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Order Form
Comprehensive form to order Natrelle® breast implants.
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Hospital Order Form
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Cash Pay Order Form
Two-Stage Breast Reconstruction Guide
Provides color-coded matchups between implant and tissue expander based on width measurements. To help ensure a tight pocket, a slightly larger shaped implant is matched with a smaller shaped tissue expander.
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Augmentation Preoperative Planning Form
A detailed form to help you plan for your patient’s breast augmentation surgery with a full line of Natrelle® gel breast implants.
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Two-Stage Reconstruction Preoperative Planning Form
Track every step of two-stage reconstruction: mastectomy, first stage with Natrelle® 133S Smooth Tissue Expanders, and second stage with Natrelle® gel breast implants.
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Natrelle® Reconstruction Guide
Everything your patients should know about breast implants to help them prepare for their consultation.
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Natrelle® Breast Augmentation Guide
Information your patients should know about breast implants to help them prepare for their consultation.
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Silicone-Filled Breast Implant Surgery Decision Checklist
An important form that both you and your patient must agree to prior to her breast surgery with Natrelle® silicone-filled breast implants.
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Saline-Filled Breast Implant Surgery Decision Checklist
An important form that both you and your patient must agree to prior to her breast surgery with Natrelle® saline-filled breast implants.
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Natrelle® Breast Implant Device Tracking Requirements
What you need to know about the breast implant device tracking process.
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Device Management Portal
Conveniently submit device tracking information, warranty claims, product complaints, and adverse events all in one location.
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not considered lifetime devices. The longer patients have them, the greater chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
  • Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
  • Breast reconstruction. This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
  • 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.
ADDITIONAL WARNINGS
  • See Boxed Warning
  • Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
  • Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
  • Autoimmune diseases (eg, lupus and scleroderma)
  • A compromised immune system (eg, currently receiving immunosuppressive therapy)
  • Planned chemotherapy or radiation 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 prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use 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 this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
Natrelle® 133S Smooth Tissue Expanders With MAGNA-SITE® Injection Sites IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle® 133S Smooth Tissue Expanders are indicated for:
  • Breast reconstruction following mastectomy
  • Treatment of underdeveloped breasts
  • Treatment of soft tissue deformities
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Natrelle® 133S Smooth Tissue Expanders should not be used in patients:
  • Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices and artificial sensing devices)
  • Whose tissue at the expansion site is determined to be unsuitable
  • Who have an active infection or a residual gross tumor at the expansion site
  • Who are undergoing adjuvant radiation therapy
  • Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications
  • Who are psychologically unsuitable
WARNINGS
  • Do not use Natrelle® 133S Smooth Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications) because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133S Smooth Tissue Expanders in place
  • Do not alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. Do not expose to contaminants
  • Do not expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed
  • Do not reuse explanted products
  • Active infection anywhere may increase risk of periprosthetic infection. Do not expose the tissue expander or injection needles to contaminants. Postoperative infections should be treated aggressively
  • Adverse reactions may require premature explantation
  • When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs
  • Natrelle® 133S Smooth Tissue Expanders are temporary devices and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months
PRECAUTIONS
Active infections may need to be treated and resolved before surgery. Follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.
ADVERSE REACTIONS
Possible adverse reactions include deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Natrelle® 133S Smooth Tissue Expanders, please call Allergan® at 1-800-624-4261
Natrelle® 133S Smooth Tissue Expanders are restricted to sale by or on the order of a licensed physician.
Intraoperative Breast Implant Sizers IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle INSPIRA® Single-Use Gel Sizers, Allergan® Single-Use Saline Sizers, and Natrelle® Resterilizable Sizers are indicated for use during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Natrelle INSPIRA® Single-Use Gel Sizers, Allergan® Single-Use Saline Sizers are for single-patient use, one sizer per breast.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
All sizers are contraindicated for use in women contraindicated for breast implant surgery.
WARNINGS
Sizers are designed for temporary intraoperative use only and are not long-term implants. Do not alter, insert, or attempt to repair a damaged sizer. Do not reuse or resterilize the Natrelle INSPIRA® Single-Use Gel Sizer or the Allergan® Single-Use Saline Sizer. The gel sizers may rupture and release silicone gel. Infection, necrosis, hematoma/seroma, and pain may occur following any type of surgery. Minute quantities of silicone gel may diffuse through the elastomer envelope.
PRECAUTIONS
The surgeon must carefully evaluate patient suitability and be knowledgeable about the use of this device. Do not expose the sizer to contaminants. Avoid damaging the sizer with surgical instruments (eg, sharp, blunt, or cautery devices). Do not attempt to repair damaged products. Do not damage the sizer by overhandling, manipulation, or excessive force. Maintain a sterile back-up sizer during surgery.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Intraoperative Breast Implant Sizers, please call Allergan® 1-800-624-4261.
