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(b)(4).
Further information from the reporter regarding event, product, or patient details has been requested.
No additional information is available at this time.
The events of erythema, ecchymosis, purple area, edema, ischemia, and occlusion are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Device labeling addresses the reported events as follows: contra-indications ¿ "do not inject juvéderm® volbella¿ with lidocaine into the eyelids.
The application of juvéderm® volbella¿ with lidocaine in the bags under the eyes is reserved to specialists specifically trained in this technique and having a sound knowledge of the physiology for this particular area.
¿ do not inject into the blood vessels (intravascular).
Intravascular injection may lead to embolization, occlusion of the vessels, ischemia or infarction.
" undesirable effects "the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.
These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.
) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.
These reactions may last for a week.
In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of these tissues.
Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.
¿ haematomas.
¿ staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect).
¿ rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying structures.
Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure.
Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur.
Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.
It is therefore advisable to take these potential risks into account.
¿ patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.
The medical practitioner should use an appropriate treatment.
" method of use ¿ posology ¿ "after needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular.
".
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Healthcare professional reported injecting theirself to the malar eyelid groove with 0.
2ml of juvéderm® volbella¿ with lidocaine.
Right after injection physician noticed a small area of "erythema/ecchymosis" and decided to perform radiofrequency on the injected area that day.
After 2 sessions of radiofrequency on the eyelid area, physician noticed increase of the purple area and local edema.
Physician refers to the event as "suspicious ischemia" and believes they are with occlusion.
A company representative noted "this event is related to a probable ecchymosis after injection and increased hematoma and local edema due to radiofrequency heat.
" symptoms are ongoing, though the next day the area was improved.
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Healthcare professional reported injecting theirself to the malar eyelid groove with 0.
2ml of juvéderm® volbella¿ with lidocaine.
Right after injection physician noticed a small area of "erythema/ecchymosis" and decided to perform radiofrequency on the injected area that day.
After 2 sessions of radiofrequency on the eyelid area, physician noticed increase of the purple area and local edema.
Physician refers to the event as "suspicious ischemia" and believes they are with occlusion.
A company representative noted "this event is related to a probable ecchymosis after injection and increased hematoma and local edema due to radiofrequency heat.
" symptoms are ongoing, though the next day the area was improved.
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