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Full information on Patient Labeling and Patient Decision Checklist requirements See More
Realize Your Vision With the Natrelle® Difference
Your Patients’ Safety Is Our Top Priority4-7
Natrelle® is dedicated to patient safety and transparency through:
- Continuous device tracking11
- Informed consent via patient decision checklists for silicone and saline implants12,13
- An implant gel certification course for surgeons14
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For each of the Natrelle INSPIRA® Smooth Gel Breast Implants, reported "adverse event" (AE) rates of interest were preidentified through surgeon surveys as15-18,*, †, ‡, §:
Implant rupture
Capsular contracture
Device malposition
From the introduction on the US market to March 2024:
Individual adverse events were about 1%18
- *Based on post-market surveillance data of 1,034,027 devices reported by HCPs from January 2015 to March 2024.15
- †Based on post-market surveillance data of 507,866 devices reported by HCPs from January 2017 to March 2024.16
- ‡Based on post-market surveillance data of 305,239 devices reported by HCPs from January 2016 to March 2024.17
- §Based on post-market surveillance data of 1,847,132 devices reported by HCPs from January 2015 to March 2024.18
Did you know?
More than 1.8 million Natrelle® Smooth Gel Breast implants have been implanted in patients in the US since 2015.18
Adverse event rates are based on Post Market Surveillance (PMS) data. PMS data is physician-reported data and is often underreported.
PMS data is used to identify trends in adverse event occurrences and should not be interpreted as complication incidence rates or replace the clinical study data.
Actual Natrelle® INSPIRA patients.
Individual results may vary.
Designed to Retain Upper Pole Fullness19,a,*
Natrelle INSPIRA® Smooth Round Breast Implants are designed to achieve and maintain a range of upper pole fullness.19,a,*
Low
110 cc–610 cc
Low plus
125 cc–640 cc
Moderate
140 cc–755 cc
Full
180 cc–770 cc
Extra full
200 cc–800 cc
NATRELLE INSPIRA®
RESPONSIVE
NATRELLE INSPIRA®
SOFTTOUCH
NATRELLE INSPIRA®
COHESIVE
Images for representation only.
In vivo significance has not been established.
- *Based on implant performance testing; clinical significance has not been established.
- †Based on surgeon survey data, August 2024 (N = 478).
- aMethodology Breast implant devices (n = 6 per group) were placed in a horizontal orientation on a sliding stage; the width and maximum projections of the implants were measured using fixed calipers. The devices were then placed in a vertical-supported orientation using a 90° angle, and the width and maximum projections were measured again. From those measurements, the retention of dimension was calculated, and the relative change was determined.
Advanced Implant Technology6
A shell designed to protect6
The Natrelle INSPIRA® Collection is designed with patented INTRASHIELTM SHELL TECHNOLOGY providing a barrier layer, which minimizes gel diffusion through the shell (< 1% gel diffusion rate).6,*
A gel designed to stay in place21
- *Low molecular weight silicones and platinum.
- †In vivo significance has not been established.
A patch created with a special tapered cut22
The Natrelle® patch, with the same INTRASHIEL™ barrier shell technology6,22
The Natrelle® patch, with the same INTRASHIEL™ barrier shell technology, is designed with a unique tapered cut to create a smooth transition from the patch to the shell6,22
Navigate Natrelle® in 3 Easy Steps
with a simple breast implant selection system
to help you meet your patients' unique needs1
Natrelle INSPIRA® uses consistent systematic diameter sizing increments (0.25 cm or 0.50 cm), providing an organized and predictable portfolio to allow for an optimal implant selection that best matches your patient's breast.1
Ask your Rep to learn more about biodimensional planning.
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Smooth, Compact, Secure Placement24-26,*,†
Tailor your tissue expander to the specific needs of each patient.
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Smooth surface
provides less surface area and less tissue adherence24,*
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Secure Placement
with a 360° tab orientation for greater placement support26
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Compact Design
featuring a narrow port and thin shell may allow for a smaller incision25,†
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MAGNA-SITE® Injection Site
MAGNA-FINDER®
Xact port finder with dermal depression–marking feature is stronger than any other manufacturer’s port finder29,a,‡
MAGNA-FINDER® Xact port finder with dermal depression–marking feature is stronger than any other manufacturer’s port finder27,a,‡
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Orientation line and white tab
assist in precise placement within the pocket
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Narrow Port
with a diameter measuring 1.42 inches (3.6 cm) using calipers28
Features the FOURTÉ® Expander Fill System27,b
Nearly 4X faster fill than a standard 21-gauge needle27,b,*
- *Clinical significance has not been established.
- †Based on tissue expanders comparable in size: Natrelle® Style 133MX, 500 cc; and MENTOR™ ARTOURA™ High Profile, 500 cc.
- ‡When used with Natrelle® 133S Tissue Expanders.
- aMethodology Tissue expanders were matched to round breast implants. A precise match was defined as a breast implant that falls within a range of 0.5 cm smaller to 1.0 cm larger in base width and 1.5 cm smaller to 2.0 cm larger in projection of a tissue expander. The percentage of precise matches was calculated for each style of tissue expander.
