MAUDE Adverse Event Report: MENTOR SALINE IMPLANTS

Lot Number	5896978/LEFT
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Tinnitus (2103); Anxiety (2328); Skin Inflammation (2443); No Code Available (3191)
Date of Event	10/31/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
In 2005, i had mentor smooth saline implants placed above the muscle.In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile.Starting in (b)(6) 2014, i started having alopecia areata.I was treated by several different dermatologist with steroids im as well as into the bald patches on my head.There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014.This included all body hair (underarms, pubic, legs) as well as any head hair.(scalp, eye brows, eye lashes, nasal hair, facial peach fuzz).I have been to a multitude of doctors, none of which have been able to treat the problem.It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants.On (b)(6) 2017, i had the mentor implants removed and no implant replacement.Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears.I also tested positive for lyme disease.Adrenal fatigue.

• Brand Name: SALINE IMPLANTS
• Common Device Name: SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6940466
• Report Number: MW5072707
• Device Sequence Number: 14820454
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/09/2017
• 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
• Operator of Device: No Information
• Device Lot Number: 5896978/LEFT
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2017
• Patient Sequence Number: 1
• Patient Weight: 68