MAMMARY PROSTHESIS 354-3757

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for MAMMARY PROSTHESIS 354-3757 manufactured by Mentor.

Event Text Entries

[63826502] Examination history: implanted with mentor memory gel round breast implants (375cc) in 2007. Saw ob-gyn in 2016 due to abnormal swelling and pain in one breast. Ob-gyn made order for bilateral mammogram and ultrasound on side showing swelling. Ultrasound revealed fluid around implant and silicone particles in lymph nodes on affected side. Plastic surgeon who did original implant advised that i should wrap my chest with ace bandage when flying, and that implants could stay in. She conceded that removal was optional, and that replacement of implants was optional and that they (implants) were still covered under warranty. She disagreed that any symptoms (outlined below) could be related to possible implant rupture. Radiology report from a second exam revealed collapsed intracapsular rupture on right side with silicone identified within the capsule of the right external to implant, as well as bilateral adenopathy. Second opinion exam from a different plastic surgeon resulted in recommendation for explant surgery performed by en bloc procedure with drains. The following reflects some of the symptoms i've experienced include: severe vertigo, requiring medical treatment and hospitalization, numbness in hands and feet pain in chest low blood pressure, frequent fever blisters and canker sores; hair loss, dry skin, severe fatigue and loss of strength, frequent shock from static, irregular menses, difficulty with concentration, memory loss, changes in balance, regular headaches, joint pain and problems with corrective tissue; fungal rashes. The experience of these symptoms has resulted in a severe and negative impact on my life, including my ability to work and my overall quality of life.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067001
MDR Report Key6217845
Date Received2016-12-29
Date of Report2016-12-29
Date Added to Maude2017-01-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameMAMMARY PROSTHESIS
Generic NameMAMMARY PROSTHESIS
Product CodeMRD
Date Received2016-12-29
Model Number354-3757
Lot Number5627077
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMENTOR

Device Sequence Number: 2

Brand NameMAMMARY PROSTHESIS
Generic NameMAMMARY PROSTHESIS
Product CodeMRD
Date Received2016-12-29
Model Number354-3757
Lot Number5627077
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerMENTOR


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2016-12-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.