Important Natrelle^® Safety Information

Indications

• Breast Augmentation for women at least 22 years old. Breast augmentation 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. 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

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
Every effort should be made to avoid damage to the breast implants 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
• 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 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 Betadine® solution
• Do not re-use 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, as it 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 (for example, lupus and scleroderma)
• A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease)
• Planned chemotherapy following breast implant placement
• Planned radiation therapy to the breast following breast implant placement
• Conditions 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 with your surgeon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery

Adverse events
The most commonly reported adverse events for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), implant rupture, and Baker grade III/IV capsular contracture.

Other potential complications for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants include: swelling, implant malposition, pain, ptosis, infection, changes in breast sensation, nipple complications, seroma, delayed wound healing, hematoma, redness, scarring, asymmetry, wrinkling/rippling, extrusion, bruising, implant palpability/visibility, upper pole fullness, and necrosis.

The most commonly reported adverse events for Natrelle® Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), Baker grade III/IV capsular contracture, implant malposition, and asymmetry.

Other potential complications for Natrelle® Silicone-Filled Breast Implants include: unsatisfactory results, pain, changes in nipple and breast sensation, infection, hematoma/seroma, difficulties breastfeeding, calcium deposits in the tissue around the implant, extrusion, necrosis, delayed wound healing, breast tissue atrophy / chest wall deformity, and lymphadenopathy.

Important: For full safety information please visit www.natrelle.com or call Allergan Product Support at 1-800-433-8871.

Caution: Rx only