Natrelle® Breast Implants are approved for women for the following:
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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.
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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.
- 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.
- Breast implants are not lifetime devices, and not necessarily a one-time surgery.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
- Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
- Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
- With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening. Tell your doctor of these symptoms and remove ruptured implants.
- Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
- 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 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 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.
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.
Natrelle® Breast Implants are available by prescription only.
Natrelle® 133S Smooth Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.
Do not use if you:
- Already have implanted devices that would be affected by a magnetic field.
- Have tissue unsuitable for expansion.
- Have an active infection or a residual gross tumor at the expansion site.
- Are undergoing adjuvant radiation therapy.
- Have a physiological condition (eg, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.
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Natrelle® 133S Smooth Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
- Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
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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.
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.
Natrelle® 133S Smooth Tissue Expanders are available by prescription only.
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.
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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.
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