MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Model Number	SALINE
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Pain (1994); Arthralgia (2355); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6338997
• Report Number: MW5067929
• Device Sequence Number: 1021533
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: SALINE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 62