CLAIM STEPS FOR THE SURGEON/DISTRIBUTOR
Please register your clinical complaint through our Professional Support Center (https://motiva.health/surgeons-contact/).
Choose "Breast Implants" and select "I want to file a complaint" (last option), click on "Filing a claim", where you can download the FOR-302 Complaint Notification form and "SID-129 Explanted Implant Handling Protocol".
Fill out the form as detailed as possible (you can do this on the computer, without printing it). Scroll down to "Request Support". Fill in all the requested information (be sure to click on "I want to file a claim" on the drop-down menu, because each form is different depending on the option selected), attach the FOR-302 and all other required documents as indicated in the Support Center (photos of the patient, copy of the MRI or ultrasound, etc).
You can also ask your sales rep and/or local Motiva Customer Care department for assistance.
For claims related to rupture, the explanted unit must be returned to our laboratory for analysis. Please follow our "SID-129 Explanted Implant Handling Protocol". Customer Care will send you a return kit for the decontaminated product with instructions on how to do this. This should be sent along with a copy of the FOR-302, detailed in previous paragraphs.
Upon submission of the online form, a ticket will be opened and assigned to our Post-Market Surveillance department and you will receive an email notification with the assigned case number.
Once the documentation is complete, the investigation should take a maximum of 90 days to complete. Upon completion, we will send you a letter detailing the results of the investigation.
Please note that if your medical diagnosis is that the patient should be reoperated as soon as possible, it is not necessary to wait for our approval. You may proceed with the surgery and, once the investigation is completed, we will replace the implant and, if applicable, pay the extended warranty. In order to make use of the Motiva® Implant Warranty, you must have reported suspected implant rupture or Baker Capsular Contracture III or IV.
Let us know if you have any additional questions.