- bMethodology The FOURTÉ® Expander Fill System and 21-gauge needle are attached to 60-cc syringes filled with water. The injector starts the injection at maximum effort while the time is tracked. When the plunger reaches the end of the syringe barrel, the time is stopped and recorded. This is repeated 20 times, recorded, and compared.
A Breast Implant Warranty Program With
LIFETIME COVERAGE FOR YOUR PATIENTS
for certain covered events30,*
*See full warranty program terms and conditions by clicking the link below.
-
-
ConfidencePlus® gel warranty
Give your patients peace of mind with FREE coverage and automatic enrollment in the most current warranty plan30
Choose ANY size and style of Natrelle® Gel Breast Implants for replacement in the case of any covered event.30
Rupture30
- Implant replacement: Lifetime for both affected and contralateral implants
- Out-of-pocket financial assistance: Up to $3500 for 10 years
Capsular contracture Baker Grade III/IV30,†
- Implant replacement: 10 years for both affected and contralateral implants
- Out-of-pocket financial assistance: Up to $2000 for 2 years (augmentation patients only)
Late seroma30
- Implant replacement: 20 years for both affected and contralateral textured implants
Late seroma diagnostic testing coverage30
If the patient has textured gel or textured saline breast implants, Allergan Aesthetics will cover up to $1000 of out-of-pocket fees toward diagnostic testing for late seroma to rule out breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).
BIA-ALCL treatment coverage30
In the event of a BIA-ALCL diagnosis, the patient is eligible for up to $7500 out-of-pocket financial assistance toward the removal of the breast implant(s) and the associated scar tissue (complete capsulectomy).
Allergan Aesthetics will also provide replacement implant(s) at no charge. For coverage eligibility, surgeons are directed to contact Allergan Aesthetics and provide appropriate documentation.See the Natrelle® ConfidencePlus® Warranty Brochure for full details.
† Covers one incident per patient; recurring capsular contracture is not covered.
Actual Natrelle INSPIRA® patients.
Individual results may vary.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
- Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- Breast reconstruction. This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
- 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
ADDITIONAL WARNINGS
- See Boxed Warning
- Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
- Autoimmune diseases (eg, lupus and scleroderma)
- A compromised immune system (eg, currently receiving immunosuppressive therapy)
- Planned chemotherapy or radiation 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 prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use 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 this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
Natrelle® 133S Smooth Tissue Expanders With MAGNA-SITE® Injection Sites IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle® 133S Smooth Tissue Expanders are indicated for:
- Breast reconstruction following mastectomy
- Treatment of underdeveloped breasts
- Treatment of soft tissue deformities
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Natrelle® 133S Smooth Tissue Expanders should not be used in patients:
- Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices, and artificial sensing devices)
- Whose tissue at the expansion site is determined to be unsuitable
- Who have an active infection or a residual gross tumor at the expansion site
- Who are undergoing adjuvant radiation therapy
- Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications
- Who are psychologically unsuitable
WARNINGS
- Do not use Natrelle® 133S Smooth Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications) because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133S Smooth Tissue Expanders in place
- Do not alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. Do not expose to contaminants
- Do not expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed
- Do not reuse explanted products
- Active infection anywhere may increase risk of periprosthetic infection. Do not expose the tissue expander or injection needles to contaminants. Postoperative infections should be treated aggressively
- Adverse reactions may require premature explantation
- When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs
- 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 to 6 months
PRECAUTIONS
Active infections may need to be treated and resolved before surgery. Follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.
ADVERSE REACTIONS
Possible adverse reactions include deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Natrelle® 133S Smooth Tissue Expanders, please call Allergan® at 1-800-624-4261.
