Infant head-shaping pillows can cause suffocation, experts have warned.
The head-shaping pillows should not be used on infants because they create an unsafe sleep environment and are not effective for preventing or treating positional plagiocephaly or other medical conditions, according to the Food and Drug Administration (FDA).
The agency is reminding parents, caregivers and health care providers that the pillows are unapproved medical devices that contribute to the risk of suffocation and death.
The pillows continue to be marketed with claims that they can prevent or improve an infant’s head shape or symmetry.
Infant head-shaping pillows can cause suffocation
Use of the pillows could also delay the necessary evaluation and management of conditions such as positional plagiocephaly and craniosynostosis, it's been warned.
Head-shaping pillows typically are small with an indent or hole in the center to cradle the back of a baby’s head while the infant lays face up on his or her back.
Others are rectangular with no hole or indent.
Pediatricians should continue to remind parents not to use the devices and to discard them.
Medical advice
Health care providers can also educate their communities about the importance of a safe sleep environment for infants and associated management options for positional plagiocephaly.
The FDA has cleared caps, helmets or headbands for use as cranial orthosis devices intended to improve cranial symmetry or shape in infants and toddlers ages 3-18 months, with moderate to severe non-synostotic positional plagiocephaly.
If parents or caregivers experience a problem with an infant head-shaping pillow, they should report it to the FDA and the manufacturer.
Warning
Recently, the FDA became aware of companies marketing infant head shaping pillows with claims for the prevention and treatment of flat head syndrome without FDA clearance or approval.
The FDA has communicated its concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these medical devices.
The FDA will keep the public informed if significant new information becomes available.
