For information on BIOCELL® textured implants and tissue expanders, please click here.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. BIA-ALCL is not a cancer of the breast tissue. Breast implant patients should consult their healthcare professional if they are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue.
As per Health Canada, the exact cause of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unknown. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant. A patient’s genetic predisposition may then add to the inflammatory response, resulting in transformation to BIA-ALCL.
The incidence appears to vary depending on the type of implant texturing, although BIA-ALCL has been identified in patients with all types/brands of texturing. A higher incidence of BIA-ALCL has been reported with higher surface area/roughness devices.
Patients can find more information through the following resources:
Food and Drug Administration (FDA), United States of America via: https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
Patient associations RETHINK and Canadian Cancer Society
Patient safety is Allergan’s highest priority and we will continue to collaborate with clinicians, societies and global health authorities to advance research, understanding and awareness about breast implant effectiveness and safety. Should you have any questions about Allergan’s breast implants, you can contact our Medical Information team: MR-MedicalInformation@Allergan.com or 1-800-668-6424.
NATRELLE®’s textured implant collection was comprised of NATRELLE® 410 and NATRELLE® INSPIRA® gel-filled breast implants. These implants were available in two different shapes: teardrop and round. The NATRELLE® 410 implants were anatomical or “teardrop” shaped. The NATRELLE® INSPIRA® implants were round shaped.
NATRELLE® 410 and select NATRELLE® INSPIRA® breast implants were offered with a texturing called BIOCELL®. The textured surface was designed to promote tissue adherence, which facilitated stable positioning of the implant and reduced the possibility of implant rotation.
BIOCELL® textured breast implants used TruForm®, a cohesive silicone gel-filler that acts more like a soft solid than a liquid. There were three categories of TruForm® gel. The NATRELLE® INSPIRA® implants used TruForm® 1 and TruForm® 2, while the NATRELLE® 410 implants used TruForm® 2 and TruForm® 3.
As a result of Health Canada’s suspension of the BIOCELL® textured implant licence, Allergan Canada has made the decision to voluntarily recall these textured breast implants from the Canadian market.
As part of this voluntary recall, any unused BIOCELL® saline-filled and silicone-filled textured breast implants (medical device licences 3112, 72262, 72263, 87277 and 87279) have been removed from the Canadian market and website and will no longer be sold.
We encourage you to speak with your plastic surgeon should you have questions or concerns regarding your implants.
Silicone is used safely in many medical devices and products, including pacemakers and heart valves, artificial joints, medical tubing, as well as everyday household items like baking pans, detergents and fabrics. Silicone gel-filled breast implants are arguably the most studied medical devices in the world – there have been decades of research evaluating the safety and effectiveness of silicone implants. Silicone implants have been used extensively throughout the world, and are thought to look and feel natural. Read more about silicone breast implants
An implant rupture is a tear or hole in the breast implant shell. When this occurs in a silicone gel-filled implant, the gel may remain in the shell, leak into the tissue (or capsule) that forms around the implant or spread beyond the capsule.
After surgery, your body begins to naturally surround the implant with a layer of scar tissue. This tissue is called a “capsule” because it encapsulates (or surrounds) the implant. Sometimes, for a number of reasons, the capsule can tighten and squeeze the implant—this is called capsular contracture. It can cause the breast to feel hard, look misshaped and can be painful.
Yes. All NATRELLE® breast implants are covered under a warranty program.
If your surgery was on or before December 31, 2018, please visit www.cppwarranty.ca for details. For surgeries that took place on or after January 1, 2019, you can read more about the warranty coverage here.
As a result of the global recall of BIOCELL® textured devices from the market, Allergan has established the BIOCELL® Replacement Warranty for Canadian patients currently implanted with textured implants. Canadian patients who are looking to replace their BIOCELL® textured implants with smooth implants will be provided Allergan smooth implants of a similar size at no charge. The program will run until July 24, 2021. For more information regarding this Replacement Warranty and eligibility please speak to your Plastic Surgeon.
Reports in the medical literature indicate that patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer. Women with breast implants are still able to have accurate mammograms, though it may be more difficult. Women should ask to have their mammography exams performed and interpreted at centres experienced in the evaluation of women with breast implants. Other breast screening exams such as ultrasound and MRI can also be performed when necessary.
Studies have shown that mothers with breast implants do not have higher levels of silicone concentration in their breast milk than women who do not have breast implants. Many women with breast implants have successfully breastfed their children. However, breast surgery of any kind has the potential to impact lactation ability. Your plastic surgeon will discuss your options for incision placement, implant position and other factors that could affect future breastfeeding. For more information, please read the complete patient information.
Women with breast implants are still able to have mammograms, though it may be more difficult. Women should ask to have their mammography exams performed and interpreted at centres experienced in the evaluation of women with breast implants. Other breast screening exams such as ultrasound and MRI can also be performed when necessary. For more information, please read the complete patient information.
While most women are happy with their implants, bodies and lifestyles change over time. Some women choose to remove them or replace them with an implant that is better suited to them today. Like any other medical device, breast implants are not considered lifetime devices, and women with implants will potentially undergo implant removal, with or without replacement, over the course of their lives. Learn more about the quality of NATRELLE® silicone product
The cost of breast augmentation surgery will depend on your surgeon, where the operation is performed, and the type of implant you choose to have.
In Canada, breast reconstruction after a mastectomy is covered by provincial health plans. However, breast implants are not lifetime devices and will need to be replaced. Speak with your doctor to discuss the options available to you.
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If you are a U.S. resident interested in breast augmentation, please visit www.natrelle.com.