MAUDE Adverse Event Report: ANTEIS S.A. BELOTERO BLANCE; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, filler migrated to the orbit (device migration), was deemed to meet the serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for belotero could not be reviewed as the lot number was not reported.Citation: shirin hamed-azzam, md, cat burkat, md facs, abed mukari, md, daniel briscoe, md, narish joshi, md frcophth, richard scawn, md frcophth, eran alon, md, morris hartstein, md facs, filler migration to the orbit, aesthetic surgery journal, , sjaa264, https://doi.Org/10.1093/asj/sjaa264.

Event Description

This case is related to mdr 3013840437-2020-00092, referring to the same patient.This case is related to mdr 3013840437-2020-00083, mdr 3013840437-2020-00084, mdr 3013840437-2020-00085, mdr 3013840437-2020-00086, 3013840437-2020-00087, 3013840437-2020-00088, mdr 3013840437-2020-00089, mdr 3013840437-2020-00090, mdr 3013840437-2020-00091, mdr 3013840437-2020-00094, mdr 3013840437-2020-00095, and mdr 3013840437-2020-00096, referring to the same literature article.This is a literature report from a retrospective, multicenter analysis performed on patients who underwent dermal filler injection to the face with subsequent orbital complications.This literature report from israel, concerns a (b)(6) -year-old male patient who was injected with hyaluronic acid, to his left nasolabial folds (nlf), to address facial asymmetry secondary to bell's palsy.The patient was previously injected with dermal filler, into the face.Three years after the hyaluronic acid treatment, the patient developed a complete left lacrimal obstruction followed by filler migration.T2-weighted mri image revealed a diffuse hyperintense filler present in the left cheek and in the left lacrimal sac.Based on these findings it was presumed that the filler was responsible for the lacrimal obstruction.It was further reported that the filler migrated to the orbit.The patient underwent a successful dacryocystorhinostomy surgery and remained stable at 12 months follow up.Due to the provided information, the outcome of the event left lacrimal obstruction was considered as resolved.The outcome of the event filler migrated to the orbit, was unknown.In the opinion of the authors, orbital complications secondary to migrated filler may occur long after the initial procedure.Since the site of the complication is distant from the injection site, patients and physicians may not immediately make the connection.This may lead to unnecessary examinations and a delay in diagnosis while looking for standard orbital masses.Dermal fillers should be considered in the differential diagnosis of patients presenting with a new onset orbital masses.This may lead to a delay in diagnosis and excessive and unnecessary examinations.So far, there is a lack of understanding as to precise mechanism how the filler migrated to the orbit.The authors suggest post-injection massage with subsequent delayed symptomatic, high volumes of injected filler, facial muscle activity and pressure-induced migration as possible explanations.

Event Description

Follow-up information was received on 13-nov-2020: the reporter informed that it was a retrospective research and it was not know which company was used, as they did not inject the fillers.The outcome of the events remained unchanged.

• Brand Name: BELOTERO BLANCE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• MDR Report Key: 10646713
• MDR Text Key: 210405211
• Report Number: 3013840437-2020-00093
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 11/13/2020
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE.; CONCOMITANT DRUG NOT AVAILABLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR