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

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

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria of necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Event Description

This literature report from (b)(6) concerns a (b)(6) male patient who developed a granulomatous foreign body reaction after the injection of hyaluronic acid to augment the nasal columellar area.The patient had undergone rhinoplasty, including alar base wedge resections that were performed abroad.Following this surgery, a hyaluronic acid filler was used to augment the nasal columellar area.This treatment, also performed abroad, was initially intended to improve the nasolabial angle.Reportedly, symptoms developed approximately six months after filler injection, and remained stable over the next three years.The patient was presented at hospital with nasal obstruction, on an unspecified date.Inspection of the nose showed a swollen tumour-like mass of the columella, with progression in the membranous and caudal areas of the cartilaginous nasal septum.Due to this mass, the external nasal valve, the nasal vestibule, was blocked.The lateral view showed a bulbous nasal tip with loss of nasal tip projection and definition due to a round and hanging columella.Subsequently, the mass was completely removed by external approach rhinoplasty, without destruction of the nasal septal cartilage.Histopathologic examination of the mass showed evidence of a foreign body reaction.Although the authors could not identify the type of filler used histologically, they assumed that this was a hyaluronic acid filler based on the medical history.Postoperatively, there were no complications.Nasal breathing improved and examination of the nose showed a normal aspect of the columella and nasal septum 12 months after surgery.Due to the provided information, the outcome of the events was considered resolved.In the opinion of the authors, this case illustrated a late complication of filler rhinoplasty, the development of a granulomatous foreign body reaction against the injected material.Such unpredictable reactions, often occurring many years after the procedure, could result in permanent tissue damage.The injection of filler into subcutaneous tissue elicited a resorption process, which included a cellular response necessitating the differentiation of monocytes into epithelioid cells, and the formation of foreign-body giant cells.Fibroblasts were recruited a month later, and collagen deposition began.Ordinarily, this foreign body response was going to gradually decline to a low-grade response, and eventually fade away after 2 years.This reaction pattern was seen for most injectables and was considered to be the normal host response to a foreign material.Follow-up information was received on 04-apr-2018: full text article was received.The patient received hyaluronic acid in his columella.He had undergone endonasal rhinoplasty.Histopathology of the removed tumour-like lesion (mass) revealed an active foreign body reaction.Twelve months after surgery, the columella and nasal septum were within normal limits, and the valve area had a normal configuration.In the opinion of the authors, inflammatory granulomas are likely to disappear spontaneously within a few months in case of biodegradable fillers including hyaluronic acid and calcium hydroxylapatite.Nevertheless, in this case hyaluronic acid induced long lasting tissue reactions, with the need for surgical intervention.While intra-lesional steroid injections can be attempted as treatment, the surgical resection of these "granulomas" may ultimately be required.

• Brand Name: HYALURONIC ACID
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, switzerland ; SZ
• Manufacturer (Section G): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, switzerland ; SZ
• Manufacturer Contact: scott sykes, md ; 6501 six forks road; raleigh, NC 27615
• MDR Report Key: 7437591
• MDR Text Key: 105714421
• Report Number: 2135225-2018-00017
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 MEDICATIONS NOT AVAILABLE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR