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The Natrelle® Two-Stage Reconstruction System Just Got Better

The Natrelle® Two-Stage Reconstruction System is designed to help you achieve positive outcomes. It starts with the Natrelle® 133 series, tissue expander now available with optional suture tabs, featuring our exclusive BIOCELL® texturing. This patented tissue expander facilitates enduring stability and softer results.1,2 It's followed by Natrelle® gel implants now with the most projection available to suit your patients' needs. Natrelle® tissue expanders and gel implants complement each other to help you achieve optimal reconstruction results.

Even more options

Natrelle® tissue expanders and gel implants offer the widest range of base width, height and projection options. As a result, you can find the right fit to meet your patient's needs.

Optimal orientation for easy access to suture tabs

Optimal orientation for easy access to suture tabs

133 Series Tissue Expanders are available in 84
sizes and configuration options.

133 Series Tissue Expanders are available in 84 sizes and configuration options.

Stage One:

Natrelle® 133V Series Tissue Expanders
Now with Optional Suture Tabs
Natrelle® has the most tissue expander choices available: 84 sizes, including 18 extra projection options.
 


The BIOCELL® texturing experience.

BIOCELL® expander with visible tissue adhesion, Siltex® expander with minimal tissue adhesion.

See BIOCELL® Texturing Intraoperatively:
Click below to learn more about BIOCELL®.

See Siltex® Intraoperatively: Click below to see the performance of Siltex®.

BIOCELL® Technology

What effect does BIOCELL® texturing have in
the prevention of synovial metaplasia?

  • Synovial metaplasia can be a result of micro movements of the device within a capsule.3
  • Micro movements can be eliminated by ensuring adherence between the device and the capsule through effective texturing.3
  • Clear evidence of the effectiveness of texturing in eliminating micro movements is when a capsule forms a mirror image of the textured surface it contacts.3
  • BIOCELL® texturing is the only documented texturing that is able to show a mirror-image capsular response.3

ENHANCED EASE OF USE

Easy and precise MAGNA-FINDER® Xact port finder MAGNA-FINDER® Xact port finder

30% greater magnet strength than Mentor's
Centerscope™, for faster location and greater accuracy*
  • No need for raised palpation ring
  • Smooth 360o rotation provides greater precision with a full range of motion
  • New Four Point Marking System for simple, fast and precise needle placement

    *Data on file, Allergan
Natrelle® MAGNA-SITE®

The BIOCELL® Difference

  • Tissue adherence within the capsule for greater immobility1,2
  • Soft results within a compliant, thin, vascular capsule2
  • Easy expansion with minimal patient pain1
OVER A DECADE OF DOCUMENTED POSITIVE OUTCOMES
The Natrelle® Two-Stage Reconstruction System has shown documented positive outcomes in peer-reviewed literature.

SEE THE ARTCILES

“ A textured implant with adhesive effect seems to be the best choice for Breast Reconstruction.”

— Dr. Alain M. Danino M.D.

“Our survey confirms the critical importance of the porous surface to induce tissue formation.”

— Dr. Alain M. Danino M.D.
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Natrelle® offers 143 implants giving you the most choices, with different base width, height and projection options — 46 of which feature BIOCELL® texturing. Beyond facilitating a precise fit, the Natrelle® implant collection offers a smooth transition from expander to implant.

Natrelle® Gel Implants now with more projection

Natrelle® Style 45 Extra-High Profile Implant

Patented taper-cut patch design

Stage Two:

Natrelle® Gel Implants with More
Projection

Natrelle® gel implants offer you the greatest number of options with the most projection available on the market today.


OVER A DECADE OF DOCUMENTED POSITIVE OUTCOMES
The Natrelle® Two-Stage Reconstruction System has shown documented positive outcomes in peer-reviewed literature.

SEE THE ARTCILES
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Unique patented
planning tools

The Natrelle® Two-Stage Reconstruction System—
including our additional planning tools — can help you
achieve optimal outcomes. Contact your breast aesthetics
sales representative for information about our tools, or call
1-800-766-0171
We offer you industry-leading planning tools in a variety of formats, including: Web-based interfaces, iPad applications, tear-off planning pads, and slide rules. Natrelle® Interactive Surgery Planner (ISP) Natrelle® Interactive Surgery Planner (ISP)

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Peer reviewed published articles.

See what surgeons who have used the 133V Series Tissue Expander — and Natrelle® gel implants — have written in peer-reviewed articles.

Click the article titles below to read the abstract of each article.

The Tissue Expander with Over a Decade of Documented Positive Outcomes.

