MAUDE Adverse Event Report: MENTOR TEXTURED SALINE IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hair Loss (1877); Pain (1994); Burning Sensation (2146); Anxiety (2328); Palpitations (2467)

Event Date 09/10/1994

Event Type  Injury  

Event Description

I got textured saline implants over muscle. I was told that these were lifetime devices. These implants unknowingly caused me severe neurological problems, extreme unnatural fatigue, hair loss, developed lipomas, heart palpitations, experience severe burn like pain in arms, neck, under armpit, early menopause, anxiety, loss of dreams and more. I believe the body's eventual reaction to the implants aged me prematurely.

• Brand Name: TEXTURED SALINE IMPLANT
• Type of Device: TEXTURED SALINE IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6972010
• MDR Text Key: 90208550
• Report Number: MW5072914
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• 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: 10/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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: 10/24/2017 Patient Sequence Number: 1