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BOTOX®

Side effects of cosmetic use of BOTOX® treatments are generally mild and include bruising, tenderness, headache or swelling. These side effects are transient, meaning they don't last long. A small percentage (less than 5%) experience a temporary eyebrow droop. Sometimes, the physician may be able to add a small amount of BOTOX® in opposing muscles to counteract or lessen the droop. In very rare instances, a patient may temporarily be unable to lift an eyelid (ptosis), which can be treated with prescription eye drops to alleviate symptoms. Although possible with any physician, some occurrences of these infrequent side effects are likely a result of injector inexperience.

BOTOX® is not recommended for individuals with infections at the injection sites, neuromuscular disorders such as ALS, myasthenia gravis or Lambert-Eaton syndrome, and is not recommended for use during pregnancy, while breastfeeding or for children under 18. With almost any medication there can be severe risks; however, for cosmetic use of BOTOX® severe risks are very rare and include the possibility of anaphylaxis, dysphagia, dyspnea, myasthenia gravis, focal facial paralysis and spatial disorientation. Be sure to inform your physician of any medical conditions and any medications you may be taking.

Post-marketing 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, blurred vision, ptosis, dysphagia, 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 or other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX®/BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.

BOTOX® Cosmetic is contraindicated in the presence of infection at the injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to the components in the formulation. Risks resulting from administration at higher dosages other than those approved by the FDA are unknown. Individuals with pre-existing neuromuscular disorders should only receive BOTOX® Cosmetic with caution. Co-Administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission should only be performed with caution as the effect of the toxin may be potentiated. BOTOX® is not recommended for use during pregnancy.

For additional information, please refer to the BOTOX® Package Insert and Medication Guide .

Dysport®

With Dysport®, there is typically little to no downtime after injection. Side effects are generally mild and include bruising, tenderness, headache or swelling. These side effects are transient, meaning they don’t last long. It is recommended that you should wait at least 90 days between treatments.

Do not take Dysport® if you are allergic to any of the ingredients in Dysport®. Consult with your physician for a complete list of ingredients. Do not take Dysport® if you are allergic to cow’s milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc or BOTOX®, or have a skin infection at the planned site. Dysport® may not be right for you if you have had surgical changes to your face, very weak muscles in the treatment area, your face looks very different from side to side, the injection site is inflamed, you have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, or if your wrinkles can’t be smoothed by spreading them apart. (1) Consult your physician for a complete list of side effects and to determine if Dysport® is right for you. Be sure to tell your physician about all of your medical conditions, including if you have: a disease that affects your muscles and nerves, breathing problems, swallowing problems, bleeding problems, diabetes, a problem with your heart rate, plan to have facial surgery, have had surgery on your face, weakness of your forehead muscles, drooping eyelids, or any other change in the way your face normally looks.1

Be sure to tell your doctor if you have received any other botulinum toxin product in the last 4 months, if you have received injections of botulinum toxin in the past (and what brand was injected), have recently received an antibiotic by injection, take muscle relaxants, take allergy or cold medicine, or take sleep medicine.

Post-marketing reports indicate that the effects of Dysport® 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, blurred vision, ptosis, dysphagia, 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 or other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Dysport® at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.

Dysport® is contraindicated in the presence of infection at the injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to the components in the formulation. Risks resulting from administration at higher dosages other than those approved by the FDA are unknown. Individuals with pre-existing neuromuscular disorders should only receive Dysport® with caution. Co-Administration of Dysport® and aminoglycosides or other agents interfering with neuromuscular transmission should only be performed with caution as the effect of the toxin may be potentiated. Dysport® is not recommended for use during pregnancy.

For additional information, please refer to the Dysport® Package Insert and Medication Guide and other important safety information.

XEOMIN®

Side effects of cosmetic use of XEOMIN® treatments are generally mild and include bruising, tenderness, headache or swelling. These side effects are typically transient. A very small percentage of patients may experience a temporary eyebrow droop. Sometimes, the physician may be able to add a small amount of XEOMIN® in opposing muscles to counteract or lessen the droop. In very rare instances, a patient may temporarily be unable to lift an eyelid (ptosis), which can be treated with prescription eye drops to alleviate symptoms.

