Find information when you need itand support
At Allergan, we believe in helping you stay informed through every step of your journey.
At Allergan Aesthetics,we put our patients first
When you partner with us, you partner with a Canadian leader in breast surgery. That’s why we offer automatic enrolment in our Natrelle® ConfidencePlus™ Warranty Program—at no charge to you. Stay protected with comprehensive coverage, surgical cost assistance, product replacement, and more. Find out more information about the program by downloading our Warranty Brochure.GET YOUR WARRANTY BROCHURE
Frequently asked questions
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 .
Implant Rupture 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.
Capsular contracture 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 several 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 be painful. Capsular contracture occurs more commonly in revision augmentation than in primary augmentation.
Systemic symptoms 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.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) BIA-ALCL is not breast cancer—it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but, in some cases, it can spread throughout the body. In the cases that it has spread beyond the scar tissue and fluid near the implant, rare cases of death have been reported.
Health Canada recognizes a higher risk of BIA-ALCL with implants having a textured surface, especially those with a more highly textured surface as opposed to implants with a smoother surface.
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:
Allergan Medical Information team: [email protected] or 1-800-668-6424.
Health Canada via: https://www.canada.ca/en/health-canada/services/drugs-medical-devices/breast-implants/risks.html
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 Aesthestics’ 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: [email protected] or 1-800-668-6424.
Yes. All Natrelle® breast implants are covered under our Natrelle® ConfidencePlus™ Warranty Program. 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.
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.
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.
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 used.
In Canada, breast reconstruction after a mastectomy for cancer is covered by most provincial and territorial health plans. Speak with your surgeon to discuss the options available to you.
After your breast implant surgery, most doctors will recommend that you sleep only on your back for the first few weeks. This allows the tissue around your implant to heal and lowers the risk of deforming the implant by sleeping on them. Once your body has had a chance to heal, sleeping on your side or stomach poses no risk to the implants. Talk to your doctor to find out what they recommend and any tips they can offer for sleeping after your surgery.
Anaplastic large cell lymphoma (ALCL)
A type of lymphoma, which is a cancer that begins in the cells of the immune system and can also occur in the breasts. A variety of ALCLs may occur in women with and without breast implants. When associated with implants, ALCL is often referred to as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). ALCL is not the same as primary breast cancer.
The pigmented or darker-coloured area of skin surrounding the nipple of the breast.
To make something larger in size.
Nodes located in the armpit area.
Affecting the right and left sides of the body (i.e., both breasts).
BIOCELL® is Allergan’s unique patented textured surface breast implant designed to maintain positioning and promote tissue adherence.
A surgical procedure to increase breast size. For this site, it refers to the placement of a breast implant.
A surgical procedure 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.
A tightening of the tissue capsule surrounding an implant, resulting in firmness or hardening of the breast, and squeezing of the implant if severe. Capsular contracture is classified by Baker Grades, where grades III or IV are the most severe, and contracture often results in the need for additional surgery because of pain and possible abnormal appearance. Capsular contracture can be a risk for rupture.
Scar tissue which forms around the breast implant.
Cubic centimetre. The measurement used for breast volume.
The implant and breast are found as 2 separated layers, or capsules, rather than as one unified capsule.
Tubes may be placed at the site of implant(s) post-surgery in order to remove any excess fluid build-up.
Dual plane placement
Placement of breast implants partially underneath the chest muscles.
A collection of blood within a space.
A cut made to the body tissue during surgery.
Below the breast. An inframammary incision is an incision made in the fold below the breast.
The production and secretion of milk by glands in the breast.
A type of X-ray examination of the breast used to detect cancer.
Major muscle of the chest; also known as “pec.”
Around the darkened or pigmented area surrounding the nipple of the breast.
The first time a breast implant is placed for the purpose of breast augmentation.
The correction or improvement of primary-augmentation. For this brochure, it refers to the surgical removal and replacement of breast implants.
A tear or hole in the implant shell. Saline implants will deflate when they rupture.
A liquid solution that is made up of water and a small amount of salt.
A build-up of the watery portion of the blood in a tissue location.
Placement of breast implants underneath and within the breast glands, but on top of the chest muscles.
Placement of breast implants wholly or partially underneath the chest muscles.
Having proportion of shape, size, and position between the two breasts.
Axillary pertains to the armpit area. A transaxillary incision is an incision made in the armpit area.
Affecting either the right or left side of the body (i.e., one breast).