Soft Touch Breast Implants at DermSA

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.
• 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.

† Methodology Breast implant gel was measured for material properties using the BTC-2000 ™. The BTC-2000 ™ applies a controlled vacuum, or negative pressure, to the gel while measuring the dynamic response of material deformation using a synchronized target laser. The gel for each device (n = 8 per group) was tested at 3 sites, all at or near the apex of the implant (anterior side). From those measurements, the gel cohesivity was calculated and the relative change was determined. 6,† Methodology 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 90º 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. 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 precancer of their breast who have not received adequate treatment for those conditions.
• Women who are currently pregnant or nursing.

WARNINGS

• Breast implants are not lifetime devices or necessarily a one-time surgery.
• Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Use care when using surgical instruments in proximity with the breast implant. For more information, please see the full Directions for Use.

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 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. 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 INSPIRA® Natrelle INSPIRA® Soft Touch Natrelle INSPIRA® Cohesive Natrelle® 410 *Based on implant performance testing. Clinical significance has not been established. 5 Natrelle ® 133Plus and 133 Tissue Expanders With/Without Suture Tabs and With MAGNA-SITE® Injection Sites Important Information INDICATIONS Natrelle ® 133Plus and 133 Tissue Expanders are indicated for:

• Breast reconstruction following mastectomy.
• Treatment of underdeveloped breasts.
• Treatment of soft tissue deformities.

CONTRAINDICATIONS

• Who have an active infection or a residual gross tumor at the expansion site.
• 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 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.

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 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. WARNINGS

• DO NOT use Natrelle ® 133Plus and 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 ® 133Plus and 133 Tissue Expanders in place. Please see additional Natrelle ® 133Plus and 133 Tissue Expanders Important Safety Information on following pages.
• Natrelle ® 133Plus and 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 4 months to 6 months.
• When using suturing tabs be careful to avoid piercing the shell. Use a new one if damage occurs. Please see additional Natrelle ® 133Plus and 133 Tissue Expanders Important Safety Information on back.

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. For more information, please visit www.allergan.com/labeling/usa.htm. To report a problem with Natrelle ®, please call Allergan at 1-800-433-8871. Natrelle ® 133Plus and 133 Tissue Expanders are available by prescription only. References: 1. Data on file, Allergan, January 2017; Allergan Plastic Surgery Order Form. 2. More of Everything: Natrelle ® Product Catalog. Irvine, CA: Allergan; 2015. 3. Our products: breast implants. Mentor Worldwide LLC website. http://www.mentorwwllc.com /global-us/Breast.aspx. Updated April 2016. Accessed February 13, 2017. 4. Sientra ® HSC & HSC+ Breast Implant Product Catalog. Santa Barbara, CA: Sientra, Inc., 2015. http://sientra.com/Content/pdfs/MDC-0177%20R2%20HSCHSC%2B%20Breast%20Implants%20Product%20Catalog.pdf. Accessed February 13, 2017. 5. Data on file, Allergan, February 8, 2017; Study Report MD16075-DV2. 6. Data on file, Allergan, February 3, 2017; Study Report MD16075-DV1. 7. Natrelle ® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2016. 8. Natrelle ® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Directions for Use, 2014. 9. Data on file, Allergan, March 2016; Plastic Surgery A&Us: PLS and Patients. 10. Data on file, Allergan, December 2016; Plastic Surgery Monthly Tracker: Breast Implants & Tissue Expanders. 11. Data on file, Allergan, November 2016; Breast Implant + Tissue Expander Share Tracker. 12. Kline & Company, Inc. Professional Skin Care: US Market Analysis and Opportunities. Parsippany, NJ: Kline & Company, Inc.; January 19, 2017. 13. Data on file, Allergan, 2016; EAME Brand Share. 14. Data on file, Allergan, February 2016; US Neurotoxin Market Share Report.