There are several policies and warranties for the duration of the study.
Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk®/SilkSurface® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
This document describes the terms, conditions and claim procedures for Motiva Implants® warranty and product replacement programs.
Information for the Patient
Before the breast implant surgery, the surgeon should explain the details of the Motiva Always Confident Warranty®; the Product Replacement Policy, to the patient, and provide the patient with a copy of this document.
In addition to explaining the terms, the surgeon should also advise the patient about possible adverse events and complications associated with Breast Implants as well as the benefits and risks of surgery with Motiva Implants® silicone breast implants according to the Informed Consent for the Clinical Trial.
Always Confident Warranty®
All Motiva Implants® silicone breast implants are covered by the Always Confident Warranty® against rupture for the first 10 years of the device lifetime.
Establishment Labs will replace the products qualified as rupture with the same or similar type as the qualifying product free of charge for the warranty period. Implantation of the replacement product, as well as any subsequent procedures, must be in strict accordance with current Motiva`s product Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix (DOC-034 Directions For Use, DFU) and accepted surgical procedures by appropriately qualified licensed surgeons for such product to qualify for replacement.
The explanted product must be returned to Establishment Labs within 10 days of its explantation, properly decontaminated and sterilized by the surgeon, following the indications and procedures contained in the Establishment Labs S.A. Explanted Breast Implants Handling Protocol (SID-129), and any additional applicable regulations regarding biological risk. Shipping charges will be covered by Establishment Labs
Failure to abide by these terms will invalidate any claim.
Product Replacement Policy
All Motiva Implants® silicone breast implants are covered by our Product Replacement Policy in the event of capsular contracture Baker grades III and IV for a period of 10 years.
Establishment Labs will replace the products qualified as rupture with the same or similar type as the qualifying product, free of charge for ten years since the first implantation surgery. Implantation of the replacement product, as well as any subsequent procedures, must be in strict accordance with current Motiva`s product Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix (DOC-002 Directions For Use, DFU) and accepted surgical procedures by appropriately qualified licensed surgeons for such product to qualify for replacement.
Qualifying replacement product will be sent without shipping charges. Motiva will neither provide nor pay for a non-Motiva product, nor in any event provide money for or in lieu of a Motiva replacement product.
Failure to abide by these terms will invalidate any claim.
Motiva Implants® silicone breast implants warranty shall not apply to any implantations performed without strict accordance to current product “Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix” (DOC-034) and accepted surgical procedures by appropriately qualified licensed surgeons.
Motiva Implants® standard and extended warranty program do not apply to:
•Removal of intact implants for capsular contracture, Baker Grade I or Baker Grade II
•Removal of intact implants for size alteration
•Removal of intact implants 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
Establishment Labs may exclude from the applicable warranty program patients with previous history of capsular contracture Baker grades III and IV
Filing a Warranty Claim
To file a claim for any warranty program the patient´s surgeon should file the warranty claim through Motiva support site at:
Rupture and Capsular Contracture Baker grades III and IV cases should have been reported Establishment Labs within the stated eligibility timeframe.
The following information is required to apply for either program product replacement approval:
• Information to document the patient’s implant information and the patient’s event description FOR302 – Complaint Notification (Customer) This document must be completed and signed by the treating surgeon. This report includes vital information that must be accurately stated, such as the device reference, 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: an ultrasound or an MRI scan with the correspondent technician report and photographs of the patient as clinical evidence; and the doctor’s report on the case showing the appearance of the breast 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 it the patient must require for the surgeon to send the removed and decontaminated product following the Explanted Breast Implants Handling Protocol (SID-129), to:
Establishment Labs S.A., Coyol Free Zone and Business Park, 0 Street, Building B-25, Alajuela, Costa Rica.
For guidance on providing the necessary information and support documentation BEFORE any implant is explanted the patient or its surgeon should contact the local representative or through Motiva support site.
Establishment Labs reserves the right to cancel, change or modify the terms established in this document. Any such cancellation, change or modification will not affect the stated terms as of the date of their implantation for those already registered and covered under the existing warranty programs in effect on the date of the applicable implantation.