MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ MENTOR MENTOR SMOOTH ROUND BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Rash (2033)

Event Date 10/01/2010

Event Type  Injury  

Event Description

I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. Anaphylactic symptoms. Memory problems, disturbing enough to affect me emotionally as well. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Hair thinning and lost. Muscle pains and joints. Implants are poisonous.

• Brand Name: MENTOR SMOOTH ROUND BREAST IMPLANTS
• Type of Device: MENTOR SMOOTH ROUND BREAST IMPLANTS
• Manufacturer (Section D): JOHNSON AND JOHNSON/ MENTOR
• MDR Report Key: 7027559
• Report Number: MW5073305
• Device Sequence Number: 1
• Product Code: FTR
• 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: 11/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• 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 Age: 46 YR
• Patient Weight: 70
• Patient Outcome(s): Required Intervention