LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
Important Safety Information
Do not use LATISSE® if you are allergic to one of its ingredients. If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
These are not all the possible side effects of LATISSE®. For more information, please talk to your doctor.
Please see LATISSE® full Product Information.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as 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 and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic 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 BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, and swelling of your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
JUVÉDERM® Injectable Gel Fillers Important Information
JUVÉDERM® VOLUMA™ XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE™ XC and JUVÉDERM® XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE™ XC injectable gel is for adults over 21.
JUVÉDERM® VOLBELLA™ XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.
JUVÉDERM® Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA™ XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLLURE™ XC and JUVÉDERM® VOLBELLA™ XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
JUVÉDERM® VOLUMA™ XC is intended for use in the chin and cheek areas. JUVÉDERM® VOLLURE™ XC and JUVÉDERM® XC are intended for use in facial wrinkles and folds. JUVÉDERM® VOLBELLA™ XC and JUVÉDERM® Ultra XC are intended for use in the lips and perioral area. The safety and effectiveness for treatment in other areas have not been established in clinical studies
Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients and may result in additional scars or changes in pigmentation
Tell your doctor if you are on therapy used to decrease the body's immune response (immunosuppressive therapy). Use may result in an increased risk of infection
Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may result in increased bruising or bleeding at the injection site
Patients who experience skin injury near the site of injection may be at a higher risk for adverse events
JUVÉDERM® VOLUMA™ XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA™ XC injection into the chin on facial hair growth has not been studied
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA™ XC, dryness was also reported. For JUVÉDERM® VOLUMA™ XC, most side effects resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC injectable gels, most resolved within 14 days or less. For JUVÉDERM® VOLBELLA™ XC, most resolved within 30 days or less. These side effects are consistent with other facial injection procedures.
Most side effects will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
One of the risks with these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.
As with all skin injection procedures, there is a risk of infection.
Visit Juvederm.com or talk to your doctor for more information. To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Natrelle® Breast Implants Important Information
Who may get breast implants?
Natrelle® Breast Implants are approved for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants. Breast augmentation for women at least 18 years old for saline-filled implants.Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
Women with active infection anywhere in their body.
Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions.
Women who are currently pregnant or nursing.
What should I know before getting breast implants?
Breast implants are not lifetime devices and not necessarily a one-time surgery.
Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening. Tell your doctor of these symptoms and remove ruptured implants.
Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
Autoimmune diseases (for example, lupus and scleroderma).
A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease).
Planned chemotherapy following breast implant placement.
Planned radiation therapy to the breast following breast implant placement.
Conditions or medications that interfere with wound healing and blood clotting.
Reduced blood supply to breast tissue
Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
What are some complications with breast implants?
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.