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During the two studies that have been conducted with
Derma Veil
(2001-2003 & 2002-2005) several adverse events occurred caused by trauma to the tissues
by the puncture of the needle during application
of anesthesia or the implant. The
most frequent adverse reactions
registered in the participants were erythema and ecchymosis. Also there were several cases of edema and hematoma as well as some bleeding
During both studies none of the
participants showed serious reactions, or secondary complications
of any nature neither during the investigation’s treatment
sessions, nor afterwards during the close to two year’s observation
periods of each study.
Participants expressed various levels
of pain caused by the injection of anesthesia and the implant, as well as due to the sensation of the implant’s presence. In every case, an ice
compress was applied to the participants for a few minutes to
diminish blood flow. Afterwards topical anesthesia (
Anestop – Pro-Medic ) was applied to diminish pain due to the needle’s puncture
when applying local anesthesia
(Xylocaine, 2% lidocaine – Astra Zeneca ) to
neutralize in turn the pain of the injection to infiltrate the product.
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"Adverse events"
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