Filing a clinical complaint
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For additional guidance on how to file a claim, please contact the local representative or Establishment Labs® Customer Service Department.
To file a claim for any warranty program patient must be accompanied by their surgeon and submit the required documentation as follows:
The following information is required to verify eligibility for financial assistance and/or product replacement under the Extended Warranty Program
- Information to document the patient’s implant information and the patient’s event description FOR-302 COMPLAINT NOTIFICATION (CUSTOMER) / FOR.S-302 NOTIFICACIÓN DE QUEJAS (CLIENTE). 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.
- A copy of the operative report for the revision surgery
- Copies of bills showing operating room, anesthesia, and surgeon fees incurred for the replacement surgery.
- For Baker III/IV capsular contracture claims: a clinical history (clinical report from the surgeon indicating the evolution of the patient after the surgery and the evolution of the complication) and photographs (frontal and lateral), showing the appearance of the breast before and after the complication.
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For rupture claims: when local applicable laws allow it, the patient must require the surgeon to send the removed and decontaminated product following the Explanted Breast Implants Handling Protocol (SID- 129). In cases in which the explant is not available for return, the following clinical evidence should be provided: clinical history (clinical report from the surgeon indicating the evolution of the patient after the surgery and the evolution of the complication) and imaging: CT Scan, Ultrasound, high-resolution ultrasound, or MRI scan (including the technical report confirming the diagnosis).