Author/Journal

 

Title

Spear, S.L. Parikh, P.M., Reisin, E. and Menon, N.G. Aesthetic Plastic Surgery. 32: 418-425. 2008   Acellular Dermis-Assisted Breast Reconstruction.
Percec, Ivona M.D., PhD; Bucky, Louis P. M.D. Annals of Plastic Surgery. 60(5), 527-531, May 2008   Successful Prosthetic Breast Reconstruction after Radiation Therapy.
Borschel, Gregory H. M.D.; Costantino, David, M.D.; Cederno, Paul, M.D. Annals of Plastic Surgery, 59(5), 507-514 November 2007   Individualized Implant-Based Reconstruction of Poland Syndrome Breast and Soft Tissue Deformities.
Ascherman, Jeffrey, M.D.Hanasono, Matthew, M.D.; Hughes, Duncan, M.D. Plast Reconstr Surg. 117(2) 359-365, February 2006   Implant Reconstruction in Breast Cancer Patients Treated with Radiation Therapy.
Cordeiro, P.G. and C.M. McCarthy Plast Reconstr Surg. 118(4): 825-31. 2006   A single surgeon’s 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications.
Cordeiro, P.G. and C.M. McCarthy Plast Reconstr Surg. 118(4): 832-9. 2006   A single surgeon’s 12-year experience with tissue expander/implant breast reconstruction: part II. An analysis of long-term complications, aesthetic outcomes, and patient satisfaction.
Schulman, Matthew R. M.D.; Chun, Jin K. M.D. Annals of Plastic Surgery. 55 (6): 672, December 2005   The Conjoined Sternalis-Pectoralis Muscle Flap in Immediate Tissue Expander Reconstruction after Mastectomy.
Spear, S.L., Pelletiere, C.V. Plast Reconstr Surg. 113(7): 2098-2113, 2004.   Immediate breast reconstruction in two stages using textured, integrated-valve tissue expanders and breast implants.
Pusic, Andrea L. M.D., M.H.S.; Cordeiro, Peter G. M.D. Plast Reconstr Surg. 111 (6), 1871-1875. May 2003   An Accelerated Approach to Tissue Expansion for Breast Reconstruction. Experience with Intraoperative and Rapid Post Operative Expansion in 370 Reconstructions.
Nahabedian, Maurice Y. M.D.; et al Plast Reconstr Surg 2003. 112 (2) 467-476, October, 2003.   Infectious Complications following Breast Reconstruction with Expanders and Implants.
Darouiche, Rabith O. M.D.; et al. Annals of Plastic Surgery 2002. 49 (6):567-571, December 2002   Activity of Antimicrobial-Impregnated Silicone Tissue Expanders.
Spear, S.L.; Spittler, Christopher J. M.D. Plast Reconstr Surg 2001. 107 (1): 177-187, January 2001   Breast Reconstruction with Implants and Expanders.
Danino A.M, M.D., Basmacioglu, Phillip, M.D.; Saito, Seiko, M.D.; et al. 2001; 108(7):2047-2052   Comparison of the capsular response to the BIOCELL RTV and Mentor 1600 Siltex Breast Implant Surface Texturing: A Scanning Electron Microscopic Study.
Disa, J.J., Ad-El, D.D., Cohen, S.M., Cordeiro, P.G., Hildago, D.A. Plast Reconstr Surg 104: 1662, 1999.   The premature removal of tissue expanders in breast reconstruction.
Spear, S.L., Majidian, A. Plast Reconstr Surg 101(1): 53-63, 1998   Immediate breast reconstruction in two stages using textured, integrated valve tissue expanders and breast implants: A retrospective review of 171 consecutive breast reconstructions from 1989-1996.
Maxwell, G.P., Falcone, P.A. Plast Reconstr Surg 89(6): 1022-1034, 1992   Eighty-four consecutive breast reconstructions using a textured silicone tissue expander.
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  • Maxwell GP, Falcome PA. Eighty-four Consecutive Breast Reconstructions Using a Textured Silicone Tissue Expander. Plast. Reconstr Surg. 1992;89(6): 1022-1034
  • Beasley, Michael Maxwell GP, Falcone PA. Discussion: Eighty-four Consecutive Breast Reconstructions Using a Textured Silicone Tissue Expander by G. Patrick Maxwell, et al. Plast. Reconstr Surg. 1992;89(6): 1035-1036.
  • Danino AM, Basmacioglu P, Saito S, et al. Comparison of the Capsular Response to the Biocell RTV and Mentor 1600 Siltex Breast Implant Surface Texturing: A Scanning Electron Microscopic Study. Plast Reconstr Surg. 2001;108(7):2047-2052.
  • Hodgson ELB, Malata CM. Implant-based breast reconstruction following mastectomy. In: Hultman CS, ed. Breast Reconstruction. Fairfax, VA: IOS Press; 2003:47-64.
       

Contact your Allergan breast aesthetics sales representative to feel the BIOCELL® difference, or call 1-800-766-0171 to order tissue expanders and gel implants for your next case.

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Natrelle® Breast Implants Important 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.
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.

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indication
BOTOX® Cosmetic for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ≤ 65 years of age. 

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX
® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX
® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive, serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) have been reported. 

Injections In or Near Vulnerable Anatomic Structures
Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had preexisting dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

Human Albumin
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s); and when used in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart.

ADVERSE REACTIONS
The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.

DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like nondepolarizing blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.

USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women.

Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.

 

LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Indication
LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.

Important Safety Information

Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.

Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes.

There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes.

LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.

Adverse Reactions: The most frequently reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.

Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE® in clinical practice: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.

Use in Specific Populations: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

For more information on LATISSE®, please see the full Prescribing Information.

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JUVÉDERM ® mark owned by Allergan Industrie, SAS
Mentor®, Centerscope® and Siltex® are registered trademarks of Mentor Worldwide LLC.
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