Natrelle INSPIRA® Silicone-Filled Breast Implants Important Information
Indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-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
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
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.
Breast implants are not lifetime devices or necessarily a one-time surgery.
Avoid damage during surgery: Care should be taken to avoid the use of excessive
force and to minimize handling of the implant. Use care when using surgical instruments
in proximity with the breast implant. For more information, please see the full Directions
Safety and effectiveness have not been established in patients with the following:
Autoimmune diseases (eg, lupus and scleroderma).
A compromised immune system (eg, currently receiving immunosuppressive therapy).
Planned chemotherapy following breast implant placement.
Planned radiation therapy to the breast 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. Please discuss any history of mental health
disorders prior to surgery. Patients with a diagnosis of depression, or other mental
health disorders, should wait until resolution or stabilization of these conditions
prior to undergoing breast implantation surgery.
Key adverse events are reoperation, implant removal with or without replacement, implant rupture,
and capsular contracture Baker Grade III/IV.
Other potential adverse events that may occur with breast implant surgery include: asymmetry,
breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing,
hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant
palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin
For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm. To report a problem with
Natrelle INSPIRA® Breast Implants, please call Allergan at 1‑800‑433‑8871.
Natrelle INSPIRA® Breast Implants are available by prescription only.