Fake Botox, Real Threat - How to Safeguard Yourself Against Falling Victim to Fake Botox

Cases of botched botox incidents are abundant and well documented, such as the November 2004 case at a medical clinic in Florida where four people became paralyzed after receiving fake Botox injections. The four victims were hospitalized with severe botulism poisoning upon having the procedure done using bottles of potent, unapproved botulinum toxin that were clearly marked “not for human use.” The doctor who injected the toxin had passed it off as Botox®.

As a result of that unfortunate mishap in Florida,  the FDA's Office of Criminal Investigations (OCI) was called to investigate, which prompted a wide-scale probe of more than 200 clinics throughout the United States, and lead to dozens of arrests and convictions of individuals who purposely injected an unapproved, cheaper substitute for Botox® into approximately a thousand unsuspecting patients. More recently (2013), the FDA announced that more than 350 doctors and medical practitioners may be injecting patients with an unapproved Botox-like product that is neither safe nor effective.

Botox® is hardly the first pharmaceutical to illicit the illegal manufacture of fraudulent versions, but the high demand for botox injections has spurred the manufacture of many fake, often dangerous versions to capitalize from its popularity. However, the active ingredient in botox differs from other pharmaceuticals in a profound way:  In its pure form, it is the deadliest substance known to science.

Botox® Cosmetic, made by Allergan, Inc. (of Irvine, California), is the first type of botulinum toxin to be approved by the FDA to temporarily soften wrinkles and frown lines. Botox® Cosmetic is the leading injectable because it is safe and provides immediate results. Dysport® (manufactured in the UK by Ipsen) and Xeomin® (manufactured in Germany by Merz) are other alternatives produced by reputable pharmaceutical companies and  licensed for both therapeutic and cosmetic use. 

While the FDA maintains a task force to govern the illegal activity of botox manufacture and distribution in the United States, other countries remain ungoverned and unregulated. With the use of fake botox products on the rise, and the dangers associated with using fake versions, it is the patients responsibility to do their due diligence when choosing a doctor and to make sure that they are getting the Real Botox®.

Remember, Botox® is a brand name. Fake versions may be compromised, contaminated, adulterated, or improperly stored, rendering them unsafe or ineffective, since authentic Botox® is stored and transported by Allergan according to rigorous specifications.

Some people may minimize the dangers of fake botox by assuming that ineffectiveness is the worst possible scenario, but fake botox can have disastrous consequences such as paralysis of the muscles that control swallowing and breathing. Injections in the wrong doses can cause respiratory distress, even fatalities.

How to avoid becoming a cautionary tale?

1. Avoid Spas, beauty salons and home parties*. The danger of getting a substitute product or a diluted** version of Botox is more likely to happen in a non-medical setting. Even on the off-chance that the spa or hair salon has real Botox®, the likelihood of the person performing the procedure being skilled, is slim. Even real Botox® injected in the wrong dosage or the wrongful placement of injections can cause physical deformities such as droopy eyelids, blurred or double vision or severe arching of the brows resulting in a 'joker face'.

2. Seek a reputable, board-certified dermatologist or plastic surgeon that has experience with injectable products. Ask questions. Ask for referrals. Look at before and after pictures before making the final decision on which physician you trust with your face.

3. Ask to see the bottle before you undergo treatment to ensure that you are getting the real Botox® or Dysport®. Sadly, sometimes even a licensed physician does not guarantee that you will get the real Botox®. All approved Botox® produced by Allergan displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and on the vial (100 units/vial) and all the bottles have a 3D hologram on the label (check photo below). A good dermatologist will have no problem showing you the product if it’s legitimate.

4. Another caution, if the price is too good to be true, be skeptical. It is likely that you are not getting real Botox® or the Botox could be over-diluted**, which means the effects will not last as long as promised and you will need additional procedures sooner.



*The popularity of Botox and the quest for cheaper botox have led to an alarming new trend, Botox parties, where attendees can have the procedure done at home, as opposed to a dermatologist’s office. However, doctors strongly advise against this due to the non-sterile environment that may lead to infections and due to the questionable skill and training of the person administering the injections. A board-certified doctor would not be found at such parties, as they could lose their licence.

**a result of the Botox crystal being overly diluted with saline or not being mixed to recommended specifications of the manufacturer, rendering it less effective. If your results do not last as long as expected, then it is possible that the Botox® Cosmetic was over-diluted.


More Reading on the Subject:

Hospitalized After 'Botox'

FDA Law Enforcers Crack down on Illegal Botox Scammers

Business Pleads Guilty to $3 Million Scheme to Sell Foreign Versions of Botox

Brownsville Woman Arrested for Selling Fake Botox

Las vegas Doctor and Wife Sentenced to Prison for Botox Fraud Scheme

Fraudulent Versions of Botox Found in the United States

What to look for in an authentic Botox® or Dysport® vial

Botox - What Should First Time Users Expect

With the ever increasing use of this "wonder-drug", there is no doubt that the word 'Botox' has become a part of our everyday lexicon and has become an interchangeable alternative to 'botulinum toxin'. However, Botox® is a brand name for botulinum toxin A. There are also other brand names which are used for cosmetic purposes, such as Dysport and Xeomin. These brands are all approved by the FDA (US Food and  Drug Administration).

As of 2007, it is the most common cosmetic procedure. A new survey has confirmed that wrinkle-relaxing injections are the world's most popular non-surgical procedure, as they now account for 38% of cosmetic procedures worldwide. In fact, Botulinum Toxin Type A beat the nearest competitor by over a million injections last year.*

The cosmetic effect of botulinum toxin type A for the treatment of wrinkles and frown lines has been proven to significantly improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines), on the forehead and around the eyes. Wrinkles caused by sun damage and gravity will not respond to Botox.

Botox is a minimally invasive procedure, that does not require surgery.  The procedure takes only a few minutes and doesn't require anesthesia. In cosmetic applications, Botox is injected with a fine needle into specific muscles with only minor discomfort. The injections help prevent development of wrinkles by paralyzing facial muscles (Botox blocks signals from the nerves to the muscles). As a result, the injected muscle can't contract, which, subsequently, makes the wrinkles relax and soften. It generally takes three to seven days for Botox to to take full effect.

The effects from Botox is temporary and will last four to six months, depending on the individual. As muscle action gradually returns, the lines and wrinkles begin to reappear and need to be treated again. However, the lines and wrinkles often appear less severe with time because the muscles are being trained to relax.

Temporary bruising is the most common side effect of Botox. Headaches, which end in 24 to 48 hours, can happen, but this is a rare side effect. A small percentage of patients may develop eyelid drooping. This usually ends within three weeks. Drooping usually happens when the Botox moves around, so rubbing the treated area for 12 hours after injection or lying down for three to four hours after the procedure, are not advised.

It is best to avoid alcohol starting at least one week before the procedure. You should also stop taking aspirin and anti-inflammatory medications two weeks before treatment to reduce bruising. People who are pregnant or breastfeeding should not use Botox.

*(These figures are based on a 2011 poll of Plastic Surgeons worldwide, carried out by the ISAPS - International Society of AestheticPlastic Surgeons). The statistics for 2012 and 2013 are not yet available.