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Although no deaths were reported, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.
"Patients don't want to get rid of wrinkles and end up with large bumps on the face instead," said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families.
Most cases reported to the FDA involved complications that could be foreseen, such as swelling and redness. But there were also "serious and unexpected" reactions, including facial, lip and eye paralysis, disfigurement, vision problems and some severe allergic reactions.
Nineteen patients went to the emergency room with life-threatening allergic reactions. Twelve developed infections that required hospitalization.
Some problems reported to the FDA may be due to unapproved or "off-label" use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.
Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.
"Some of these products don't have a lot of adverse events and some do," said Zuckerman. "How are we going to help patients make decisions without more information?"
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