Mia^® Comprehensive Coverage

Considering the needs of our modern and empowered consumers, the Mia^® procedure includes authenticity backing through the creation of beautiful art just for you, which may be transformed into a unique Mia^® Diamond Digital Art Piece. This proof of authenticity or unique art assures you that a Mia^® certified Clinic and Surgeon performed the procedure.

It doesn’t stop there! Upon registration^(a) of the Mia^® system and diamonds, you are enrolled into a comprehensive warranty program which provides product replacement in case of Capsular Contracture^(b) occurring in the 10 years after the procedure or lifetime replacement in case of Rupture^(c) and financial assistance should the need arise during the 10 years after the procedure. ^(d)

We’ve created the following chart for your convenience that summarizes the coverage provided by the Mia^® Comprehensive Coverage:

Mia^® Comprehensive Coverage and Product Replacement Policy: Terms and Conditions

This document (the “Terms & Conditions”) describes the terms, conditions, and claim procedures for Mia^® Comprehensive Coverage warranty program, including the Product Replacement Policy and available financial assistance which may be provided. The Mia^® Comprehensive Coverage applies only to the Mia^® Diamonds which have been implanted.

Information for the Patient

Before the Mia Femtech^™ procedure, the surgeon should explain to the patient who will undergo a Mia Femtech^™ procedure (“consumer”) the details of Establishment Labs’ Mia^® Comprehensive Coverage and provide the consumer with a copy of these Terms & Conditions. In addition to explaining the details of the Mia^® Comprehensive Coverage, the surgeon should also advise the consumer about possible adverse reactions and complications associated with the Mia^® Diamonds, as well as the benefits and risks of surgery with Mia^® Diamonds according to DOC-026 “Breast Augmentation with Motiva Implants^® Information for the Patient.” The surgeon must inform the consumer that the Mia^® Comprehensive Coverage provided hereunder by Establishment Labs is separate from, and does not limit or exclude, any warranties that apply in the contractual relationship directly between the consumer and the surgeon or clinic which entered the contract for surgical services with the consumer.

Product Replacement Policy

All Mia^® Diamonds are covered by our Product Replacement Policy in the event of either (1) rupture ^* occurring during the lifetime of the Mia Diamonds, or (2) capsular contracture with Baker grades III or IV, occurring during a period of 10 years after the Mia^® procedure (each referred to as the “Product Replacement Policy Period”). Establishment Labs will provide, free of charge, the same or a similar type of Mia^® Diamonds as a replacement Mia^® Diamond for the affected Mia^® Diamond, and the consumer may, at the surgeon’s recommendation, be provided, free of charge, with a replacement Mia^® Diamond for the contralateral side Mia^® Diamond at the same time even if the contralateral side Mia^® Diamond did not experience a rupture or capsular contracture with Baker grades III or IV. Implantation of the replacement product, as well as any subsequent procedures, must be in strict accordance with the current DOC-001037 Directions For Use Establishment Labs Silicone Breast Motiva Implants^® Ergonomix2^® with Zen^® and accepted surgical procedures performed by appropriately qualified licensed surgeons. To the maximum extent permitted under applicable law, Establishment Labs will neither provide nor pay for any replacement product which is not a Mia^® Diamond, nor provide money in lieu of a replacement Mia^® Diamond. Failure to abide by these requirements will invalidate any claim under the Product Replacement Policy. The terms of this Product Replacement Policy will resume for the remainder of the Product Replacement Policy Period Subject to the foregoing, if any event that triggers the use of the Product Replacement Policy occurs during the Product Replacement Policy Period (“Product Replacement Policy Event”), the Product Replacement Policy will be applied to the affected Mia^® Diamonds and such Mia^® Comprehensive Coverage may only be applied once for a given pair of Mia^® Diamonds. For clarity, any applicable Mia^® Warranties covering a consumer’s Mia^® Diamonds can be applied to only one Product Replacement Policy Event, and all Mia^® Comprehensive Coverage applicable to such Mia^® Diamonds will be voided for both Mia^® Diamonds at the time of replacement, even if only one of such Mia^® Diamonds is replaced at that time. Any replacement Mia^® Diamonds will have their own separate Mia^® Comprehensive Coverage.

Financial Assistance

The financial assistance is coverage that only applies to Mia^® Diamonds with Zen^®. To enroll, the consumer must, within the first 90 days after the procedure of the applicable Mia^® Diamonds, register the applicable Mia^® Diamonds with Zen^® on the Mia Femtech^™ website. The financial assistance coverage will then be in effect for 120 months from the date of the procedure (the “10Y Coverage Period”) The financial assistance coverage provides enrolled consumers with replacement Mia^® Diamonds and up to $5,000 USD of financial assistance for a 10Y Coverage Event (as defined below). The financial assistance can be applied to the actual incurred and documented costs of the replacement surgery when the consumer and surgeon have fully complied with the Mia^® Comprehensive Coverage, conditions, and claim procedures in these Terms & Conditions. If a rupture or capsular contracture with Baker grades III or IV occurs during the 10Y Coverage Period (a “10Y Coverage Event”), the Product Replacement Policy and financial assistance coverage will be applied to the affected Mia^® Diamonds. For clarity, any applicable Mia^® Comprehensive Coverage covering a patient’s Mia^® Diamonds can be applied to only one 10Y Coverage Event; if there is no 10Y Coverage Event, then the Product Replacement Policy Period for capsular contracture and the financial assistance will void at the end of the 10Y Coverage Period.

