MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN GEL IMPLANT

Device Problem Material Rupture (1546)

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

Event Date 05/20/2015

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.(b)(4).The device was not returned to mentor.

Event Description

It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011.The patient felt discomfort which she had not previously experienced.After approximately 1.5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome.She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection.Patient took advil, various muscle relaxants, heat and other remedies.Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015.Patient felt symptom-free almost immediately after removing implants.She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since.

• 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: 6734607
• MDR Text Key: 80751568
• Report Number: 1645337-2017-00042
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/21/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 07/21/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention