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warranty patient safety information breast augmentation for surgeons
For US patients

Your Safety. Our Priority.

Natrelle®
Quality

Our commitment to you

Did you know that Natrelle® is the most selected breast implant by plastic surgeons?* Your safety is our number one priority, and our commitment to quality, consistency, and transparency are an important part of that.

*Based on surgeon survey data, April 2021 (N=104).

A HISTORY OF INNOVATION

Breast implants have come a very long way. The first breast implants were introduced in the early 1960s. They had thinner shells, and the gel had a runnier consistency.

The Natrelle INSPIRA® Smooth Breast Implant Collection evolved to meet your needs with:

  • Thick, protective shells
  • More cohesive silicone gels
  • Higher gel fill ratio
  • All smooth-surface options
35yeras

HIGH MANUFACTURING STANDARDS

Natrelle® breast implants are made with high standards of manufacturing and quality testing.

High Quality

State-of-the-art facility designed specifically to produce breast implants

High Quality

Each implant goes through an intensive 12-day production

High Quality

Each implant is sterilized and given a unique serial number

High Quality

Multiple quality checks through the manufacturing process

High Quality

Handmade by a highly skilled workforce

Natrelle® looks at common myths about breast implants

Each Natrelle INSPIRA® Breast Implant is made by hand by members of our highly skilled workforce.

Natrelle® Breast Implants go through an extensive, rigorous testing process to ensure quality.

THE SCIENCE OF GEL TECHNOLOGY AND WHAT'S INSIDE

Natrelle INSPIRA® Breast Implants are made with advanced silicone gel technology. A state-of-the-art shell protects the gummy gels that are designed to hold together.†

†When the implant is cut outside the body.

The Natrelle® shell difference

INTRASHIEL™ barrier shell technology minimizes diffusion through the shell with less than a 1% gel diffusion rate.

Shall Difference

The Natrelle® gel difference

The cohesive gel in all Natrelle® gel Breast Implants is designed to hold together. When Natrelle® gel implants are cut outside the body, the gel stays in place when held in your hand.‡ Check out the video below to see a demonstration.

‡Significance inside the body has not been established.

Silicone Gel

The shells of Natrelle® gel breast implants and the gels inside are made with a medical-grade silicone, and there are varying types of gel cohesivity to choose from. Studies have shown that Natrelle® gel breast implants have a less than 1% gel diffusion rate. That means it’s highly unlikely for gel to diffuse through the shell, but in the event that it does, toxicology testing has established that there is no toxicological concern.

Medical-grade silicone material is used in clinically tested products designed not to cause any adverse responses in the majority of patients, making them suitable for implantable devices, such as breast implants and surgical reconstructive components. Medical-grade silicone must meet high standards of biocompatibility that are set forth by the FDA.

As always, Natrelle® continues to adhere to the most up-to-date requirements of silicone gel implant manufacturing, which is why Natrelle® breast implants are rigorously tested for quality and safety.

Breast Implant Ingredients

The materials found in breast implants have been evaluated to assess the exposure levels in comparison to the amount determined to be likely safe. Very small quantities of these materials in breast implants have been determined to be safe by the FDA.

For more information about the materials in Natrelle® Breast Implants, please refer to the Breast Reconstruction with Natrelle® Silicone-Filled Breast Implants patient labeling and the Natrelle® Saline-Filled Breast Implants patient labeling documents.

Metals

Platinum is a metal added to the shell and gel of breast implants during the manufacturing process. The FDA has concluded that the platinum contained in breast implants does not pose a significant risk to patients.

The FDA has published a backgrounder with some key information about platinum found in breast implants.

Please contact a plastic surgeon if you have any additional questions.

Breast Implant
Surgery Considerations

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.

Candidates for breast reconstruction surgery:

Breast reconstruction includes primary breast 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. This also includes revision surgery to correct or improve the result of a primary breast reconstruction.

