Recently, dermal fillers had come under the scanner of the Food and Drug Administration (FDA) after it received reports of serious and unexpected problems in people who were treated with it. As a result, it appointed a panel of outside experts to take a look at the problem. The panel met to discuss issues regarding popular fillers that included Restylane and Juvederm among others. It was agreed that product labeling should be revised.

Highlights of the panel’s advice
a. The panel highlighted the need for labels to include the more serious adverse events.
b. Dermal fillers should carry stronger and more specific warning labels about potential adverse effects.
c. It should also mention the duration of time that the product has been in the market and how long it might take for events to appear.
d. The final recommendations of the panel will be made to the FDA, which is not bound to follow them but often does.
e. The panel has advised the FDA to ask manufacturers to note that some events may occur months or years after the injection.
f. But, there was disagreement on whether the label should list adverse events for all fillers in that class or only for the adverse events associated with a specific type of filler.
g. The question of how clinical studies on dermal fillers should be conducted in future was also discussed by the panel.
h. The panel has asked for the setting up of a consensus panel to develop guidelines on how clinical studies should be done and formulate guidance for the industry.
i. They concluded that there cannot be one rigid guideline for all products in the category since certain products have more reactivity than others.
j. Some members want manufacturers to conduct more rigorous pre-market studies.
k. However, industry representatives and some plastic surgeons have said that stronger labels are not required.

Plastic surgeons’ reactions
a. Serious adverse events associated with the fillers are extremely rare.
b. According to them, adverse effects are more likely when the fillers are used by inexperienced physicians or others.
c. Others welcomed most of the recommendations.
d. They say that informing consumers about side effects that might appear months after the injection is a good idea.