MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Pain (1994); Rash (2033); Weakness (2145); Myalgia (2238); Arthralgia (2355); Palpitations (2467)

Event Date 01/01/2000

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6604639
• MDR Text Key: 76537027
• Report Number: MW5070126
• Device Sequence Number: 2
• 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: 05/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/27/2017 Patient Sequence Number: 1