Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that 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
Natrelle® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants.
This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
Breast reconstruction. This includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery
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
- See Boxed Warning in bold type above
- 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
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
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 uncommon systemic conditions have been reported with breast implants.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
Natrelle® 133S Smooth Tissue Expanders With MAGNA-SITE® Injection Sites Important Information
Natrelle® 133S Smooth Tissue Expanders are indicated for:
- Breast reconstruction following mastectomy.
- Treatment of underdeveloped breasts.
- Treatment of soft tissue deformities.
IMPORTANT SAFETY INFORMATION
Natrelle® 133S Smooth Tissue Expanders SHOULD NOT be used in patients:
- Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices, artificial sensing devices).
- Whose tissue at the expansion site is determined to be unsuitable.
- Who have an active infection or a residual gross tumor at the expansion site.
- Undergoing adjuvant radiation therapy.
- Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications.
- Who are psychologically unsuitable.
- DO NOT use Natrelle® 133S Smooth Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications) because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133S Smooth Tissue Expanders in place.
- DO NOT alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. DO NOT expose to contaminants.
- DO NOT expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed.
- DO NOT reuse explanted products.
- Active infection anywhere may increase risk of periprosthetic infection. DO NOT expose the tissue expander or injection needles to contaminants. Postoperative infections should be treated aggressively.
- Adverse reactions may require premature explantation
- When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs.
- Natrelle® 133S Smooth Tissue Expanders are temporary devices and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months.
Active infections may need to be treated and resolved before surgery. Allergan relies on the surgeon to know and follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.
Deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.
For more information, please visit www.allergan.com/products. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.
Natrelle® 133S Smooth Tissue Expanders are available by prescription only.
Intraoperative Breast Implant Sizers Important Information
The Natrelle® Silicone Sizer and the Allergan Saline Sizer are indicated for single use only for temporary intraoperative insertion in the surgical pocket to evaluate and assist in determining the final breast implant size/volume. The Natrelle® Re-sterilizable Silicone Breast Implant Sizer is used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of a breast implant to use.
IMPORTANT SAFETY INFORMATION
All sizers are contraindicated for use as long-term breast implants or tissue expanders. The Natrelle® Silicone Sizer and the Allergan Saline Sizer are contraindicated for multiple patient use or multiple sterilizations.
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 the Natrelle® Silicone Sizer or the Allergan Saline Sizer, which are for single use only. The Silicone 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.
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.
Adverse events and/or complications may include sepsis, hemorrhage, thrombosis, bleeding, and/or infection.
For more information, please visit www.allergan.com/products. To report a problem, please call Allergan at 1-800-433-8871.
Intraoperative Breast Implant Sizers are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
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.
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.
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.
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.
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%).
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