Natrelle -Breast Implants
Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL. Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
- Autoimmune diseases (eg, lupus and scleroderma)
- A weakened immune system (eg, taking medications to decrease the body’s immune response)
- Planned chemotherapy or radiation therapy following breast implant placement
- Conditions or medications 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
- Those 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
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 includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation
- Breast reconstruction. This includes primary 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 also includes revision surgery to correct or improve the result of a primary breast reconstruction
Breast implant surgery should NOT be performed in:
- Women with active infection anywhere in their body
- Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
- Women who are currently pregnant or nursing