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warranty patient safety information breast reconstruction for surgeons
For US patients
Advanced
implant technology—it’s a
thing
Actual Natrelle INSPIRA® patient.
Individual results may vary.
A shell designed
TO PROTECT
The gel in Natrelle® gummy implants is surrounded by a state-of-the-art breast implant shell that is designed to keep the gel inside.*
*Significance inside the body has not been established.
The gummiest round gel implant in the US.
Gel that holds TOGETHER
When Natrelle INSPIRA® Cohesive is cut outside the body, the gel stays in place.*
*Significance inside the body has not been established.
CHOOSE Natrelle®—
get ConfidencePlus®
The Natrelle® ConfidencePlus® warranty offers you more coverage for your breast implants—all designed for your peace of mind and satisfaction.
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When You Choose Natrelle® Silicone-Filled Implants†
What warranty am I automatically enrolled in for free?
ConfidencePlus® gel warranty
What events are covered?
  • Rupture
  • Capsular contracture Baker Grade III/IV
  • Late seroma
  • Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL)
What’s covered if my implant ruptures or deflates?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $3500 for 10 years
What’s covered for capsular contracture Baker Grade III/IV?
  • Implant replacement: 10 years for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $2000 for 2 years (augmentation patients only)§,||
What’s covered for late seroma?
  • Implant replacement: 20 years for both affected and contralateral textured implants
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants#
  • Out-of-pocket financial assistance:
    • Up to $1000 for diagnostic testing if you have textured implants§
    • Up to $7500 toward the removal of the breast implant(s) and the associated scar tissue (complete capsulectomy)#
Can I cancel my warranty?
No
Can I upgrade my warranty?
No
When You Choose Natrelle® Saline-Filled Implants‡
What warranty am I automatically enrolled in for free?
ConfidencePlus® saline warranty
What events are covered?
  • Rupture/deflation
  • Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL)
What’s covered if my implant ruptures or deflates?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • If you upgrade your warranty:
    • Out-of-pocket financial assistance up to $2400 for 10 years
What’s covered for capsular contracture Baker Grade III/IV?
Not covered
What’s covered for late seroma?
Not covered
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants#
  • Out-of-pocket financial assistance:
    • Up to $1000 for diagnostic testing if you have textured implants§
    • Up to $7500 toward the removal of the breast implant(s) and the associated scar tissue (complete capsulectomy)#
Can I cancel my warranty?
No
Can I upgrade my warranty?
Yes. For $200, you can enroll in the ConfidencePlus® Premier saline warranty within 45 days of your surgery (see below).
†Valid for surgeries on or after November 1, 2014.
‡Valid for surgeries on or after July 1, 2014.
§Valid for procedures on or after January 1, 2019.
||Covers one incident per patient; recurring capsular contracture is not covered.
Valid for cases diagnosed on or after January 1, 2019.
#Valid for cases diagnosed on or after January 1, 2018.
Important terms and conditions to know

Products covered
The ConfidencePlus® warranty program applies to all FDA-approved Natrelle® breast implants, provided the products have been used:
  • As intended by appropriately qualified and licensed surgeons, in accordance with current and accepted plastic surgery techniques
  • In accordance with the current Natrelle® Breast Implant Directions for Use, found at www.allergan.com/labeling/usa.htm
Events covered
  • Loss of shell integrity, resulting in implant rupture or deflation that requires surgical intervention. Valid for surgeries on or after November 1, 2014
  • Capsular contracture (Baker Grade III/IV) with Natrelle® gel implants that requires surgical intervention
    • Allergan has the right to request photographs to confirm diagnosis
    • Implant replacement valid only for surgeries on or after November 1, 2014
    • Financial assistance valid only for surgeries on or after January 1, 2019
  • Late seroma for patients with textured implants only. Previous Allergan textured implants that have since been replaced with smooth implants are not covered
    • A diagnosis qualifies as > 50 cc of fluid presented at least 12 months after surgery
    • Cases must be diagnosed by a surgeon and confirmed by photographs, pathology, or other reports deemed acceptable by Allergan
    • Valid for cases diagnosed on or after January 1, 2019
  • BIA-ALCL diagnosis that requires surgical intervention. Valid for cases diagnosed on or after January 1, 2018
  • Diagnostic testing for BIA-ALCL, when suspected, which may include one or more of cell cytology, CD30 immunohistochemistry, or flow cytometry. Valid for cases diagnosed on or after January 1, 2019
Special considerations
Each Natrelle® breast implant is covered individually. So in case of any covered event above, you may choose to replace both implants or only the damaged implant. Coverage of the opposite (contralateral) implant will continue for the remaining life of the warranty.
Events not covered
The ConfidencePlus® warranty program does not apply to the following:
  • Removal for capsular contracture for saline implants
  • Dissatisfaction with implant size or aesthetics
  • Adverse reactions other than the covered events listed above
  • Loss of product integrity caused by cosmetic revision surgery
  • Loss of product integrity caused by open or closed capsulotomy
  • Other manufacturers’ products
  • Financial reimbursement for a replacement product that is not a Natrelle® style breast implant in lieu of a Natrelle® style replacement product
To submit a claim
For coverage eligibility, your surgeon must contact the Allergan Product Surveillance team prior to surgery at 1-800-624-4261 and provide the appropriate documentation. The surgeon is required to return the explanted, disinfected Natrelle® breast implant(s) within 3 months of the date of explantation. Allergan requests the return of all explanted breast implants associated with a complaint to assist with evaluating and maintaining the quality and safety of Natrelle® breast implants.

