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 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.
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.
Important Safety Information
MENTOR™ MemoryGel™ Breast Implants, MENTOR™ MemoryShape™ Breast Implants, and MENTOR™ Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel™ Implants and MemoryShape™ Implants, and 18 years old for Saline Implants) or 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 breast who have not received adequate treatment for those conditions, or who are currently pregnant or nursing.
Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The chance of developing complications increases over time. The most common complications for breast augmentation and reconstruction with MemoryGel™ Implants include any reoperation, capsular contracture, 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 with MemoryShape™ Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. 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. The most common complications with MENTOR™ Saline-filled Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation.
For MemoryGel™ Implants, patients should receive a copy of Important Information for Augmentation Patients about MENTOR™ MemoryGel™ Breast Implants or Important Information for Reconstruction Patients about MENTOR™ MemoryGel™ Breast Implants. For MemoryShape™ Implants, patients should receive a copy of Patient Educational Brochure – Breast Augmentation with MENTOR™ MemoryShape™ Breast Implants or Patient Educational Brochure – Breast
Reconstruction with MENTOR™ MemoryShape™ Breast Implants, and a copy of Quick Facts about Breast Augmentation & Reconstruction with MENTOR™ MemoryShape™ Breast Implants. For MENTOR™ Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery.
The ARTOURA™ Breast Tissue Expander or CONTOUR PROFILE™ Breast Tissue Expander can be utilized 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 Expander and CONTOUR PROFILE™ Tissue Expanders include magnetic injection domes, which contain a rare earth permanent magnet, 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™ Tissue Expander nor CONTOUR PROFILE™ Tissue Expander in patients where an MRI may be needed. 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 in vivo effects of radiation therapy with ARTOURA™ Breast Tissue Expander and CONTOUR PROFILE™ Expander devices and cannot warrant the safety of such use. 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.
For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR™ Implantable Devices, which include MENTOR™ Saline-filled Implants, MemoryGel™ Implants, MemoryShape™ Implants, ARTOURA™ Expanders, and CONTOUR PROFILE™ Expanders, please refer to the Instructions for Use (IFU) provided with each product or visit mentorwwllc.com.
