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warranty patient safety information breast reconstruction for surgeons
For US patients
Advanced
implant technology—it’s a
thing
Actual Natrelle INSPIRA® patient.
Individual results may vary.
A shell designed
TO PROTECT
The gel in Natrelle® gummy implants is surrounded by a state-of-the-art breast implant shell that is designed to keep the gel inside.*
*Significance inside the body has not been established.
The gummiest round gel implant in the US.
Gel that holds TOGETHER
When Natrelle INSPIRA® Cohesive is cut outside the body, the gel stays in place.*
*Significance inside the body has not been established.
CHOOSE Natrelle®—
get ConfidencePlus®
The Natrelle® ConfidencePlus® warranty offers you more coverage for your breast implants—all designed for your peace of mind and satisfaction.
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When You Choose Natrelle® Silicone-Filled Implants
What warranty am I automatically enrolled in for free?
ConfidencePlus® gel warranty
What events are covered?
  • Rupture
  • Capsular contracture Baker Grade III/IV
  • Late seroma
  • Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL)
What’s covered if my implant ruptures or deflates?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $3500 for 10 years
What’s covered for capsular contracture Baker Grade III/IV?
  • Implant replacement: 10 years for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $2000 for 2 years (augmentation patients only)a
What’s covered for late seroma?
  • Implant replacement: 20 years for both affected and contralateral textured implants
  • Out-of-pocket financial assistance: Up to $1000 for diagnostic testing to rule out BIA-ALCL (textured implants only)
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $7500 for treatment
Can I cancel my warranty?
No
Can I upgrade my warranty?
No
When You Choose Natrelle® Saline-Filled Implants
What warranty am I automatically enrolled in for free?
ConfidencePlus® saline warranty
What events are covered?
  • Rupture/deflation
  • Late seroma
  • Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL))
What’s covered if my implant ruptures or deflates?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • If you upgrade your warranty:
    • Out-of-pocket financial assistance up to $2400 for 10 years
What’s covered for capsular contracture Baker Grade III/IV?
Not covered
What’s covered for late seroma?
  • Implant replacement: 20 years for both affected and contralateral textured implants
  • Out-of-pocket financial assistance: Up to $1000 for diagnostic testing to rule out BIA-ALCL (textured implants only)
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $7500 for treatment
Can I cancel my warranty?
No
Can I upgrade my warranty?
Yes. For $200, you can enroll in the ConfidencePlus® Premier saline warranty within 45 days of your surgery (see below).
  • aCovers one incident per patient; recurring capsular contracture is not covered.
Important terms and conditions to know

Products covered
The ConfidencePlus® warranty program applies to all FDA-approved Natrelle® breast implants, provided the products have been used:
  • As intended by appropriately qualified and licensed surgeons, in accordance with current and accepted plastic surgery techniques
  • In accordance with the current Natrelle® Breast Implant Directions for Use, found at www.allergan.com/products
Events covered
  • Loss of shell integrity, resulting in implant rupture or deflation that requires surgical intervention
  • Capsular contracture (Baker Grade III/IV) with Natrelle® gel implants that requires surgical intervention
    • Allergan® has the right to request photographs to confirm diagnosis
  • Late seroma for patients with textured implants only. Previous Allergan® textured implants that have since been replaced with smooth implants are not covered
    • A diagnosis qualifies as > 50 cc of fluid presented at least 12 months after surgery
    • Cases must be diagnosed by a surgeon and confirmed by photographs, pathology, or other reports deemed acceptable by Allergan®
  • BIA-ALCL diagnosis that requires surgical intervention
  • Late seroma diagnostic testing to rule out BIA-ALCL, when suspected, which may include one or more of cell cytology, CD30 immunohistochemistry, or flow cytometry
Special considerations
Each Natrelle® breast implant is covered individually. So in case of any covered event above, you may choose to replace both implants or only the damaged implant. Coverage of the opposite (contralateral) implant will continue for the remaining life of the warranty.
Events not covered
The ConfidencePlus® warranty program does not apply to the following:
  • Removal for capsular contracture for saline implants
  • Dissatisfaction with implant size or aesthetics
  • Adverse reactions other than the covered events listed above
  • Loss of product integrity caused by cosmetic revision surgery
  • Loss of product integrity caused by open or closed capsulotomy
  • Other manufacturers’ products
  • Financial reimbursement for a replacement product that is not a Natrelle® style breast implant in lieu of a Natrelle® style replacement product
To submit a claim
For coverage eligibility, your surgeon must contact the Allergan® Product Surveillance team prior to surgery at 1-800-624-4261 and provide the appropriate documentation. The surgeon is required to return the explanted, disinfected Natrelle® breast implant(s) within 3 months of the date of explantation. Allergan® requests the return of all explanted breast implants associated with a complaint to assist with evaluating and maintaining the quality and safety of Natrelle® breast implants.