Exclusions:

The Mia^® Comprehensive Coverage will not apply to any procedures performed without strict accordance to the then-current DOC-002 “Directions for Use, Sterile Silicone Breast Implants Motiva^® Implant Matrix” and accepted surgical procedures by appropriately qualified, licensed surgeons. Notwithstanding the foregoing, for the Mia^® Comprehensive Coverage, the consumer will still be eligible for financial assistance if she can demonstrate that non-compliance with the foregoing directions and procedures did not cause the warranty case at hand. The Mia^® Comprehensive Coverage does not apply to:

Consumers with previous history of capsular contracture with other brands of breast devices.

• Removal of intact Mia^® Diamonds for capsular contracture grades I or II.
• Removal of intact Mia^® Diamonds for size alteration.
• Removal of intact Mia^® Diamonds due to wrinkling or rippling.
• Loss of shell integrity caused by or during re-operative procedures.
• Loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures.
• Loss of shell integrity resulting from sharp instrument damage.

Making a Claim & Financial Assistance Application

To make a claim under the Mia^® Comprehensive Coverage or to apply for financial assistance, the consumer should make the warranty claim on the Mia^® support website at: https://miafemtech.com/contact. Rupture and capsular contracture Baker grades III and IV cases must be reported to Establishment Labs within the eligibility time frame defined in the Mia^® Comprehensive Coverage. The following is required to verify eligibility for Mia^® Diamond replacement and/or financial assistance (as applicable) under the Mia^® Comprehensive Coverage:

• Document the consumer’s implant information and the event description in FOR-302 “Complaint Notification (Customer).” This document must be completed in full and signed by the treating surgeon. This report includes vital information that must be accurately provided, such as the device and tool references, series and lot numbers, volume, base, projection, expiration date, and type. It also must contain a detailed description of the event being reported.
• For capsular contracture Baker grades III and IV claims, provide an ultrasound or high-resolution ultrasound, including the technician's report confirming the diagnosis.
• Provide a clinical report from the surgeon indicating the evolution of the consumer after the procedure and the evolution of the complication.
• Provide post-procedure and post-complication photographs of the consumer (frontal and lateral), showing the appearance of the breast before and after the complication, prior to the explant procedure.
• For rupture claims: the explanted product is required; exceptionally, when local applicable laws do not allow it, please contact Establishment Labs for assistance. When local applicable laws allow for the return of the explanted product, the patient must instruct the surgeon to send the removed and decontaminated and sterilized product following SID-129 “Returned Devices Handling Protocol”, and all applicable laws, rules and regulations to: Establishment Labs, Coyol Free Zone and Business Park, Building B25, Alajuela, Costa Rica.
• Establishment Labs may, at its own discretion, request a copy of the operative report for the revision procedure and/or copies of bills showing procedure room, local anesthesia, and surgeon fees incurred for the replacement procedure.
• Establishment Labs reserves the right to exclude from the Mia^® Comprehensive Coverage surgeons with repetitive complaints for capsular contracture Baker grades III and IV whose ratios fall significantly out of the range of reasonable and proportional amounts of such claims, considering the number of procedures performed and known post-market complication rates for Mia^® Diamonds. This is without prejudice to the respective consumer’s right to file a warranty claim based on the Mia^® Comprehensive Coverage through a different surgeon.
• Establishment Labs reserves the right to investigate and request additional evidence and documentation in the event of repetitive claims from a single consumer, from a single surgeon, or from a single clinic or hospital.
• Establishment Labs has up to 90 days to solve and close a complaint but will use reasonable efforts to solve a complaint in a shorter time period.
• In the case where there is a lack of clinical evidence provided for a Mia^® Comprehensive Coverage claim, Establishment Labs will make up to three attempts to request additional evidence. If no response is received, Establishment Labs is authorized to close the complaint.
• For guidance on providing the necessary information and support documentation BEFORE any Mia^® Diamond is explanted, the consumer or their surgeon should contact the local representative or Establishment Labs Consumer Care Department at https://miafemtech.com/contact.

Establishment Labs will not pay for any replacement operation expenses until Establishment Labs has received the complete form FOR-302 “Complaint Notification (Customer).” In addition, Establishment Labs may require the claimant to submit a copy of bills or receipts associated with the replacement procedure before payment will be made. Other documentation, such as procedure notes, may be required prior to payment. Claims for financial assistance must be made to Establishment Labs through: https://miafemtech.com/contact. Establishment Labs reserves the right to cancel, change, or modify the terms in this document without notice and without the consent of a consumer or surgeon. Any such cancellation, change, or modification will not affect claims regarding implants already registered and covered under the existing Mia^® Comprehensive Coverage in effect on the date of the procedure. The Mia^® Comprehensive Coverage is non-transferable and non-refundable. The Mia^® Comprehensive Coverage is void to the extent that it is prohibited by local law.