. It was felt that she had an anaphylactic reaction to the lidocaine⁴.

In 2006 there was a report of 4 adults who were felt to have developed botulism after cosmetic injections. However, the botulinum preparation used was an unlicensed, highly concentrated mixture, and the patients received doses 2857 times the estimated human lethal dose. There is no report of them dying⁵.

In 2008, 15 BOTOX^® users and their relatives sued Allergan claiming that the company failed to warn of the drug’s dangers. There were four deaths which included two children and two adults involving off-label use of the drug. The children received very high doses for limb spasticity related to cerebral palsy. One adult died from complications from injections for neck and shoulder pain, and one died from treatment for excessive salivation. Of the remaining eleven plaintiffs, the complaints were for droopy eyelids, numbness, headaches and swallowing and breathing difficulties. Three in this group had been treated for cosmetic reasons, but it was not reported what dose was used or which complaints they had^6,7.

Later in 2008, a Consumer group called Public Citizen reported linking 16 deaths to use of botulinum toxin between 1997 and 2006. They also reported finding 180 adverse effects reported⁴. I cannot find any information on the actual patients in this claim. However, this lead the FDA to do a Safety Review of BOTOX^®, BOTOX^® Cosmetic ( both botulinum toxin type A) and Myobloc^® (botulinum toxin type B)^7,8.

The conclusion of the FDA Safety Review was reported in April 2009. It stated that the manufactures of botulinum toxin products must add a boxed warning about the risk of adverse events that may occur when the effects of the toxin spread beyond the injection site⁹. The FDA had received reports of systemic adverse reactions suggestive of botulism that would occur if the toxin spread beyond the injection site, including respiratory compromise and death, after use of these products for both approved and unapproved uses. The deaths in children occurred when treating limb spasticity associated with cerebral palsy. The adult cases had been also treated for spasticity and cervical dystonia. However, the adult cases of death could not be attributed to botulinum toxin because of other pre-existing conditions. There had been reports of symptoms after cosmetic use, but no definitive serious adverse event had been found with on-label use of BOTOX^® Cosmetic⁹.

In February 2010, a lawsuit was filed by a woman in Virginia who claimed that after being treated for head tremors with BOTOX^® in 2008 she suffered brain injuries, movement disorders and dementia. She stated that she developed autoimmune encephalitis movement disorder. She alleged that Allergan failed to warn consumers that a side effect of BOTOX^® can cause serious autoimmune responses, brain injury and botulism. The FDA “black box” warning about potential spread beyond the site of injection had been added in 2009. Her case settled out of court in October 2011^10,16.

In March 2010, Allergan was found not liable in the death of a 7 year old who died after being treated with BOTOX^® for limb spasms caused by severe cerebral palsy^11,16.

In May 2010, a physician in Oklahoma sued Allergan stating that she suffered botulism poisoning after using 50 units of BOTOX^® to treat wrinkles. This occurred in July 2006 and was after her fifth similar treatment¹¹. Allergan was found negligent because the 2006 product labeling did not have adequate information about side effects. Another point made in that trial was the fact that Allergan had known about potential botulism dangers but had denied the connection in promotional materials to doctors and patients. An independent study commissioned by Allergan in 2007 found 207 adverse events being due to the spread of the toxin, including this plaintiff’s case. It was reported that Allergan had the study revised to show only 26 adverse event cases, eliminating any incident that had a plausible explanation other than an effect from BOTOX^®12,13.

In September 2010, Allergan settled a BOTOX^® wrongful death lawsuit on behalf of a woman who died in 2008 after receiving 100 units to treat pain in her shoulder. The family claimed that the patient was never informed about the potential side effects before she was injected^11,16.

In April 2011, Allergan was sued by a Virginia man who claimed he developed brain damage after being treated with BOTOX^® in 2007 for cramps and tremors in his hand. He claimed that Allergan failed to warn him that injections could trigger an autoimmune reaction leading to brain damage¹⁴. Allergan claimed that the injuries weren’t caused by BOTOX^® but by a pre-existing genetic stroke condition²³. During the trial, it came to light that in 2007 Allergan had sent European regulators a letter that contained warnings about BOTOX^® , but had failed to do so in the U.S. market¹⁵.

