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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)a
What’s covered for late seroma?
  • Implant replacement: 20 years for both affected and contralateral textured implants
  • Out-of-pocket financial assistance: Up to $1000 for diagnostic testing to rule out BIA-ALCL (textured implants only)
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $7500 for treatment
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
  • 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
  • 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?
  • Implant replacement: 20 years for both affected and contralateral textured implants
  • Out-of-pocket financial assistance: Up to $1000 for diagnostic testing to rule out BIA-ALCL (textured implants only)
What’s covered for BIA-ALCL?
  • Implant replacement: Lifetime for both affected and contralateral implants
  • Out-of-pocket financial assistance: Up to $7500 for treatment
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).
  • aCovers one incident per patient; recurring capsular contracture is not covered.
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/products
Events covered
  • Loss of shell integrity, resulting in implant rupture or deflation that requires surgical intervention
  • Capsular contracture (Baker Grade III/IV) with Natrelle® gel implants that requires surgical intervention
    • Allergan® has the right to request photographs to confirm diagnosis
  • 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®
  • BIA-ALCL diagnosis that requires surgical intervention
  • Late seroma diagnostic testing to rule out BIA-ALCL, when suspected, which may include one or more of cell cytology, CD30 immunohistochemistry, or flow cytometry
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.

To receive additional coverage for out-of-pocket financial assistance, you may choose to enroll in the Natrelle® ConfidencePlus® Premier saline warranty within 45 days of your surgery by visiting cpp.natrelle.com.

Application complete!

Thank you for choosing Allergan and for your purchase of a ConfidencePlus ® Premier warranty. You will receive an email confirmation. 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 SAFETY INFORMATION AND APPROVED USES
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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 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.
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.
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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 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.
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.
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