SILICONE BREAST IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for SILICONE BREAST IMPLANT manufactured by .

Event Text Entries

[32221270] Circa 1985-87, dr. (b)(6) of (b)(6) plastic surgeon implanted (b)(4) imported silicone breast implants. I cannot remember name of company, can someone help me out here. Circa 2000-2001 i began to not be able to walk in an upright position. I thought it was from a sciatic attack. Went to (b)(6), they prescribed vioxx, stopped taking vioxx 9 months later. Began having numbness of extremities, arms, hands, legs, stiff neck all the time. Circa 1996, endomethacin prescribed by prison doctors while incarcerated. Very difficult, mri squashed breasts, very painful. Endomethacin ended due to stomach problems. Lack of mobility continued. Circa 2015, still unable to walk upright position. Physical maladies include medium raynaud's disease symptoms breast implants not removed since original operation. Hardened encapsulated and getting painful gout type symptoms persist approx 4x a year. I am questioning if i need to absolutely have these implants removed as i am living only from (b)(6). I want dr. (b)(6) to be my plastic surgeon (b)(6). Is there a medical insurance which might assist me in re-implant procedure? If possibly decided as ok and have no health insurance dr (b)(6) has since retired, i need to find out what silicone implants were imported from (b)(4) in 1985-7. I believe third generation. He told me they cost an extra (b)(6) per implant as they were superior quality. I was never told i needed to have mri or re-implant surgery by dr (b)(6). My stupidity for lack of self education. I believe i have third generation implants still intact or not??
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058131
MDR Report Key5250198
Date Received2015-11-20
Date of Report2015-11-20
Date Added to Maude2015-11-25
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 Report3

Device Details

Brand NameSILICONE BREAST IMPLANT
Generic NameSILICONE BREAST IMPLANT
Product CodeNOJ
Date Received2015-11-20
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2015-11-20

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