FDA Adverse Event Injury Summary report: N

SILHOUETTE INSTALIFT

MDR report key: 17409822 · Received July 26, 2023

Report

Report Number
MW5120224
Event Type
Injury
Date Received
July 26, 2023
Date of Event
April 5, 2023
Report Date
July 25, 2023
Manufacturer
SINCLAIR PHARMA US, INC.
Product Code
GAM
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PRODUCT: SILHOUETTE INSTALIFT 16-CONE I UNDERWENT A SILHOUETTE INSTALIFT PROCEDURE FOR MY MIDFACE AND JOWLS ON (B)(6) AND AM EXPERIENCING COMPLICATIONS. THE INDIVIDUAL THAT PERFORMED THE PROCEDURE (AN LPN (LICENSED PRACTICAL NURSE) WHO THOUGHT WAS AN RN (REGISTERED NURSE) TRAINED BY (B)(6) TO DO THE PROCEDURE) USED EIGHT 16-CONE THREADS. FOUR THREADS WERE INSERTED ON EACH SIDE OF MY FACE. THE PROVIDER USED A TECHNIQUE WHERE SHE DROVE THE NEEDLE AND PULLED THE SUTURES WELL BEYOND MY HAIRLINE TO EXIT HIGH UP ON MY SCALP. EVER SINCE THE PROCEDURE, I HAVE HAD TERRIBLE HEADACHES, JAW MISALIGNMENT AND PAIN. I ALSO CANNOT SLEEP ON MY SIDES BECAUSE OF THE PAIN THE CONES CAUSE IN MY TEMPLES AND SIDES OF MY HEAD. IT FEELS LIKE A CONSTANT CRAMPING SENSATION. A VISIBLE V-SHAPED DENT/PUCKER IS ALSO IN THE MIDDLE OF MY LEFT CHEEK. WHEN I REPORTED THIS TO THE DELEGATING DOCTOR WHO OWNS THE PRACTICE, HE ARGUED WITH ME AND OFFICIALLY RELEASED ME FROM CARE. I CAN'T FIND A PROVIDER OR ANY INFORMATION ABOUT THE 16-CONE SUTURES AND THE TECHNIQUE OF THREADING SUTURES BEYOND THE HAIRLINE TO EXIT OUT OF THE SCALP. THE PERSON WHO PERFORMED THE PROCEDURE NEVER WENT OVER WHAT SHE WAS GOING TO DO BEFORE SHE DID IT. I CAN'T FIND INFORMATION ANYWHERE. I HAVE ASKED THE FEW PROVIDERS AROUND TOWN WHO OFFER SILHOUETTE INSTALIFT AND EACH HAS SAID THAT THEY DO NOT DO THAT TECHNIQUE AND WOULD NOT RECOMMEND IT. ALSO, EVERYONE ELSE I'VE SPOKEN TO USES THE 8-CONE SUTURES. SINCE MY INJURY, I HAVE BEEN PRESCRIBED A BITE GUARD FROM MY DENTIST AND A MUSCLE RELAXER TO EASE THE TENSION AND PAIN. OTHERWISE, I CAN'T FIND ANY PROVIDER WHO WILL TREAT ME. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
773165 SILHOUETTE INSTALIFT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM SINCLAIR PHARMA US, INC.

Patients

Seq Age Sex Outcome Treatment
1 51 YR Female Disability