Consumer Loyalty Program
Terms and Conditions
RECEIVE A TREATMENT OR PURCHASE A PRODUCT
The Consumer Loyalty Program ("Program"), owned and operated by Allergan, Inc. ("Allergan," "we," "us" or "our") is provided to you ("you," "you," or "User") under the following terms and conditions, including the amendments thereto and with any additional terms and conditions, rules, or polices that may be applicable to particular offerings made in connection with the Program (collectively, the "Terms and Conditions"). Your failure to follow the Program's rules, whether listed below or in supplemental notices posted at various points in the Program, may result in termination of your access and membership to the Program and all points you have accrued in the Program, without notice, in addition to Allergan's other remedies. Your membership, access to, and use of the Program are subject to the terms and conditions of this agreement and all applicable laws and regulations, including the laws and regulations governing copyrights and trademarks. The Terms and Conditions of this agreement shall supersede all previous loyalty program rules and/or terms and conditions. The following rules may be modified by Allergan from time to time. Any such changes shall be reflected in an updated version of the Terms and Conditions posted on this site. BY ACCESSING THE PROGRAM, YOU ACCEPT, WITHOUT LIMITATION OR QUALIFICATION, ALL OF THE TERMS AND CONDITIONS IN THIS USER AGREEMENT.
DESCRIPTION OF THE PROGRAM
The Program is an on-line, points-based program where registered users of the Program may accrue points by engaging in certain activities, and may, in turn, redeem points for certain benefits ("Benefits") provided by Allergan. The current Benefits offered shall be described in the Program FAQs of the Program Information. Points accrued in the Program are non-transferrable to other users or accounts and have no cash or monetary value. The Program may be changed from time to time in Allergan's sole discretion. Any change to the Program or these Terms and Conditions will be posted on this site so you are encouraged to visit the site often.
Registered users of the Program must be legal residents of the United States or Puerto Rico and be 18 years of age or older at the time of registration to be eligible. Void where prohibited by law. Employees of Allergan and its related entities and their immediate families are eligible. Only one member account per person. All products purchased to qualify for this program must be purchased within the United States.
RESERVATION OF RIGHTS
The Program and its Benefits are offered at Allergan's discretion, and Allergan has the right to modify or discontinue, temporarily or permanently, the Program, including the point levels and Benefits offered, in whole or in part, for any reason, at our sole discretion. Allergan may, among other options, withdraw, limit, modify, or cancel any Benefit; increase the points required for any Benefit; or modify or condition the transferability of Benefits. You agree that Allergan will not be liable to you or any third party for any modification or discontinuance of the Program of Benefit offered, in whole or in part.
In consideration of your use of the Program, you agree to provide true, accurate, current, and complete information about yourself as prompted by the online registration form and to maintain and promptly update your personal data to keep it true, accurate, current, and complete. If you provide any information that is not true, inaccurate, not current, or incomplete; or if we have reasonable grounds to suspect that such information is not true, inaccurate, not current, or incomplete; we have the right to suspend or terminate your account and to refuse any and all current or future use of the Program (or any portion thereof) by you. Only one member account per person. If you attempt to obtain more than one Program account, we may terminate your registration and all earned points may be forfeited.
You will receive a password and account designation upon completing the registration process. You agree to maintain the confidentiality of your password and account, and that you are fully responsible for all activities that occur under your password or account or any other breach of security, and to log out at the end of each session. We will not be liable for any loss or damage arising from your failure to comply with these conditions. If for any reason your account is terminated by either you or by us, all of your points accrued will be forfeited.
EARNING PROGRAM POINTS
Brilliant Distinctions® points can only be earned and redeemed on cash-pay (i.e., no government or private health plan reimbursement) breast augmentation procedure with Natrelle® Gel Breast Implants, and are subject to additional rules and regulations.
