Download presentation
Presentation is loading. Please wait.
Published byAbner Lewis Modified over 8 years ago
1
1 ® Allergan’s Best-in-Class Physician Loyalty Program
2
2 How Does APP Work? It starts with purchasing select Allergan Aesthetics products PRODUCT PURCHASES EARN POINTS POINTS PLACE PHYSICIANS IN DESIGNATED LEVELS AND TIERS EACH LEVEL AND TIER OFFERS BENEFITS PHYSICIANS PURCHASE ALLERGAN ® AESTHETICS PRODUCTS Please see Indications and Important Safety Information beginning on page 17.
3
3 New APP Pyramid Allergan Partner Privileges ® Partnership Levels Take your practice to the next level Platinu m 400 points 4% rebate Platinu m Plus Diamon d 1000 points 8% rebate Black Diamond 1500 points 1% rebate
4
4 New Product Tier Overview TIER 5 TIER 4 TIER 3 TIER 2 TIER1 400 POINTS 25% instant savings Buy 10 boxes, get 2 free 200 POINTS 22% instant savings Buy 10 boxes, get 1 free 100 POINTS 16% instant savings Buy 10 boxes, get 1 free 50 POINTS 10% instant savings Buy 10 boxes, get 1 free 20 POINTS Buy 10 boxes, get 2 free 300 POINTS 12% instant savings 150 POINTS 8% instant savings 75 POINTS 4% instant savings 50 POINTS 20 POINTS 175 POINTS 10% instant savings 10 POINTS 2% instant savings 500 GEL IMPLANTS 12% instant savings Top 10 14% instant savings 600 POINTS 12% instant savings 300 POINTS 10% instant savings 150 POINTS 8% instant savings 60 POINTS 4% instant savings 20 POINTS 2% instant savings 80 POINTS 8% instant savings 40 POINTS 6% instant savings 25 POINTS 4% instant savings 325 GEL IMPLANTS 10% instant savings 160 GEL IMPLANTS 6% instant savings 75 GEL IMPLANTS 4% instant savings 30 GEL IMPLANTS 2% instant savings TIER 1 TIER 2 TIER 3 TIER 4 TIER 5 Please see Indications and Important Safety Information beginning on page 17.
5
5 2016 Growth Reward-Year End Kicker Evaluated Based On Year- Over-Year Gross Sales Growth on Qualifying Allergan Product Purchases Rebate Percentage Paid Off The Incremental Growth Amount Paid In The Q4 2016 Rebate Payout Main Street Dermatology Gross Sales 2015: $100,000 Gross Sales 2016: $150,000 2016 Sales Growth*: 50% 2016 Growth Reward Kicker*: 4% *Based on qualifying Allergan product purchases.
6
6 Please refer to the Allergan Partner Privileges ® Business Rules document for a list of eligible and ineligible customer group codes. Ship-to Account Membership With APP Sold-to vs ship-to accounts SOLD-TO ACCOUNT Owns the points and status in Allergan Partner Privileges ®
7
7 How to Register Sign up online Accounts can accumulate points and achieve status without registering, but they must register in order to receive benefits Benefits begin at the Silver Level (25 points) Accounts are permitted to register when they earn 1 point with APP To stay eligible from year to year, accounts must earn 1 point each calendar year Online registration is available at: www.AllerganNetwork.com Or www.AllerganOne.com
8
8 Earning Points Purchases earn designated points Please see Indications and Important Safety Information beginning on page 17.
9
9 Savings! Levels and tiers translate to 3 ways to save Allergan Partner Privileges ® Member Rebate (4% up to 18%) Awarded as accounts gain levels. Member rebates start at the Platinum Level. Growth Reward Kicker Awarded to all Silver and above members who achieve positive year- over-year gross sales growth on qualifying Allergan product purchases. The rebate is applied to the incremental growth amount, and paid in the Q4 rebate statement. Accounts can qualify at the 1%, 2%, and 4% levels. Instant Product Savings Awarded as accounts progress through individual product tiers for JUVÉDERM ®, JUVÉDERM VOLUMA ® XC, LATISSE ®, Natrelle ® Gel, and SkinMedica ®. For select products, discounts are applied directly to invoices. In the JUVÉDERM ® tiers, accounts can earn free boxes of JUVÉDERM ®. PLUS: Additional benefits at each level Online Physician Locator Listing Priority Customer Service Line access Preferred shipment status Certificates and status displays Please see Indications and Important Safety Information beginning on page 17.
10
10 Up to 18% in Rebates Allergan Partner Privileges ® Member Rebates LEVEL TOP 500DIAMOND PLATINUM PLUS PLATINUMGOLDSILVER POINT REQUIREMENT N/A1200 POINTS800 POINTS500 POINTS250 POINTS25 POINTS APP REBATE % UP TO 18%8%6%4%--
11
11 Rebate Rules and Reminders In order to qualify for the Allergan Partner Privileges ® Member Rebate, accounts must have a 7-point minimum of a second product or product family purchase during the corresponding 3-month period. No exceptions Qualifying purchase example: 2 vials of BOTOX ® Cosmetic (onabotulinumtoxinA) (2 points), 2 boxes of JUVÉDERM ® (2 points), and 1 case of LATISSE ® (bimatoprost ophthalmic solution) 0.03% (5 mL kits; 12 kits/case) (3 points) Accounts earn points with purchases even if they are not registered. However, they will not be eligible for rebates until they register If an account registers any time within a 3-month period, the rebate percentage they earn is retroactive to the beginning of the period, meaning it is applied to all purchases for that period When accounts upgrade in the middle of a rebate cycle, the rebate percentage they receive for their purchases is determined based on their level at the time of those purchases Rebates are paid out via credit memo on a quarterly basis: LEVEL Payout Occurs Last business day of March Within 2 to 3 weeks of the rebate cycle closing. Last business day of June Last business day of September Last business day of December Please see Indications and Important Safety Information beginning on page 17.
12
12 Program Structure Account upgrades Instant upgrades When an account attains the full point total required to achieve the next level or tier, that account’s upgrade will take effect within 24 to 48 hours after the qualifying purchase is made Once an account achieves a new level or tier during the calendar year, that account will retain that level or tier and receive all corresponding benefits for the balance of the year Instant upgrades apply to both APP levels and individual product tiers Midyear courtesy upgrades Midyear courtesy upgrades are applicable to accounts that have current Silver or higher level status Accounts that have not yet achieved sufficient points to obtain Silver Level or higher status are not eligible for midyear courtesy upgrades At midyear (June 30), if an account’s points have reached 50% of the threshold for the next level or tier, the account will receive a courtesy upgrade to the next level or tier Accounts that achieve a level or tier via a midyear courtesy upgrade, but that do not accumulate the full points total required for that level or tier by the end of the year, will downgrade to the level or tier associated with their point total at the end of the year
13
13 Natrelle ® Guidelines for APP and Gel Tier Programs Declaring reimbursement percentage Only implants used in nonreimbursed augmentation procedures may earn points in the program In order to earn Natrelle ® points in the program, accounts must accept specific Natrelle ® terms and conditions and declare their Natrelle ® reimbursement percentage annually The Natrelle ® reimbursement percentage is the declaration of the percentage of Natrelle ® implants purchased, invoiced, and delivered to that location for reimbursed procedures. Hospitals and surgery centers are not eligible to participate in APP, and implants purchased through a hospital or surgery center are not eligible to earn points Accounts are required to proactively review their reimbursement percentages and update appropriately every year. Accounts may only change their reimbursement percentages during the open enrollment period Accounts that do not declare their reimbursement percentages will be ineligible to earn points on Natrelle ® purchases, ineligible for gel savings, and ineligible for a rebate Allergan employees are prohibited from editing or influencing an account’s Natrelle ® reimbursement percentage Please see Indications and Important Safety Information beginning on page 17.
14
14 Natrelle ® Guidelines for APP and Gel Tier Programs (continued) Declaring reimbursement percentage The percentage of Natrelle ® implants purchased for procedures submitted for reimbursement to any third party, such as a governmental entity or other private health plan payer, affects the calculation of points in the program: An account that purchases 50% or less of Natrelle ® implants for reimbursable procedures is eligible to earn Natrelle ® points or rebates for their Natrelle ® augmentation (i.e., non- reimbursed procedures) purchases in the program; an account that purchases more than 50% of Natrelle ® implants for reimbursable procedures is ineligible to earn Natrelle ® points or rebates for their Natrelle ® purchases in the program Any percentages less than or equal to 50% will be deducted from the account’s Natrelle ® points. For example, if an account claims 20% reimbursable procedures, 20% will be deducted from the account’s Natrelle ® points Additionally, only purchases of augmentation implants will be considered when calculating rebate values and tier savings Hospital accounts that purchase Natrelle ® receive 0 points for Natrelle ® Remember: Points are only accumulated for actual purchases and are applied to the sold- to account. If a surgeon is part of a surgery center and the surgery center purchases the implants, points are applied to the surgery center, not the individual surgeon A ship-to account with Natrelle ® purchases must be registered in Allergan Partner Privileges® to be included in the rebate and tier savings calculations of the sold-to account. No exceptions Please see Indications and Important Safety Information beginning on page 17.