Where applicable, financial assistance will be issued upon receipt and verification of the explanted product(s), the Returned Goods Authorization (RGA), and the patient’s warranty general release.
Enrollment
For patients with Natrelle® gel breast implants, enrollment in the ConfidencePlus® warranty is automatic and free. You do not need to do anything.

For patients with Natrelle® saline-filled breast implants, the ConfidencePlus® saline warranty is automatic and free. However, if you would like to upgrade to the ConfidencePlus® Premier saline warranty, the enrollment fee is $200 and must be completed within 45 days of surgery by submitting the completed enrollment form by mail, fax, or online here.

To receive additional coverage for out-of-pocket financial assistance, you may choose to enroll in the Natrelle® ConfidencePlus® Premier saline warranty within 45 days of your surgery by visiting cpp.natrelle.com.

Application complete!

Thank you for choosing Allergan and for your purchase of a ConfidencePlus ® Premier warranty. You will receive an email confirmation. Please allow 8-10 weeks for processing.

ASK your surgeon for more details about the Natrelle® ConfidencePlus® warranty program.
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
SEE MORE +
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
Who can get breast implants?
Natrelle® Breast Implants are approved for the following:
Who should NOT get breast implants?
 Breast implant surgery should NOT be performed in:
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:
What else should I consider?
What are key complications with breast implants?
 Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.
Talk to your doctor about other complications.
For more information, see the patient brochures at www.allergan.com/products.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.

Natrelle® 133S Tissue Expanders Important Information

Approved Uses

Natrelle® 133S Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
What else should I consider?

What are possible complications?

Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.

For more information, please visit www.allergan.com/products. To report a problem with Natrelle®, please call Allergan at 1-800-624-4261.
Natrelle® 133S Tissue Expanders are available by prescription only. The sale and distribution of Natrelle® 133S Tissue Expanders is restricted to licensed physicians.
BOTOX® Cosmetic (onabotulinumtoxinA)
Approved Uses
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:
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: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel Fillers Important Information
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.
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, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra 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® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 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), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?
  • One of the risks with using dermal fillers is the 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. Most of these events are irreversible.
  • If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse.
  • The effectiveness of removal of any dermal filler has not been studied.
What precautions should my doctor advise me about?
  • JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
  • 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® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
  • Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • 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
  • Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
What are possible side effects of treatment?

