MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Pain (1994); Thyroid Problems (2102); Complaint, Ill-Defined (2331); No Code Available (3191); Constipation (3274)
Date of Event	01/01/2006
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669670
• Report Number: MW5070657
• Device Sequence Number: 17384226
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/24/2017
• 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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 29 YR
• Patient Weight: 59