To earn and accumulate points, you must undertake an activity outlined in the Program FAQs of the Program Information provided to you by your participating physician or contained within this site, which may include: purchasing BOTOX® Cosmetic (onabotulinumtoxinA), and/or JUVÉDERM® XC treatments, and/or JUVÉDERM VOLUMA® XC treatments, and/or JUVÉDERM VOLLURE™ XC treatments, JUVÉDERM VOLBELLA® XC treatments, and/or KYBELLA® (deoxycholic acid) injection 10 mg/mL, and/or LATISSE®(bimatoprost Opthalmic solution) 0.03% kit(s), and/or SkinMedica® products, and/or Natrelle® Gel Breast Implants, from a preferred physician participating in this Program, as well as purchasing products in the Brilliant Distinctions® Mall. We expressly reserve the right to establish additional means of accruing points; to remove any or all of the means currently in effect; to exclude certain types of transactions from the accumulation of points; to specify periods after which unused points will be forfeited or reduced in percentage. Points can be accrued only for activity taken and completed by you and can be applied only to your account. We will use reasonable efforts to allocate earned points to your account; however, you are responsible for ensuring that your points are properly credited. If you believe that points have been earned but not credited, we reserve the right to require proof of accrual; including, but not limited to, copies or receipts or similar documentation verifying any transactions claimed to have been performed. We must receive any claims of points by you and proof of accrual within sixty (60) days after the date such points are claimed to have been earned. Points will be maintained in your account until they are redeemed for benefits or are forfeited, whichever occurs first. All decisions regarding point balances, benefits, forfeitures, and the identity of any individual accessing an account, are within our sole discretion.
Points earned from purchasing in-office BOTOX® Cosmetic treatments from a participating physician can only be earned every three (3) calendar months. If you receive BOTOX® Cosmetic treatments less than three (3) calendar months from your last treatment, you will not be eligible to receive points from the later treatment. Points are awarded for only one breast augmentation procedure with Natrelle® Gel Breast Implants.
Points are only eligible for BOTOX® Cosmetic treatments, JUVÉDERM® XC treatments, JUVÉDERM VOLUMA® XC treatments, and/or JUVÉDERM VOLLURE™ XC treatments, and/or JUVÉDERM VOLBELLA® XC treatments, and/or KYBELLA®(deoxycholic acid)injection 10 mg/mL, LATISSE® kit purchases, Natrelle® Gel Breast Implant purchases, and SkinMedica® products purchases.
Points will only be issued if you have provided your participating physician with authorization to share information about your treatment with the Program. You may revoke this authorization at any time, but if you do so, you may no longer be eligible to participate in the Program.
When you purchase in-office BOTOX® Cosmetic treatments, and/or JUVÉDERM® XC treatments, and/or JUVÉDERM VOLUMA® XC treatments, and/or JUVÉDERM VOLLURE™ XC treatments, and/or JUVÉDERM VOLBELLA® XC treatments, and/or Kybella®(deoxycholic acid) injection 10 mg/mL, and/or LATISSE® kit(s), and/or SkinMedica® products, and/or Natrelle®Gel Breast Implants, you will be issued points by your physician. Points are automatically deposited within 24 to 48 hours (if not cancelled by the physician).
As a member of the Program, you will automatically be signed up to receive personalized e-mails, information, and offers from Allergan and/or its partners ("Partners") or as otherwise specified by Allergan via electronic mail or physical mail. At any time after you register you may opt out of emails regarding information and offers by clicking on the unsubscribe link at the bottom of each email.
You may view a summary of your Program points by logging onto www.brilliantdistinctionsprogram.com.
REDEEMING PROGRAM POINTS
You may redeem points accrued in your account for available Benefits, provided that your account is in good standing at the time of the points redemption request. Points may be redeemed at any participating physician’s office and can be applied to in-office BOTOX® Cosmetic and/or JUVÉDERM® XC treatments, and/or JUVÉDERM VOLUMA® XC treatments, and/or JUVÉDERM VOLLURE™ XC treatments, and/or JUVÉDERM VOLBELLA® XC treatments and/or KYBELLA® (deoxycholic acid) injection 10 mg/mL and product purchases for LATISSE® (bimatoprost ophthalmic solution) 0.03%, SkinMedica® products, and/or Natrelle® Gel Breast Implants, or as a donation to the charitable partners of the program (currently Dress for Success® and Make-A-Wish Foundation®).
