SILICON TESTICULAR IMPLANTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-01 for SILICON TESTICULAR IMPLANTS manufactured by Unk.

Event Text Entries

[5568189] In 1981 i had anaplastic seminoma in the left testicle. The testicle was removed followed by radiation treatment. In 1990 i had seminoma in the right testicle which was removed followed by bilateral silicon prosthetic implants. I had a metastasized seminoma in the abdominal lymph nodes in 1991 followed by combination chemotherapy, vp-16, cisplatin and bleomycin. Somewhere around 2000, i noticed that the right implant had adhered to the scrotum. Around 2004, i started feeling a difference in the palpability of the two implants. The right one was definitely harder than the left. I complained to several doctors, but my concerns were dismissed. In 2006 i started getting small hard patches of skin primarily on the abdomen and arms, most have been burned off. Three ct scans spaced at two year intervals have shown a definite thickening shell around the right implant. It is now extremely hard and still adhered to the scrotum. In 2010 i had clear cell renal cancer treated with a partial nephrectomy. About a year and a half ago i had what was diagnosed as a genital wart burned off the shaft of the penis. Even though i am on androgel testosterone replacement, due to polycythemia when at higher doses, i take a small dose leaving me with very low libido. I have not had sex with anyone in nearly 10 years. My concern is that the genital warts was a misdiagnosis and is similar to the hardened skin areas possibly caused by an autoimmune reaction to the long term exposure to the silicon implant. I am also experiencing some recent hardening of the scar tissue from the groin incision to remove the left testicle from 1981.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5040622
MDR Report Key4491671
Date Received2015-02-01
Date of Report2015-02-01
Date of Event1990-09-17
Date Added to Maude2015-02-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSILICON TESTICULAR IMPLANTS
Generic NameTESTICULAR IMPLANTS
Product CodeFAF
Date Received2015-02-01
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameSILICON TESTICULAR IMPLANTS
Generic NameTESTICULAR IMPLANTS
Product CodeFAF
Date Received2015-02-01
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-02-01

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