Buyer Beware - "Illicit Botox Sparks Alert"

Illicit Botox Sparks Alert reads a recent headline in the Wall Street Journal. In the current case, physicians purchasing illicit Botox from outside the US likely received counterfeit medications. It is unclear whether the vials contain Botox and if they do whether the drug is provided at safe concentrations. 

Only MDs in the United States are allowed to purchase Botox from its manufacturer, Allergan. There are illegal arrangements where nurses, estheticians or those with even less training  obtain Botox from an absentee physician and then perform unsupervised injections. This practice is unsafe, unethical and unfortunate. This is, however, increasing in frequency as poorly trained "practitioners" or "injectors" swarm the field of cosmetic medicine and, in some tragic cases, plastic surgery.

Like many ethical issues, these practices result from financial pressure. An ethical physician would never put his or her patients at risk to make a profit. However, there are those physicians and other providers who have decided that offering cut rate injectable treatments (Botox, Dysport, Juvederm, Restylane, Perlane) is the path to a tidy sum. For very good reasons, legitimate FDA-approved drugs are not cheap (hence the higher cost of being treated by a reputable Plastic Surgeon or Dermatologist). 

When the $8 per unit Botox provider realizes that they lose money on every unit injected, there is tremendous pressure to reduce costs. This can sometimes involve overly diluting the medication such that patients receive fewer units of Botox than they paid for. Alternatively, medications can be purchased from foreign companies in India, China and Canada, to name a few. In some cases, there is no active medication in the purchased product. In other, more dangerous cases, there is excessive or non-medical grade product masquerading as an FDA-approved, safe medication. 

I am reminded of a case in which research grade Botulinum toxin was reconstituted and injected by a chiropractor. He injected himself, his (soon to be ex-) girlfriend and another couple. All four survived but wound up in the hospital for prolonged periods due to a ludicrous overdose of the drug. This type of complication is a "never event" and does not occur when Botox is purchased from its manufacturer in the US. 

The take home message is that there is an increasing number of unscrupulous providers entering the practice of cosmetic medicine. There will always be those that look to make a quick buck rather than building relationships and providing exceptional, long-term care to their patients. Warning signs include:

1. non-core physicians (those other than Facial Plastic Surgeons, Plastic Surgeons and Dermatologists) offering cosmetic services. Many among us have seen ads for injectable treatments at their internal medicine or OB-GYN office. A patient of mine was actually offered Botox by his gastroenterologist! 
2. non-physician "injectors" with no physician affiliation are suspect. To reiterate, they cannot legally buy the product they're offering to inject at bargain basement prices. Thus, you must ask where the product came from. 
3. prices that are too good to be true. In fact, they are. 

It is important to note, that fixing bad Botox is much more expensive than having it done right the first time. There is no substitute for exceptional training and experience.

If you would like to discuss Botox or other injectable treatments with a board-certified Facial Plastic Surgeon in the Denver area, schedule a consultation.

Stephen Weber, M.D., F.A.C.S.
Lone Tree, Colorado

What does "off label" mean?

"Off label" is a term frequently used in the practice of cosmetic medicine. But what exactly does "off label" mean and is it safe for patients?

Background:

All drugs and devices are tightly controlled by the US Food and Drug Administration to ensure safety and effectiveness. Drug and device companies spend years and untold millions of dollars running trials to satisfy the demands of the FDA in order to receive approval. However, FDA approval is limited to the indication for which those time-consuming and expensive studies are performed.

Example:

In the case of the available neuromodulators (Botox, Dysport, Xeomin) that treat facial wrinkles, FDA approval was sought for the treatment of glabellar lines. The FDA did approve these three medications for softening of the "11s" or lines between the eyebrows. Thus, their FDA-approved use is for one specific area of the face.

How does "off label" use evolve?

