The US Food and Drug Administration warned parents and caregivers that infant head-shaping pillows are not intended to alter a child’s head or treat any medical condition.
FDA released a statement saying that head-shaping pillows could create an unsafe sleeping environment for infants.
According to the FDA, the pillows with an “indent or hole in their center” that cradle infants’ heads while they sleep on their backs are not FDA-approved.
The FDA stated in a statement that it was unaware of any evidence of a benefit from the use of infant-shaped pillows for medical purposes. Head-shaping pillows can make infants’ sleep uncomfortable and increase the risk of death and suffocation.
According to the UK’s National Health Service, infant head-shaping pillows can be used to correct or prevent plagiocephaly (a flat head syndrome in babies who spend most of their time on their backs).
The flat head syndrome is not a developmental problem and usually resolves on its own.
The agency stated that if you have a baby head-shaping pillow, it should be thrown away.
The FDA advises healthcare professionals to discourage infant head-shaping pillows and make sure that patients are aware of the danger of infant death. The FDA recommends that healthcare providers educate patients and promote safe sleeping environments.
Parents should seek medical advice if their infants have a strange head shape. The flat head syndrome can be treated with helmets, caps, and headbands that have been approved by the FDA.
According to the FDA, infant head-shaping pillows can delay treatment and evaluation. This is not only for flat head syndrome but also for other more serious conditions such as craniosynostosis (where the skull bones of a newborn infant are too close together).
According to Dr. Sarah Schaffer (pediatrist at the National Children’s Hospital), infant head-shaping pillows can be found in many major retailers.
Schaffer stated that he hoped the recommendation would lead to their removal.
According to the American Academy of Pediatrics, “Sudden Unexpected Infant Death” (SUID) is the leading cause of injury death during infancy. Safe sleep recommendations can help families with babies avoid many SUID deaths.
According to the National Institutes of Health, infants should be able to sleep on their backs with a blanket covering them on a level surface. Their sleeping space should not contain any toys, blankets, or other objects.
Schaffer stated, “Do not use any pillow/head shaping device that was not included in your baby gear,” and that car seat attachment can also be dangerous.