MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN GEL IMPLANT

Device Problem Material Rupture (1546)

Patient Problems Autoimmune Disorder (1732); Breast Mass (2439); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).The product is not returned.

Event Description

It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants.Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression.The patient also reported breast pain which appeared in 2016 along with lump in her breast.Mri confirmed that the breast implant had ruptured.In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed.

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: carl hansen ; north irving, TX 75038-3540 ; 9497893858
• MDR Report Key: 6754036
• MDR Text Key: 81401473
• Report Number: 1645337-2017-00048
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability