What is Botox Cosmetic®?
- Botox Cosmetic® is a highly purified muscle-relaxing agent that is derived from the bacterium, Clostridium Botulinum.
- It also known as Botulinum Toxin Type A and belongs to a group of drugs known as neurotoxins.
- There are 7 different types of Botulinum toxins (Type A, B, C, D, E, F, G). Each has its own unique properties and effects. Botulinum Toxin Type A is Botox Cosmetic®, and it is the most widely studied of all types.
- Botulinum Toxin Type A has been safely used in the fields of neurology and ophthalmology for many years. It is approved by the Food and Drug Administration (FDA) for the treatment of eyelid spasm, muscle spasm causing crossed eyes, as well as for correcting one-sided facial muscle spasm.
- Botox Cosmetic® gained general acceptance in the field of cosmetic surgery in 2003 when it received approval by the FDA for cosmetic treatment of the wrinkles in between the eyes. Although that has remained the only FDA-approved cosmetic indication, most physicians use Botox Cosmetic® to treat wrinkles in many other parts of the face. These uses are considered "off-label” uses.
- Botox Cosmetic® injections are the most common cosmetic procedure performed today.
How does Botox Cosmetic® work?
- Botox Cosmetic® causes a temporary relaxation of the muscle into which it is injected.
- Botox Cosmetic® acts at the level of the nerve-muscle junction to prevent muscle contraction.
- Normally, the motor nerves in the body stimulate the movement and contraction of specific adjacent muscles. The nerve sends a message to the muscle to cause it to contract. This message is "transmitted” to the muscle by a "neurotransmitter” known as acetylcholine. When acetylcholine is released from the nerve into the adjacent muscle, the muscle receives the message to contract.
- Botox Cosmetic® enters the nerve ending and blocks the release of this neurotransmitter, acetylcholine. Consequently, the muscle does not get the message to contract and is temporarily paralyzed.
What does Botox Cosmetic® accomplish?
- Years of muscle contraction have an effect on the skin that is attached to these muscles. As the muscles contract repeatedly over many years, the attached skin is being pulled repeatedly according to the direction of the muscle contraction. Since each muscle will contract in only one direction, the pull on the skin is only in one direction. This leads to creases and wrinkles in the skin that follow a predictable pattern. Initially these wrinkles and creases are present only when you are making a particular expression and contracting a particular muscle. Eventually with years of repetitive movement, the wrinkles become etched into the skin and are visible even when your face is at rest. For example, the smile lines around the eyes become noticeable when we smile in our 20’s or 30’s. With repetitive smiling, these wrinkles eventually become etched in the skin leading to persistent crows’ feet.
- Botox Cosmetic® softens or prevents wrinkles and creases by limiting the ability of the underlying muscles to contract.
- The only FDA-approved use of Botox Cosmetic® is in the treatment of the vertical lines in between the eyebrows. All other uses which will be discussed are considered off-label uses.
- Botox Cosmetic® is most commonly used to treat the vertical creases in between the eyebrows caused by frowning, the creases across the forehead due to raising the brows, and the crows feet that develop from smiling (Figs. 15-1, 15-2). The use of Botox Cosmetic® is also extending to the lower third of the face. Although this is not as common as use in the upper third of the face, Botox Cosmetic® is being used to treat wrinkles around the lips, decrease deep nasolabial folds, soften prominent neck bands, and lift the downward turn of the corner of the mouth that occurs with aging.
- Generally, Botox Cosmetic® is very useful in the upper one-third of the face, and the combination of Botox
- Cosmetic® with soft tissue fillers is useful in the lower third of the face. Soft tissue fillers will be discussed in Chapter 14.
- Botox Cosmetic® gives the face a smoother and softer appearance by improving existing wrinkles and slowing down the formation of new wrinkles.
How is it done?
- A small needle is used to inject a very small amount of Botox Cosmetic® into the muscles that are causing the wrinkles. Several injections are given per specific muscle.
- There is a slight stinging sensation that lasts a few seconds after the injection. Ice is helpful with the discomfort.
- It takes approximately 3 -7 days for the Botox Cosmetic® to begin working. The full effect of Botox Cosmetic® is normally seen after 2 weeks.
How long does the effect of Botox Cosmetic® last?
- Injection of Botox Cosmetic® into the small muscles causes those specific muscles to halt their functions temporarily.
