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:
Breast augmentation for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants. Breast augmentation includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation Breast reconstruction. This 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
Who should NOT get breast implants?
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
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:
- Autoimmune diseases (eg, lupus and scleroderma)
- A weakened immune system (eg, taking medications to decrease the body’s immune response)
- Planned chemotherapy or radiation therapy 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
- Those 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
What else should I consider?
There is a Boxed Warning for breast implants.
Please see bold text at beginning
Many changes to your breasts following implantation are irreversible. If you later choose to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent.
Breast implantation is likely not a one-time surgery. The longer implants are in place, the greater the potential risk for complications. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Thus, you should also consider the complication rates for later (revision) surgery since you may experience these risks in the future.
Cancer treatments and surgery will affect the outcome and timing of breast reconstruction
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. Even if you have no symptoms, you should have your first ultrasound or MRI at 5 to 6 years after your initial implant surgery and then every 2 to 3 years thereafter regardless of whether your implants are for augmentation or reconstruction. If you have symptoms of or uncertain ultrasound results for breast implant rupture, an MRI is recommended. Additional imaging may be required depending on your medical history and status. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established
Routine screening mammography for breast cancer will be more difficult, and implants may rupture during the procedure. Perform self-examination every month for cancer screening and ask your surgeon to help you distinguish the implant from your breast tissue. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging
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 www.allergan.com/products.
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.
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:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
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® 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® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.
JUVÉDERM® Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 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), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
Tell your doctor if you are pregnant or breastfeeding. 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® 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
JUVÉDERM® VOLUMA® XC is intended for use in the chin and cheek areas. JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC are intended for use in facial wrinkles and folds. JUVÉDERM® VOLBELLA® XC and JUVÉDERM® Ultra XC are intended for use in the lips and perioral area. The safety and effectiveness for treatment in other areas have not been established in clinical studies
Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients and may result in additional scars or changes in pigmentation
Tell your doctor if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use may result in an increased risk of infection
Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners. As with any injection, this may result in increased bruising or bleeding at the injection site
Patients who experience skin injury near the site of injection may be at a higher risk for adverse events
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
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. For JUVÉDERM® VOLUMA® XC, most side effects resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels, most resolved within 14 days or less. For JUVÉDERM® VOLBELLA® XC, most resolved within 30 days or less. These side effects are consistent with other facial injection procedures.
Most side effects will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
One of the risks with these products is 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.
As with all skin injection procedures, there is a risk of infection.
Visit Juvederm.com or talk to your doctor for more information. To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871.
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.
