Every procedure involves a certain amount of risk, and it is important that you understand the risks involved. An individual’s choice to undergo this procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience the following complications, you should discuss each of them with your practitioner to make sure you understand the risks, potential complications, and consequences of BOTOX®/VISTABEL® injections.
Bleeding – Bruising in soft tissues may occur. Do not take any aspirin or anti-inflammatory medications for seven days before BOTOX®/VISTABEL® injections, as this may contribute to a greater risk of a bleeding problem.
Damage to deeper structures – Deeper structures, such as nerves and blood vessels, may be damaged during the course of injection. Injury to deeper structures may be temporary or permanent.
Corneal exposure problems – Some patients experience difficulties closing their eyelids after BOTOX®/VISTABEL® injections and problems may occur in the cornea due to dryness. Should this rare complication occur, additional treatments, protective eye drops, contact lenses, or surgery may be necessary.
Dry eye problems – Individuals who normally have dry eyes may be advised to use special caution in considering BOTOX®/VISTABEL® injections around the eyelid region.
Migration of BOTOX®/VISTABEL® – BOTOX®/VISTABEL® may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects.
Drooping Eyelid (Ptosis) – Muscles that raise the eyelid may be affected by BOTOX®/VISTABEL® should this material migrate downward from other injection areas.
Double-Vision – Double-vision may be produced if the BOTOX®/VISTABEL® material migrates into the region of muscles that control movements of the eyeball.
Eyelid Ectropion – Abnormal looseness of the lower eyelid can occur following BOTOX®/VISTABEL® injection.
Other Eye Disorders – Functional and irritative disorders of eye structures may rarely occur following BOTOX®/VISTABEL® injections.
Asymmetry – The human face and eyelid region is normally asymmetrical with respect to structural anatomy and function. There can be a variation from one side to the other in terms of the response to BOTOX®/VISTABEL® injection.
Pain – Discomfort associated with BOTOX®/VISTABEL® injections is usually of short duration.
Skin disorders – Skin rash and swelling may rarely occur following BOTOX®/VISTABEL® injection.
Unknown risks – The long term effect of BOTOX®/VISTABEL® on tissue is unknown. There is the possibility that additional risk factors may be discovered.
Unsatisfactory result – There is the possibility of a poor or inadequate response from BOTOX®/VISTABEL® injection. Additional BOTOX®/VISTABEL® injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity.
Allergic reactions – As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment.
Antibodies to BOTOX®/VISTABEL® – Presence of antibodies to BOTOX®/VISTABEL® may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to BOTOX®/VISTABEL® is unknown.
Infection – Infection is extremely rare after BOTOX®/VISTABEL® injection. Should an infection occur, additional treatment including antibiotics may be necessary.
Long-term effects – Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss or gain, sun exposure, or other circumstances not related to BOTOX®/VISTABEL® injections. BOTOX®/VISTABEL® injection does not arrest the aging process or produce permanent tightening of the eyelid region. Future surgery or other treatments may be necessary.
Pregnancy and nursing mothers – Animal reproduction studies have not been performed to determine if BOTOX®/VISTABEL® could produce foetal harm. It is not known if BOTOX®/VISTABEL® can be excreted in human milk.
Blindness – Blindness is extremely rare after BOTOX®/VISTABEL® injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. The occurrence of this is very rare.
Drug Interactions – The effect of BOTOX®/VISTABEL® may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.
Additional Treatment Necessary
There are many variable conditions in addition to risk and potential complications that may influence the long term result of BOTOX®/VISTABEL® injections. Even though risks and complications occur infrequently, the risks cited are the ones that are particularly associated with BOTOX®/VISTABEL® injections. Other complications and risks can occur but are even more uncommon. Should complications occur, additional surgery or other treatments may be necessary. The practice of medicine and surgery is not an exact science. Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained.
