Rare Complications
Breast implants are widely considered among the most intensely studied and regulated devices in the medical industry. For nearly four decades, Mentor, along with FDA and other regulatory bodies, have closely tracked and monitored patient satisfaction and complications associated with breast implants through clinical studies, registries, and real-world complaint data to better understand the breast implant benefits and safety.
In 2011, FDA identified an association between breast implants and the development of Anaplastic Large Cell Lymphoma (ALCL). Today it is believed that women with breast implants have a very small, but increased risk of developing Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). More recently some women with breast implants have reported a range of systemic symptoms that they refer to as “breast implant illness.” To date, the overall body of scientific evidence does not support claims that breast implants cause systemic illness, however further research is underway to better understand any possible connection.
Breast Implant Associated Anaplastic Large Cell-Lymphoma (BIA-ALCL)
Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma(a cancer of a type of cell of the immune system)typically occurring in a delayed fluid collection around a textured implant or surrounding scar capsule.1
Breast implants are associated with increased risk of BIA-ALCL, but the absolute risk remains small.2
BIA-ALCL patients most commonly present with a spontaneous peri-prosthetic fluid collection or capsular mass at an average of eight to ten years following implantation with a breast implant for either cosmetic or reconstructive indication.1
Many factors may contribute to the development of BIA-ALCL, including biofilm organisms, possible rare genetic predisposition and the surface texture of the implant.3
Current literature indicates that the risk of developing BIA-ALCL differs between different textured devices and has been shown to be rare with MENTOR® SILTEX® Breast Implants.4-5
While MENTOR® SILTEX® Breast Implants have a low rate of BIA-ALCL, it remains a concern we take seriously. We closely monitor the clinical performance of our breast implants through clinical studies, registries and post market surveillance activities and continue to work with industry groups, physicians, scientists and health authorities to better understand the associated risks and causes of this type of lymphoma.
Breast Implant Illness (BII)
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. While the current body of scientific evidence does not support claims that breast implants cause systemic illness, FDA, in partnership with industry, medical and plastic surgery societies, and researchers are taking steps to better characterize the set of conditions and its risk factors and researchers are working to understand the origins of the symptoms.
We support these efforts and have been partnering with the regulatory authorities around the world and diligently reviewing our long-term implant safety and real-word complaint data seeking to better understand any possible connection.
WARNING:
- Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that 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 systematic 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.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel® Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least 18 years old for MENTOR® Saline Breast Implants. MENTOR® Breast Implants are also indicated for breast reconstruction.
Breast implant surgery should not be performed in women:
- With active infection anywhere in their body
- With existing cancer or pre-cancer of their breasts who have not received adequate treatment for those conditions
- Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. 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.
There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.
Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications for breast reconstruction with MENTOR® MemoryGel® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. The most common complications with MENTOR® MemoryShape® Breast Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the incidence of worldwide cases.
Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures for both augmentation and reconstruction:
For Augmentation: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
For Reconstruction: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
Saline-Filled Breast Implants: Making an Informed Decision.
These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA® Breast Tissue Expander and CONTOUR PROFILE® Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com
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