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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event cheilitis glandularis/ stomatitis glandularis (pt: cheilitis), was deemed to meet the serious criteria of required surgical intervention to prevent permanent damage.The device history record could not be reviewed, as the lot number was not reported.Piperi, e., georgaki, m., andreou, a., pettas, e., tziveleka, s., & nikitakis, n.G.(2022).Cheilitis glandularis: a clinicopathologic study with emphasis on etiopathogenesis.Oral diseases, 00, 1-9.Https://doi.Org/10.1111/odi.14144.

Event Description

This case was linked to lssmv case number (b)(4), referring to the same literature article.This is a literature report from a retrospective cases series study aimed to present the clinicopathologic features of 14 additional cases of cheilitis glandularis, giving emphasis on the possible etiopathogenesis of the disorder.This literature report from greece concerns a (b)(6) female patient.She was injected with hyaluronic acid, bilaterally into the nasolabial folds and lips (off label use of device, intentional device misuse), for cosmetic reasons.She was a smoker.After the hyaluronic acid injection, the patient experienced cheilitis glandularis/ stomatitis glandularis.The lesions were located on the upper lip and buccal mucosa (contralateral).The patient had multiple lesions that were asymptomatic and accompanied by mucus excretions upon palpation.As reported, the duration was 24 months.Multiple submucosal, firm nodules were observed.The patient did not manifest with ulceration, crusting, eversion of the labial mucosa, or macrocheilia.Formalin-fixed, paraffin-embedded 4 [?]m thick tissue sections stained with hematoxylin and eosin were re-evaluated by two of the authors.Microscopic features were recorded, including, but not limited to, those listed in the aforementioned criteria (i.E., ductal ectasia, oncocytic and/or mucous metaplasia, intraductal mucin, and chronic inflammation).Her histopathologic features showed sialectasia (ductal ectasia), intraductal mucins, mucous oncocytic metaplasia, a chronic inflammation, papillary intraluminal projections, microcalculi and interstitial fibrosis.Pools of hyaluronic acid in close proximity to the salivary gland parenchyma without an accompanying inflammatory reaction were also affirmed.The biopsy-proven cheilitis glandularis was identified.It was further described as stomatitis glandularis, as the buccal mucosa was affected.Surgical excision of all or the most prominent and/or troublesome lesions was performed.No recurrences of the excised lesions were reported during the follow-up period (length: 6 months to 7 years).The remaining lesions, with selective removal, did not show an increase in size nor did they develop painful symptomatology during follow-up and remained under monitoring.Due to the provided information, the outcome of the events was considered as resolving.In the opinion of the authors, studies showed that long-term smokers had a reduced salivary flow rate and thicker saliva compared to nonsmokers.Dilation of the ductal orifices due to pressure by the viscous saliva accumulated in the terminal excretory ducts possibly enabled retrograde bacterial infection through the salivary gland orifices resulting into suppuration and the uperficial type of cheilitis glandularis, while extension of infection in deeper tissue planes possibly led to the deep suppurative cheilitis glandularis type.The authors hypothesized that a decreased salivary flow rate, either as a result or coexistent with an increased viscosity of saliva due to qualitative changes, possibly played a role in the etiopathogenesis of cheilitis glandularis, especially in the initial stages.Future studies on cheilitis glandularis should focus on the possible effects of the reduced salivary flow and the defective mechanisms of saliva extrusion through the ducts that possibly induced mucin retention and ductal dilation, initiating a cascade of events that manifested clinically as cheilitis glandularis.Further to hyposalivation, previous multiple injections in the area for cosmetic procedures possibly further aggravated the condition, inducing chronic inflammation and possibly contributing to cheilitis glandularis development and manifestation, possibly first as the simple type.

Event Description

Follow up information was received on 21-feb-2022: the author informed that belotero hyaluronic acid (ha) fillers were not excluded, because, there was no information from the patients about the brand of the filler that was used by the physicians.As reported, some were injected years ago.The outcome of the events remained unchanged.

• Brand Name: BELOTERO BALANCE
• 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 rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 13563524
• MDR Text Key: 290462916
• Report Number: 3013840437-2022-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female