I found an abstract by Dr. Anna Hristova titled “Neurological complications to botulinum toxin A therapy” published by the International Congress on Bacteriology & Infectious Diseaese¹⁹. Dr. Hristova is the physician who treated the man in Virginia who claimed to have developed autoimmune encephalopathy after having botulinum toxin type A injections for hand tremors in 2007²³. Interestingly, she was also a key witness for the Virginia man against Allergan in that lawsuit²³. She suggests that there is evidence that the toxin can spread and cause clinical illness. She postulates that there can be CNS damage resulting in autoimmune encephalitis and persistent fatigue and lack of endurance, peripheral nervous system damage resulting in an autoimmune reaction such as Guillaine-Barre and small fiber polyneuropathy, and autonomic nervous system damage such as heart arrhythmias¹⁹. She makes her claim based on personal experience, personal observation and a review of the literature¹⁹, however she cites no references or studies in support of her statements. She also acknowledged that currently there are no tools or methods to prove the causality of death or damage due to botulinum toxin type A¹⁹.

In September 2011, Allergan settled a case of a San Francisco woman who had cosmetic injections and claimed to have developed systemic problems including weakness and fatigue¹⁶. No other information on that case was found.

In May 2012, a Missouri man settled a $60.5 million lawsuit with Allergan. He claimed he was diagnosed with Guillain-Barre Syndrome after having BOTOX^® injections for back pain in 2008. Guillian-Barre Syndrome is a paralyzing condition that can occur after a viral illness. Allergan denied any awareness of the condition being caused by BOTOX^®16.

In April 2014, a physician who injected a patient for TMJ and migraines as well as cosmetic enhancements was sued for failing to adequately inform her of known serious and debilitating side effects of BOTOX^®. She was injected with 75 units of BOTOX^®. It was reported that she developed an acute severe immune reaction to BOTOX^®, and that reaction resulted in permanent devastating injury to her. She gradually became worse and died. Allergan was not a party to the lawsuit¹⁷.

In November 2014, two parents sued Allergan after their 7 year old son developed life-altering damage after BOTOX^® injections in 2010 for leg spasms secondary to cerebral palsy. It was claimed that the boy suffered an allergic reaction leading to development of seizures. Though BOTOX^® is not approved by the FDA for pediatric spasticity, the parents argued that Allergan did not properly warn the public of potential dangers of using the product. The family was awarded $6.75 million¹⁸.

A literature review of peer-reviewed articles from 1988 until 2008 published in the Journal of Cutaneous and Aesthetic Surgery by HM Omprakash and SC Rajendran found two classes of adverse events reported: transient benign events and potentially serious events⁴. Transient benign events, associated with smaller doses used for cosmetic treatments, included hematoma, injection site pain, intractable headache, ptosis, diplopia and hyperactivity of the local antagonistic muscle⁴. The serious events suggestive of botulism-like symptoms were dry and red eye, accommodation difficulty, dry mouth, gastrointestinal disturbances, dysphagia, hoarseness and breathing difficulties⁴. Deaths have been associated with large doses of botulinum toxin type A or B used for muscle spasms in children and other medical indications⁴.

A review of lawsuits filed between 1985 and 2012 involving complications from the clinical administration of botulinum toxin products was performed by Dr. John Korman, Department of Dermatology, Massachusetts General Hospital, Harvard Medical School²⁰. For the 27 year period of review, only 24 relevant cases were identified. Of those, most were dismissed, settled or were for therapeutic use of botulinum toxin. Only 8 cases involved cosmetic use²⁰.

Of the reported lawsuits that I could find information on searching Medscape, FDA’s MedWatch and Google, only two cases involve the cosmetic use of BOTOX^®. Neither of these cases had life-threatening consequences^11,16.

Back to the original question, “Is BOTOX^® Cosmetic safe?” Certainly, there is a risk when using any drug, and you should be able to make an informed decision. In my practice, I have had patients experience transient benign events after a BOTOX^® Cosmetic treatment. But is the risk of a serious adverse event occurring after a BOTOX^® Cosmetic treatment high? Not according to what information I have found and presented.

Let me make a comparison of risk to another common medication. Would you say taking acetaminophen (Tylenol) is safe? Did you know that acetaminophen is the leading cause of acute liver failure in the U.S.²¹, and according to the U.S. Centers for Disease Control and Prevention, more than 300 people die annually in the U.S. as the result of acetaminophen poisoning²². That would make taking acetaminophen much more of a risk than having a BOTOX^® Cosmetic treatment. Yet I’d bet if you are someone afraid of using BOTOX^® Cosmetic, which has a low rate of adverse events, you aren’t afraid of using acetaminophen with its high annual death rate.

