MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Material Integrity Problem (2978)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Pain (1994); Thyroid Problems (2102); Complaint, Ill-Defined (2331); No Code Available (3191); Constipation (3274)

Event Date 01/01/2006

Event Type  Injury  

Event Description

I had saline breast implant in 2005. My sickness started about a year later. I recently explanted in (b)(6) 2016. I had suffered from thyroid disease, autoimmune disorder, hashimoto's and p. O. T. S. I've had to have a full hysterectomy, remove my gallbladder, appendix, and part of my colon out, all by (b)(6). Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669670
• MDR Text Key: 78630868
• Report Number: MW5070657
• Device Sequence Number: 1
• 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: 06/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• 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: 06/24/2017 Patient Sequence Number: 1