MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Inflammation (1932); Rash (2033); Depression (2361); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 05/01/2015

Event Type  Injury  

Event Description

A few years ago i was having hormone inbalance issues.After seeking medical attention for this, i learned through labwork.I had very high levels of several heavy metals in my blood.I underwent treatment for this.I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression.I was informed that many women are having similar issues that have breast implants.The correlation makes sense to me.I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle.I should not be sick like i am.Labs show inflammation in my body, which is likely due to the implants.I am having the implants removed on (b)(6).Please look at breast implant illness and healing by (b)(6).There is a group of 30,000 women.Many of having symptoms even much worse then i.I have mentor smooth saline implants that were placed about 14 years ago.

• Brand Name: SALINE BREAST IMPLANT
• Type of Device: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7179039
• MDR Text Key: 96960363
• Report Number: MW5074505
• 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: 01/06/2018
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 61