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:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Breast implant surgery should not be performed in:

WARNINGS

AVOID DAMAGE DURING SURGERY

PRECAUTIONS

Safety and effectiveness have not been established in patients with the following:

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:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Natrelle® 133 Tissue Expanders SHOULD NOT be used in patients:

WARNINGS

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.