15
15 1.Your accounts must register with APP to receive benefits. They can accumulate points and achieve status without registering, but they will not receive any benefits until they sign up. 2.To qualify for the Allergan Partner Privileges ® Member Rebate, accounts must have a 7-point minimum of a second product or product family purchase during the corresponding 3-month period. No exceptions. The second product or product family purchase can be 7 points of 1 additional product OR a combination of multiple products Qualifying purchase example: 2 vials of BOTOX ® Cosmetic (onabotulinumtoxinA) (2 points), 2 boxes of JUVÉDERM ® (2 points), and 1 case of LATISSE ® (bimatoprost ophthalmic solution) 0.03% (5 mL kits; 12 kits/case) (3 points) 3.Points and status are owned by the sold-to account and are not transferable. 4.Account levels and product tiers are determined at the beginning of each year, based on the prior year’s points earned. The number of points an account has accumulated as of the end of the APP sales year dictates the member level and product tiers for the following year. Throughout the year, when an account attains the full point total required to achieve the next level or tier, the account upgrades. The upgrade takes effect within 24 to 48 hours after the qualifying purchase is made. Once an account achieves a new level or tier during the calendar year, that account will retain that level or tier and receive all corresponding benefits for the balance of the year Remember, points reset at the beginning of the APP sales year, meaning everyone starts with 0 points. If an account starts the year at one level or tier, but does not accumulate the total points required for that level or tier by the end of the year, the account will downgrade Important Business Rules to Remember To review Please see Indications and Important Safety Information beginning on page 17.
16
16 Important Business Rules to Remember (continued) To review 5.Not all accounts are eligible for rebates. Hospitals are ineligible to receive APP rebates. They may be eligible for consumer or other product savings, such as JUVÉDERM ® or LATISSE ® (bimatoprost ophthalmic solution) 0.03% tier savings. See individual program rules for details. 6.Accounts must be Silver Level and above to qualify for the Yearly Growth Reward Kicker—sales are measured on a calendar year basis. Year-over-year Gross Sales comparisons are used, and the rebate is paid based on the incremental yearly sales growth on qualifying Allergan product purchases. 7.Only Natrelle ® implants used in nonreimbursed augmentation procedures may earn points in APP. In order to earn Natrelle ® points in the program, accounts must accept specific Natrelle ® terms and conditions and declare their Natrelle ® reimbursement percentage annually. Registration is required to receive instant savings in the Natrelle ® Gel tier program. Please see Indications and Important Safety Information beginning on page 17.
17
17 Thank You! BOTOX® Cosmetic (onabotulinumtoxinA) Important Information Indications Glabellar Lines BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procures muscle activity in adult patients. Lateral Canthal Lines BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients. 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, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses. Please see additional Indications and Important Safety Information on next page.
18
18 Thank You! 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), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported. 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. Please see additional Indications and Important Safety Information on next page.
19
19 Thank You! WARNINGS AND PRECAUTIONS (cont’d) 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. 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). Please see additional Indications and Important Safety Information on next page.
20
20 Thank You! WARNINGS AND PRECAUTIONS (cont’d) 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). 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. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. ADVERSE REACTIONS The most frequently reported adverse event following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%). The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%). 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. Please see additional Indications and Important Safety Information on next page.
21
21 Thank You! USE IN SPECIFIC POPULATIONS BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman. Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.Prescribing Information Medication Guide LATISSE ® Important Information Indication LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness. IMPORTANT SAFETY INFORMATION Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure. Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent. Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients. Please see additional Indications and Important Safety Information on next page.
22
22 Thank You! Warnings and Precautions (cont’d) There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes. LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated. Adverse Reactions: The most frequently reported adverse events were eye pruritis, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients. Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE® in clinical practice: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred. Please see LATISSE® full Prescribing Information.Prescribing Information Please see additional Indications and Important Safety Information on next page.
23
23 Thank You! KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information Indication KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. Important Safety Information Contraindications KYBELLA® is contraindicated in the presence of infection at the injection sites. Warnings and Precautions Marginal Mandibular Nerve Injury Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA ® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. Dysphagia Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA ® in patients with current or prior history of dysphagia as treatment may exacerbate the condition. Please see additional Indications and Important Safety Information on next page.
