MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - RIGHT SIDE IMPLANT 350-7504BC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-18 for MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - RIGHT SIDE IMPLANT 350-7504BC manufactured by Mentor.

Event Text Entries

[55317144] I have bilateral (b)(4) memory gel silicone gel filled breast implants. First surgery with mastectomy was in 2010. Had implants on both sides to try to match size. In (b)(6) 2012, i had surgery again, and the left implant was exchanged for a smaller one and placed with strattice contour number 2 to help hold the implant up. After getting the implants, starting in 2012 through current, i have developed nerve problems in my hand and foot, carpel tunnel, tennis elbow, shoulder inflammation, thyroid nodules, hashimotos thyroiditis, fibromyalgia, infertility, irregular menses with early menopause, shortness of breath, mild chest pain, irregular t-wave abnormality on ekg that resolved, and most recently, high blood pressure. I had an mri in (b)(6) 2016 and was found to have a ruptured left breast implant within the capsule. I saw my plastic surgeon and was told i also have a grade ii capsular contraction. That left implant was placed (b)(6) 2012. Explant was (b)(6) 2016 on both. The pathology report says on the left capsule, "breast implant capsule showing dense fibrosis. Oleogranulomatous and chronic inflammation with small focal reactive lymphoid infiltrates. Comment also say, immunohistochemical stains on block b2 shows an admixture of cd3 and cd20 positive t and b lymphocytes. The stains for cd30 or alk are negative. The stains support a benign reactive inflammatory reaction. The hospital kept both the implants and the capsules. My physician took photos of them in the operating room prior to sending to pathology. I believe these implants have caused many, if not all, of my medical problems as they did not exist prior to having implants. The one reported on this report is the right implant. On my right side, (already reported) was surgery with mastectomy in 2010, left side, was placed at the same time but exchanged in (b)(6) 2012 for a smaller mentor gel implant with strattice contour #2 to help hold the implant up. After getting the implants, starting in 2012 to current. In fact, i was a runner and in very good condition. Because of foot nerve problems, with chronic inflammation, even after having the nerve excised, i can not get out and run.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5064843
• MDR Report Key: 5962826
• Date Received: 2016-09-18
• Date of Report: 2016-09-18
• Date of Event: 2012-09-01
• Date Added to Maude: 2016-09-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - RIGHT SIDE IMPLANT
• Generic Name: MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - RIGHT SIDE IMPLANT
• Product Code: MRD
• Date Received: 2016-09-18
• Catalog Number: 350-7504BC
• Lot Number: 6406514
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MENTOR

Device Sequence Number: 2

• Brand Name: MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - LEFT SIDE IMPLANT
• Generic Name: MENTOR MEMORY GEL BREAST IMPLANT SILICONE GEL - LEFT SIDE IMPLANT
• Product Code: MRD
• Date Received: 2016-09-18
• Lot Number: 5975686
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MENTOR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2016-09-18