FDA Warns Against the Use of Infant Head-Shaping Pillows

The FDA recently warned parents, caregivers, and healthcare providers about using infant head-shaping pillows that claim to treat or prevent medical conditions.

The pillows are made with a small indent, so when the child is laid on their back, it cradles the back of their head. Manufacturers are known to market these pillows with claims that they could improve an infant’s head symmetry or even prevent flat head syndrome entirely.

According to the National Institutes of Health, infants should sleep on a comfortable, firm surface with a wearable blanket, lying on their backs. Loose blankets, toys, and pillows should not be in their sleeping area and could be a potential hazard.

The release, issued on November 3rd, clarifies that flat head syndrome, or plagiocephaly, is a common condition for small children as they spend a significant amount of time sleeping on their backs. Plagiocephaly is known to go away without any medical intervention and does not cause the child any pain or developmental issues.

The FDA is urging parents and caregivers to discontinue the use of their head-shaping pillow immediately and not to donate or give it to anyone else, citing the potential for Sudden Unexpected Infant Death (SUID)

“If your infant has an unusual head shape, talk to your infant’s health care provider about management options,” the agency stated. “Know that the use of infant head shaping pillows may delay the necessary evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis.”

Healthcare providers are asked to discourage the use of head-shaping pillows and steer parents and caregivers towards FDA-approved options such as helmets, cleared caps, or headbands to improve cranial symmetry.

Contact TruLaw today if your child was harmed due to the use of an infant head-shaping pillow. Our attorneys will make it their mission to recover the maximum amount of compensation on for individuals injured through no fault of their own. For additional information, try our Instant Case Evaluation ℠.