Did the clinical trials show Macrolane to be safe?
The safety of Q-MED products is always monitored in clinical trials. In the two pilot studies described above, there were no reports of serious adverse events. Mild and transient injection site pain, six-week inflammatory symptoms and some capsular formation were reported in the breast augmentation study. All these events resolved without medical intervention and no clinical or radiological alterations of the breast occurred.In the second study, the majority of adverse events were reported on the day of injection and were of mild to moderate intensity. There were some reports of fever, but all were resolved within one week, either spontaneously or after treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDS).In the breast augmentation study in Japan, there were few adverse events reported.
