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Natrelle® BREAST IMPLANTS IMPORTANT INFORMATION
Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants.
Breast augmentation for women at least 18 years old for saline-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 augmentation surgery.
- Breast reconstruction. 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 pre-cancer of their breast who have not received adequate treatment for those conditions.
- Women who are currently 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 during surgical insertion.
- Care should be taken when using surgical instruments in proximity with the breast implant, including scalpel, sutures, and dissection instrumentation.
- Do not treat capsular contracture by closed capsulotomy or forceful external compression, which will likely result in implant damage, rupture, folds, and/or hematoma.
- Use care in subsequent procedures such as open capsulotomy, breast pocket revision, hematoma/seroma aspiration, and biopsy/lumpectomy to avoid damage to the implant.
- Do not place drugs or substances inside saline-filled implants other than sterile saline for injection. Do not inject through the implant shell.
- Do not contact the implant with disposable, capacitor-type cautery devices.
- Do not alter the implants or attempt to repair or insert a damaged prosthesis.
- Do not immerse the implant in povidone-iodine solution. If povidone-iodine is used in the pocket, ensure that it is rinsed thoroughly so no residual solution remains in the pocket.
- Do not reuse or resterilize any product that has been previously implanted. Breast implants are intended for single use only.
- Do not place more than one implant per breast pocket.
- Do not use the periumbilical approach to place the implant.
- Do not use microwave diathermy in patients with breast implants. Microwave diathermy has been reported to cause tissue necrosis, skin erosion, and implant extrusion.
Safety and effectiveness have not been established in patients with the following:
- Autoimmune diseases (e.g., lupus and scleroderma).
- A compromised immune system (for example, 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 with silicone-filled implants, implant deflation with saline-filled implants, 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 necrosis, wrinkling/rippling.
For more information see the full Directions for Use at www.allergan.com/labeling/usa.htm or call the Allergan Product Support line at 1-800-433-8871.
To report a problem with Natrelle®, please call Allergan Product Surveillance at 1-800-624-4261.
Natrelle® Breast Implants are available by prescription only.
Please click here for full Natrelle® directions for use.