The United States Food and Drug Administration (FDA) cautions parents and caregivers to not use head-shaping pillows that are intended to change the shape of the infant’s head or to treat any medical ailment.
FDA claimed that the pillows can result in an unsafe sleep environment for the child and could also contribute to the danger of choking and death. FDA also clarified that these pillows that have a head support in the form of an indent or a hole for the infant to sleep on its back, are not approved by the FDA.
The agency, while stating the possible negatives, also stated that it is unaware of any established medical benefit of these head-shaping pillows.
According to the United Kingdom’s Health Service, the head-shaping pillows for infants are supposed to prevent or treat flat head syndrome, otherwise known as plagiocephaly. It is a mainstream issue in babies as most of their time is spent sleeping on their backs.
In the news release, FDA said that the flat head syndrome or plagiocephaly does not hurt infants or cause any developmental hindrance, and usually goes away with time. The FDA also urged people to simply throw away the head-shaping pillow if they own one instead of donating it or handing it over to someone else.
FDA also recommends healthcare providers inform patients about the hazards of using head-shaping pillows to discourage them from using them for their infants. FDA further advised the healthcare providers to help spread awareness regarding safe sleeping environments, and educate people about treatment options for plagiocephaly that are safer.
Upon noticing unusual head shape in their infants, parents should pursue guidance from their healthcare provider. Healthcare providers can suggest the use of multiple treatment options that are approved by the FDA, such as headbands, caps, or helmets.
FDA also said that the use of head-shaping pillows might interrupt essential assessment and treatment, not only for the flat head syndrome but also for conditions that could be more serious in nature, like craniosynostosis, in which the skull bones of the infant are joined together prematurely.
According to Dr. Sarah Schaffer, a pediatrician at the National Children’s Hospital, these pillows are widely available at most major stores that sell infant-related products. She expressed hope for the removal of these products from the stores following the recommendation from the FDA. She also mentioned that car seat attachments are also not very safe and one should not consider using anything that did not come with the baby gear.
American Academy of Pediatrics mentions on its website:
“Sudden Unexpected Infant Death (SUID), which includes Sudden Infant Death Syndrome (SIDS), is the leading cause of injury death in infancy… Sleep is a big challenge for families with babies, but following safe sleep recommendations can prevent many SUID fatalities.”
The National Institutes of Health said that a safe sleeping environment is one where the infant sleeps on its back on a stable, balanced surface with a wearable blanket, and in the absence of any toys or other items that could potentially be harmful during sleep.
