Patient Educational Brochure – Breast Augmentation with MENTOR ® MemoryShape ® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR ® MemoryShape ® Breast Implants. For Augmentation: Important Information for Augmentation Patients about MENTOR ® MemoryGel ® Breast Implants.An individual’s risk of developing BIA-ALCL with MENTOR ® Breast Implants is low based on the incidence of worldwide cases.ĭetailed information regarding the risks and benefits associated with MENTOR ® Breast Implants is provided in several educational brochures for both augmentation and reconstruction: Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. 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 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 ® MemoryGel ® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. 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 augmentation with MemoryGel ® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. Use care in the selection of your doctors and hospital, based on their skill and experience.īreast implants are not lifetime devices and breast implantation may not be a one-time surgery. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. 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. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. There are risks associated with breast implant surgery. 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. 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. With existing cancer or pre-cancer of their breasts who have not received adequate treatment for those conditions.With active infection anywhere in their body.MENTOR ® Breast Implants are also indicated for breast reconstruction.īreast implant surgery should not be performed in women: 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. The third party trademarks used herein are the properties of their respective owners. Mentor Worldwise, LLC, Internal Memo - Surface Area November 6, 2012 Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness Aesthetic Surgery Journal 2014, Vol. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report.ĩ. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion ReportĨ. FM-0001306_v6 Flexa Design Requirements Matrixħ. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion ReportĦ. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Reportĥ. FM-0001306 v6 Flex Design Requirements MatrixĤ. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Reportģ. FM-0001306 SILTEX ® Sizes and Styles MemoĢ. ** As compared to Allergan 133 ® and CPX ®4 Breast Tissue Expanderġ. *As compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression
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