Mia® Woman’s Choice Program
Terms and Conditions
This document (the “Terms & Conditions”) describes the terms, conditions, and claim procedure for the Mia® Woman’s Choice Program (the “Program”). Subject to these Terms & Conditions, the Program is offered by Establishment Labs S.A., with registered office at 4th Street, Coyol Free Zone #B15, Alajuela 20102, Costa Rica, and its affiliates (collectively, “Manufacturer”) and is available to individuals implanted with Mia® Diamonds (the “WCP Participants”) purchased directly from Manufacturer or its authorized distribution partners specifically via the Mia® branded experience offering, as evidenced by product serial numbers permitting registration for the Program (the “Qualified Mia® Diamonds”). The Program is intended to enable WCP Participants’ choice by providing the financial support indicated in these Terms & Conditions in the event a WCP Participant elects to remove the Qualified Mia® Diamonds during the Program Validity Period (defined below). There is no additional cost to WCP Participants to participate in the Program provided that the eligibility and registration requirements contained in these Terms & Conditions are fully satisfied and the Validity Period remains in effect.
1. Program Overview & Program Credit
Under the Program and subject to these Terms & Conditions, an eligible WCP Participant who elects for any reason to have a Qualified Removal (as defined in Section 2 below) can receive financial support (the “Program Credit”) towards the cost of such Qualified Removal, as further described below. Except where limited or prohibited by law, the Program Credit shall comprise a payment of up to One Thousand five hundred US Dollars (USD $1500) or its equivalent in local currency at the conversion rate in effect on the actual date of payment as determined by Manufacturer in its sole discretion, and without reimbursement for currency fluctuations or bank transaction fees. For further details on the Program Credit, see Section 7 (Payment) below. Where legally permissible and authorized by Manufacturer, a WCP Participant may have the option to direct that the Program Credit be issued to a licensed medical professional or clinic to directly offset the costs associated with the Removal of the Qualified Mia® Diamonds.
A WCP Participant’s eligibility to receive a Program Credit is strictly subject to compliance with the following criteria and the Claim procedure referenced in Section 6 below. A procedure for removal of the Qualified Mia® Diamonds. which satisfies all of the eligibility conditions below and is not otherwise excluded under Section 3 below shall be referred to as a “Qualified Removal”.
2.1. Each WCP Participant must ensure their Qualified Mia® Diamonds are pre-registered, either by themselves or by their Mia® Certified Clinic, and confirmed via email or otherwise request assistance from the Mia® Consumer Care team at miafemtech.com/contact within ninety (90) calendar days following the original implantation procedure (the “Registration Deadline”). The WCP Participant is solely and exclusively responsible for accepting or confirming the registration process, even if led by the Mia® Certified Clinic staff, complying with the 90-day Registration Deadline, and verifying within their Mia® Profile account via the website: account.miafemtech.com/s/login/ the Qualified Mia® Diamonds’ serial numbers from the Mia® Certified Surgeon or Mia® Certified Clinic to ensure registration had taken place prior to the Registration Deadline. In no event shall Manufacturer or its representatives be liable or responsible for any failure to successfully transmit any online registration link to a WCP Participant due to an incorrect email address, Junk/SPAM filtering, service level disruption, or other factors. The WCP Participant may submit a registration support ticket via the website at miafemtech/contact. to request assistance with registration prior to the Registration Deadline. Neither Manufacturer nor its representatives is able to provide the Mia® Diamonds serial numbers to be used for registration, as they must be obtained from the Removing Surgeon only.
2.2. By registering for the Program and/or initiating any Claim, each WCP Participant accepts and agrees to comply in full with these Terms & Conditions.
2.3. A WCP Participant must elect to have the Qualified Mia® Diamonds completely and permanently removed, and actually undergo the Qualified Removal procedure during the Validity Period in order to claim the Program Credit.
2.4. Any Mia® Diamond removal procedure which is covered in whole or in part by private, public, government or social insurance benefits or reimbursement is explicitly excluded from the Program and will not qualify for the Program Credit.
