Important Natrelle® Breast Implants Safety Information
Indications
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
Every effort should be made to avoid damage to the breast implants 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
- 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 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 Betadine® solution
- Do not re-use 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, as it 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 (for example, lupus and scleroderma)
- A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease)
- Planned chemotherapy following breast implant placement
- Planned radiation therapy to the breast following breast implant placement
- Conditions 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 with your surgeon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery
Adverse events
The most commonly reported adverse events for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), implant rupture, and Baker grade III/IV capsular contracture.
Other potential complications for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants include: swelling, implant malposition, pain, ptosis, infection, changes in breast sensation, nipple complications, seroma, delayed wound healing, hematoma, redness, scarring, asymmetry, wrinkling/rippling, extrusion, bruising, implant palpability/visibility, upper pole fullness, and necrosis.
The most commonly reported adverse events for Natrelle® Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), Baker grade III/IV capsular contracture, implant malposition, and asymmetry.
Other potential complications for Natrelle® Silicone-Filled Breast Implants include: unsatisfactory results, pain, changes in nipple and breast sensation, infection, hematoma/seroma, difficulties breastfeeding, calcium deposits in the tissue around the implant, extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, and lymphadenopathy.
The most commonly reported adverse events for Natrelle® Saline-Filled Breast Implants are: reoperation, Baker grade III/IV capsular contracture, implant removal, and implant deflation.
Other potential complications for Natrelle® Saline-Filled Breast Implants include: breast pain, wrinkling, unsatisfactory results, infection, hematoma/seroma, changes in nipple and breast sensation, difficulty breastfeeding, calcium deposits in the tissue around the implant, delayed wound healing, extrusion, necrosis, and breast tissue atrophy/chest wall deformity.
Important: For full safety information please visit www.natrelle.com or call Allergan Product Support at 1-800-433-8871.
Caution: Rx only.
Important Natrelle® Tissue Expander Safety Information
Indications
The Natrelle® Tissue Expanders are indicated for tissue expansion prior to breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.
Contraindications
The Natrelle® Tissue Expanders are contraindicated in patients with:
- Implanted devices that would be affected by a magnetic field,
- Tissue deemed unsuitable for expansion,
- Active infection at the expansion site,
- Residual gross tumor at the expansion site,
- Physiologic conditions posing an unduly high risk for surgical or post-surgical complications,
- Drug use that might result in high surgical risk or post-operative complications, and
- Unstable psychological conditions.
The Natrelle® Tissue Expanders are also contraindicated in patients undergoing adjuvant radiation therapy.
Warnings
- Do not use in patients with implanted devices that could be affected by a magnetic field.
- Do not alter the tissue expander.
- Do not use adulterated fill. Tissue expanders are to be filled only with sterile saline.
- Do not reuse explanted tissue expanders.
- Do not expand if the pressure will compromise wound healing. Do not expand beyond patient or tissue tolerance.
- Do not expose tissue expander or injection needles to contaminants, which increase the risk of infection.
- Do not use for permanent implantation or beyond six months.
- Adverse reactions may require premature explantation.
Precautions
- Patients with active infections may need to be treated and infection resolved prior to implantation.
- Use proper surgical planning to minimize occurrence of adverse reactions.
- Use proper aseptic technique to avoid contamination.
- Use extreme care to avoid damage to the tissue expander from sharp surgical instruments during surgery and needles used during filling or hematoma/fluid evacuation.
- Postoperative hematoma and seroma may be minimized by meticulous attention to hemostasis during surgery, and possibly by postoperative use of closed drains.
- Avoiding tissue damage during expansion requires careful attention to tissue tolerance.
- Extreme care should be taken to avoid needle puncture or other damage to the tissue expander or the injection site during the expansion process.
Adverse events
Complications may include deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, chest wall compression, pain, loss of sensation, distortion, inadequate tissue flap, and inflammatory reaction.
Important: For full safety information please visit www.natrelle.com or call Allergan Product Support at 1-800-433-8871.
Caution: Rx only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indication
BOTOX ® Cosmetic 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 ≤ 65 years of age.
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.
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) 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 preexisting 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.
Human Albumin
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.
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); and when used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart.
ADVERSE REACTIONS
The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.
DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like nondepolarizing blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) 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 serotypes 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.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
LATISSE® 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.
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 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: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.
Use in Specific Populations: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
Please see the full Prescribing Information.
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