The amount of points available for each qualified Benefit and the types of Benefits available for redemption shall be determined in the sole discretion of Allergan, all of which is subject to change, modification, addition, or deletion from Allergan at any time and without prior notice.
Points that you redeem shall immediately be deducted from your account upon presenting a valid redemption coupon to any physician participating in this Program. Coupons that have expired or been cancelled will not be honored or accepted by either the participating physician or Allergan.
Points earned in two or more different accounts may not be combined to redeem for any Benefit. Redeemed Benefits are not refundable, exchangeable, replaceable, redeemable, or transferable for cash, credit, or other benefits, or points under any circumstances.
EXPIRATION OF PROGRAM POINTS AND TREATMENT VOUCHERS AND COUPONS
Any points earned will expire 9 months from the date issued. Points are automatically deposited 24 to 48 hours after your physician issues them (if not cancelled by the physician). If your account is closed due to inactivity, all points will be forfeited. In-office coupons are valid for sixty (60) days from the issue date of the coupon. All coupons will expire at 11:59 PM Pacific Time (PT) on the date of expiration specified. You acknowledge that any Program points or coupons that are not redeemed or entered during the redemption or entry periods described shall be foreifted at 11:59 PM PT at the end of that period.
PRIVACY AND USE OF YOUR INFORMATION
Fraud or abuse relating to the accrual of points or redemption of points for Program Benefits may result in forfeiture of accrued points as well as the termination of your account. You are solely responsible for any fraudulent use of your points that could occur due to the theft or sharing of your password. The Program is provided to individual users who are natural persons for their own personal use. IT WILL BE CONSIDERED FRAUDULENT AND A VIOLATION OF THESE TERMS AND CONDITIONS FOR YOU TO SHARE WITH OTHER MEMBERS POINTS AND/OR OTHER INFORMATION THAT CAN BE REDEEMED FOR POINTS AND/OR BENEFITS. IT IS CONSIDERED FRAUDULENT AND A VIOLATION OF THESE TERMS AND CONDITIONS FOR YOU TO REDEEM POINTS OR OTHER INFORMATION THAT CAN BE REDEEMED FOR POINTS AND/OR BENEFITS THAT WERE RECEIVED FROM OTHER MEMBERS. ANY MEMBER SHARING IN THIS MANNER OR REDEEMING INFORMATION SHARED IN THIS MANNER WILL HAVE THEIR ACCOUNT DELETED AND WILL NOT BE AWARDED ANY BENEFITS. You are solely responsible for any fraudulent use of your Points that may occur due to the theft of or sharing of your password.
VIOLATIONS OF THE TERMS
You understand and agree that in our sole discretion, and without prior notice, we may remove points from your account as a penalty, terminate your access to the Program, and/or deactivate or delete your membership account if we determine that you have violated our Terms and Conditions.
You should assume that all contents of this site are copyrighted unless otherwise noted and may not be used except as provided herein and without our express written permission. Except as expressly provided herein, nothing contained herein shall be construed as conferring any license or right under any Allergan copyright.
All product names, logos, and service marks displayed on this site that are identified by ® or ™ or appearing in type form different from that of the surrounding text (collectively, the "Trademarks") are registered or unregistered trademarks owned by or licensed to Allergan or our affiliates, unless otherwise identified as being owned by another entity. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right, either express or implied, under any patent or Trademark of Allergan or any third party. No use of any Trademark may be made without our prior written authorization, except to identify the product or services of the company.
