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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION 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. Natrelle® Breast Implants are 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. You should not get breast implants if you currently have an active infection, untreated breast cancer or precancer, or are pregnant or nursing. Tell your doctor about any conditions you have, any medications you are taking, and any planned cancer treatments. Breast implantation is likely not a one-time surgery. Having implants removed and not replaced may lead to permanent cosmetic changes of the breasts. Breast implants may affect breastfeeding. Gel implants may rupture without symptoms, so periodic imaging after surgery is recommended. Key complications are reoperation, implant removal, implant rupture, implant deflation with saline-filled implants, and severe capsular contracture. Talk to your doctor for more information. The use of Natrelle® Breast Implants is restricted to licensed physicians who provide information to patients about the risks and benefits of breast implant surgery.