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: 2
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/18/2016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 29 YR
• Patient Weight: 59