MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Model Number SALINE

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Pain (1994); Arthralgia (2355); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 11/17/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years.Capsules were thick, yellowish and my chest full of yellow murk liquid.Right implant was yellow and full of particles inside.Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others.After surgeon removed the implants, my health has improved by at least 90 percent.It's clear that the silicone toxins released through the shells were attacking my autoimmune system.

• Brand Name: SALINE BREAST IMPLANT
• Type of Device: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6338997
• MDR Text Key: 67848536
• Report Number: MW5067929
• 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: 02/15/2017
• 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?: Yes
• Device Operator: No Information
• Device Model Number: SALINE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 62