For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL® textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements for free. The program will run for 24 months, until July 24, 2021, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019. If you are a patient with BIOCELL® textured breast implants in Pasadena, San Gabriel Valley, Inland Empire, or Orange County area, and would like to discuss your replacement options, you may request a consultation online or call Wang Plastic Surgery at (888) 360-6688 today to schedule your appointment.
The decision to get a breast implant revision is a personal decision between patients and their plastic surgeons, and must be decided based on the appropriate discussion of benefits and risks. As part of this program, Allergan will not provide surgical fee assistance to revision patients. This decision is in-line with the FDA’s recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (“BIA-ALCL”) due to the low risk of developing BIA-ALCL. Patients who decide to keep their BIOCELL® textured devices will continue to be covered under the NATRELLE® ConfidencePlus® warranty, which includes reimbursement for up to $1,000 in diagnostic fees and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL.
What is the BIOCELL® Replacement Warranty?
For patients in the U.S. who choose to replace their BIOCELL® textured devices with smooth devices, as a result of the recall announcement on July 24, 2019, Allergan will provide smooth device replacements for free.
When does the program take effect and for how long?
For patients in the U.S. who choose to replace their BIOCELL® textured devices with smooth devices, as a result of the recall announcement on July 24, 2019, Allergan will provide smooth device replacements for free.
This program started on July 24, 2019 and will last until July 24, 2021.
What patients are covered?
Patients must be U.S. based, and they must have a BIOCELL® textured implant. This program is intended to assist patients who, as a result of the BIOCELL® recall, are concerned about their textured implants. Patients should have carefully considered the benefits and risks of a revision surgery through a discussion with their plastic surgeon.
What devices are covered?
The BIOCELL® Replacement Warranty covers all BIOCELL® textured implants that may have been originally manufactured under the brands MCGHAN, INAMED, or ALLERGAN NATRELLE®. Both saline and silicone gel filled textured implants are covered.
Which replacement devices may patients select as part of this replacement program?
Silicone gel-filled texture implant patients are eligible for gel-filled smooth implant replacements, and saline-filled texture implant patients are eligible for saline-filled smooth replacements. Allergan will provide replacement implants within a similar product type, gel or saline, but the exact material fill or product dimensions do not need to match exactly. For example, a Style 410 (e.g. SKU FM-410-310) textured anatomical implant may be replaced with any similar size NATRELLE INSPIRA® smooth implant containing either Responsive (e.g. SKU SRM-310), SoftTouch (e.g. SSM-310), or Cohesive gel (e.g. SCM-310). Or, a Style 168 textured saline (e.g. SKU 168-300) implant may be replaced with any similar size NATRELLE® Style 68 smooth saline-filled implant (e.g. SKU 68-300). In these examples, all implants have a similar base width, projection, and volume. In some cases, an exact matchup of the device dimensions may not be possible, in which case a similar device will be allowed. The program is not intended to assist patients with reoperations for size changes or correcting non-implant related changes to the breast over time. However, Allergan understands that some exceptions to this rule will be required based on patient needs, and Allergan will evaluate these requests as necessary. The BIOCELL® Replacement Warranty is intended to assist patients concerned about their BIOCELL® textured implants as a result of the recall.
Does this apply to all of my revision surgeries for BIOCELL® implant patients?
This program is not intended for all BIOCELL® revision surgeries. The program is intended for BIOCELL® patients who are looking to replace their textured implants with smooth implants as a result of the recall announced on July 24, 2019.
Are surgery fees covered?
As part of this program, Allergan will not be providing surgical fee assistance to revision patients. This decision is in-line with the FDA’s recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (“BIA-ALCL”) due to the low risk of developing BIA-ALCL.
Patients who decide to keep their BIOCELL® textured devices will continue to be covered under the NATRELLE® ConfidencePlus® Warranty, which includes reimbursement for up to $1,000 in diagnostic fees and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL. More information about the NATRELLE® ConfidencePlus® Warranty can be found at www.natrelle.com/warranty.
