INITIATE A BIOCELL® REPLACEMENT WARRANTY CLAIM

Please review the form and have all required information ready prior to initiating a claim. For technical support, contact Allergan Web Services at 844-246-2461. For other questions or concerns, contact the Allergan Product Surveillance Team by calling 1-800-624-4261 or emailing AUS-PSReporting@allergan.com.

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SURGEON INFORMATION

EVENT DESCRIPTION
(LEFT SIDE)

Yes
No

EVENT DESCRIPTION
(RIGHT SIDE)

Yes
No

PATIENT INFORMATION

Male
Female

BIOCELL® DEVICE INFORMATION

SMOOTH REPLACEMENT DEVICE INFORMATION

DEVICE RETURN STATUS

Yes
No
Yes
No

Please note that Allergan will not be able to finalize processing the claim until all required information is provided and explanted Natrelle® breast implant(s) are returned to Allergan. Allergan requests the return of all explanted breast implants associated with a complaint to assist with evaluating and maintaining the quality and safety of the Natrelle® breast implants. Where applicable, replacement devices will be issued upon receipt and verification of the explanted product(s), the Returned Goods Authorization (RGA), and the patient’s signed informed consent form.

By clicking the SUBMIT button below, I represent that I am disclosing this information to Allergan, its affiliates, agents, representatives, and service providers (together “ALLERGAN”) to help enable treatment for this patient. I further certify that the patient is aware of, has consented to, and has directed my disclosure of their information to ALLERGAN to enable services to the patient for such purposes, including to perform product warranty registration and administration purposes, and that such consent and direction applies to disclosures made through the duration of the patient’s therapy.

Natrelle® Breast Implants Important Information
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Natrelle® Breast Implants Important Information
INDICATIONS
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
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.
WARNINGS
  • 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 for Use.
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 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.
ADVERSE EVENTS
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. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.
Natrelle® Breast Implants Important Information
SEE MORE +
Natrelle® Breast Implants Important Information
INDICATIONS
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
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.
WARNINGS
  • 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 for Use.
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 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.
ADVERSE EVENTS
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. To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.