MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Asthma (1726); Autoimmune Disorder (1732); Cyst(s) (1800); Fungus (1872); Hypersensitivity/Allergic reaction (1907); Hernia (2240); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191)

Event Date 12/27/2010

Event Type  Injury  

Event Description

I got mentor saline breast implants.Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog.Within a year i developed a hernia, then had another hernia the following year.After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed.I also developed asthma, and allergies to foods that were never an issue before.

• Brand Name: MENTOR SALINE BREAST IMPLANT
• Type of Device: MENTOR SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6975780
• MDR Text Key: 90301728
• Report Number: MW5072931
• Device Sequence Number: 2
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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): Disability
• Patient Weight: 76