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In the LATISSE® US phase 3 clinical study (N = 278), the primary efficacy end point was overall eyelash prominence, measured using the Global Eyelash Assessment (GEA) scale,* a photonumeric rating scale. Eyelash prominence was graded from 1 (minimal eyelash prominence) to 4 (very marked eyelash prominence). Prominence is defined by length, fullness, and darkness.1-3

In the clinical study, an increase in overall eyelash prominence equated to at least a 1-grade increase on the 4-point GEA scale from baseline to the end of the treatment period (week 16).2 At 16 weeks in the clinical trial, LATISSE® patients (n = 137) experienced greater improvement in eyelash prominence compared to the vehicle (n = 141).1-3 Increased prominence for LATISSE® patients was statistically significant starting at week 8.

  • At week 4: 14.6% of LATISSE® patients (20/137) had more prominent eyelashes vs 7.8% for vehicle (11/141)
    (P = .0719)
  • At week 8: 50.4% of LATISSE® patients (69/137) had more prominent eyelashes vs 14.9% for vehicle (21/141)
    (P < .0001)
  • At week 12: 69.3% of LATISSE® patients (95/137) had more prominent eyelashes vs 19.9% for vehicle (28/141)
    (P < .0001)
  • At week 16: 78.1% of LATISSE® patients (107/137) had more prominent eyelashes vs 18.4% for vehicle (26/141)
    (P < .0001)

Select a case study and slide the time-lapse bar below to see the full effects of LATISSE®.
Remember, the onset of effect with LATISSE® solution is gradual. Individual results may vary.1





Individual results may vary.
Upon discontinuation of treatment, eyelash growth is expected to return to its pretreatment level.

*Patent pending.

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.

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. LATISSE® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

Adverse Reactions: The most frequently reported adverse events were eye pruritus, 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.


BOTOX® Cosmetic (onabotulinumtoxinA) 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 at lower doses.

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 procerus 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 (continued)
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.

Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.

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 junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

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.

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.



JUVÉDERM® XC Important Information

Indication

JUVÉDERM® 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).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

JUVÉDERM® XC injectable gel 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.

WARNINGS

  • JUVÉDERM® XC injectable gel must not be injected into blood vessels and should not be used in vascular-rich areas. Use in these areas, such as glabella and nose, has resulted in cases of vascular embolization, occlusion of the vessels, ischemia or infarction, or blindness. Symptoms of vessel occlusion and embolization include pain that is disproportionate to the procedure or remote to the injection site, immediate blanching extending beyond the injected area, and color changes that reflect ischemic tissue such as a dusky or reticular appearance
  • 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

  • The safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds (such as lips) have not been established
  • As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
  • The safety for use during pregnancy and in breastfeeding females has not been established
  • The safety for use in patients under 18 years has not been established
  • The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
  • JUVÉDERM® XC injectable gel should be used with caution in patients on immunosuppressive therapy
  • Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
  • Patients should be limited to 20 mL of JUVÉDERM® XC 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 are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Most side effects are mild or moderate in nature, lasting 7 days or less.

To report a problem with JUVÉDERM® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see www.JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® XC injectable gels is available by prescription only.



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.

  • Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
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.
  • 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.

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.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

IMPORTANT SAFETY INFORMATION
EXPAND SAFETY INFORMATION

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.

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. LATISSE® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

Adverse Reactions: The most frequently reported adverse events were eye pruritus, 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.


BOTOX® Cosmetic (onabotulinumtoxinA) 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 at lower doses.

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 procerus 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 (continued)
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.

Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.

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 junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

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.

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.



JUVÉDERM® XC Important Information

Indication

JUVÉDERM® 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).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

JUVÉDERM® XC injectable gel 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.

WARNINGS

  • JUVÉDERM® XC injectable gel must not be injected into blood vessels and should not be used in vascular-rich areas. Use in these areas, such as glabella and nose, has resulted in cases of vascular embolization, occlusion of the vessels, ischemia or infarction, or blindness. Symptoms of vessel occlusion and embolization include pain that is disproportionate to the procedure or remote to the injection site, immediate blanching extending beyond the injected area, and color changes that reflect ischemic tissue such as a dusky or reticular appearance
  • 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

  • The safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds (such as lips) have not been established
  • As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
  • The safety for use during pregnancy and in breastfeeding females has not been established
  • The safety for use in patients under 18 years has not been established
  • The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
  • JUVÉDERM® XC injectable gel should be used with caution in patients on immunosuppressive therapy
  • Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
  • Patients should be limited to 20 mL of JUVÉDERM® XC 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 are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Most side effects are mild or moderate in nature, lasting 7 days or less.

To report a problem with JUVÉDERM® XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see www.JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® XC injectable gels is available by prescription only.



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.

  • Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

IMPORTANT SAFETY INFORMATION
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.
  • 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.

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.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.

References
  1. LATISSE® Prescribing Information, September 2014.
  2. Data on file, Allergan, Inc., 2008; Study No. 192024-032: Full Clinical Study Report.
  3. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.
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