24
24 Thank You! Warnings and Precautions (cont’d) Injection-Site Hematoma/Bruising In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Adverse Reactions The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration. For additional information, please see full Prescribing Information.Prescribing Information Please see additional Indications and Important Safety Information on next page.
25
25 Thank You! JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC Important Information INDICATIONS JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVÉDERM® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) are for injection into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth. JUVÉDERM VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine contained in these products. Please see additional Indications and Important Safety Information on next page.
26
26 Thank You! WARNINGS Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled PRECAUTIONS In order to minimize the risk of potential complications, these products should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications The safety and effectiveness for the treatment of anatomic regions other than moderate to severe facial wrinkles and folds with JUVÉDERM® XC, the lips and perioral area for lip augmentation with JUVÉDERM® Ultra XC, and the mid-face with JUVÉDERM VOLUMA® XC, have not been established in controlled clinical studies As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials Please see additional Indications and Important Safety Information on next page.
27
27 Thank You! PRECAUTIONS (cont’d) The safety for use during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied The safety for use of JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC in patients under 18 years has not been established The safety for use of JUVÉDERM VOLUMA® XC in patients under 35 or over 65 years has not been established Use with caution in patients on immunosuppressive therapy Patients who are using products that can prolong bleeding (such as aspirin, non steroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events The safety of JUVÉDERM VOLUMA® XC injectable gel for use in patients with very thin skin in the mid-face has not been established Patients may experience late onset nodules with use of dermal fillers, including JUVÉDERM VOLUMA® XC ADVERSE EVENTS The most commonly reported side effects for JUVÉDERM® XC injectable gels were temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® Ultra XC or JUVÉDERM® Ultra Plus XC, they were mild or moderate in severity, with a duration of 14 days or less; and for JUVÉDERM VOLUMA® XC, they were predominantly moderate in severity, with a duration of 2 to 4 weeks. To report an adverse reaction with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261. For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.JuvedermDFU.com JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only. Please see additional Indications and Important Safety Information on next page.
28
28 Thank You! Natrelle® Breast Implants Important Information INDICATIONS Natrelle® Breast Implants are indicated 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. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Breast implant surgery should not be performed in: Women with active infection anywhere in their body. Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions. Women who are currently pregnant or nursing. WARNINGS AVOID DAMAGE DURING SURGERY Care should be taken to avoid the use of excessive force and to minimize handling of the implant during surgical insertion. Care should be taken when using surgical instruments in proximity with the breast implant, including scalpel, sutures, and dissection instrumentation. Do not treat capsular contracture by closed capsulotomy or forceful external compression, which will likely result in implant damage, rupture, folds, and/or hematoma. Use care in subsequent procedures such as open capsulotomy, breast pocket revision, hematoma/seroma aspiration, and biopsy/lumpectomy to avoid damage to the implant. Please see additional Indications and Important Safety Information on next page.
29
29 Thank You! WARNINGS (cont’d) Do not place drugs or substances inside saline-filled implants other than sterile saline for injection. Do not inject through the implant shell. Do not contact the implant with disposable, capacitor-type cautery devices. Do not alter the implants or attempt to repair or insert a damaged prosthesis. Do not immerse the implant in povidone-iodine solution. If povidone-iodine is used in the pocket, ensure that it is rinsed thoroughly so no residual solution remains in the pocket. Do not reuse or resterilize any product that has been previously implanted. Breast implants are intended for single use only. Do not place more than one implant per breast pocket. Do not use the periumbilical approach to place the implant. Do not use microwave diathermy in patients with breast implants. Microwave diathermy has been reported to cause tissue necrosis, skin erosion, and implant extrusion. PRECAUTIONS Safety and effectiveness have not been established in patients with the following: Autoimmune diseases (e.g., lupus and scleroderma). A compromised immune system (for example, currently receiving immunosuppressive therapy). 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 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. Please see additional Indications and Important Safety Information on next page.
30
30 Thank You! ADVERSE EVENTS Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV. Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling. For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.www.allergan.com/labeling/usa.htm To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261. Natrelle® Breast Implants are available by prescription only © 2016 Allergan. All rights reserved. All trademarks are the property of their respective owners. Allergan, P.O. Box 19534, Irvine, CA 92623 Allergan reserves the right to alter or cancel the program with no advance notice or obligation. APC81HJ16
Similar presentations
© 2025 SlidePlayer.com Inc.
All rights reserved.