SILIKON 1000 LIQUID SILICONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-21 for SILIKON 1000 LIQUID SILICONE manufactured by Alcon.

Event Text Entries

[53005609] I visited an ear, nose and throat dr for zyplast lip injection. He injected liquid silicone at his own discretion without consulting or even mentioning until it was done. He said "this will last you a little longer. " i had been in for zyplast before and was happy with the results although temporary. I knew nothing about liquid silicone injections and immediately started researching it online. There was not a lot of cases for lip injection except for doctors explaining the protocol of injecting tiny amounts several month apart, which my doctor did not do. In 3 months, i noticed my lips were getting larger and changing shape as well as occasionally inflamed. I filed a complaint with the state medical board and i was asked to testify, but at the time, i had children at home and could not leave for an out of town trip. The doctor managed to get off with a reprimand for not having written notes about our 'consultation,' which never happened, and a (b)(6) fine. I have a witness to my account, my friend who sent to the appt with me and also decided to get zyplast injection and now has silicone lips too. We were in the room together at the time. A few years ago, i went to a plastic surgeon who said he would not touch my lips because there was an "off label" material in them. I gave up and suffered being self conscious for all these years, all the while my lips continue to change shape and are puffy and bumpy. In the last few years, there are many more stories about botched silicone lips as well as surgeons who are skilled and experienced in removing most or some of it. I have an appointment next week with a plastic surgeon to discuss whether or not he can help me. I want to know why liquid silicone is allowed to be used at all "off label"? It is not a good injectable and should be illegal for use as a face or body filler in its liquid form. I resent having to be embarrassed all these years and have to deal with the result of a stupid doctor's decision made without my consent. It's a physical, emotional and financial burden for me and now i truly understand the affects of liquid silicone, can show up decades after injection and i have so much evidence of malpractice, the statute of limitations has passed and i'm stuck with the unk complications in the future while the doctor is still injecting liquid silicone into lips. By the way he offered to "suck out" the silicone with a syringe or excise it when i called him the 1st 3 months afterward. He shared that he injected silicone in his wife's lips and she didn't like it, so he cut it out, adding "she wasn't happy with her lips" (after he excised the silicone), "but i think she looks fine. " there was no way i would let him touch me after that. Fda owes the public to warn against injecting liquid silicone. It causes very long-term problems well after status of limitation for holding doctors liable. Route: given into/under the skin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064287
MDR Report Key5900573
Date Received2016-08-21
Date of Report2016-08-21
Date Added to Maude2016-08-24
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 Details

Brand NameSILIKON 1000 LIQUID SILICONE
Generic NameSILIKON 1000 LIQUID SILICONE
Product CodeLWL
Date Received2016-08-21
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALCON


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-21

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