MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT; 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 of nodules / foreign body granulomas from radiesse® was deemed to meet the serious criteria of resulting in permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.

Event Description

This spontaneous report received from a (b)(6) physician concerns a female patient who experienced serious reportable event of trachea swelling/angioedema (mdr 2135225-2019-00011) and serious reportable event of nodules/foreign body granulomas from radiesse® (mdr 2135225-2019-00015).The events 'nodules / foreign body granulomas from radiesse®' and 'trachea swelling/angioedema' were added.The patient's initials, date of birth, weight ((b)(6)) and height (166.6 cm) were provided.The patient was (b)(6) at the time of the events.She was injected with 2 vials (as reported) of radiesse®, into the cheeks (also reported as cheekbones) and nasolabial folds, on(b)(6) 2014.The patient had no previous aesthetic treatments.She had no disposition to lymph drainage problems and no allergies.The patient's medical history and concomitant medication were reported as none.On (b)(6) 2017, the patient went to see a dermatologist as she experienced upper lip swelling and swelling of the lower half of the face (also reported as chin), with no other general symptoms.Corrective treatment included celestamine n liquidum n1 and fenistil 40 drops.As reported, it was already slightly declining by itself and she was advised to go to the local hospital in a case of emergency.On the same day, the patient was seen by another dermatologist to clarify if she had quincke's like oedema or a reaction to radiesse® treatment.The patient was prescribed cortisone by her general practitioner, on (b)(6) 2017 and again by her dermatologist, in (b)(6) 2017 (a high dosage).From (b)(6) to (b)(6) 2017, the patient did not experience any noteworthy swelling.On (b)(6) 2017, she experienced swelling, again.On (b)(6) 2017, the patient was seen in an allergology clinic.On (b)(6) 2017, the patient went to the ear, nose and throat accident and emergency department with trachea swelling.Consequently, she was admitted to hospital with suspected angioedema.The examination showed a clear swelling of the upper and lower lip.The hypo-pharynx was slightly swollen at the tongue base and pocket fold area as well as slightly glassy on the arytenoid cartilage.The patient reported having recurrent swellings in the mouth and lip area.Corrective treatment included intravenous administration of solu-decortin (500 mg), berinert (500 mg) and inhalation of epinephrine.She was kept for in-patient monitoring and was due to a significant regression of findings, discharged on (b)(6) 2017.On (b)(6) 2017, the patient had a follow up appointment in the hospital, with no new findings.On the (b)(6) 2018, the patient was seen in a dermatology clinic, which was followed by a blood test (no results provided), on (b)(6) 2018.On (b)(6) 2018, due to the results (not reported), the patient was prescribed cortisone and lora-adgc.On (b)(6) 2018, the patient was referred to the hospital by her dermatologist.On (b)(6) 2018, the patient was seen by a specialist physician, due to a recurrent i.E.Permanent (as reported) swelling of the lip.There was no family history in regards to an angioedema tendency.As reported, the patient was in a good general condition and had a good nutritional status.Her medication included prednisolone 5-10 mg /per day (currently on 5 mg a day), loratadine 10 mg (20 mg twice a day, reported as 2-0-2) and emergency medication (fenistil drops and celestamine).Upon local examination, she had a symmetrical, indurated swelling off the upper lip, as well as palpable and visible symmetric induration on both sides below the corner of the mouth.There was no angioedema, no erythema and no urticarial symptoms.Her blood pressure was 161/92 mmhg and pulse 96 / min.Consequently, she was diagnosed with a suspected cheilitis granulomatosa with an exclusion of a c1 inhibitor deficiency.Due to a possible dental tooth abscess, which was in the physician's opinion, perhaps the cause for the cheilitis, the patient was planning a dental treatment.The physician advised to completely discontinue the treatment with prednisolone before proceeding with the dental remediation which, in his opinion had to be done in a timely manner.A lip biopsy at a later stage was advisable.As reported, the lip biopsy was in a previous dermatological clinic pursued; however, once it was due, it was not performed, as the patient was being without symptoms at the time.The hospital dermatologist referred the patient to a dental clinic.On (b)(6) 2018, the patient was consulted by a dentist, if the swellings were possibly caused by the teeth.On (b)(6) 2018, she started an entire dental restoration (on (b)(6), (b)(6) 2018).On (b)(6) 2018, the patient was referred again to the hospital, by her dermatologist.On (b)(6) 2018, the patient had a biopsy, taken from her left cheek (intraorally) and one from the lower lip (intraorally).The sample collection was taken during a dental treatment; however, it was unfortunately taken into the same sampling pot and made it therefore impossible to distinguish the localization of each sample.The histology report stated that here were two tissue fragments.One of the two showed a largely downright epithelium.In the connective tissue there was a mild inflammatory infiltrate of lymphocytes and macrophages.In the second piece of tissue there was no epithelium.In the connective tissue a dense infiltrate of lymphocytes and macrophages was evident, also with multinucleated giant cells in places, partly with fibrotic areas.In this area vacuoles were noted, without content.There was no evidence of intracorneal fungal hyphae in alcian-pas staining.The assessment confirmed foreign body type granulomas, which were not typical for a melkersson-rosenthal syndrome.On (b)(6) 2018, the patient was prescribed cortisone by her general practitioner.On (b)(6) 2018, she was seen by her general practitioner and the hospital dermatologist who started the patient on minocyclin 100 mg.The patient continued with dental treatments, on (b)(6)/(b)(6) 2018, (b)(6) 2018 and (b)(6) 2018.On (b)(6) 2018, the patient's general practitioner referred her for another blood test (no results provided).On (b)(6) 2018, the patient was seen by the hospital dermatologist.Upon examination, the patient had swellings on her left cheek, slightly on the right cheek and multiple palpable indurations and nodules.As reported, she had less visible swellings.The patient was given comprehensive information due to the permanent swelling and histological confirmed foreign body granulomas from radiesse®.It was also confirmed that all the dental fillings were changed.The treatment with minocyclin 100 mg (started in (b)(6), and taken for over 8 weeks) was discontinued, due to no improvement.As reported, a high dose of antihistamines also gave no improvement.The patient responded well on cortisone (5 mg) treatments.During the appointment, the patient was still taking prednisolone 5-10 mg per day (currently on 5 mg a day), loratadine 10 mg (20 mg twice a day, reported as 2-0-2) and emergency medication (fenistil drops and celestamine).She was advised against local injections, but was given an alternative to see a mouth, jaw and facial plastic surgeon for an excision.The patient decided to first think about this option.Reportedly, she was still experiencing swelling, although her last dental treatment was on (b)(6) 2018.On (b)(6) 2018, the patient's general practitioner prescribed cortisone and her emergency medication (reported as emergency kit).On (b)(6) 2018, the patient was referred to a mouth, jaw and facial plastic surgeon for an advice and possible excision.On (b)(6) 2018, the patient had a magnetic resonance imaging (reported as rmt).On (b)(6) 2018, the patient had an emergency in (b)(6), caused by the swelling.On (b)(6) 2018, she was seen by her general practitioner for a prescription and advice.On (b)(6) 2018, the patient was examined by the surgeon and added to the waiting list for the operation.In (b)(6) 2018, she was seen by her general practitioner and her dermatologist.On (b)(6) 2018, the patient went to another physician to get a second opinion in regards to the surgery.On (b)(6) 2019, the patient received the information for the operation by the mouth, jaw and facial plastic surgeon; however, she decided to take some distance from it and was given another appointment for (b)(6) 2019.On (b)(6) 2019, the patient was seen by her general practitioner and was given a new prescription for cortisone.The patient informed that her vision was suddenly greatly reduced and she was wondering if this was caused by the cortisone.On (b)(6) 2019, the patient took her emergency medication, due to very severe swelling.On (b)(6) 2019, the patient was seen in an eye clinic.On (b)(6) 2019, she had cataract operation and on (b)(6) 2019, she had a cataract operation of the other eye.On (b)(6) 2019, the patient was seen by her dermatologist.The patient had no aesthetic treatments since.As per reporter, there were no other factors which were causing the swelling.According to the reporter, the recurrent swellings were diagnosed as preliminary quincke´s edema.Furthermore, foreign body granuloma from radiesse® was confirmed by biopsy.The outcome of the event 'trachea swelling / angioedema' was considered as not resolved and the outcome of the event nodules / foreign body granulomas from radiesse®' was considered as not resolved.In the opinion of the reporter, the events are considered permanent, related to radiesse® and not related to the incorporated local aesthetic in the product.

