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 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 capsular contracture, Baker grades III and IV claims: an ultrasound with the correspondent technician report or an MRI scan 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 the surgeon to send the removed and decontaminated product following the Explanted Breast Implants Handling Protocol (SID- 129), to Other topics.