Gel Technology | Natrelle® Gummy Implants

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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.

download brochure

When You Choose Natrelle® Silicone-Filled Implants

When You Choose Natrelle® Saline-Filled Implants

What warranty am I automatically enrolled in for free?

ConfidencePlus® gel warranty

ConfidencePlus® saline warranty

What events are covered?

Rupture
Capsular contracture Baker Grade III/IV
Late seroma
Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL)

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
Out-of-pocket financial assistance: Up to $3500 for 10 years

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?

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

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?

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).

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.

COVERAGE DETAILS
Saline patients:

UPGRADE TO ConfidencePlus® Premier

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.

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:

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

IMPORTANT SAFETY INFORMATION
Who 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.

What should I know before getting breast implants?

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 breastfeed, 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 risks 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.

What is BIA-ALCL?
Breast Implant–Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a type of non-Hodgkin’s lymphoma (cancer of the immune system). While uncommon, BIA-ALCL has been associated with silicone and saline breast implants. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. In most cases it is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treatment with chemotherapy and radiation therapy. BIA-ALCL is most commonly associated with textured implants. If you are experiencing symptoms of persistent swelling, the presence of a mass, or pain in the area of an implant months or years after your implant surgery, please contact your healthcare provider.

Talk to your doctor. For more information see the patient brochures at www.allergan.com/products. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.

Natrelle® Breast Implants are available by prescription only.

Natrelle® 133S Smooth Tissue Expanders Important Information

Approved Uses
Natrelle® 133S Smooth 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:

Already have implanted devices that would be affected by a magnetic field.
Have tissue unsuitable for expansion.
Have an active infection or a residual gross tumor at the expansion site.
Are undergoing adjuvant radiation therapy.
Have a physiological condition (eg, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.

What else should I consider?

Natrelle® 133S Smooth Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
Natrelle® 133S Smooth Tissue Expanders are temporary devices and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months.

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/products. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.

Natrelle® 133S Smooth Tissue Expanders are available by prescription only.

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.

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:

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

IMPORTANT SAFETY INFORMATION
Who 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.

What should I know before getting breast implants?

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 breastfeed, 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 risks 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.

Talk to your doctor. For more information see the patient brochures at www.allergan.com/products. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.

Natrelle® Breast Implants are available by prescription only.

Natrelle® 133S Smooth Tissue Expanders Important Information

Approved Uses
Natrelle® 133S Smooth 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:

Already have implanted devices that would be affected by a magnetic field.
Have tissue unsuitable for expansion.
Have an active infection or a residual gross tumor at the expansion site.
Are undergoing adjuvant radiation therapy.
Have a physiological condition (eg, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.

What else should I consider?

Natrelle® 133S Smooth Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
Natrelle® 133S Smooth Tissue Expanders are temporary devices and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 months to 6 months.

For more information, please visit www.allergan.com/products. To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.

Natrelle® 133S Smooth Tissue Expanders are available by prescription only.

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.

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.