- Each individual’s response to Botox Cosmetic® depends upon their own metabolism of the drug.
- In general, the therapeutic effect of Botox Cosmetic® will last approximately 3 months. Consequently, most people require Botox Cosmetic® injections 4 times per year in order to maintain its effect.
What can I expect immediately after the Botox Cosmetic® injections?
- Generally, there is minimal recovery following Botox Cosmetic® injections.
- The injection session lasts only a few minutes..
- You may experience very mild redness and swelling at the injection site for several minutes after the injection.
- If you have a tendency to bruise, ice is helpful.
- You will have slight stinging at the site of the injections, but this lasts only a few seconds.
- You may apply make-up almost immediately after the injections.
- Patients undergoing any kind of injection procedures should try to abstain from products that increase bleeding.
- If there is slight bleeding at the site of the injection, you may gently apply pressure to it.
What are the side effects and potential risks following Botox Cosmetic® injections?
- Although Botox Cosmetic® is safe to use repeatedly, every product has potential side effects. In general, Botox Cosmetic® treatments have very limited risks or complications.
- There have not been any reported cases of systemic toxicity from accidental injection or oral ingestion of Botox Cosmetic®.
- The effect of Botox Cosmetic® may be altered by certain antibiotics (aminoglycosides) or other drugs that interfere with neuromuscular transmission. Consequently, a thorough review of the patient’s medical history, including their daily medications is crucial.
- Complications are rare but may include paralysis of nearby muscles, headaches, local numbness, rash, and bruising.
- Although any muscle adjacent to the injection site may be temporarily paralyzed by Botox Cosmetic®, the results are temporary and will resolve.
- If injected to treat the wrinkles in between the eyes or along the forehead, Botox Cosmetic® may cause a temporary drooping of the eyelid or drooping of the forehead. There are prescription eye drops available to correct the eyelid drooping until the full Botox Cosmetic® effect has dissipated.
- If injected for treatment of prominent nasolabial folds (off-label use), Botox Cosmetic® may cause a temporary vertical lengthening of the upper lip by relaxing the muscles that normally elevate the lip border. If this occurs, a soft tissue filler substance may be injected into the lip to help elevate the border.
Can repeat injections of Botox Cosmetic® diminish its effect over time?
- Infrequently, repeat injections of Botox Cosmetic® may be associated with decreased efficacy. Usually, the longer one uses Botox Cosmetic®, the longer the benefits. So, why does it have a diminished effect in some people over time?
- Botox Cosmetic® contains very small amounts of proteins. When these proteins enter the human body, the natural response is to form antibodies to them. After they are formed, these antibodies attack the Botox Cosmetic® proteins when they enter the body, making Botox Cosmetic® less effective.
- The likelihood of forming antibodies is reduced by having treatments no more frequently than is necessary to achieve the desired result. Treatments with Botox Cosmetic® should not be administered until the effect of the previous treatment has dissipated. In general, this is approximately every 3 months.
- The cumulative dose of Botox Cosmetic® should not exceed 200 units in a 30-day period. Fortunately, this is a high number of units and is not normally exceeded with cosmetic applications of Botox Cosmetic®.
Who is not a candidate for Botox Cosmetic® injections?
- Active inflammatory skin reactions such as herpetic blisters, rashes, or hives necessitate postponing Botox Cosmetic® injections until the condition has resolved.
- Women, who are pregnant, attempting to become pregnant or breast feeding should avoid Botox Cosmetic® since its safety during these conditions has not been established.
- The safety of Botox Cosmetic® injections has not been established in individuals 12 years of age or younger.
- Patients with certain neuromuscular diseases (involve nerves and muscles) should avoid Botox Cosmetic®®. These include:
- Amyotrophic lateral sclerosis (ALS)
- Motor neuropathy
- Neuromuscular junctional disorders
- Myasthenia gravis
- Lambert-Eaton syndrome
Patients with neuromuscular disorders may be at increased risk of the systemic effects of Botox, including difficulty swallowing and breathing.
- Serious and/or immediate hypersensitivity (allergic) reactions have been rarely reported. These reactions include:
- Soft tissue swelling
- Difficulty breathing
- Options for alternative treatment may include injection of fillers or the surgical excision of the muscles, depending on the area in question.