2.5. If the WCP Participant received two (2) Qualified Mia® Diamonds, both Qualified Mia® Diamonds must be removed to receive the Program Credit.
2.6. The WCP Participant must not intend to receive, actually receive, or undergo a revision surgery involving, any replacement, substitute, new or alternate breast implants (of any manufacturer) and must intend to remove the Qualified Mia® Diamonds to remain without breast implants indefinitely.
2.7. In order to limit fraud, misrepresentation and abuse, the Mia® Diamond removal procedure must be performed by appropriately qualified and licensed medical professionals who affirm their adherence to these Terms & Conditions, as set forth in the Claim forms (each a “,”). See Section 5 below for more information.
3. Exclusions and Limitations
The following Program exclusions apply:
3.1. The Program is not valid in any jurisdiction in which the Mia® brand experience offering is unavailable (including but not limited to Japan), or to any individual who received Mia® Diamonds or other breast implants from surgeons or distribution channels not authorized by the Manufacturer to offer the Mia® branded experience, even if the applicable implants are successfully registered within Manufacturer’s systems or records. Any registration of Mia® Diamonds or other breast implants received outside of the Mia® branded experience shall be valid only with respect to otherwise applicable Manufacturer benefit programs and the registrant shall not comprise a “WCP Participant” as defined in these Terms & Conditions.
3.2. The Program is void where prohibited by law and has no cash value. For purposes of eligibility for Program registration, the location of the Mia® Procedure shall be controlled. For purposes of initiating a Claim and receiving the Program Credit, the location of removal and/or the WCP Participant’s residence shall control to verify compliance with applicable laws for a Program Credit to be issued to the Removing Surgeon or the WCP Participant, respectively. Based on the foregoing, and whether prohibited by law or these Terms & Conditions, if a WCP Participant is ineligible either to register or to receive the Program Credit in their geographic location, the Claim shall be denied in either case.
3.3. In no event shall the Program Credit be remitted in advance of the Qualified Removal. WCP Participants seeking a Program Credit are encouraged to complete the pre-qualification portion of the Claim procedure referenced in Section 6 below to confirm eligibility, including in connection with receipt of genuine Qualified Mia® Diamonds, valid Program registration in advance of the Registration Deadline, no local exclusion, continuity of the Validity Period, non-use of an Excluded Clinic, and other Qualified Removal criteria as set forth herein. For the avoidance of doubt, the Qualified Removal must be performed within the Validity Period to qualify for the Program Credit.
3.4. The Program will not apply to any Qualified Mia® Diamonds used, Mia® Diamonds removals performed, without adherence to Manufacturer’s then-current Directions for Use (DFU) and surgical procedure manuals applicable to the Qualified Mia® Diamonds.
3.5. The Program only applies to the surgical procedure for the complete and permanent removal of the Mia® Diamonds. By accepting these Terms & Conditions, WCP Participants acknowledge that there may be other procedures that may be necessary or appropriate in the medical professional’s judgment (such as the replacement or revision of the Qualified Mia® Diamonds or other medical or surgical procedures) and which are not covered by the Program or Program Credit.
3.6. The Program will not apply in the case where the removal of the Qualified Mia® Diamonds is totally or partially covered by a private or public insurance, reimbursement system, or similar scheme. Therefore, Manufacturer will deny the award of the Program Credit to any WCP Participants who benefit from total or partial private or public insurance, reimbursement system, or similar scheme covering the removal of the Qualified Implants. The Manufacturer reserves the right to investigate and request restitution of any amount provided in relation to WCP Participants who benefit from private or public insurance, reimbursement system, or similar scheme for the removal of the Qualified Mia® Diamonds.
