FDA-APPROVED Natrelle INSPIRA ROUND GEL BREAST IMPLANTS
Nikki Natrelle INSPIRA™ Style SRF-415
Individual results may vary.

Full just got fuller.

The latest breast implant from Allergan.

Natrelle INSPIRA(TM) Round Gel
  • Designed for increased fullness
    and a soft feel
  • 5 projection styles
  • 200 options to help you give patients a customized result
see the results
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Natrelle INSPIRA(TM) Round Gel logo

Please see Indications and
Important Safety Information below on page.
Kortnie Natrelle® 410 Style FM
Individual results may vary.

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the leading SHAPED gel breast implant* now has more options.1

Introducing the NEW X & L styles from Natrelle® 410.

*Based on US market share data through March 2014.
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Please see Indications and Important Safety Information below on page.

Kortnie Natrelle® 410 Style FM
Individual results may vary.

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breast augmentation

#1-selected shaped
implant in the US.1,*

*Based on US market share data through March 2014.
Please see Indications and Important Safety Information below on page.

Jessica Natrelle® 133 Style MV, 400 cc Natrelle® 410 Style FF 425
Individual results may vary.

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A tissue expander and implant system engineered for a precise pocket and a tight fit.

breast reconstruction

#1-selected shaped tissue expander
& shaped gel implant in the US.1,*

*Based on US market share data through March 2014.
Please see Indications and Important Safety Information below on page.

Phaedra Natrelle® 410 Style MF
Individual results may vary.

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Resources

Product catalog, before & after photos, and so much more.

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Please see Indications and Important Safety Information below on page.

Natrelle® Breast Implants Indications and Important Safety Information

INDICATIONS

Natrelle® Breast Implants are indicated 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

CONTRAINDICATIONS

Breast implant surgery should not be performed in:
  • Women with active infection anywhere in their body.
  • Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
  • Women who are currently pregnant or nursing.

WARNINGS

AVOID DAMAGE DURING SURGERY
  • Care should be taken to avoid the use of excessive force and to minimize handling of the implant during surgical insertion.
  • Care should be taken when using surgical instruments in proximity with the breast implant, including scalpel, sutures, and dissection instrumentation.
  • Do not treat capsular contracture by closed capsulotomy or forceful external compression, which will likely result in implant damage, rupture, folds, and/or hematoma.
  • Use care in subsequent procedures such as open capsulotomy, breast pocket revision, hematoma/seroma aspiration, and biopsy/lumpectomy to avoid damage to the implant.
  • Do not place drugs or substances inside saline-filled implants other than sterile saline for injection. Do not inject through the implant shell.
  • Do not contact the implant with disposable, capacitor-type cautery devices.
  • Do not alter the implants or attempt to repair or insert a damaged prosthesis.
  • Do not immerse the implant in povidone-iodine solution. If povidone-iodine is used in the pocket, ensure that it is rinsed thoroughly so no residual solution remains in the pocket.
  • Do not reuse or resterilize any product that has been previously implanted. Breast implants are intended for single use only.
  • Do not place more than one implant per breast pocket.
  • Do not use the periumbilical approach to place the implant.
  • Do not use microwave diathermy in patients with breast implants. Microwave diathermy has been reported to cause tissue necrosis, skin erosion, and implant extrusion.

PRECAUTIONS

Safety and effectiveness have not been established in patients with the following:
  • Autoimmune diseases (e.g., lupus and scleroderma).
  • A compromised immune system (for example, currently receiving immunosuppressive therapy).
  • 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 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

Key adverse events are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture Baker Grade III/IV.

Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling.

For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

Natrelle® Breast Implants are available by prescription only.


Natrelle® 133 Tissue Expanders with/without Suture Tabs and with Magna-Site® Injection Sites Important Information

Indications

Natrelle® 133 Tissue Expanders are indicated for:
  • Breast reconstruction following mastectomy.
  • Treatment of underdeveloped breasts.
  • Treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Natrelle® 133 Tissue Expanders SHOULD NOT be used in patients:
  • Who already have implanted devices that would be affected by a magnetic field (e.g., pacemakers, drug infusion devices, 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.
  • Undergoing adjuvant radiation therapy.
  • Whose physiological condition (e.g., 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® 133 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® 133 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.
  • Active infection anywhere may increase risk of periprosthetic infection. Postoperative infections should be treated aggressively. Unresponsive or necrotizing infection may require premature removal.
  • Natrelle® 133 Tissue Expanders are temporary, single use only devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires four to six months.
  • When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs.

PRECAUTIONS

Active infections may need to be treated and resolved before surgery. Allergan relies on the surgeon to know and 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 back-up 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

Deflation, tissue damage, infection, extrusion, hematoma/seroma, capsular contracture, premature explantation, displacement, effects on bone, pain, sensation, distortion, inadequate tissue flap, and inflammatory reaction.

To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please visit www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.

Natrelle® 133 Tissue Expanders are available by prescription only.


Intraoperative Breast Implant Sizers Important Information

INDICATIONS

The Natrelle® Silicone Sizer and the Allergan Saline Sizer are indicated for single use only for temporary intra-operative insertion in the surgical pocket to evaluate and assist in determining the final breast implant size/volume. The Natrelle® Re-sterilizable (410 and Round) Silicone Breast Implant Sizer is used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of a breast implant to use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

All sizers are contraindicated for use as long-term breast implants or tissue expanders. The Natrelle® Silicone Sizer and the Allergan Saline Sizer are contraindicated for multiple patient use or multiple sterilizations.

WARNINGS

Sizers are designed for temporary intra-operative use only and are NOT long-term implants. DO NOT alter, insert or attempt to repair a damaged sizer. DO NOT reuse the Natrelle® Silicone Sizer or the Allergan Saline Sizer, which are for single use only. The Silicone Sizers may rupture and release silicone gel. Infection, necrosis, hematoma/seroma and pain may occur following any type of surgery. Minute quantities of silicone gel may diffuse through the elastomer envelope.

PRECAUTIONS

The surgeon must carefully evaluate patient suitability and be knowledgeable about the use of this device. DO NOT expose the sizer to contaminants. Avoid damaging the sizer with surgical instruments (e.g. sharp, blunt or cautery devices). DO NOT attempt to repair damaged products. DO NOT damage the sizer by overhandling, manipulation, or excessive force. Maintain a sterile back-up sizer during surgery.

ADVERSE EVENTS

Adverse events and/or complications may include sepsis, hemorrhage, thrombosis, bleeding, and/or infection.

To report a problem, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please visit www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.

Intraoperative Breast Implant Sizers are available by prescription only.