What are some of the reasons you should not consider using BOTOX^® Cosmetic? If you have a known neuromuscular condition such as myasthenia gravis, Lambert-Eaton Myasthenic Syndrome or ALS, you are not a candidate for a treatment. If you have a severe chronic respiratory illness, you are not a candidate. If you are pregnant or breast feeding, you are not a candidate. If you are allergic to any component of the drug such as albumin or egg white or had an allergic reaction to another form of botulinum toxin type A, you are not a candidate. If you are on an aminoglycoside antibiotic such as gentomycin, tobramycin, clindamycin, or streptomycin, you are not a candidate. If you have a condition resulting in difficulty swallowing, you are not a candidate. If you have a bleeding disorder, you are probably not a candidate.

Caution should be used if you are taking muscle relaxants, allergy or cold medications, sleep medications or anti-platelet or anti-coagulant medications. Be aware that albumin used in BOTOX^® Cosmetic preparation is a derivative of human blood that carries an extremely remote risk for transmission of viral diseases with no cases ever being reported.

Understand that there have been reports of serious adverse events occurring after botulinum toxin type A treatments that are felt to be due from spread of the toxin beyond the injection site, and that there have been reports of death with its use for medical therapeutic treatments. There is no conclusive way to know with any medical certainty that botulinum toxin type A was the cause of these adverse events. There has been no reported death with the use of BOTOX^® Cosmetic when being used for aesthetic and cosmetic treatments.

Once again, “Is BOTOX^® Cosmetic safe?” I would answer by saying that if you are a relatively healthy individual seeking BOTOX^® Cosmetic treatments for aesthetic reasons such as relaxing facial wrinkles you have a very low risk of developing any complication from a treatment – benign or serious. You need to understand the risks and warnings that have been elucidated, and make an informed decision whether BOTOX^® Cosmetic is right for you. My opinion is that yes it is safe, and you are going to love it…just ask my three sisters!

I want to close with a quote I came across while researching this information. A cosmetic dermatologist in Southern California said, “If BOTOX^® were lethal, half of Beverly Hills would be dead and the other half would be suicidal.”³

Written By:
Dr. Nello Rossi – Willo MediSpa

Phone: (602) 296-4477
Email: CustomerService@WilloMediSpa.com
Website: https://www.willomedispa.com/

Office Hours

Sunday – Monday: Closed
Tuesday: 4pm – 6pm
Wednesday – Friday: 12pm – 6pm
Saturday: 12pm – 4pm

REFERENCES

1. “2013 Plastic Surgery Statistics Report.” American Society of Plastic Surgeons. American Society of Plastic Surgery, 26 February 2014. Web. 9 March 2015.
2. “Botox-Type Injectables Guide.” American Board of Cosmetic Surgery. American Board of Cosmetic Surgery, n.d. Web. 1 March 2015.
3. Fabio, Michelle Esq. “Jury Finds No Liability for Botox Manufacturers in Medavoy Suit.” LegalZoom. LegalZoom, December 2009. Web. 11 February 2015.
4. Omprakash, HM and Rajendran, SC. “Botulinum Toxin Deaths: What is the Fact?” National Center for Biotechnology Information. U.S. National Library of Medicine, July-December 2008. Web. 17 January 2015.
5. Chertow, DS, et al, “Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation.” MEDLINE/PubMed. U.S. National Library of Medicine, 2006. Web. 9 Feburary 2015.
6. Doheny, Kathleen. “Botox Lawsuit Claims Drug Has Fatal Flaws.” WebMD. WebMD, 11 July 2008. Web. 11 February 2015.
7. Buppert, Carolyn. “How To Reduce Your Risks When Providing Botulinum Toxin.” Medscape. Medscape, 2008. Web. 9 February 2015.
8. Barclay, Laurie MD. “Respiratory Compromise, Death May Be Linked to Botulinum Toxin.” Medscape. Medscape, 8 February 2008. Web. 9 February 2015.
9. Jeffrey, Susan. “FDA to Require Boxed Warning for Botulinum Toxin Products.” Medscape. Medscape, 30 April 2009. Web. 9 February 2015.
10. “Botox Lawsuit Alleges Brain Damage from Treatment.” AboutLawsuits. About Lawsuits, 18 February 2010. Web. 1 March 2015.
11. “Botox Side Effect May Lead To Injury Lawsuits.” YourLawyer. Your Lawyer, n.d. Web. 11 February 2015.
12. “Botox Victim Wins $18 Million.” MarketWatch. MarketWatch, 9 May 2014. Web. 11 February 2015.
13. Stewart, Colin. “What Allergan doesn’t want you to know about Botox.” Orange County Register. Orange County Register, 18 June 2010. Web. 1 March 2015.
14. Fisk, Margaret Cronin. “Allergan Loses $212 Million Federal Botox Lawsuit in Virginia.” Bloomberg. Bloomberg, 28 April 2011. Web. 1 March 2015.
15. “Botox Brain Injury Lawsuit Results in $212 Million Judgment for Plaintiff.” YourLawyer. YourLawyer, 29 April 2011. Web. 8 March 2015.
16. Kalfus, Marilyn. “Botox lawsuit that asked $60.5 million settles.” Orange County Register. Orange County Register, 24 May 2012. Web. 11 February 2015.
17. Bouboushian, Jack. “Widower Blames Wife’s Death on Botox.” Courthouse News Service. Courthouse News Service, 29 April 2014. Web. 11 February 2015.
18. Murray, Elizabeth. “Family awarded $6.75 million in Botox lawsuit.” Burlington Free Press. Burlington Free Press, 20 November 2014. Web. 1 March 2015.
19. Hristova, Anna. “Neurological complications to botulinum toxin A therapy.” International Congress on Bacteriology & Infectious Diseases. OmicsGroup, 20-22 November 2013. Web. 1 March 2015.
20. Petrou, Ilya MD. “Botulinum toxin treatments safe, but adverse event lawsuits on the rise.” Dermatology Times. ModernMedicine, 1 July 2013. Web. 1 March 2015.
21. “Tylenol.” DrugWatch. Drug Watch, 23 January 2015. Web. 12 March 2015.
22. Miller, TC and Gerth, J. “Behind the Numbers.” ProPublica. ProPublica, 20 September 2013. Web. 12 March 2015.
23. “Ground-breaking Botox case results in $212M jury verdict.” New Orleans City Business. New Orleans Publishing Group, 9 May 2011. Web. 11 March 2015.