3.7. The Program applies to Qualified Removal procedures performed by Removing Surgeons who have adhered to these Terms & Conditions. Manufacturer may, in its sole and absolute discretion, decline to issue the Program Credit (a) to any medical professional or clinic that: (i) is not licensed to perform Qualified Removal procedures in the applicable WCP Participant’s location, (ii) has been debarred, excluded from any government healthcare program, or been subject to any disciplinary action or legal enforcement action relating to the practice of medicine or surgery, fraud or abuse of public or private funds, corruption or bribery, crimes of moral turpitude, regulatory violations (including off label use of medical devices or pharmaceuticals), or violent crimes, (iii) in Manufacturer’s sole and absolute discretion, is suspected of engaging in fraud or abuse relating to the Program and/or any Manufacturer warranty, or (iv) raises concerns, in Manufacturer’s sole and absolute discretion, with respect to compromising patient safety (e.g. as a result of patient complaints or similar evidence) and/or the safe and effective use of Manufacturer’s products (an “Excluded Clinic”); or (b) directly to any WCP Participant who elects to have the Qualified Mia® Diamonds removed at an Excluded Clinic. If a WCP Participant’s Claim is denied at the pre-qualification stage of the Claim procedure referenced in Section 6 below solely on the basis that an Excluded Clinic was selected as the Removing Surgeon, such WCP Participant may re-apply for the Program Credit after selecting an alternate Removing Surgeon. It is the WCP Participant’s sole responsibility to verify that the Removing Surgeon is not an Excluded Clinic by initiating a Claim and obtaining Manufacturer’s determination of pre-qualification prior to undergoing the removal procedure in order preserve eligibility for the Program Credit.
3.8. Manufacturer reserves the right, in its sole discretion, to deny the issuance of multiple Program Credits to any individual WCP Participant, including but not limited to any WCP Participant who elects to purchase new Qualified Mia® Diamonds (i.e., excluding any implants received as part of a Manufacturer warranty or replacement program) at any time after previously undergoing a Qualified Removal for which a Program Credit was remitted.
3.9. Except as explicitly set forth in this paragraph, WCP Participants may not combine the Program Credit with any other benefits offered by the Manufacturer, including warranty benefits. Issuance of the Program Credit shall disqualify a WCP Participant from receiving any additional claimed benefits under any other Manufacturer warranty or benefit program with respect to the applicable Qualified Mia® Diamonds, including with respect to any procedures performed prior to the issuance of the Program Credit. Notwithstanding the foregoing, a WCP Participant shall remain eligible for a Program Credit if such WCP Participant (or their surgeon) applies for and receives Manufacturer warranty benefits or other benefits offered by Manufacturer’s polices from time to time; provided, however, that the Validity Period shall not be extended in such cases. For clarification, if a WCP Participant receives any no cost replacement implant under any Manufacturer warranty program covering the original Qualified Mia® Diamonds, the applicable Validity Period to complete a Claim procedure to qualify for a Program Credit with respect to a Qualified Removal to remove the replacement implants shall be calculated from the implantation date of the originally registered Qualified Mia® Diamonds and not from the date of implantation of the replacement implants offered under Manufacturer’s warranty programs.
4. Independent Program; No Warranty
The Program, while included as part of the Mia® branded experience offering, is a stand-alone and independent policy which is unrelated to and not part of the Qualified Mia® Diamonds separate warranties. The Qualified Mia® Diamonds may be subject to the Manufacturer’s standard warranty programs, which remain unaffected by this Program. For full warranty terms, please click visit: miafemtech.com/legal/mia-comprehensive-coverage.
The Program is also separate from any contract between the WCP Participant and third parties, including any medical professionals or institutions for providing surgical services to the WCP Participant, and does not limit or exclude any warranties or representations established under such contracts. The Manufacturer is neither part of any contract between the WCP Participant and third parties, including for surgical services to implant or remove the Qualified Mia® Diamonds, nor does the Manufacturer advise or otherwise influence such third parties or the WCP Participants with regard to any surgical services in connection with the Manufacturer’s products. The Program is intended as a courtesy benefit to support WCP Participants’ health and well-being and is not intended and shall not to the maximum extent permitted by law, be construed as a promotional practice, kickback, rebate or reward.