After years of safe and effective use for treatment of lines between the eyebrows, plastic surgeons and dermatologists began expanding use of Botox, Dysport and Xeomin to other areas of the face. In the United States, this is perfectly legal. Since FDA-approval is costly and time consuming, physicians will often use medications for reasons other than the initial FDA indication. Thus, we began using Botox for softening of horizontal lines in the forehead, wrinkles around the eyes, "bunny lines" or wrinkles in the nose, treatment of muscles around the mouth to accentuate the smile as well as treatment of the masseter muscle to slim the lower face. We also began using Botox to treat migraine headaches which after years of successful use recently received FDA approval.

What are the advantages of "off label" medication use?

If "off label" use was not available, the pace of medical advances would be dramatically slowed. Thus, physicians have the option in the United States to use an FDA-approved medication outside of its initial indication to provide cutting-edge treatment to patients. This is only done after significant thought. Typically, a new technique will be presented at a national meeting of plastic surgeons that catches on. A physician will present data and patient photos that demonstrate safety and effectiveness for a medication beyond what the FDA had considered. This is slowly adopted by physicians in practice and the drug company might, or might not, perform a study and submit the new indication for FDA-approval. Regardless of whether that costly study is performed, physicians and patients will benefit from the new information and it can be immediately deployed to improve patient care.

Sculptra Aesthetic Now Available at Lone Tree Facial Plastic & Cosmetic Surgery Center!

Sculptra Aesthetic is an FDA-approved injectable treatment designed to correct aging-related facial volume loss and sagging of facial tissues. I have extensive experience with Sculptra treatment and think that in the properly selected patient, the results are outstanding.

Sculptra Aesthetic is composed of poly-L-lactic acid which triggers your body to create its own new collagen, resulting in tighter and fuller facial tissues. Unlike short-term filler products, Sculptra Aesthetic treatment causes your body to lay down its own collagen resulting in long-lasting benefits. Treatment results in gradual, progressive restoration of facial volume and the facial contours associated with youth. We can restore lost volume in the temples, cheeks and lines around the mouth to create the youthful appearance of midface volume and counter the tendency of our volume to shift to the jowls and neck, both obvious signs of facial aging. 

Most of our patients require three to four treatment sessions in the office, each separated by one month. You can return to work or your daily activities the morning following each treatment. Creation of new collagen takes place gradually during the course of treatment resulting in long-lasting improvement in facial contours. The results should last two years

If you are interested in learning more about Sculptra Aesthetic, I am happy to answer your questions. I've been using this product for four years and have had great results with Sculptra Aesthetic for the treatment of aging-related facial volume loss as well as treatment of lipodystrophy. In the properly-selected patient, Sculptra Aesthetic can produce life-changing results.

Call us at (303) 788-6632 or visit Lone Tree Facial Plastic & Cosmetic Surgery Center for more information.

Before (left) and after (right) four Sculptra treatments.

Before (left) and after (right) four Sculptra treatments.

Is there a clinically-significant difference between Botox and Dysport?

This is a common question among our patients at Lone Tree Facial Plastic & Cosmetic Surgery Center. We answer alot of specific questions about these products. Some ask for Brand X or Y because they saw an ad or because a girlfriend recommended it. Some of our clients have been told to "avoid" certain products. I hope to dispel some of this misinformation and allow you to become a more informed consumer of neuromodulator products by answering a series of questions for you.

What is the difference between these two products?

Botox (onabotulinumtoxin A) and Dysport (abobotulinumtoxin A) are different at a molecular level but act via the same mechanism. They block communication between nerve endings and the facial muscles that those nerves control. The clinical effect is softening or weakening of muscle contraction rather than "paralysis." The effects are temporary and any muscle weakening resolves once new nerve endings have sprouted and connected with the muscle. This typically requires two to three months.

Of note, Dysport is a smaller molecule and thus has some tendency to "spread" from the site of injection. In my experience this is an issue when higher dilutions (larger volumes of injection) of the product are used. This is mainly a concern during injection of the forehead, where excess "spread" can lead to temporary heaviness of the eyebrow. The best option when treating forehead wrinkles in a person who already has heavy brows is to use a lower dilution of the product (we always do) or using Botox to minimize the risk of "spread" and excessive forehead weakening. 

Are Botox and Dysport safe? 

