Mentor Warranty for Memory Gel and Memory Shape Silicone Implants
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The document outlines the warranty options for Mentor® memorygel® and memoryshape® breast implants, including a lifetime replacement policy for rupture and financial assistance for complications like capsular contracture. It emphasizes the importance of patient education through brochures and the need for consultations with surgeons prior to surgery. Additionally, the document specifies the steps for claim processing and the safety information regarding implant surgeries.
Mentor Warranty for Memory Gel and Memory Shape Silicone Implants
- 1. for MENTOR® MemoryGel® Breast Implants and MemoryShape® Breast Implants Implanted in the United States (including Puerto Rico) on or after October 06, 2014 ® THE MENTOR WARRANTY & THE MENTOR ENHANCED WARRANTY
- 2. YOUR PEACE-OF-MIND COMES FIRST Partnering with the right surgeon and choosing the best implants are your core choices when it comes to breast surgery and what drives your overall experience. The best implants should come with a generous product warranty to ensure you are supported long after the surgery. Mentor stands firmly behind the integrity of our products with our lifetime replacement policy so you can have complete confidence when making MENTOR® MemoryGel® Breast Implants and MENTOR® MemoryShape® Breast Implants your choice.
- 3. Please read the appropriate patient brochures: For MemoryGel® Implants: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. For MemoryShape® Implants: Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. These educational brochures provide you with information about the risks and benefits of silicone breast implants. It is very important that you take the time to read and fully understand the brochure, consult with your surgeon, and ask any questions you may have. For gel filled breast implants, you will also be asked to sign the Acknowledgement of Informed Decision Form in the brochure. You should then wait at least one to two weeks prior to deciding on surgery. After reading and signing the Informed Decision Form in your brochure, your surgeon will help you decide which implant is the right choice for you. Mentor is committed to your long-term well-being Our relationship with you does not end with your surgery. We are here before your surgery to answer questions and provide perspective. And importantly, we are there after your surgery —with a long-term commitment. The first company to offer patients a limited warranty on all our breast implants Clinically tested. FDA approved. The choice by millions of women for over 25 years. Our faith in our breast implants is based on results and this is why we can so confidently offer the Mentor and Mentor Enhanced Warranties. COULD NOWBE THE TIME? First and foremost: MENTOR® Breast Implants are guaranteed for your lifetime All recipients of MENTOR® MemoryGel® Breast Implants and MENTOR® MemoryShape® Breast Implants are automatically enrolled in the Mentor Product Replacement Policy.1 What this means to you is that should a confirmed rupture occur, you are eligible for up to two replacement breast implants of any size in the same style…at no charge. 1 Product Replacement Policy: In the event of unexpected rupture (loss of shell integrity), Mentor will provide replacement of a MENTOR® Product of any size in the same style as the originally implanted product free of charge for the lifetime of the patient. Upon the surgeon’s request, a different implant style may be selected (subject to a charge of the difference between product list prices).
- 4. SUMMARY OF WARRANTY OPTIONS MENTORWARRANTY MENTOR ENHANCED WARRANTY Enrollment in our Product Replacement Policy1 Automatic Automatic Financial assistance for rupture3 Up to $3,500 Up to $3,500 An additional product replacement policy covering capsular contracture Baker Grade III & IV, double capsule, and late-forming seroma2 First 3 years Up to 10 years Financial assistance for capsular contracture Baker Grade III/IV 2, 3, 4 Up to $3, 500 Financial assistance for double capsule 2, 3, 4 Up to $3, 500 Financial assistance for late-forming seroma 2, 3, 4 Up to $3, 500 Contralateral (opposite side) implant replacement upon surgeon request FREE FREE Enrollment Fee FREE Purchase for $200 within 45 days from implantation HERE’S WHERE TO BEGIN: BECOME INFORMED 2 Applies only to primary5 implant surgeries, whether augmentation or reconstruction, conducted on or after October 6, 2014. If you had breast surgery prior to Oct 6, 2014, your warranty coverage is what was offered at the time of your original surgery. 3 Operating room and anesthesia charges to be given payment priority. In order to qualify for financial assistance, you will need to sign a Release before Mentor will make payment to you or on your behalf. 4 Pays up to $3,5003 financial assistance for operating room, anesthesia, and surgeon fees not covered by insurance for replacement surgery resulting from capsular contracture Baker Grade III & IV, double capsule, and late-forming seroma for up to 10 years from the date of primary5 implant surgery occurring on or after date of implant October 6, 2014. Your surgeon must diagnose these events and provide documentation to Mentor to support your date of implant, product implanted, and event experienced in order to qualify. 