Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not considered lifetime devices. The longer patients have them, the greater the 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:
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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
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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 rxabbvie.com.
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®.
Intraoperative Breast Implant Sizers IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle INSPIRA® Single-Use Gel Sizers and Allergan Aesthetics® 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 and Allergan Aesthetics® 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 Aesthetics® 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 rxabbvie.com.
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® Collection of Fillers Important Information
INDICATIONS
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 and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation 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.
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, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, 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
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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
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To minimize the risks of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
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The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
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The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
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The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
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The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
-
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
-
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
-
Dermal fillers should be used with caution in patients on immunosuppressive therapy
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Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
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Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
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If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
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The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
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The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
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JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
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The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
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Patients may experience late-onset adverse events with use of these dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
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Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call the Allergan®
Product Support Department at 1-877-345-5372.
Please visit JuvedermDFU.com 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
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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