The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Natrelle Perks℠ Terms and Conditions
  • Allē Members who undergo breast augmentation with Natrelle® gel implants (“Member”) may qualify to receive either (a) one (1) complimentary treatment of BOTOX® Cosmetic (onabotulinumtoxinA) up to 50 units OR (b) one (1) complimentary treatment of JUVÉDERM® Ultra XC up to two .55 mL syringes at participating Allē provider offices only. Allergan Aesthetics is not responsible for any associated injection costs.
  • Members enrolled in Medicare, Medicaid, or other federal or state healthcare programs are not eligible for this offer.
  • Member must claim offer in the Allē app via text message link within 6 months of their Natrelle® breast augmentation and select their complimentary treatment.
  • Once claimed, the selected complimentary treatment cannot be changed and the offer must be redeemed within 6 months of the offer being deposited into Member’s Allē Wallet. Offer expires 6 months after issue date into Allē Wallet.
  • Limit 1 per Member.
  • A healthcare provider will determine if Member is an appropriate candidate for a BOTOX® Cosmetic or JUVÉDERM® Ultra XC treatment.
    • If Member is an appropriate candidate, offer can be redeemed at a participating provider’s office.
  • Standard Allē Loyalty Program Terms and Conditions apply.
  • Members will earn Allē points on all qualifying Earnings Eligible Product purchases, subject to applicable earnings caps.
  • The value of this offer cannot be redeemed or exchanged for cash.
  • Offer cannot be applied to past transactions.
  • Offer cannot be combined with other Allē offers on BOTOX® Cosmetic or the JUVÉDERM® Collection of Fillers but can be combined with Allē and Allē brand-specific gift cards, Allē points offers, including Double Points offers, and other Allē brand-specific offers.
  • The complete value of this offer must be used in a single transaction.
  • If you have questions, please contact Allē Customer Support at 1-888-912-1572 Monday - Friday, 8 am – 6 pm CT.
  • Allergan Aesthetics, an AbbVie company, reserves the right to alter or cancel this offer at any time.
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
SEE MORE +
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
Who can get breast implants?
Natrelle® Breast Implants are approved for the following:
Who should NOT get breast implants?
 Breast implant surgery should NOT be performed in:
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:
What else should I consider?
What are key complications with breast implants?
 Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.
Talk to your doctor about other complications.
For more information, see the patient brochures at www.allergan.com/products.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.

Natrelle® 133S Tissue Expanders Important Information

Approved Uses

Natrelle® 133S Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
What else should I consider?

What are possible complications?

Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.

For more information, please visit www.allergan.com/products. To report a problem with Natrelle®, please call Allergan at 1-800-624-4261.
Natrelle® 133S Tissue Expanders are available by prescription only. The sale and distribution of Natrelle® 133S Tissue Expanders is restricted to licensed physicians.
BOTOX® Cosmetic (onabotulinumtoxinA)
Approved Uses
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:
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: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel Fillers Important Information
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.
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, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra 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® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 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), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?
  • One of the risks with using dermal fillers is the 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. Most of these events are irreversible.
  • If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse.
  • The effectiveness of removal of any dermal filler has not been studied.
What precautions should my doctor advise me about?
  • JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
  • 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® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
  • Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • 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
  • Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
What are possible side effects of treatment?

The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Natrelle Perks℠ Terms and Conditions
  • Allē Members who undergo breast augmentation with Natrelle® gel implants (“Member”) may qualify to receive either (a) one (1) complimentary treatment of BOTOX® Cosmetic (onabotulinumtoxinA) up to 50 units OR (b) one (1) complimentary treatment of JUVÉDERM® Ultra XC up to two .55 mL syringes at participating Allē provider offices only. Allergan Aesthetics is not responsible for any associated injection costs.
  • Members enrolled in Medicare, Medicaid, or other federal or state healthcare programs are not eligible for this offer.
  • Member must claim offer in the Allē app via text message link within 6 months of their Natrelle® breast augmentation and select their complimentary treatment.
  • Once claimed, the selected complimentary treatment cannot be changed and the offer must be redeemed within 6 months of the offer being deposited into Member’s Allē Wallet. Offer expires 6 months after issue date into Allē Wallet.
  • Limit 1 per Member.
  • A healthcare provider will determine if Member is an appropriate candidate for a BOTOX® Cosmetic or JUVÉDERM® Ultra XC treatment.
    • If Member is an appropriate candidate, offer can be redeemed at a participating provider’s office.
  • Standard Allē Loyalty Program Terms and Conditions apply.
  • Members will earn Allē points on all qualifying Earnings Eligible Product purchases, subject to applicable earnings caps.
  • The value of this offer cannot be redeemed or exchanged for cash.
  • Offer cannot be applied to past transactions.
  • Offer cannot be combined with other Allē offers on BOTOX® Cosmetic or the JUVÉDERM® Collection of Fillers but can be combined with Allē and Allē brand-specific gift cards, Allē points offers, including Double Points offers, and other Allē brand-specific offers.
  • The complete value of this offer must be used in a single transaction.
  • If you have questions, please contact Allē Customer Support at 1-888-912-1572 Monday - Friday, 8 am – 6 pm CT.
  • Allergan Aesthetics, an AbbVie company, reserves the right to alter or cancel this offer at any time.
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