MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN GEL IMPLANT
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); No Code Available (3191)
Date of Event	05/20/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6734607
• Report Number: 1645337-2017-00042
• Device Sequence Number: 1418358
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention