Warranty Information - Mentor

LIMITED WARRANTIESfor SALINE FILLED Breast ImplantsStandard Advantage & EnhancedAdvantage Limited WarrantiesOur REASSURANCEthat you’re makinga great choice.®

NOTHING IS MORE IMPORTANTthan your well-being before,during and after breast surgeryAt Mentor, we pride ourselves in thedevelopment of medical products basedon the finest science, research andmanufacturing. And we stand behind thoseproducts with Limited Warranties that givepatients the confidence that they, and theirsurgeons, have made the right choice.MENTOR was the FIRST COMPANY tooffer patients a limited warranty on allour breast implants.The first step: BECOME INFORMEDLearn about saline filled breast implants andfinancial assistance* available through theMentor Limited Warranties.Please read this patient brochure: Saline Filled Breast Implant Surgery: Making aninformed Decision. This educational brochure, also available in electronic format atwww.Mentorwwllc.com, provides you with information about the risks and benefitsof saline breast implants. It is very important that you take the time to read and fullyunderstand the brochure, consult with your surgeon, and ask any questions you may have.*Financial assistance does not imply a loan to the patient, and instead means eligiblepayments under the warranty programs described in this brochure.

WHY IS A WARRANTY SO IMPORTANT?Our Saline Filled Breast Implant guaranteeWith a strong belief in the long-term integrity of ourproducts, it’s easy for us to stand behind them. That’swhy all recipients of MENTOR® Saline Filled BreastImplants are automatically enrolled in the MentorLifetime Product Replacement Policy at no additionalcharge. In addition, once you receive MENTOR® BreastImplants, you are automatically enrolled in the MentorStandard Advantage Limited Warranty.What this means to you is that should a confirmeddeflation occur, you are eligible for one to tworeplacement breast implants of any size in a similarstyle…at no charge.SUMMARY OF WARRANTY OPTIONSThe Mentor Standard Advantage($1,200 toward out-of-pocket costs)This warranty is free of charge to all patients who areimplanted with MENTOR® Saline Filled Breast Implantproducts. Here is what’s included:≥ Automatic enrollment in our Lifetime ProductReplacement Policy**≥ Enrollment in this warranty is FREE and automatic;registration is encouraged≥ Coverage for 10 years, and up to $1,200 financialassistance for operating room, anesthesia, andsurgical charges not covered by insurance***≥ Free contralateral (opposite side) implantreplacement upon surgeon request**Lifetime Product Replacement Policy: Mentor will provide replacement of a MENTOR ® Product ofany size in the same or similar style as the originally implanted product free of charge for the lifetimeof the patient. Upon the surgeon’s request, a different implant style may be selected (subject to acharge of the difference between product list prices).***Operating room and anesthesia charges to be given payment priority. In order to qualify forfinancial assistance, you will need to sign a Release Form.

AND NOW THERE’S AN EXTRAREASON TO SAY ‘YES’ TO MOREBEAUTIFUL BREASTS.The Optional Mentor Enhanced Advantage($2,400 toward out-of-pocket costs)This optional warranty is available for saline filledbreast implant products and, to be eligible, must bepurchased for an enrollment fee of $100 within 45days from implantation.† The Enhanced Advantagereplaces the Mentor Standard Advantage allowingfor a total financial reimbursement of up to $2,400.Here is what’s included:≥ Automatic enrollment in our Lifetime ProductReplacement Policy**≥ Coverage for 10 years, and up to $2,400 financialassistance for operating room, anesthesia, andsurgical charges not covered by insurance***≥ Free contralateral (opposite side) implantreplacement upon surgeon requestA SPECIAL NOTEFor both Mentor StandardAdvantage and Mentor EnhancedAdvantage Limited Warranties,please be sure to maintain yourown records to ensure validationof your enrollment, as it is possibleyour surgeon may not retainyour records for the entireduration of the warranty.† One warranty payout per enrollment fee; enrollment in the program for replacement devicewill require additional $100 enrollment fee.**Lifetime Product Replacement Policy: Mentor will provide replacement of a MENTOR ®Product of any size in the same or similar style as the originally implanted product free ofcharge for the lifetime of the patient. Upon the surgeon’s request, a different implant stylemay be selected (subject to a charge of the difference between product list prices).***Operating room and anesthesia charges to be given payment priority. In order to qualify forfinancial assistance, you will need to sign a Release Form.

YOU MAY BE WONDERING…What products are covered under thisspecial warranty?The Mentor Standard Advantage and EnhancedAdvantage (if purchased) coverages apply to allMENTOR® Saline Filled Breast Implants that havebeenimplanted in the United States and Puerto Ricoafter May 1, 2005;† † provided implants have been:≥≥Implanted in accordance with the Mentorpackage insert, current to the date ofimplantation, and other notifications orinstructions published by MentorUsed by appropriately qualified, licensedsurgeons, in accordance with acceptedsurgical proceduresWhat events are covered?The Mentor Standard Advantage and EnhancedAdvantage coverages apply to the following:≥Deflation due to crease fold failure, patienttrauma, or unknown cause≥Loss of valve integrityOther loss of shell integrity events also may becovered by this program. Mentor reserves the rightto determine if specific, additional eventsare covered.What events are not covered?The Mentor Standard Advantage and EnhancedAdvantage coverages do not apply to the following:≥≥≥≥Adverse reactions other than deflationRemoval of intact implants due to capsularcontracture, wrinkling, or ripplingLoss of implant shell integrity resulting fromreoperative procedures, open capsulotomy, orclosed compression capsulotomy proceduresRemoval of intact implants for size alteration†† For saline breast implants implanted prior to this date, visit www.Mentorwwllc.comfor information regarding any applicable warranty terms.

