Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not lifetime devices. The longer patients have them, the greater the chance they will develop complications, which may require more surgery. Breast implants have been associated with a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). Some patients have died from BIA-ALCL. Patients have also reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Some patients report complete resolution of symptoms when the implants are removed without replacement.
INDICATIONS
Natrelle® Breast Implants are indicated for breast augmentation in women at least 22 years old for silicone-filled implants, women at least 18 years old for saline-filled implants, and for breast 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. This indication also includes revision surgery for primary breast augmentation and breast reconstruction.
IMPORTANT SAFETY INFORMATION
Breast implant surgery should NOT be performed in women with an active infection, untreated breast cancer or precancer, or who are pregnant or nursing.
Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure.
Safety and effectiveness have not been established in patients with autoimmune diseases, a compromised immune system, planned chemotherapy or radiation following breast implant placement, conditions or medications that interfere with wound healing and blood clotting, reduced blood supply to breast tissue, or clinical diagnosis of depression or other mental health disorders.
Possible adverse events include implant rupture with silicone-filled implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.
For more information, please see the full Directions for Use at www.allergan.com/products. To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.
The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.
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