William Atkins
Sunday, 16 November 2008 20:28
Science -
Health
Page 2 of 3
The Report also states,
“Dermal filler devices are, in general, approved for injection into the mid to deep dermis for the correction of moderate to severe wrinkles and folds. Two injectable dermal fillers have been approved for restoration and/or correction of signs of facial fat loss (lipoatrophy) in patients with human immunodeficiency virus (HIV). Of these two devices, one is also approved for the general indication of correction of wrinkles.”
Some of the serious problems reported to the FDA include severe allergic reactions and anaphylactic shock, and, also, less severe problems such as swelling infections, and allergic reactions.
The conclusions of the FDA report are:
1. … the majority of dermal implant reports note injection in sites other than nasolabial fold, the indication of use for most of them.
2. While many of reported adverse events, such as minor swelling and erythema, are expected problems and are specified in the labeling of the products, there are a numbers of adverse events that are serious and unexpected such as facial, lip, and eye palsy, disfigurement, retina vascular occlusion, as well as rare but life-threatening events such as severe allergic reactions and anaphylactic shock.
3. Some of the common adverse events that are expected to occur shortly after injection and resolve quickly, have delayed onset and/or remain for a long period of time and turn into a more serious problems.
4. A number of reports’ narrative implies that the allergic reactions occurred after patients had their second or third injection.
Page three continues with the last two conclusions.