5. Removing Surgeons; Fixed Benefit Amount
In certain jurisdictions, WCP Participants may be able to locate potential Removing Surgeons via the Manufacturer’s searchable medical professional locator database, available at: miafemtech.com/clinic-finder. For the avoidance of doubt, the physicians and clinics listed in the Manufacturer’s searchable database are not complete or exhaustive and Manufacturer cannot guarantee that the information represented by third party clinicians on its website is current or accurate. WCP Participants must verify all information, including pricing and Mia® Diamond removal costs, with their selected clinician directly. The Manufacturer does not endorse, approve, favor or recommend any particular medical professionals and does not offer any medical advice, background or licensing checks, or recommendations. In no event shall the Manufacturer or its affiliates or representatives be liable or responsible with respect to the performance of any clinical procedure by a third-party healthcare professional, including but not limited to claims of malpractice. Subject to Section 3.7 above, any medical professional who complies with these Terms & Conditions and affirms the truthful and accurate submission of Claim data may qualify as a Removing Surgeon for purposes of the Program, including physicians not listed in the online locator database.
WCP Participants are encouraged to seek the advice of a licensed medical professional with respect to clinical judgment, patient safety and suitability for any medical procedure, potential risks and benefits of any Qualified Removal, procedure recovery times, prescription of medication or anesthesia, and related matters. Each WCP Participant’s healthcare provider should advise whether any ancillary procedures are or are not necessary or preferred in connection with a Qualified Removal for either health or aesthetic purposes.
The Manufacturer does not set or influence any medical professionals’ procedural or service costs, overhead or facility costs. The Program Credit is fixed independent of the aggregate cost of the Qualified Removal. Accordingly, WCP Participants are encouraged to discuss all procedure, medication and facility costs with one or more medical professionals in addition to seeking the Program Credit. Manufacturer is not liable to any WCP Participant or third party for the cost of any procedure (including the removal of the Mia® Diamonds) not covered by or within the Program Credit, or for which a Claim was denied for noncompliance with these Terms & Conditions.
6. Claim Procedure
WCP Participants may initiate a request for a Program Credit (a “Claim”) by visiting: miafemtech.com/contact. Both the WCP Participant and the Removing Surgeon must verify the criteria in Sections 2 and 3 above as part of the Claim process. Manufacturer may, in its sole discretion, require the submission of supporting documentation to validate and/or document any eligibility criteria, the absence of exclusion criteria or compliance with applicable laws or regulations prior to approving any Claim. All Claims must be initiated prior to the conclusion of the Validity Period and full verification details must be submitted no later than 180 days following the conclusion of the Validity Period to qualify for the Program Credit.
All Claims shall be subject to an initial pre-qualification check which, if approved, must be followed by a verification submission following the Qualified Removal to confirm eligibility to receive the Program Credit.
As part of the initial pre-qualification step in the Claim procedure, the WCP Participant must submit, among other things,
- Accurate information or documentation to verify the WCP Participant’s identity, receipt of Qualified Mia® Diamonds and timely registration for the Program prior to the Registration Deadline, such as the device serial and lot numbers and registration e-mail address. Such information can be derived from electronic records, transponder readings, and Qualified Mia® Diamonds purchase and delivery records with the help of the medical professional that performed the implantation.
- The WCP Participant’s location of Mia® procedure and proposed location of the removal, to verify geographical eligibility.
- The name, clinic address, telephone number and email address of the Removing Surgeon to confirm such Removing Surgeon is not an Excluded Clinic.
- An acknowledgement that the WCP Participant has no plans to, and shall not, receive any substitute or replacement breast implants in connection with the removal procedure or at any point in the future.
- Confirmation that the removal procedure shall not be covered by private or public insurance, reimbursement system, or any similar scheme.