These Terms and Conditions shall be governed by and construed in accordance with the laws of the State of California. All applicable federal, state, and local laws and regulations apply. The invalidity or unenforceability of any provisions of these Terms and Conditions shall not affect the validity or enforceability of any provision. In the event that any provision of these Terms and Conditions is found to be invalid or unenforceable, these Terms and Conditions shall be construed in accordance with their terms as if the invalid or unenforceable provision was not contained therein. Allergan and their affiliates, representatives, agents, directors, officers, shareholders, and employees are not responsible for and shall not be liable for: (i) late, lost, delayed, damaged, misdirected, inaccurate, incomplete, or unintelligible registration or point entries; (ii) telephone, electronic, hardware or software program, network, Internet, computer or other malfunctions, failures, or difficulties of any kind, whether human or technical; (iii) failed, incomplete, garbled, or delayed computer transmissions; (iv) any condition caused by events beyond our control; (v) any injuries, losses, or damages of any kind arising in connection with or as a result of the benefit or acceptance, delivery or failure to timely deliver, possession, or use of the benefit, or from participation in the Program; or (vi) any printing or typographical errors in any materials associated with the Program. Further, in no event shall we, or any of our affiliates, and/or their respective officers, directors, employees, agents, representatives, information providers, and licensors and/or their respective heirs and assigns be liable for any damages of any kind or nature, including but not limited to, direct, indirect, incidental, consequential, exemplary, special (including loss or profit), punitive, or other damages arising from or in connection with the existence or use of this site or any such dispute, regardless of whether Allergan or any of the other entities or persons listed above have been advised as to the possibility of such damages. Under no circumstances will you be permitted to obtain benefits for, and hereby waives all rights to claim punitive, incidental or consequential damages, including attorney's fees, other than participant's actual out-of-pocket expenses (i.e. costs, if any, associated with participating in the Program), and participant further waives all rights to have damages multiplied or increased. Under no circumstances shall we be liable to you or any third party for any indirect, incidental, consequential, special or exemplary damages, even if advised of the possibility of such damages, arising from the use or inability to use the Program or any other provision of these Terms and Conditions. You accept all responsibility for, and hereby indemnify and hold us, our subsidiaries, and affiliates harmless from and against, any actions taken by any user authorized to use your account, including, but not limited to, accrual of points, redemption of points, and disclosure of passwords to third parties.
No information contained on this site is provided with the intention to give medical advice or instructions on the accurate use of our products. We cannot answer unsolicited e-mails requesting personal medical advice; visitors should always consult a health care professional.
By participating in the Program, participants agree to release, discharge, and hold harmless Allergan and their affiliates, representatives, agents, directors, officers, shareholders and employees from any and all liability from any injuries, losses, or damages of any kind arising from or in connection with the Program.
For BOTOX® Cosmetic (onabotulinumtoxinA) Full Prescribing Information, including Boxed Warning and Medication Guide, please visit: http://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf
For JUVÉDERM® XC Safety Considerations, please visit: http://www.juvederm.com/
For KYBELLA® (deoxycholic acid) injection 10 mg/mL Full Prescribing Information, please visit: http://www.allergan.com/assets/pdf/kybella_pi
For LATISSE® (bimatoprost ophthalmic solution) 0.03% Full Product Information, please visit: http://www.allergan.com/assets/pdf/latisse_pi.pdf
Approved Uses and Important Safety Information
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
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, 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, or both at the same time.
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 take 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; weakness of forehead muscles: 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 nonprescription medicines, vitamins, and herbal products. 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: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.
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.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information
LATISSE® is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes.
IMPORTANT SAFETY INFORMATION
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. May cause brown darkening of the colored part of the eye which is likely permanent. LATISSE® may cause eyelid skin darkening which may be reversible. Only apply at base of upper lashes. DO NOT APPLY to lower lid. Hair may grow outside the treatment area. If you have eye problems/surgery, consult your doctor. Common side effects include itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
To report a side effect, please call Allergan at 1-800-678-1605.
Please see LATISSE® full Product Information.
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
KYBELLA is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called “double chin.” It is not known if KYBELLA is safe and effective for use outside of the submental area or in children less than 18 years of age.
IMPORTANT SAFETY INFORMATION
Who should not receive KYBELLA?
