MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Lot Number 6646221

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

Patient Problems Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Blurred Vision (2137); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously.Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6560080
• MDR Text Key: 74933901
• Report Number: MW5069699
• Device Sequence Number: 1
• Product Code: FTR
• 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: 05/10/2017
• 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
• Device Lot Number: 6646221
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BIO IDENTICAL HORMONES; MULTIPLE VITAMINS; OTC MEDS: PROBIOTICS; RX MEDS: NEURONTIN
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 58