Not a candidate for 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, because surgery may interfere with the safety of the pregnancy/nursing. Since breast reconstruction is an elective surgery, it should be postponed until you are no longer pregnant or nursing

If you have any of these conditions, be sure to speak with your plastic surgeon, as breast surgery would not be appropriate.

Precautions

Natrelle® Breast Implants have not been studied in patients with certain conditions, and may increase certain risks in patients who have any of 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 until these conditions have resolved or stabilized prior to undergoing breast implantation surgery

Please contact a plastic surgeon if you have any additional questions.

Common
Complications

The most common complications women with breast implants experience are reoperation, implant removal, capsular contracture, and rupture.

After surgery, be sure to follow your surgeon’s instructions and schedule follow-up exams as needed. If you notice any changes in your breast implants, or any signs or symptoms of potential health issues, be sure to schedule an appointment with your plastic surgeon right away.

Reoperation

Additional surgery to breast and/or implant will likely be necessary over the course of your life. This can be due to implant rupture, other complications, or unacceptable cosmetic outcomes. You may also decide to undergo a reoperation to change the size or type of your implants or improve outcomes.

Speak to your plastic surgeon about higher risks of complications with revision surgeries. Additional surgeries come with higher risks compared to those of primary augmentation surgery. There is also a risk that implant shell integrity could be compromised inadvertently during reoperation surgery, potentially leading to product failure.

The 10-year reoperation rate was 71.5%, based on 98 primary reconstruction patients in the Allergan Core Study.

Implant Removal

Implants are not considered lifetime devices, and you likely will undergo implant removal(s), with or without replacement, over the course of your life. When implants are explanted without replacement, changes to the patient’s breasts may be irreversible.

The main reasons for implant removal after primary augmentation are:

  • Capsular contracture
  • Size change
  • Suspected rupture

The 10-year implant removal rate with or without replacement was 53.5%, based on 98 primary reconstruction patients in the Allergan Core Study.

Capsular Contracture

After any kind of implant (medical or cosmetic) is placed in the body, the formation of a “capsule” of scar tissue around the implant is the body’s natural response. With breast implants, this is usually a good thing because it can help keep the implants in place. However, in some patients, the scar tissue becomes unusually hard or starts to contract, which can cause pain and affect the appearance of the breast. Capsular contracture is a risk factor for implant rupture.

The 10-year capsular contracture rate was 24.6%, based on 98 primary reconstruction patients in the Allergan Core Study.

Be sure to ask your plastic surgeon about capsular contracture and how to reduce your risk.

Rupture

A rupture is a tear or hole in the breast implant shell, which may expose the gel.

Ruptures are caused by implants wearing out over time, folding or wrinkling of the implant shell, severe capsular contracture, excessive force to the chest, or damage by surgical instruments. The longer breast implants are in place, the higher the chance of a rupture.

Because ruptures are often silent, it is recommended that you have periodic imaging (eg, MRI, ultrasound) of your silicone gel-filled breast implants to screen for implant rupture regardless of whether your implants are for cosmetic augmentation or reconstruction. These recommendations do not replace other additional imaging that may be required depending on your medical history or circumstances (ie, screening mammography for breast cancer). Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.

In Allergan's Core Study, there was an MRI screening cohort who had regular MRIs to screen for implant rupture whether or not they had symptoms, and a cohort who did not have regular screening MRIs. The 10-year MRI-cohort implant rupture rate was 35.4%, based on 57 primary reconstruction patients in the Allergan Core Study.

For the full list of complications, including those for revision reconstruction, please see the patient labeling for Breast Reconstruction With Natrelle® Silicone-Filled Breast Implants.

Please contact a plastic surgeon if you have any additional questions.

Uncommon
Complications

BIA-ALCL

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not breast cancer—it is a type of non-Hodgkin's lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. BIA-ALCL is most commonly associated with textured breast implants. This cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treated with chemotherapy and radiation therapy.