Intraoperative Breast Implant Sizers are restricted to sale by or on the order of a licensed physician.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
  • - Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
  • - Moderate to severe lateral canthal lines associated with orbicularis oculi activity
  • - Moderate to severe forehead lines associated with frontalis activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing 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, ptosis, dysphagia, dysphonia, 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 and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
JUVÉDERM®Injectable Gel Fillers Important Information

APPROVED USES
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® 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® Ultra Plus 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, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra 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® Ultra Plus 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 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.
  • Once claimed, 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.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
SEE MORE +
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not considered lifetime devices. The longer patients have them, the greater chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
  • Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
  • Breast reconstruction. This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
  • 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.
ADDITIONAL WARNINGS
  • See Boxed Warning
  • Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
  • Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
  • Autoimmune diseases (eg, lupus and scleroderma)
  • A compromised immune system (eg, currently receiving immunosuppressive therapy)
  • Planned chemotherapy or radiation 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 prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use 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 this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
Natrelle® 133S Smooth Tissue Expanders With MAGNA-SITE® Injection Sites IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle® 133S Smooth Tissue Expanders are indicated for:
  • Breast reconstruction following mastectomy
  • Treatment of underdeveloped breasts
  • Treatment of soft tissue deformities
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Natrelle® 133S Smooth Tissue Expanders should not be used in patients:
  • Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices and artificial sensing devices)
  • Whose tissue at the expansion site is determined to be unsuitable
  • Who have an active infection or a residual gross tumor at the expansion site
  • Who are undergoing adjuvant radiation therapy
  • Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications
  • Who are psychologically unsuitable
WARNINGS
  • Do not use Natrelle® 133S Smooth Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications) because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133S Smooth Tissue Expanders in place
  • Do not alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. Do not expose to contaminants
  • Do not expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed
  • Do not reuse explanted products
  • Active infection anywhere may increase risk of periprosthetic infection. Do not expose the tissue expander or injection needles to contaminants. Postoperative infections should be treated aggressively
  • Adverse reactions may require premature explantation
  • When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs
  • Natrelle® 133S Smooth Tissue Expanders are temporary devices and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months
PRECAUTIONS
Active infections may need to be treated and resolved before surgery. Follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.
ADVERSE REACTIONS
Possible adverse reactions include deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Natrelle® 133S Smooth Tissue Expanders, please call Allergan® at 1-800-624-4261
Natrelle® 133S Smooth Tissue Expanders are restricted to sale by or on the order of a licensed physician.
Intraoperative Breast Implant Sizers IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle INSPIRA® Single-Use Gel Sizers, Allergan® Single-Use Saline Sizers, and Natrelle® Resterilizable Sizers are indicated for use during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.
Natrelle INSPIRA® Single-Use Gel Sizers, Allergan® Single-Use Saline Sizers are for single-patient use, one sizer per breast.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
All sizers are contraindicated for use in women contraindicated for breast implant surgery.
WARNINGS
Sizers are designed for temporary intraoperative use only and are not long-term implants. Do not alter, insert, or attempt to repair a damaged sizer. Do not reuse or resterilize the Natrelle INSPIRA® Single-Use Gel Sizer or the Allergan® Single-Use Saline Sizer. The gel sizers may rupture and release silicone gel. Infection, necrosis, hematoma/seroma, and pain may occur following any type of surgery. Minute quantities of silicone gel may diffuse through the elastomer envelope.
PRECAUTIONS
The surgeon must carefully evaluate patient suitability and be knowledgeable about the use of this device. Do not expose the sizer to contaminants. Avoid damaging the sizer with surgical instruments (eg, sharp, blunt, or cautery devices). Do not attempt to repair damaged products. Do not damage the sizer by overhandling, manipulation, or excessive force. Maintain a sterile back-up sizer during surgery.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Intraoperative Breast Implant Sizers, please call Allergan® 1-800-624-4261.
Intraoperative Breast Implant Sizers are restricted to sale by or on the order of a licensed physician.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
  • - Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
  • - Moderate to severe lateral canthal lines associated with orbicularis oculi activity
  • - Moderate to severe forehead lines associated with frontalis activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing 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, ptosis, dysphagia, dysphonia, 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 and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
JUVÉDERM®Injectable Gel Fillers Important Information

APPROVED USES
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® 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® Ultra Plus 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, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra 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® Ultra Plus 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 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.
  • Once claimed, 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.