You should not receive KYBELLA if you have an infection in the treatment area.
Before receiving KYBELLA, tell your healthcare provider about all of your medical conditions, including if you: Have had or plan to have surgery on your face, neck, or chin; have had cosmetic treatments on your face, neck, or chin; have had or have medical conditions in or near the neck area; have had or have trouble swallowing; have bleeding problems; are pregnant or plan to become pregnant (it is not known if KYBELLA will harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if KYBELLA passes into your breast milk; talk to your healthcare provider about the best way to feed your baby if you receive KYBELLA).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take a medicine that prevents the clotting of your blood (antiplatelet or anticoagulant medicine).
What are the possible side effects of KYBELLA?
KYBELLA can cause serious side effects, including nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness), or trouble swallowing.
The most common side effects of KYBELLA include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.
These are not all of the possible side effects of KYBELLA. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/safety/MedWatch or call 1-800-FDA-1088.
Please talk to your healthcare provider or see full Prescribing Information for additional information.
CoolSculpting® Treatment Important Information
In the US, the CoolSculpting procedure is FDA-cleared for the treatment of visible fat bulges in the submental area, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. Please talk to your healthcare provider or see full Important Safety Information for additional information.
JUVÉDERM® Injectable Gel Fillers Important Information
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21.
JUVÉDERM® XC injectable gel is 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 injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds in adults over 21.
JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® injectable gel 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?
- 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 in patients under 35 years or over 65 years, the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
- The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA®XC in areas other than the lips and perioral area have not been established in clinical studies
- Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
- Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
- Patients who experience skin injury near the site of injection with this product may be at higher risk for side effects
- Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of these products may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included injection-site 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 were moderate and lasted 2 to 4 weeks. For JUVÉDERM® XC, JUVÉDERM VOLLURE™ XC, and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less. For JUVÉDERM VOLBELLA® XC, most side effects were mild or moderate and lasted 30 days or less.
One of the risks with using these products is unintentional injection into a blood vessel, and, while rare, 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.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.
Available by prescription only.
Natrelle® Breast Implants Important Information
Who may get breast implants?Natrelle® Breast Implants are approved for women for the following:
- 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.
IMPORTANT SAFETY INFORMATIONWho should NOT get breast implants?
- 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 breast-feed, 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.
What should I tell my doctor?Tell your doctor if you have any of the following conditions, as the risk 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.
What are some complications with breast implants?
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.
Talk to your doctor. For more information or to report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871. Please also see the patient brochures at www.allergan.com/labeling/usa.htm.
Natrelle® Breast Implants are available by prescription only.
REVOLVE™ Advanced Adipose System
Important Safety Considerations for REVOLVE™ System
REVOLVE™ System is a single use, sterile, disposable canister that is intended for processing, filtering, and transferring of autologous adipose tissue. The system is intended to be used by a plastic surgeon to perform autologous fat grafting in aesthetic body contouring procedures.
Autologous fat grafting should not be performed in the presence of any disease process that adversely affects wound healing, and in patients who are in poor overall health. Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under correction of the treatment site, tissue lumps, bleeding, and scarring.
Every patient's situation is different, so be sure to ask your surgeon if the use of REVOLVE™ System is right for you. This Safety Information is not intended to replace a patient’s discussion with a surgeon. It does not describe all the potential risks and potential benefits associated with fat grafting procedures.
REVOLVE™ System is available only through licensed plastic surgeons. Complete product and safety information is available at lifecell.com.
Most of the SkinMedica® products described here are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.
SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+), Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35), SkinMedica Daily Physical Defense® Sunscreen Broad Spectrum SPF 30+, Environmental Defense Sunscreen™ SPF 50+ with UV ProPlex™, and TNS Ultimate Daily Moisturizer™ SPF 20 Sunscreen are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. Part 352.
SkinMedica® Acne System, Acne Treatment Lotion, Purifying Foaming Wash, and Purifying Toner, are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 C.F.R. § 333.301 et seq.