According to the received information, the case seems linked to a granuloma.Granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively.The risk of such reaction is mentioned in the instructions for use of teosyal products.
|
This case occurred outside the us, in (b)(6).According to the received information, the patient was injected with teosyal rha 3 in the marionettes lines on (b)(6) 2020.The patient presented the following symptoms: in (b)(6) 2020: a cyst developed near the corner of the eye on the right side only, whereas no filler was ever injected in this area.In (b)(6) 2021: lumpiness of the marionette lines detected.In (b)(6) 2021: large palpable lumps on both sides of the face.The patient believes that the filler has migrated from the marionette lines.The lumps were reported to be firm and large in size, not painful nor inflamed.An ultrasound was performed and concluded to the diagnosis of subcutaneous granulomatous solid lesions in the lower cheek region, bilaterally near the angles of the mouth, and a cystic foci superiorly in the bilateral cheek regions.According to the latest received information, the patient wanted to wait and see if the symptoms settled.
|