Natrelle® 133S Smooth Tissue Expanders are restricted to sale by or on the order of a licensed physician.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
- Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- Breast reconstruction. This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
- 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
ADDITIONAL WARNINGS
- See Boxed Warning
- Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:
- Autoimmune diseases (eg, lupus and scleroderma)
- A compromised immune system (eg, currently receiving immunosuppressive therapy)
- Planned chemotherapy or radiation 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 prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use 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 this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
Natrelle® 133S Smooth Tissue Expanders With MAGNA-SITE® Injection Sites IMPORTANT SAFETY INFORMATION
INDICATIONS
Natrelle® 133S Smooth Tissue Expanders are indicated for:
- Breast reconstruction following mastectomy
- Treatment of underdeveloped breasts
- Treatment of soft tissue deformities
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Natrelle® 133S Smooth Tissue Expanders should not be used in patients:
- Who already have implanted devices that would be affected by a magnetic field (eg, pacemakers, drug infusion devices, and artificial sensing devices)
- Whose tissue at the expansion site is determined to be unsuitable
- Who have an active infection or a residual gross tumor at the expansion site
- Who are undergoing adjuvant radiation therapy
- Whose physiological condition (eg, sensitive over- or underlying anatomy, obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use of certain drugs (including those that interfere with blood clotting or affect tissue viability) poses an unduly high risk of surgical and/or postoperative complications
- Who are psychologically unsuitable
WARNINGS
- Do not use Natrelle® 133S Smooth Tissue Expanders in patients who already have implanted devices that would be affected by a magnetic field (see Contraindications) because the MAGNA-SITE® integrated injection site contains a strong rare-earth, permanent magnet. Diagnostic testing with Magnetic Resonance Imaging (MRI) is contraindicated in patients with Natrelle® 133S Smooth Tissue Expanders in place
- Do not alter the tissue expander or use adulterated fill. Fill only with sterile saline for injection as described in INSTRUCTIONS FOR USE. Do not expose to contaminants
- Do not expand if the pressure will compromise wound healing or vasculature of overlying tissue, or beyond patient or tissue tolerance. Stop filling immediately if tissue damage, wound dehiscence, abnormal skin pallor, erythema, edema, pain, or tenderness are observed
- Do not reuse explanted products
- Active infection anywhere may increase risk of periprosthetic infection. Do not expose the tissue expander or injection needles to contaminants. Postoperative infections should be treated aggressively
- Adverse reactions may require premature explantation
- When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs
- 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 to 6 months
PRECAUTIONS
Active infections may need to be treated and resolved before surgery. Follow proper surgical procedures and carefully evaluate patient suitability using standard practice and individual experience. Avoid damage to the tissue expander and use a sterile backup in case of damage. Pay careful attention to tissue tolerance and hemostasis during surgery. Expansion should proceed moderately and never beyond patient or tissue tolerance. Avoid contamination in any postoperative procedure.
ADVERSE REACTIONS
Possible adverse reactions include deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.
For more information, please see the full Directions for Use at www.allergan.com/products.
To report a problem with Natrelle® 133S Smooth Tissue Expanders, please call Allergan® at 1-800-624-4261.
Natrelle® 133S Smooth Tissue Expanders are restricted to sale by or on the order of a licensed physician.
References:
- Data on File, Allergan Aesthetics, Hospital Order Form Update, January 2022.
- Mentor Product Catalog: Tissue Expanders, Breast Implants and Sizers, January 2022.
- Sientra Breast Products Portfolio Guide, 2022.
- Data on File, Allergan Aesthetics, PLS Aug AU Report 2022.
- Data on File, Allergan Aesthetics, PLS Recon AU Report 2022.
- Natrelle® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth Surface Implants Directions for Use, 2022.
- FDA Company Announcement. Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders. July 25, 2019. Accessed August 7, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders.
- United States Securities and Exchange Commission Form 10-K. Inamed Corporation: Annual Report for the Fiscal Year Ended December 31, 2001. Accessed October 30, 2024. https://www.sec.gov/Archives/edgar/data/109831/000091205702012689/a2073866z10-k.html.
- Peters W. The evolution of breast implants. Can J Plast Surg. 2002;10(5):223-236.
- Bondurant S, Ernster V, Herdman R, eds. Safety of Silicone Breast Implants. National Academy of Sciences; 2000. Accessed October 30, 2024. https://nap.nationalacademies.org/catalog/9602/safety-of-silicone-breast-implants.
- AbbVie Device Management Portal. Accessed July 22, 2024. https://www.devicemanagement.abbvie.com/s/?language=en_US.
- Data on file, Allergan Aesthetics, April 2022; Natrelle Saline-Filled Breast Implant Patient Decision Checklist.
- Data on File, Allergan Aesthetics, April 2022; Natrelle Silicone-Filled Breast Implants Patient Decision Checklist.
- Allergan Medical Institute, Natrelle Gel Certification Course. Accessed July 22, 2024.
- Data on file, Allergan Aesthetics, January 2015 to March 2024.
- Data on file, Allergan Aesthetics, January 2017 to March 2024.
- Data on file, Allergan Aesthetics, January 2016 to March 2024.
- Data on file, Allergan Aesthetics, March 2024.
- Data on file, Allergan Aesthetics, February 3, 2017; Study Report MD16075-DV1.
- Data on file, Allergan Aesthetics, Monthly Tracker, August 2024.
- Data on file, Allergan Aesthetics, February 2018; Study Report MD16075-DV6.
- Data on file, Allergan Aesthetics, April 2005; INAMED.
- Data on file, Allergan Aesthetics, January 6, 2017; Study Report MD16076-DV.
- O’Shaughnessy K. Evolution and update on current devices for prosthetic breast reconstruction. Gland Surg.2015;4(2):97-110.
- Data on file, Allergan Aesthetics, June 6, 2016; Study Report MD15017-DV.
- Natrelle® 133S and Natrelle® 133 Plus Tissue Expanders Directions for Use, 2018.
- Data on file, Allergan Aesthetics, January 31, 2024. FOURTÉ technology memo. Flow rate performance of the FOURTÉ Expander Fill.
- Data on file, Allergan Aesthetics, July 2010.
- Data on file, Allergan Aesthetics, September 2014; Technical Report TR-1121.
- Data on file, Allergan Aesthetics, Warranty Brochure, 2021.