Sculptra and Pregnancy

The U.S. Food and Drug Administration considers Sculptra (poly-L lactic acid) a "device," rather than a medication. As a result, this product does not have a specific pregnancy rating. Because it is difficult to determine the potential risks of using it while pregnant, many healthcare providers may recommend waiting until after pregnancy before using Sculptra.

Can Pregnant Women Receive Sculptra?

Sculptra® (injectable poly-L lactic acid) is a facial filler used to treat wrinkles and lines. It is also used to treat facial fat loss in people with HIV. It is not known if the product is safe for use during pregnancy.

Understanding the Pregnancy Category System

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. However, Sculptra is not considered a medication by the FDA. Instead, it is classified as a device. Therefore, it does not have a pregnancy category rating.
Sculptra has not been adequately studied in pregnant humans, and there does not appear to be any data available from use in pregnant animals either. As a result, the possible negative effects (or lack of negative effects) of using this product during pregnancy are unknown. The studies of Sculptra specifically excluded women who were pregnant or breastfeeding.

Final Thoughts

If you are pregnant or are thinking about becoming pregnant, let your healthcare provider know. He or she will consider the benefits and risks of using this product during pregnancy before making a Sculptra recommendation in your particular situation.
Because the benefits of using this product are usually purely cosmetic and since the risks are unknown, it is likely that your healthcare provider will recommend postponing Sculptra treatment until after pregnancy (and perhaps after breastfeeding as well).
Last reviewed by: Kristi Monson, PharmD
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