MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SILICONE)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Autoimmune Reaction (1733); Fatigue (1849); Increased Sensitivity (2065); Numbness (2415); Palpitations (2467); Confusion/ Disorientation (2553); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Event Description

I had silicone breast implants from mentor in 2013.Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies.

• Brand Name: BREAST IMPLANTS (SILICONE)
• Type of Device: BREAST IMPLANTS (SILICONE)
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6656739
• MDR Text Key: 78174485
• Report Number: MW5070532
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: CY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 26 YR
• Patient Weight: 50