Alternative forms of management include not treating the skin wrinkles by any means. Improvement of skin wrinkles may be accomplished by other treatments or alternative types of surgery such as a blepharoplasty, face or brow lift when indicated. Other forms of eyelid surgery may be needed should you have intrinsic disorders affecting the function of the eyelid such as drooping eyelids from muscle problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion). Minor skin wrinkling may be improved through chemical skin peels, lasers, injection of filling material, or other skin treatments. Risks and potential complications are associated with alternative forms of medical or surgical treatment.
Risk of injections
Every procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your Nurse Practitioner to make sure you understand risks, potential complications, limitations, and consequences of BOTOX® , Xeomin®, and Jeuveau® injections.
Additional information concerning may be obtained from the package-insert sheets available upon request.
Incomplete Block: It is possible to not experience a complete block of desired muscles. Additional injections to reach the desired level of block can be performed until the goal is achieved.
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® ,Xeomin®, and Jeuveau® injections.
Drooping Eyelid (Ptosis): Muscles that raise the eyelid may be affected by BOTOX® and Xeomin® , should this material migrate downward from other injection areas.
Pain: Discomfort associated with BOTOX®, Xeomin®, and Jeuveau®injections is usually of short duration.
Migration: BOTOX®, Xeomin®, and Jeuveau® may migrate from its original injection site to other areas and produce temporary paralysis of other muscle groups or other unintended effects. BOTOX®, Xeomin®, and Jeuveau® has been reported to cause swallowing problems in patients treated for spastic muscle disorders of the cervical region (cervical dystonia).
Bleeding and Bruising: It is possible, though unusual, to have a bleeding episode from a BOTOX® , Xeomin®, and Jeuveau® injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball during deeper BOTOX® , Xeomin®, and Jeuveau® injections for crossed eyes (strabismus) has occurred. Should you develop post-injection bleeding, it may require emergency treatment or surgery. Aspirin, anti-inflammatory medications, platelet inhibitors, anticoagulants, Vitamin E, ginkgo biloba, and other “herbs / homeopathic remedies” may contribute to a greater risk of a bleeding problem. Do not take these for ten days before or after BOTOX® ,Xeomin®, and Jeuveau® injections.
Damage to Deeper Structures: Deeper structures such as nerves, blood vessels, and the eyeball 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® and Xeomin® 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.
Unknown Risks: The long-term effect of BOTOX®, Xeomin®, and Jeuveau® on tissue is unknown. The risk and consequences of accidental intravascular injection of BOTOX® and Xeomin® is unknown and not predictable. There is the possibility that additional risk factors may be discovered.
Dry Eye Problems: Individuals who normally have dry eyes may be advised to use special caution in considering BOTOX injections around the eyelid region.
Double-Vision: Double-vision may be produced if the BOTOX®, Xeomin®, and Jeuveau® 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®, Xeomin®, and Jeuveau® injections.
Other Eye Disorders: Functional and irritative disorders of eye structures may rarely occur following BOTOX® ,Xeomin®, and Jeuveau® Injections.
Blindness: Blindness is extremely rare after injections. However, it can be caused by internal bleeding around the eyeball or needle stick injury. The occurrence of eye problems appears to be very rare.
Allergic Reactions: As with all biologic products, allergic and systemic anaphylactic reactions may occur. Allergic reactions may require additional treatment.
Antibodies to BOTOX®, Xeomin®, and Jeuveau® injections: Presence of antibodies to BOTOX may reduce the effectiveness of this material in subsequent injections. The health significance of antibodies to BOTOX is unknown.
Infection: Infection is extremely rare after BOTOX® and Xeomin® injections. Should an infection occur, additional treatment including antibiotics may be necessary.
Skin Disorders: Skin rash, itching, and swelling may rarely occur following BOTOX®, Xeomin®, and Jeuveau® injections,
Neuromuscular Disorders: Patients with peripheral motor neuropathic disorders (amyotrophic lateral sclerosis myasthenia gravis, motor neuropathies) may be at greater risk of clinically significant side effects from BOTOX®, Xeomin®, and Jeuveau® injections.
Migraine Headache Disorders BOTOX®, Xeomin®, and Jeuveau® injections has been used to treat forehead muscle groups that are involved with the migraine headache condition. Patients are advised that results of BOTOX®, Xeomin®, and Jeuveau® treatments for migraine headaches may be variable and improvement in this disorder may not occur following BOTOX®, Xeomin®, and Jeuveau® injections
Unsatisfactor Result: There is the possibility of a poor or inadequate response from BOTOX®, Xeomin®, and Jeuveau® injections. Additional BOTOX®, Xeomin®, and Jeuveau® injections may be necessary. Surgical procedures or treatments may be needed to improve skin wrinkles including those caused by muscle activity.
Long-Term Effects: Subsequent alterations in face and eyelid appearance may occur as the result of aging, weight loss, weight gain, sun exposure, pregnancy, menopause, or other circumstances not related to BOTOX®, Xeomin®, and Jeuveau® injections. BOTOX®, Xeomin®, and Jeuveau® injections do 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®, Xeomin®, and Jeuveau® injections could produce fetal harm. It is not known if BOTOX®, Xeomin®, and Jeuveau® injections can be excreted in human milk. It is not recommended that pregnant women or nursing mothers BOTOX®, Xeomin®, and Jeuveau® injections treatments.
Drug Interactions: The effect of BOTOX®, Xeomin®, andJeuveau® injections may be potentiated by aminoglycoside antibiotics or other drugs known to interfere with neuromuscular transmission.
GENERAL RISKS
Bleeding: It is possible, though unusual, to experience a bleeding episode during or after procedure. Should post- operative bleeding occur, it may require emergency treatment to drain accumulated blood or you may require a blood transfusion, though such occurrences are rare. Increased activity too soon after procedure can lead to increased chance of bleeding and additional procedures. It is important to follow postoperative instructions and limit exercise and strenuous activity for the instructed time. Do not take any aspirin or anti-inflammatory medications for at least ten days before or after procedure, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary supplements can increase the risk of surgical bleeding. Hematoma can occur at any time, usually in the first three weeks following injury to the procedural area. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.
Infection: Infection is unusual after procedure. Should an infection occur, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. It is important to tell your Nurse Practitioner or Nurse of any other infections, such as ingrown toenail, insect bite, or urinary tract infection. Remote infections, infections in other parts of the body, may lead to an infection in the operated area.
ADDITIONAL ADVISORIES
Female Patient Information: It is important to inform your Nurse Practitioner or Nurse if you use birth control pills, estrogen replacement, or if you suspect you may be pregnant. Many medications including antibiotics may neutralize the preventive effect of birth control pills, allowing for conception and pregnancy.
Mental Health Disorders and Elective Procedure: It is important that all patients seeking to undergo elective procedure have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional procedures and often are stressful. Please openly discuss with your Nurse Practitioner or Nurse, prior to procedure, any history that you may have of significant emotional depression or mental health disorders. Although many individuals may benefit psychologically from the results of elective procedure, effects on mental health cannot be accurately predicted.
Sun Exposure – Direct or Tanning Salon: The effects of the sun are damaging to the skin. Exposing the treated areas to sun may result in increased scarring, color changes, and poor healing. Patients who tan, either outdoors or in a salon, should inform their Nurse Practitioner or Nurse and either delay treatment, or avoid tanning until the Nurse Practitioner or Nurse says it is safe to resume. The damaging effect of sun exposure occurs even with the use of sun block or clothing coverage.
Medications and Herbal Dietary Supplements: There are potential adverse reactions that occur as the result of taking over-the-counter, herbal, and/or prescription medications. Aspirin and medications that contain aspirin interfere with clotting and can cause more bleeding. These include non-steroidal anti-inflammatories such as Motrin, Advil, and Aleve. It is very important not to stop drugs that interfere with platelets, such as Plavix, which is used after a stent. It is important if you have had a stent and are taking Plavix that you inform the Nurse Practitioner or Nurse.
Stopping Plavix may result in a heart attack, stroke and even death. Be sure to check with your physician about any drug interactions that may exist with medications which you are already taking. If you have an adverse reaction, stop the drugs immediately and call your Nurse Practitioner or Nurse for further instructions. If the reaction is severe, go immediately to the nearest emergency room. When taking the prescribed pain medications after procedure, realize that they can affect your thought process and coordination. Do not drive, do not operate complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.
Travel Plans: Any procedure holds the risk of complications that may delay healing and delay your return to normal life. Please let the Nurse Practitioner or Nurse know of any travel plans, important commitments already scheduled or planned, or time demands that are important to you, so that appropriate timing of procedure can occur. There are no guarantees that you will be able to resume all activities in the desired time frame.
Off-Label FDA Issues: There are many devices, medications and injectable fillers and botulinum toxins that are approved for specific use by the FDA, but this proposed use is “Off-Label”, that is not specifically approved by the FDA. It is important that you understand this proposed use is not experimental and your physician believes it to be safe and effective. Examples of commonly accepted “Off-Label” use of drugs or devices include the use of aspirin for prevention of heart disease, retinoids for skin care, and injection of botulinum toxin for wrinkles around the eyes. BOTOX®, Xeomin®, and Jeuveau® injections is approved for Glabellar frown lines, crow’s feet, forehead, marionette lines, infra brow, chin, neck, nasalis, masseter, Blepharospasm, and would be Off-Label for all other uses.