Where applicable, financial assistance will be issued upon receipt and verification of the explanted product(s), the Returned Goods Authorization (RGA), and the patient’s warranty general release.
Enrollment
For patients with Natrelle® gel breast implants, enrollment in the ConfidencePlus® warranty is automatic and free. You do not need to do anything.

For patients with Natrelle® Saline-Filled Breast Implants, the ConfidencePlus® saline warranty is automatic and free. However, if you would like to upgrade to the ConfidencePlus® Premier saline warranty, the enrollment fee is $200 and must be completed within 45 days of surgery by submitting the completed enrollment form by mail, fax, or online here.

If you chose Natrelle® Saline-Filled Breast Implants, you can upgrade to the ConfidencePlus® Premier warranty within 45 days of your qualifying surgery. The enrollment fee is $200.

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Thank you for choosing Allergan and for your purchase of a ConfidencePlus ® Premier warranty. You will be notified by MAIL. Please allow 8-10 weeks for processing.

ASK your surgeon for more details about the Natrelle® ConfidencePlus® warranty program.
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Natrelle® Breast Implants Important Information
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Natrelle® Breast Implants Important Information
Who may get breast implants?
 Natrelle® Breast Implants are approved for women for the following:
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
What should I know before getting breast implants?
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 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 see the patient brochures at www.allergan.com/labeling/usa.htm. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.
Natrelle® 133 Tissue Expanders Important Information
Approved Uses
 Natrelle® 133 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 www.allergan.com/labeling/usa.htm. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.
Natrelle® 133 Tissue Expanders are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

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.
CoolSculpting® has not been studied with Natrelle® breast implants, nor is it intended to be used in combination with Natrelle® breast implants.
CoolSculpting® Important Information
Uses
The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll) and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. The CoolSculpting® procedure is not a treatment for weight loss.
Important Safety Information
The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may also occur. CoolSculpting® may cause a visible enlargement in the treated area which may develop two to five months after treatment and requires surgical intervention for correction.
Please see full Important Safety Information for additional information.
SkinMedica® is a physician-dispensed, cosmetic, and nonprescription skin care product line.

Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.

Most SkinMedica® products 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 SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.

SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
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Natrelle® Breast Implants Important Information
SEE MORE +
Natrelle® Breast Implants Important Information
Who may get breast implants?
 Natrelle® Breast Implants are approved for women for the following:
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
What should I know before getting breast implants?
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 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 see the patient brochures at www.allergan.com/labeling/usa.htm. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.
Natrelle® 133 Tissue Expanders Important Information
Approved Uses
 Natrelle® 133 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 www.allergan.com/labeling/usa.htm. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.
Natrelle® 133 Tissue Expanders are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

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.
CoolSculpting® has not been studied with Natrelle® breast implants, nor is it intended to be used in combination with Natrelle® breast implants.
CoolSculpting® Important Information
Uses
The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll) and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. The CoolSculpting® procedure is not a treatment for weight loss.
Important Safety Information
The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment.
Rare side effects may also occur. CoolSculpting® may cause a visible enlargement in the treated area which may develop two to five months after treatment and requires surgical intervention for correction.
Please see full Important Safety Information for additional information.
SkinMedica® is a physician-dispensed, cosmetic, and nonprescription skin care product line.

Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.

Most SkinMedica® products 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 SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.

SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
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