MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Pain (1994); Rash (2033); Weakness (2145); Myalgia (2238); Arthralgia (2355); Palpitations (2467)
Date of Event	01/01/2000
Type of Reportable Event	Serious Injury
Event or Problem Description
Breast implant illness.I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999.I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses.Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses.I'm going in this month for toxins testing.My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe.

• Brand Name: BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6604639
• Report Number: MW5070126
• Device Sequence Number: 734128
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/27/2017
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 45 YR
• Patient Weight: 64