As part of the verification step in the Claim procedure, each WCP Participant and designated Removing Surgeon must affirm, among other things, that all facts in the Claim are true and correct, that a Qualified Removal was duly completed within the Validity Period, that the removal procedure was not covered by insurance or healthcare program reimbursement, and that the WCP Participant did not receive replacement or substitute breast implants from the Removing Surgeon or any other medical professional in connection with the removal or otherwise. Each of the WCP Participant and Removing Surgeon must further acknowledge the designated payee of the Program Credit and the bank account to which the Program Credit will be remitted. The Manufacturer may, in its sole and absolute discretion, require proof of the invoice or other documentation to evidence the completion and/or cost of the Qualified Removal.
Manufacturer shall engage in commercially reasonable efforts to issue a determination with respect to prequalification eligibility and/or final Claim verification and approval within fifteen (15) business days following complete and accurate submission of all information requested under the Claim procedure and associated forms. If any of the required eligibility or verification information is missing or incomplete or requires additional review or verification, Manufacturer will make up to three (3) attempts to reach the WCP Participant via such WCP Participant’s indicated e-mail address in order to request the missing, incomplete or supporting details to enable Manufacturer to make a determination pursuant to these Terms & Conditions. If no response is received after the third attempt or if the WCP Participant fails to submit all requested information within a reasonable period not to exceed 180 days following the conclusion of the Validity Period, Manufacturer will deny and close the Claim, subject to such WCP Participant’s statutory rights under applicable laws. Each WCP Participant is responsible for causing their designated Removing Surgeon to timely complete and submit the Claim form(s) required to be submitted by the Removing Surgeon. No Program Credit shall be issued unless the Removing Surgeon has submitted verification of the Qualified Removal.
Manufacturer reserves the right to investigate and request additional evidence and documentation, particularly in the event of large numbers of Claims made with respect to a particular medical professional or medical institution. Additional time required for such investigation and request shall not affect the WCP Participant’s Claim.
For guidance on providing the necessary information and verification documentation, WCP Participants and their medical professionals may request support here: miafemtech.com/contact. The Manufacturer encourages WCP Participants to submit and resolve any questions related to their eligibility for the Program before a removal surgery is scheduled.
Subject to the criteria and exclusions in these Terms & Conditions, the Program Credit shall be remitted in the amount of the lesser of: (a) One-Thousand Five Hundred U.S. Dollars (USD $1500) or (b) the actual fees charged by the Removing Surgeon (as converted to U.S. Dollars applying the conversion rates of Manufacturer’s bank). Manufacturer shall issue the Program Credit within sixty (60) calendar days of its final approval and verification of a Claim. The WCP Participant and Removing Surgeon shall agree ahead of the Qualified Removal whether the Program Credit shall be granted in the form of a reimbursement paid to either the WCP Participant or the Removing Surgeon.
Manufacturer shall remit the Program Credit by wire transfer or bank transfer in U.S. Dollars, which may be converted by the recipient’s bank or any intermediary bank into the local currency of the receiving bank. The Manufacturer shall bear any costs charged by its own bank(s) in connection with the issuance of the Program Credit. The WCP Participant (or Removing Surgeon, depending on the case) shall bear any fees charged and deductions made by their own bank, and by any third-party banks involved in the transfer, including any costs or deductions related to currency conversions. The Manufacturer is not responsible for any currency fluctuation risk, sending or receiving bank conversion rates, wire transfer fees or other fees charged by the bank receiving the Program Credit or any intermediary banks.
