FDA Issues Warning About Infant Head-Shaping Pillows

The U.S. Food and Drug Administration (FDA) has issued a new safety communication regarding infant head-shaping pillows. The agency is recommending that parents and caregivers avoid using these pillows designed to change the shape of an infant’s head.

According to the FDA, these head pillows are sold as medical devices that can change the shape of an infant’s head, improving cranial symmetry or preventing cranial deformities such as flat head syndrome or craniosynostosis.

Flat head syndrome is a condition that causes parts of an infant’s skull to become flat. The most common causes of flat head syndrome are the infant’s sleeping position, premature birth, and births of multiple infants from one pregnancy. Flat head syndrome is closely associated with a neck condition known as torticollis. Torticollis is a muscular condition in which muscles in the neck become tight and challenge the ability of babies to turn their heads.

Craniosynostosis is a condition where the developing skull fuses together too early. Craniosynostosis can result in the infant’s skull fusing before the brain has had time to grow, leading to developmental difficulties in the infant.

According to the FDA, there is no demonstrated medical benefit from the use of infant head-shaping pillows. The agency has stated that infant head-shaping pillows are not FDA-approved, cleared or authorized. Not only does the agency say that “the safety and effectiveness of these products have not been established,” but they also mention that “the use of head-shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.”

The FDA safety communication notes that the use of infant head-shaping pillows is associated with Sudden Unexpected Infant Death (SUID), Sudden Infant Death Syndrome (SIDS), suffocation, and death. The FDA recommends that all parents and caregivers who own infant head-shaping pillows should throw them away. The agency emphasizes that it should not be donated or given away. Additionally, the FDA states that infant head-shaping pillows are not safe or effective for treating flat head syndrome, and in most cases, flat head syndrome will go away on its own as the infant grows and develops.

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