Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES

Breast implants are not considered lifetime devices. The longer a person has them, the higher the likelihood of developing complications, some of which will call for additional surgery.

Breast implants have been linked to the development of a cancer of the immune system known as breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer is seen more often in patients with textured breast implants than with smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.

Patients who received breast implants have reported a range of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. The individual patient risk of developing these symptoms has not been well established. Some patients report that their symptoms fully resolved after the implants were removed without replacement.

Who can get breast implants?

Natrelle® Breast Implants are approved for the following:

• Breast augmentation for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants. Breast augmentation covers primary breast augmentation to increase breast size and revision surgery to correct or improve the outcome of a primary breast augmentation
• Breast reconstruction. This covers primary breast reconstruction to replace breast tissue removed because of cancer or trauma, or tissue that did not develop properly because of a severe breast abnormality. It also covers revision surgery to correct or improve the outcome of a primary breast reconstruction

Who should NOT get breast implants?

Breast implant surgery should NOT be performed in:

• Women with an active infection anywhere in their body
• Women with existing cancer or precancer of the breast who have not received adequate treatment for those conditions
• Women who are currently pregnant or nursing

What should I tell my doctor?

Let your doctor know if you have any of the following conditions, since the risks of breast implant surgery may be greater:

• Autoimmune diseases (eg, lupus and scleroderma)
• A weakened immune system (eg, taking medications that reduce the body's immune response)
• Planned chemotherapy or radiation therapy after breast implant placement
• Conditions or medications that interfere with wound healing and blood clotting
• Reduced blood supply to breast tissue
• A clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders
• People diagnosed with depression or other mental health disorders should wait until these conditions are resolved or stabilized before having breast implantation surgery

What else should I consider?

• There is a Boxed Warning for breast implants. Please see the bold text at the beginning
• Many changes to your breasts after implantation cannot be reversed. If you later decide to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent
• Breast implantation is likely not a one-time surgery. The longer implants remain in place, the greater the potential risk of complications. You will likely need more surgeries on your breasts because of complications or unacceptable cosmetic results. For this reason, you should also consider the complication rates for later (revision) surgery, since you may face these risks in the future
• Cancer treatments and surgery will affect the outcome and timing of breast reconstruction
• Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production
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• Rupture of a silicone-filled breast implant is most often silent. Even without symptoms, you should have your first ultrasound or MRI at 5 to 6 years after your initial implant surgery and then every 2 to 3 years after that, whether your implants are for augmentation or reconstruction. If you have symptoms of breast implant rupture or uncertain ultrasound results, an MRI is recommended. Additional imaging may be needed depending on your medical history and status. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established
• Routine screening mammography for breast cancer will be more difficult, and implants may rupture during the procedure. Do a self-examination every month for cancer screening and ask your surgeon to help you tell the implant apart from your breast tissue. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging

What are key complications with breast implants?

Key complications include reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and capsular contracture (severe scar tissue around the implant). Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition, nipple complications, hypertrophic scarring, and implant palpability/visibility.

Talk with your doctor about other complications.

For more information, see the patient brochures at www.allergan.com/products.

To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-.

The sale and distribution of Natrelle® Breast Implants is restricted to licensed physicians who provide patients with information about the risks and benefits of breast implant surgery.