The WCP Participant is solely responsible for providing accurate and complete information within the Claim procedure regarding the payee bank account to which the Program Credit shall be remitted. Manufacturer is not responsible for any errors, typographical or otherwise, in the payee information or in the misdirection of funds due to such error. Manufacturer’s sole obligation with respect to the remittance of the Program Credit shall be to wire or otherwise initiate a funds transfer in the amount of the Program Credit to the payee information exactly as listed in the Claim verification. Manufacturer shall have no obligation to reverse any payment, recover any lost or misdirected funds or duplicate any payment not received by the intended payee for any reason other than Manufacturer’s sole and direct error. The Manufacturer shall have no liability in respect of payments or debts owed between a WCP Participant and their designated Removing Surgeon. If the Program Credit is remitted directly to any WCP Participant, such WCP Participant is solely responsible for remitting full payment to their Removing Surgeon for any costs associated with the Qualified Removal. If the Program Credit is remitted to the Removing Surgeon, the WCP Participant shall directly coordinate with the Removing Surgeon to ensure appropriate credit to their invoice or account.
If the Program Credit is determined by Manufacturer to be contrary to applicable laws in the WCP Participant’s jurisdiction, Manufacturer may, in its sole and absolute discretion, offer a discount coupon, voucher, gift card, clinic account credit or similar value alternative in lieu of the Program Credit, or may deny the claim for the Program Credit without penalty or compensation.
The WCP Participant shall be solely responsible for the payment of any taxes or tax liabilities associated with receipt of the Program Credit or its equivalent and shall pay any and all income, value added, stamp, or similar taxes that are due and payable under applicable laws or tax codes in the WCP Participant’s jurisdiction.
8. Program Validity Period
With respect to each WCP Participant, the Program Credit benefit shall be available for a period of two (2) years from the date of the original implantation of a Qualified Mia® Diamond (without regard to any later revision surgery dates) or such shorter period as determined by Manufacturer consistent with this Section (the “Validity Period”). Subject to applicable laws, the Manufacturer reserves the right to modify, cancel, update, terminate, limit or otherwise discontinue (each a “Modification”) the Program at any time, without notice to or consent of the WCP Participant or any third party, and including with effect to WCP Participants who previously registered for the Program prior to the Modification. Unless and to the extent retrospective Modification is prohibited by applicable law in respect to a particular WCP Participant’s case, the most recent version of these Terms & Conditions available on Manufacturer’s website shall govern and control all Program benefits applicable to such WCP Participant. Notwithstanding the foregoing, in no event shall the Validity Period exceed two (2) years from the date of the WCP Participant’s initial implantation with the Qualified Mia® Diamonds.
Where Manufacturer initiates a Modification applicable to WCP Participants that have previously registered for the Program, Manufacturer will engage in reasonable efforts to provide notice of such Modification to such WCP Participants in writing via the email addresses associated with the WCP Participants’ registration accounts and/or via the Manufacturer website and such WCP Participants shall have the right to terminate their participation in the Program upon receipt of any such notice. Nothing contained in these Terms & Conditions or any other instrument shall be construed as an obligation of the Manufacturer to maintain the Program for any particular period of time.
9. Further Terms
To the maximum extent permitted by applicable law, the rights of WCP Participants under the Program are non-transferable, non-contractual and non-promotional. Registration for the Program by a WCP Participant comprises an opt-in to the then-available Program benefits and does not create a binding contract between Manufacturer and any WCP Participant as of any particular date.
The Program and these Terms & Conditions, including any obligations, rights, and claims arising out of or in connection with them, any questions regarding valid conclusion of agreements under these Terms & Conditions, and any amendments thereto – irrespective of their legal grounds (e.g., under contract, tort or otherwise) – shall be exclusively governed by and construed in accordance with the laws of Costa Rica, excluding its conflicts of laws provisions, and the courts located in San Jose, Costa Rica will have exclusive jurisdiction on potential disputes. If the WCP Participant is a consumer within the meaning of the Regulation (EC) No. 593/2008, i.e., if the WCP Participant accepts these Terms & Conditions by registering for the Program for a purpose which can be regarded as being outside their trade or profession, the foregoing choice of governing law shall not have the result of depriving the WCP Participant of the protection afforded to them by provisions that cannot be derogated from by agreement by virtue of the law of the country where the WCP Participant has their habitual residence. Solely in such scenario, WCP Participants will be entitled to bring claims before the courts of the place of their habitual residence.