What are injectable soft tissue fillers?
As we age, the changes that occur in our face are a manifestation of the effects of gravity, sun damage, hereditary influences, and loss of volume. The change in volume is due to loss and redistribution of fat within the face, thinning of the skin dermis (deep layer of the skin) and bone loss. All of these changes lead to descent of the forehead, the eyebrows and the cheeks, downward turning of the corners of the mouth, thinning of the lips, drooping of the nasal tip, prominence of the folds along the sides of the nose and mouth (nasolabial folds), greater visibility of the bony structures, and relaxation of the tissues seen as jowls and redundancy of the neck.
Injectable soft tissue fillers consist of a group of natural or synthetic substances that restore volume within the facial skin and the deeper tissues giving rise to a fuller more youthful appearance. As of 2009, there are 14 injectable soft tissue fillers that are FDA approved for cosmetic use in the United States. These include Zyderm, Zyplast, Cosmoderm, Cosmoplast, Restylane, Perlane, Hylaform, Hylaform Plus, Captique, Prevelle Silk, Juvederm Ultra, Juvederm Ultra Plus, Radiesse, and Sculptra Aesthetic. Zyderm and Zyplast are forms of bovine collagen while Cosmoderm and Cosmoplast are forms of human collagen. Restylane, Perlane, Juvederm Ultra, Juvederm Ultra Plus, Hylaform, Hylaform Plus, Captique and Prevelle Silk (Captique with Lidocaine) are all forms of hyaluronic acid. Radiesse is a calcium-based product and Sculptra Aesthetic is a synthetic filler consisting mostly of Poly-L-Lactic acid.
Each of these soft tissue fillers will be addressed individually and in detail later in this chapter. There are other fillers available which are not FDA-approved. These will not be addressed. Caution must be exercised when considering treatment with any product or procedure that is not FDA-approved. Our FDA has strict guidelines to ensure the proper use of various therapeutic modalities. Improper or unapproved use may lead to significant complications. Patients must be very judicious in the treatment modalities they seek and the physicians they seek to perform them.
All currently available and FDA-approved soft tissue fillers are temporary in nature. They must be repeatedly injected into the tissues to maintain their effect. The length of time they remain in the soft tissues varies with the characteristics of the filler itself, the area of the face into which the filler is injected and the patient’s unique response to the filler.
Most patients who seek treatment with soft tissue fillers often wonder why there is not an FDA- approved injectable permanent filler. Although the concept of "permanent correction” of soft tissues may seem very attractive, it is important to remember that our specific facial features are not "permanent”. With aging and weight fluctuations, our facial features undergo significant change. As such, a soft tissue filler that may have appeared perfectly placed at one point in life may be very misplaced in the future as the facial features shift due to the natural forces of aging or weight change. Furthermore, permanent fillers may have long-term side effects such as migration, asymmetry, and lumpiness. In these situations, permanent fillers are very difficult to remove since they are not an implant but an injection. Consequently, it is much safer to use temporary soft tissue fillers.
The ideal filler is one that has a low risk of complications and relatively predictable as well as reproducible results. It would create a natural appearance with minimal down time and minimal side effects. It would be easily tolerated by the patient with a low risk for allergic reactions eliminating the need for a skin test. It would be cost effective and provide a long-lasting but not permanent result.
What do soft tissue filler injections accomplish?
- The objective of using soft tissue fillers is to soften wrinkles, improve depressions or add volume. These substances are used to fill in the fine or deep facial wrinkles, frown lines, smile lines, crow’s feet, acne scars, and depressed traumatic scars (Figs 16-1, 16-2). Some may also be used to enhance the lips by making them fuller.
- In adding volume to the soft tissues, the face becomes smoother and more youthful.
- With the exception of Sculptra Aesthetic, the results of these injections are immediate.
- Since all of the FDA-approved fillers are metabolized by our body, their effect is temporary. They are absorbed over a period that can vary from 3 months to 2 years. The rate at which they are metabolized depends upon the nature of the filler used, the area into which it is injected, and the individual’s response to the filler.
What can I expect during and after the soft tissue filler injection?
- All of the soft tissue filler treatments may be performed in an office setting with you fully awake.
Your face is cleansed and the area to be injected is further treated with rubbing alcohol to minimize the potential for infection.
- The majority of these injections are performed with you in an upright position. Lying down or holding the head backward often diminishes the wrinkles and depressions in the face. Maintaining an upright position improves visualization of the areas to be treated and consequently allows more accurate placement of the filler.
- You may experience slight bleeding at the needle site; this is easily controlled with mild pressure.
- You will see the effect of the soft tissue filler injections immediately.
- There is minimal recovery following the injections and you may wear make-up shortly after the procedure.
- You may experience some redness for the first few hours at the injection site.
- You may also have swelling and bruising. These symptoms are more likely to occur and tend to last longer with the hyaluronic acid injections than with the collagen injections. The swelling tends to be more noticeable and potentially more intense with injections in the lips than anywhere else in the face.
- If you have a tendency to bruise, ice is helpful during and after the procedure.
- If you are undergoing any kind of injection procedures, you should try to avoid products that increase bleeding the week prior to your procedure, as these will increase the risk of bruising.
- Some individuals may develop "bumpy areas” where the soft tissue filler was been injected. This may be a result of:
- The filler being injected too superficially
- Too much filler being placed in one area
- Migration of the filler to one region. This is especially true of areas such as the lips and marionette lines
- Inflammatory reaction to the injection
Is there treatment for the "bumpy areas”?
- Massage is helpful to soften these bumps. If severe, a topical steroid cream or a small steroid injection may be attempted.
- If hyaluronic acid fillers are the cause of the bumps, a hyaluronidase product may be used to quickly dissolve them.
- This is considered an "off-label” use of hyaluronidase products.
Often however, only the body’s natural metabolism of the injectable material over time will resolve the symptoms.
Do soft tissue filler injections hurt?
- All injections are associated with pain. The discomfort associated with soft tissue filler injections is transient and typically does not last beyond the treatment session.
- The degree of discomfort is dependant upon the type of filler used and the area into which it is injected.
- There are three types of discomfort associated with soft tissue filler injections. The first is from the actual needle itself as it penetrates the skin. The second is due to the distension of the soft tissue as the filler is being injected. The third pain is due to the burning sensation of the substance itself.
- Both human and bovine collagen have a local anesthetic (Lidocaine) mixed with them and consequently are associated with less pain than other soft tissue fillers.
- The hyaluronic acid soft tissue fillers and Radiesse do not have any local anesthetics mixed with them. As such, they are associated with a slightly greater degree of discomfort. Soft tissue injections using these substances are more easily tolerated by using a topical anesthetic or by using a local anesthetic injection (similar to those used by dentists when working on teeth).
Who is not a candidate for soft tissue filler therapy?
- Patients with active inflammatory skin reactions such as herpetic blisters, rashes, pimples, cysts or hives should postpone soft tissue filler injections until the condition has resolved.
- Patients with a strong history of herpetic blisters should undergo suppressive anti-herpetic treatment prior to undergoing soft tissue filler injections in the lips. However, this is considered an off-label use of anti-herpetic medications.
- Patients receiving immunosuppressive therapy should discuss obtaining soft tissue fillers with their physician to obtain clearance. At times, it is prudent to consider postponing these injections until patients are no longer receiving such treatment.
- Patients with connective tissue disorders may have increased susceptibility to hypersensitivity reactions making soft tissue filler therapy unpredictable and perhaps imprudent. There is no data on the effect of these soft tissue fillers in this patient population.
- Women who are pregnant, attempting to become pregnant or nursing should avoid soft tissue fillers since their safety during these conditions has not been established.
- The safety of soft tissue fillers has not been established in patients 12 years of age or younger.
Are certain fillers more suitable for certain conditions or for certain parts of the face?
- Soft tissue fillers vary in terms of type, concentration, molecular weight or degree of molecular cross linking.
- In general, fillers consisting of smaller molecules are more suitable for superficial lines and wrinkles, whereas those consisting of larger molecules are more appropriate for the deeper folds and wrinkles.
Can different fillers be used together in one area?
- It has become common practice to use multiple fillers in the face. Certain fillers are more appropriate for different parts of the face than others.
- Under some circumstances, physicians may combine two fillers in the same region of the face. For example, they may place Radiesse along the deep plane of the nasolabial folds and layer Juvederm or Restylane above it, along a more superficial level.
- We do not have data on how well these fillers mix together once injected into the same region. However, to date there have been no adverse reactions reported.