Yes. Both Botox and Dysport are FDA-approved for the treatment of dynamic facial wrinkles. They have both undergone significant study demonstrating their effectiveness and safety. The doses used for aesthetic treatments are significantly lower than those used for treatment of medical problems such as cervical dystonia. 

Do the risks or side effects differ between the two products?


Both Botox and Dysport have similar side effect profiles. The most common risk is a bruise at the site of injection. This is uncommon but can be camouflaged with makeup immediately. Most complications with neuromodulator products result from injection technique. If the wrong muscle is injected or if the target muscle is overtreated, inadvertent or excessive muscle weakness can result. For example, overtreatment of the forehead can result in drooping of the eyebrows and increased fullness in the eyelids. Temporary headache, allergy and lack of effect have also been described but are unusual.

Can these products be used together or sequentially?  

Botox and Dysport can be used at the same time. For example, for a woman with drooping eyebrows Botox might be used in the forehead to minimize the risk of spread which could result in further drooping of the eyebrows. In this case, Dysport might be used to treat the remainder of the upper facial areas. This is typically not necessary as an experienced injector who does not over-dilute Dysport should not have significant difficulty preventing drooping of the eyebrows. These products can also be alternated - Botox today and Dysport in three months when the wrinkles need to be re-treated. 

What's the deal with the "units" of Botox and Dysport? Are they the same?

No, units of Botox and Dysport cannot be compared as these are similar but different medications. Most injectors will agree that roughly 2.5 to 3 units of Dysport are required to achieve results equivalent to 1 unit of Botox. If Dysport seems like a "steal" on a per unit cost basis, there's a very good reason for this. You will need alot more units of Dysport to achieve the same effect. In practice, I find that the cost is roughly the same when achieving a similar result.

Is there a cost difference for either product? 

No. I do not believe so. In our hands, 2.5 to 3 times the number of Dysport units is required to achieve the same results as Botox. In most practices, ours included, the cost of Botox is about 2.5 times higher per unit than Dysport. Given the need for more Dysport to achieve equivalence with Botox this results in a similar cost. Of course, this is practice specific.

Which should I choose?


This is a great question! The answer does differ from person to person. Some of our patients prefer one product over the other for reasons including a more natural effect, longer duration of effect or better response to X over Y. Some patients will request Botox specifically after having had a previous issue with drooping of the eyebrows after Dysport treatment. As mentioned earlier, this issue is probably related to the manner in which the product was injected rather than the product itself. Most importantly, the practical consideration of cost is highly important to our patients. Because of this, we'll perform more injections with a given neuromodulator product if the manufactured is offering a special that month. As both products are safe and effective and well-researched this makes perfect sense.

I hope that this post answers some questions you might have had about Botox and Dysport. I will be updating this post as our experience with Xeomin, the newest neuromodulator product, grows.

I encourage you to visit Lone Tree Facial Plastic & Cosmetic Surgery Center if you have any additional questions.

Restylane now FDA-approved for in-office lip augmentation

Restylane, a hyaluronic acid dermal filler, was recently approved by the FDA for lip augmentation. We have been filling lips for years with Restylane to provide more volume, better symmetry and more definition in an "off label" fashion. However, the recent nod by the FDA should provide patients with additional comfort and confidence that Restylane can be safely used in the office for lip augmentation. Of note, this is the only hyaluronic acid filler on the market in the US that has this indication. Juvederm will still remain a great option for filling lips but does not carry this stamp of FDA approval.

Interestingly, in the study on which approval was based the most common problems following injection were bruising, swelling, redness and tenderness. However, over 80% of patients chose to be re-treated at six months suggesting that the overwhelming majority were happy with treatment. These results are consistent with what we have found at Lone Tree Facial Plastic and Cosmetic Surgery Center.

Treatments are performed in the office. The procedure requires roughly thirty minutes and is most often performed after applying a topical numbing gel. Dental blocks can also be used to increase comfort but are typically not required. A small volume goes a long way when augmenting lips so it is critically important to find an experienced injector when looking to plump your lips. Complications are highly unusual following lip augmentation.

If you're interested in further information or would like to schedule lip augmentation, give us a call at (303) 788-6632.

Medicis Press Release