Preparing Botox® Cosmetic

Do you know how much Botox® you have had injected for any given treatment? This is a question that I ask my new patients. Often they have no idea of how many units of Botox® they have been treated with for any given area in the past. I’d like to explain how Botox® is prepared and why patients should understand how many units they use.

Allergan is the maker of Botox®. The product is delivered by FedEx within 24 hours of ordering. It arrives in a styrofoam container that is packed with dry ice, and it must be placed in a freezer until it is ready to be used. The bottle that contains the Botox® has no liquid inside it but instead has a lipolyzed white ring of powder that is the Botox®. To make it injectable, I must mix a saline solution into the bottle. I use Bacteriostatic Saline which has a preservative of Benzyl Alcohol. Once mixed, the Botox® is ready to be injected and can be refrigerated until used.

Here at Willo MediSpa, the concentration of Botox® I prepare has 2.5 units in an injection volume of 0.1cc. The pattern I mark on my patients for their treatment is based on the spread and absorption of Botox® at that concentration and on the effect they want to achieve. Other injectors might use another concentration or another injection volume of Botox® in their practice. This is where I think a patient should know and understand the units of Botox® they receive in a treatment.

Knowing how many Botox® units are used in the different treatment areas is helpful for an injector and for a patient to get a consistently effective result. Some patients want a refreshed soft correction of dynamic wrinkles and others want a more frozen look. I keep a diagram of where Botox® is injected on a patient and how many units are used in each injection and in each area. This allows me to be able to make recommendations based on the pattern and the number of units used for a future treatment. If a patient feels not enough effect occurred, I can make recommendations to change the pattern and/or increase the number of units. If a patient feels the effect was too strong, I can adjust the pattern and decrease the number of units. A patient knowing the number of units of Botox® used for an effective treatment can relate this information to any injector who can reproduce the effect.

Another question a patient should ask is where the injector gets their Botox®. Believe it or not, even today in the Valley there are offices that do not purchase their products directly from the manufacturer. Allergan does not stand behind knock-off or imported products. An authentic bottle of Botox® has a hologram label. You should not feel timid about asking to see the bottle or about asking from where they purchase their Botox® to independently verify that you are receiving the real thing.

I hope this has helped you to understand how Botox® is prepared and used. Please feel free to contact me about any questions concerning Phoenix aesthetic treatments you may have.

Written By:
Dr. Nello Rossi – Willo MediSpa

Phone: (602) 296-4477
Email: CustomerService@WilloMediSpa.com
Website: https://www.willomedispa.com/

Office Hours

Sunday – Monday: Closed
Tuesday: 4pm – 6pm
Wednesday – Friday: 12pm – 6pm
Saturday: 12pm – 4pm