Natrelle^® Breast Implants Important Information

Who may get breast implants (INDICATIONS)?
Natrelle^® Breast Implants are approved 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
Who should NOT get breast implants (CONTRAINDICATIONS)?

• 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.

What else should I consider (WARNINGS)?

• Breast implants are not lifetime devices, and not necessarily a one-time surgery.
• Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
• Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
• Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
• With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning or hardening. Tell your doctor of these symptoms and remove ruptured implants.
• Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.

What types of conditions require more study (PRECAUTIONS)? 
Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:

• 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.

What are some complications with breast implants (COMPLICATIONS)?

Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring or wrinkling/rippling. Talk to your doctor about other complications.

Talk to your doctor. For more information see the Patient Brochures 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 Important Information

Approved Uses 
Natrelle

^® 133 Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts and treatment of soft tissue deformities.

IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:

• Already have implanted devices that would be affected by a magnetic field.
• Have tissue unsuitable for expansion.
• Have an active infection or a residual gross tumor at the expansion site.
• Are undergoing adjuvant radiation therapy.
• Have a physiological condition (e.g., obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.
  
  
  

What else should I consider?

• Natrelle^® 133 Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
• Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
• Natrelle^® 133 Tissue Expanders are temporary devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 to 6 months.

What are possible complications?
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.

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.