MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415); Confusion/ Disorientation (2553); Patient Problem/Medical Problem (2688)

Event Date 07/20/2008

Event Type  Injury  

Event Description

I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6).One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity.Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away.I still struggle with gut issues and joint pain.I have had years of extensive testing done.Both functional med and regular doc over (b)(6) dollars worth.

• Brand Name: SALINE BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6345452
• MDR Text Key: 67990109
• Report Number: MW5067958
• Device Sequence Number: 2
• Product Code: FWM
• 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: 02/16/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BERBERINE; OREGANO; OTC MEDS: MAGNESIUM CITRATE; RX MEDS: SUPPLEMENTS ONLY NO MEDICATIONS.; VITAMIN C; VITAMIN D
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 56