FINANCIAL ASSISTANCE ISAVAILABLE, IF NEEDED. HERE’SHOW THE CLAIM PROCESS STARTS:To file a Mentor Standard Advantage or EnhancedAdvantage claim for product replacement and/orfinancial assistance, your surgeon must contact Mentorat 1-866-250-5115 prior to replacement surgery.Required paperworkFor financial assistance claims, a patient-specificRelease Form will be generated by Mentor thatyou must sign and return.What your surgeon must send to Mentorand by when:For either replacement or financial assistance claims,your surgeon must send the explanted (removed),decontaminated MENTOR® Breast Implant(s) within60 days of the date of explantation to:Mentor Worldwide LLCProduct Evaluation Department3041 Skyway Circle NorthIrving, TX 75038Upon receipt, review and approval of the completed claim,including receipt of the explanted product and patientcompletion of a full general release, financial assistancewill be issued.This is a summary of Mentor Standard Advantage andEnhanced Advantage coverages. It is an overview onlyand not a complete statement of the program. You mayobtain a copy of the complete Mentor Standard Advantageand Enhanced Advantage Limited Warranties forsaline filled breast implants from your surgeon or bygoing to www.mentorwwllc.com.Mentor reserves the right to cancel, change, or modify theterms of the Mentor Standard Advantage or EnhancedAdvantage coverages. Any such cancellation, change, ormodification will not affect the currently stated terms ofthe Mentor Standard Advantage and Enhanced Advantagecoverages for those already enrolled.Refer to www.mentorwwllc.com forfull warranty coverage details.

MENTOR ENHANCEDADVANTAGE WARRANTYENROLLMENTThe Mentor Enhanced Advantagecoverage provides extra coveragefor $100. ENROLL ONLINE.Go to www.Mentorwwllc.comwithin 45 calendar days of yoursaline breast implant surgery. §GET YOUR QUESTIONSANSWERED AT THECONSULTATION WITHYOUR SURGEON.This brochure only provides a briefoverview of the Mentor StandardAdvantage and Enhanced AdvantageLimited Warranties and is not intendedto replace any discussion between youand your surgeon.THIS IS A LIMITED WARRANTY ONLY AND IS SUBJECT TO THE TERMS ANDCONDITIONS SET FORTH IN THIS DOCUMENT AND EXPLAINED IN GREATERDETAIL IN THE APPLICABLE MENTOR LIMITED WARRANTY. ALL OTHERWARRANTIES, WHETHER EXPRESSED OR IMPLIED, BY OPERATION OF LAWOR OTHERWISE, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OFMERCHANTABILITY AND FITNESS ARE EXCLUDED.THIS REMEDY IS THE SOLE AND EXCLUSIVE REMEDY AVAILABLE. MENTORSHALL NOT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIALOR SPECIAL LOSS, DAMAGE OR EXPENSE ARISING DIRECTLY ORINDIRECTLY FROM THE USE OF THESE PRODUCTS. MENTOR NEITHERASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANYOTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTIONWITH THESE PRODUCTS.THE TERMS IN EFFECT WHEN ORIGINAL IMPLANTATION WAS COMPLETEDWILL APPLY AT THE TIME OF CLAIM.§ Valid in the United States and Puerto Rico®

THE MENTOR LIMITEDWARRANTY PROGRAMSARE DESIGNED FOR YOURPEACE-OF-MINDCHECK OUT THE ADVANTAGES:≥ Automatic enrollment in our LifetimeProduct Replacement Policy** for anyMENTOR® Saline Filled Breast Implant≥ 10 years of financial assistance fromthe date of implant up to $1,200 in TheMentor Standard Advantage Programand up to $2,400 in The EnhancedAdvantage Program≥ Free contralateral (opposite side) implantreplacement upon surgeon requestMENTOR ® Saline-filled Breast Implants are indicated for breast augmentation - in womenwho are at least 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 receivedadequate treatment for those conditions• Who are currently pregnant or nursing.There are risks associated with breast implant surgery. You should be aware that breastimplants are not lifetime devices and breast implantation is likely not a one-time surgery.Detailed information regarding the risks and benefits associated with MENTOR ® BreastImplants is provided in a brochure, Saline-Filled Breast Implants, Making an InformedDecision available from your surgeon or on line at www.mentorwwllc.com.It is important that you read and understand these brochures when consideringMENTOR ® Breast Implants.**Lifetime Product Replacement Policy: Mentor will provide replacement of a MENTOR ® Productof any size in the same or similar style as the originally implanted product free of charge for thelifetime 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).201 Mentor DriveSanta Barbara, CA 93111 USA(805) 879-6000www.mentorwwllc.com© Mentor Worldwide LLC 2013 0903025 Rev D