SILICONE INJECTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for SILICONE INJECTION manufactured by Unknown.

Event Text Entries

[8689] In 1982, rptr had silicone injections in acne scars on both sides of her face. She is now experiencing serious medical problems. In 1980, she started seeing a dr for cystic acne. In the fall of 1981 rptr asked dr if anything could be done to make the acne scars look better. Dr said she could excise them. In 3/92 she suggested silicone injections to plump up the scars instead of excising them. Rptr was reluctant to have the injections because she has so many allergies. Dr assured rptr that the silicone injections were safe. Rptr had 2 silicone injections in each of the scars, but it was enough to cause severe damage to skin and muscle tissue. Last yr (1992) rptr made several attempts to get her medical records from dr and was told her medical records were as follows: in the archives at her old office, records were lost, office had records, "i saw your folder and i remember your name. " rptr called again and was told that dr doesn't keep medical records more than 7 yrs. In 1990, rptr saw a different dermatologist because she had a swollen, painful spot on the left side of her lip. Little white balls were erupting from this spot and it took over 6 months to heal. In the summer of 1991, rptr saw a program on tv about women who had silicone injections for cosmetic reasons. Rptr told the dermatologist she had silicone injections in the still visible scar above the eruption. He advised rptr to see a plastic surgeon. Rptr has had plastic surgery in this same spot twice. The silicone that remains has turned into hard lumps. Rptr needs a skin graft and reconstructive surgery in this area because the silicone destroyed skin and muscle tissue. If rptr tries to open her mouth wide, she feels like her lower eyelid is being pulled down. About one month ago silicone started erupting from the right side of rptr's lower lip. On saturday evening, 8/7, rptr was watching tv when this spot began to bleed. About 2 hrs later rptr stopped the bleeding by packing gauze in the opening. Sunday morning rptr was taken to the er. She needed to know if she did the right thing to stop the bleeding. Also, her right jaw was very swollen and blue as she was bleeding internally. They watched rptr for a couple of hrs and sent her home. On monday 8/9, plastic surgeon took the packing out of the wound. He thinks that silicone eroded a blood vessel; he can see the silicone still in there. Rptr was told not to go to work all wk because she had to rest and hope the blood vessel healed or she would need surgery. This spot that caused the bleeding first erupted in late 1984. Rptr can remember a hard, swollen, painful area that the very same little hard white balls erupted from. Rptr found a photograph dated 12/85 in which the scar is visible. Through the yrs these eruptions have occurred on many other areas of her face. A small piece of silicone is visible on the left side of rptr's nose. Most of it traveled down to the jaw and lower lip on both sides of her face.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000225
MDR Report Key11553
Date Received1994-02-07
Date of Report1993-08-18
Date Added to Maude1994-02-18
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 Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSILICONE INJECTION
Product CodeKGM
Date Received1994-02-07
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11553
ManufacturerUNKNOWN
Manufacturer AddressUNKNOWN *


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-07

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