INITIATE A BIOCELL® REPLACEMENT WARRANTY CLAIM
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Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- Breast reconstruction. This 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
CONTRAINDICATIONS
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
ADDITIONAL WARNINGS
- See Boxed Warning
- Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
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 or radiation 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
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone 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. Other systemic conditions have been reported with breast implants.
Possible adverse events with breast implant surgery include implant rupture with silicone 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. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use at rxabbvie.com.
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®.
Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION
WARNINGS
Breast implants are not considered lifetime devices. The longer patients have them, the greater the chance 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
INDICATIONS
Natrelle® Breast Implants are indicated for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
- Breast reconstruction. This 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
CONTRAINDICATIONS
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
ADDITIONAL WARNINGS
- See Boxed Warning
- Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
- Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure
PRECAUTIONS
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 or radiation 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
ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone 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. Other systemic conditions have been reported with breast implants.
Possible adverse events with breast implant surgery include implant rupture with silicone 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. Other systemic conditions have been reported with breast implants.
For more information, please see the full Directions for Use at rxabbvie.com.
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®.
References: 1. Data on file, Allergan, August 2019; Allergan Plastic Surgery Order Form.
2. Data on file, Allergan, January 6, 2017; Study Report MD16076-DV.
3. Data on file, Allergan, July 14, 1986; FDA Section 510(k) marketing approval letter.
4. Data on file, Allergan, February 3, 2017; Study Report MD16075-DV1.
5. Data on file, Allergan, February 15, 2018; Study Report MD16075-DV6.
6. Natrelle® Silicone-Filled Breast Implants and Natrelle INSPIRA® Breast Implants: Smooth & BIOCELL® Texture Directions for Use, 2017.
7. O’Shaughnessy K. Evolution and update on current devices for prosthetic breast reconstruction. Gland Surgery. 2015;4(2):97-110.
8. Data on file, Allergan, January 4, 2016; Protocol MM-1225-FR.
9. Data on file, Allergan, November 15, 2018; Study Report TR-2018-0000018.R.