5 primary means the very first original implantation of the MENTOR® MemoryGel or MemoryShape® Implant. Prior implant(s), regardless of type, style, or manufacturer, preclude inclusion in the Mentor Enhanced Warranty for both replacement product and financial assistance. In the event of primary reconstruction with use of a tissue expander, the temporary tissue expander does not qualify as an implant. The MENTOR ENHANCED WARRANTY offers more than any previous breast implant warranty. Check out the advantages: ≥ Automatic enrollment in our Product Replacement Policy1 for any MENTOR® MemoryGel® Breast Implants or MemoryShape® Breast Implants ≥ For a $200 enrollment fee, pays up to $3,5003 financial assistance for operating room, anesthesia, and surgeon fees not covered by insurance for replacement surgery resulting from a Baker Grade III capsular contracture, Baker Grade IV capsular contracture, double capsule, or late-forming seroma for up to 10 years from the date of primary5 implant surgery occuring on or after date of implant October 6, 2014 ≥ Free contralateral (opposite side) implant replacement upon surgeon request ≥ For surgeries occuring on or after October 6, 2014
- 5. HOW THE CLAIM PROCESS WORKS To file a claim for product replacement and/or financial assistance, your surgeon must contact the Mentor Customer Quality Department at 1-866-250-5115 prior to replacement surgery. Required paperwork: For financial assistance claims, a patient-specific Release will be generated by Mentor that you must sign and return. What your surgeon must send to Mentor and by when: For either replacement or financial assistance claims, the surgeon must send the explanted (removed), decontaminated MENTOR® Breast Implant(s) within 60 days of the date of explantation to: Upon receipt, review, and approval of the completed claim, including receipt of the explanted product and patient completion of a full general Release, financial assistance will be issued. Mentor Worldwide LLC Attn: Product Evaluation Department 3041 Skyway Circle North Irving, TX 75038 A SPECIAL NOTE Please be sure to maintain your own records to ensure validation of your enrollment, as it is possible your surgeon may not retain your records for the entire duration of the warranty. Get your questions answered at the consultation with your surgeon. This brochure only provides a brief overview of the Mentor Warranties and is not intended to replace any discussion between you and your surgeon. Please refer to www.mentorwwllc.com for full warranty coverage details.
- 6. 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® 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 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 MENTOR® MemoryShape® Breast Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis.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. 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. 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 MENTOR® CONTOUR PROFILE® Tissue Expanders 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. Do not use the CONTOUR PROFILE® Expander in patients where an MRI may be needed. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas. For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR® implantable devices, which include MENTOR® Saline-filled Breast Implants, MemoryGel® Implants, MemoryShape® Implants, and CONTOUR PROFILE® Expanders, please refer to the Product Insert Data Sheet provided with each product or visit www.mentorwwllc.com. This is a summary of coverage. It is an overview only and not a complete statement of the program. You may obtain a copy of the complete Mentor Warranty and Enhanced Warranty for MemoryGel® Breast Implants and MemoryShape® Breast Implants by going to www.mentorwwllc.com. Mentor reserves the right to cancel, change, or modify the terms of The Mentor Warranty and Enhanced Warranty coverages. Any such cancellation, change, or modification will not affect the currently stated terms of the Mentor Warranty and Enhanced Warranty coverages for those already enrolled.
- 7. THIS IS A LIMITED WARRANTY ONLY AND IS SUBJECT TO THE TERMS AND CONDITIONS SET FORTH IN THIS DOCUMENT AND EXPLAINED IN GREATER DETAIL IN THE APPLICABLE MENTOR LIMITED WARRANTY. ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS ARE EXCLUDED. THIS REMEDY IS THE SOLE AND EXCLUSIVE REMEDY AVAILABLE. MENTOR SHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL LOSS, DAMAGE OR EXPENSE ARISING DIRECTLY OR INDIRECTLY FROM THE USE OF THESE PRODUCTS. MENTOR NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. THE TERMS IN EFFECT WHEN ORIGINAL IMPLANTATION OCCURS WILL APPLY AT THE TIME OF CLAIM. MENTOR WARRANTY REGISTRATION REGISTER ONLINE for peace of mind. Even though you automatically qualify for the MENTOR WARRANTY, by completing the online registration form located at www.mentorwwllc.com we can better serve you in the future. MENTOR ENHANCED WARRANTY ENROLLMENT REGISTER AND PAY ONLINE To enroll in the MENTOR ENHANCED WARRANTY, complete the online registration form located at www.mentorwwllc.com within 45 days of your surgery. 201 Mentor Drive Santa Barbara, CA 93111 USA (805) 879-6000 www.mentorwwllc.com © Mentor Worldwide LLC 2014 022384-141013 201 Mentor Drive