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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injection Site Reaction (4562)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, left infero-medial orbital mass (injection site mass), 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 3013840437-2020-00087, 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, mdr 3013840437-2020-00089, mdr 3013840437-2020-00090, mdr 3013840437-2020-00091, mdr 3013840437-2020-00092, mdr 3013840437-2020-00093, 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 female patient.She was injected with hyaluronic acid, into the nasolabial folds.The patient was previously injected with dermal filler, into the face.Within one year after the hyaluronic acid injection, the patient experienced a palpable left infero-medial orbital mass.Reportedly, the filler migrated to the orbit.A computed tomography scan demonstrated an inferior hyperlucent mass in her left orbit.As reported, surgical intervention was required for both a diagnostic confirmation and for therapeutic purposes.An orbitotomy via a subciliary incision revealed a clear gelatinous material consistent with the hyaluronic acid filler.The patient remained stable during the 2-month follow-up.The patient was followed up for 12 months.Due to the provided information the outcome of the event left infero-medial orbital mass was considered as resolved.The outcome of the event filer migrated 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.

• 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
• Manufacturer (Section G): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• Manufacturer Contact: product safety ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 10646647
• MDR Text Key: 210397898
• Report Number: 3013840437-2020-00088
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: IS
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR