One of the most common cosmetic procedures is Botox. This powerful injection is FDA approved for use by physicians to soften facial lines. It was originally used to treat muscle spasms of the eyelids and the cosmetic benefits were subsequently discovered. Botox has been used for many years and has a great safety record. Common uses include relaxing lines of the forehead, the crow’s feet and between the eyebrows. The position of the eyebrows may also be elevated giving the effect of a forehead lift. Other uses include reducing the lines that form when nasal skin is wrinkled (bunny lines) and when the lips and chin are tightened into a pouting position. Platysmal banding in the neck can also improve with multiple injections along the cord. A conservative treatment with Botox in these areas can weaken the muscles just enough to have a nice effect without significantly altering the function of the muscle. Reports have also been published demonstrating the beneficial effects on migraine headaches and excessive sweating. Multiple injections are carried out with a small gauge needle delivering the medicine into the treated area. The effects are evident within a week and commonly last for 3 months. After several treatments, the interval between injections can increase beyond 3 months through a process called behavior modification. Patients can loose the habit of frowning or keeping their eyebrows elevated during conversation but still maintain their expressions. Adverse side effects are rare but can occur with this procedure. Misplacement or overdosing may lead to a transient malfunction of the injected muscle. This may include a droopy eyelid, lowering of the eyebrows or an asymmetric smile.
The Botox Non-Surgical Facelift elevates sagging eyebrows, sloping corners of the mouth, early jowl formation in the cheeks, and collapse of the folds beneath the corners of the mouth, which cause unwanted lines and wrinkles. The Botox Non-Surgical Facelift uses knowledge of opposing muscles of facial expression to selectively make the upward lifting muscles of the face stronger than muscles, which pull it down. Unlike the use of botox to eliminate lines and wrinkles, this is a very delicate procedure in which botox is administered in small doses to specific muscle groups over a period of weeks to achieve its desired results. For this reason, only cosmetic surgical practices with a strong knowledge of facial anatomy are performing this procedure.
The results of these procedures improve with each treatment so that patients can expect to return for their second series of injections in 3 months and their third series in 6 months or longer. While not suited for severe facial sagging, botox non-surgical facelift is a cosmetic enhancement, which promotes a youthful and relaxed appearance and can be combined with botox procedures which eliminate lines and wrinkles. Similarly it can be combined with fillers to provide more fullness for collapsing facial units, and fillers last up to twice as long as normal when combined with botox so significant cost savings can be achieved. Lastly, don’t forget to join the MetropolitanMD VIP program which provides 25 per cent discounts on botox and 10 per cent discounts on fillers.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.
Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The most frequently reported adverse event following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).
The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.
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