Before you take XEOMIN®, tell your doctor about all your muscle or nerve conditions, including if you have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome), as you may be at increased risk of serious side effects including difficulty swallowing or breathing.

Also tell your doctor about all your medical conditions, including if you have: breathing problems such as asthma or emphysema; a history of swallowing problems or inhaling food or fluid into your lungs (aspiration); bleeding problems; drooping eyelids; plans to have surgery; had surgery on your face. Also tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed (it is not known if XEOMIN® is harmful to infants or unborn children). Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. Using XEOMIN® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN® in the past.

Tell your doctor if you have received any other botulinum toxin product in the last four months or in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN® may be different from other botulinum toxin products that you have received.

XEOMIN® may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN®. If this happens, do not drive a car, operate machinery, or do other dangerous activities. XEOMIN may cause allergic reactions. Symptoms of an allergic reaction to XEOMIN® may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint.

Post-marketing reports indicate that the effects of XEOMIN® 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, blurred vision, ptosis, dysphagia, 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 or other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of XEOMIN® at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.

For additional information, please refer to the XEOMIN® Medication Guide and other important safety information .

Dermal Fillers

Side effects of dermal filler treatments are ordinarily mild and include redness, bruising, tenderness and swelling. As with any injection, there is always the risk of infection, but it is rare with dermal filler treatments. If the treatment is around the lips or mouth, and the individual has a history of cold sores or herpes virus outbreaks, the physician may prescribe specific medications like Acyclovir or Zovirax® to minimize risks of an outbreak as a result of the dermal filler procedure.

With any of the dermal fillers, it is possible to feel a lump or lumps around the injection area that is not usually visible to the naked eye and will typically resolve with time.

With Sculptra®, massaging the area after treatment as directed by your physician will help avoid any lumps.

If Restylane® is injected too superficially, it may appear as a faint blue line under the skin. This, too, may persist for a protracted period of time, and is less likely with an injector who has extensive experience with Restylane® procedures.

Physicians must avoid injecting Radiesse® too superficially or too close to the mucous membrane in the mouth so that it will not form any visible lumps. If this occurs, Radiesse® should be extracted immediately by the physician. Immediate extraction is typically easy; however, if Radiesse® is injected too superficially and is not extracted immediately, it may be difficult or impossible to extract without excision. These lumps, in some individuals, may persist for an extended period of time, but are very rare among medical practitioners who have extensive experience with Radiesse® procedures.

If ArteFill® is injected too superficially, then it may form a raised area or ridge along the injection line. If this occurs, ArteFill® should be extracted immediately by the physician. Immediate extraction is typically easy; however, if ArteFill® is not extracted immediately, it can be difficult or impossible to extract without excision. Patients must be skin tested for allergic reactions before undergoing an ArteFill® treatment. Experienced physicians will immediately massage the area of the ArteFill® injection to help avoid any lumping. ArteFill® should only be injected by physicians highly experienced with dermal filler injections because some of the results may be permanent.

Dermal filler procedures should usually be postponed if there is an active skin sore, pimple, rash, cyst or infection near the proposed injection site. In most instances, a patient should wait until the condition has resolved before undergoing a dermal filler procedure.

In very rare instances, the injected area may react to a filler, becoming inflamed and forming a nodule, papule or granuloma. In most cases these can be resolved with steroids and antibiotics. In very rare instances, surgical excision may be necessary to remove a nodule, papule or granuloma.

Also in exceedingly rare instances, a doctor can inject a blood vessel which could cause an embolism, necrosis or damage to the skin or an infarction. While this is rare in any instance, a novice injector could put a patient at greater risk if the injector does not have a complete understanding of dermal filler injection technique. For maximum safety, the injections of the fillers should take place at proper depths while the physician is withdrawing the needle.

Laser treatments, microdermabrasions, chemical peels and other skin treatments are not usually recommended at the time of dermal filler treatments. Be sure to inform your physician of any medical conditions, as well as any medications (including anticoagulants or blood thinners) you may be taking.

For more information about potential adverse reactions, please consult the web sites of the appropriate manufacturers and your physician.

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