Event Description

Follow-up information was received on 13-mar-2019: the event trachea swelling/angioedema was changed to trachea swelling/angioedema/quincke's edema and re-coded from angioedema to quincke's edema (pt remains unchanged angioedema) (mdr 2135225-2019-00011).At the moment, no improvements regarding the patient's condition were known.The swellings were still present and visible/permanent, which was extremely stressful for the patient, considering that she only temporarily felt better whenever she was under the cortisone therapy.The reporter confirmed that the previously reported diagnosis of quincke's edema and histologically confirmed foreign body granuloma from radiesse® were the final diagnoses, and no others were known to them.The reporter also noted that further documents were also available at the university of frankfurt.Due to the provided information, the outcome of both events was left unchanged.According to the reporter, at the moment, they had no further possible causes or triggers for the adverse reaction for radiesse®.

Event Description

Follow-up information was received on 10 july 2019: the reporter informed that the patient's condition did not improve and was wondering what to do to avoid that the patient was permanently placed under the cortisone therapy.Due to the provided information, the outcome of both events was left unchanged.

Event Description

Follow-up information was received on 04-sep-2019: the reporter informed that the condition of the patient remained unchanged bad.Due to the provided information, the outcome of both events was left unchanged.

Event Description

Follow-up information was received on 12-aug-2020: the event term nodules / foreign body granulomas was amended to hardening / nodules / foreign body granulomas.The patient's lawyer informed that in 2017, the patient experienced hardenings on the face, that existed at the time of this report.The filler hardened in her face and formed foreign body granulomas.When it first occurred, the physician immediately performed cortisone treatment.It did not lead to a removal of the cause, but to an inevitable permanent treatment with the corresponding side effects.The patient was informed by the physician that it was the first time the physician heard about these side effects and complications.The outcome of the event trachea swelling / angioedema / quinckes edema was left unchanged.The outcome of the event hadening/nodules / foreign body granulomas from radiesse® was reported as not resolved, and therefore left unchanged.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• MDR Report Key: 8422352
• MDR Text Key: 138900228
• Report Number: 2135225-2019-00015
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 73 YR
• Patient Weight: 76