MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

I had mentor saline implants for 17 years and had a list of health problems from them.Since explanting, all of my health issues are gone.I was told by my plastic surgeon that they were safe and never warned of the dangers, including that the outer shell is made of silicone with almost 40 toxic chemicals.

• Brand Name: SALINE BREAST IMPLANTS
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7212093
• MDR Text Key: 98071954
• Report Number: MW5074726
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 48