The main symptoms of BIA-ALCL are persistent swelling, presence of a mass, or pain in the area of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement.

The FDA has determined that based on the currently available data, the type of implant fill does not appear to be a risk factor for BIA-ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. To date, there has not been sufficient data for the FDA to determine whether BIA-ALCL may be found more or less frequently in individuals with silicone-filled breast implants compared to individuals with saline-filled breast implants.

Learn more about BIA-ALCL at:

The American Society of Plastic Surgeons (ASPS)

The American Society for Aesthetic Plastic Surgery (ASAPS)

Systemic Symptoms

Systemic symptoms, sometimes referred to as breast implant illness, are symptoms that have been reported by women with breast implants and may include fatigue, memory loss, rash, "brain fog," and joint pain. Researchers are investigating these symptoms to better understand their origins. These symptoms and what causes them are poorly understood. In some cases, removal of the breast implants without replacement is reported to reverse systemic symptoms. In other cases, removal of breast implants does not improve symptoms.

While women with breast implants have reported experiencing various systemic symptoms, the link between breast implants and systemic symptoms is unclear. We are committed to partnering with the FDA, plastic surgery societies, and researchers on better understanding any possible connection so we can take the appropriate steps to minimize any risk to you.

For the full list of complications, including those for revision reconstruction, please see the patient labeling for Breast Reconstruction With Natrelle® Silicone-Filled Breast Implants.

Please contact a plastic surgeon if you have any additional questions.

Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
SEE MORE +
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
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.
Who can get breast implants?
Natrelle® Breast Implants are approved for the following:
Who should NOT get breast implants?
 Breast implant surgery should NOT be performed in:
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
What else should I consider?
What are key complications with breast implants?
 Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.
Talk to your doctor about other complications.
For more information, see the patient brochures at rxabbvie.com.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.

Natrelle® 133S Tissue Expanders Important Information

Approved Uses

Natrelle® 133S Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
What else should I consider?

What are possible complications?

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.

For more information, please visit rxabbvie.com. To report a problem with Natrelle®, please call Allergan at 1-800-624-4261.
Natrelle® 133S Tissue Expanders are available by prescription only. The sale and distribution of Natrelle® 133S Tissue Expanders is restricted to licensed physicians.
BOTOX® Cosmetic (onabotulinumtoxinA)
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
 BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel Fillers Important Information
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.
JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® formulation?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?
  • One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.
  • If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse.
  • The effectiveness of removal of any dermal filler has not been studied.
What precautions should my doctor advise me about?
  • JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
  • The safety of these products for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
  • Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
  • The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
  • Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
What are possible side effects of treatment?

The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor 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.
  • 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.
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
SEE MORE +
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES
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.
Who can get breast implants?
Natrelle® Breast Implants are approved for the following:
Who should NOT get breast implants?
 Breast implant surgery should NOT be performed in:
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
What else should I consider?
What are key complications with breast implants?
 Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility.
Talk to your doctor about other complications.
For more information, see the patient brochures at rxabbvie.com.
To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.

Natrelle® 133S Tissue Expanders Important Information

Approved Uses

Natrelle® 133S Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
What else should I consider?

What are possible complications?

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.

For more information, please visit rxabbvie.com. To report a problem with Natrelle®, please call Allergan at 1-800-624-4261.
Natrelle® 133S Tissue Expanders are available by prescription only. The sale and distribution of Natrelle® 133S Tissue Expanders is restricted to licensed physicians.
BOTOX® Cosmetic (onabotulinumtoxinA)
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
 BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.
JUVÉDERM® Injectable Gel Fillers Important Information
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.
JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® formulation?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?
  • One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.
  • If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse.
  • The effectiveness of removal of any dermal filler has not been studied.
What precautions should my doctor advise me about?
  • JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
  • The safety of these products for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
  • Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
  • The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
  • Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
What are possible side effects of treatment?

The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor 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.
  • 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.
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