FDA Asks Parents To Throw Away Infant Head Shaping Pillows

Today the FDA issued a warning about infant head-shaping pillows.  Infant head-shaping pillows are typically small pillows, with an indent or hole in the center designed to cradle the back of an infant’s head while the infant lays face up, flat on its back. Sometimes these pillows do not have an indent or hole in the center and are rectangular shaped. These medical devices are marketed with claims to improve an infant’s head shape and symmetry and claim to prevent or treat flat head syndrome or other medical conditions.

FDA recently became aware of companies marketing the pillows with claims for the prevention and treatment of flat head syndrome without FDA clearance or approval. They have communicated their concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these medical devices.

The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head-shaping pillows marketed to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition as they are not aware of any demonstrated benefit in children who have used the devices. The use of head-shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Their communication noted that infant head-shaping pillows are not FDA-approved. They also say the safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndromeExternal Link Disclaimer (also known as positional plagiocephalyExternal Link Disclaimer or deformational plagiocephalyExternal Link Disclaimer), or the more serious condition where the developing infant’s skull bones join together too early (known as craniosynostosis).

Nine recommendations for Parents and Caregivers:

• Do not use infant head shaping pillows due to the risk of sudden unexpected infant death (SUID), inclusive of sudden infant death syndrome (SIDS), and suffocation and death.
• If you own an infant head-shaping pillow, throw it away – Do not donate or give it to anyone else.
• Be aware that infant head-shaping pillows are not safe or effective for preventing or treating flat head syndrome or other medical conditions.
• Be aware that, in most cases, the flat head syndrome will go away on its own as an infant grows, it is not painful and it does not cause any developmental concerns.
• If your infant has an unusual head shape, talk to your infant’s healthcare provider about management options. The uses 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.
• To promote a safe sleep environment, the National Institutes of Health (NIH) and the American Academy of Pediatrics(AAP) recommend infants sleep on their backs in a bare crib on a flat (not inclined) surface without pillows, toys, soft objects, or loose bedding.
• The AAP guidelines regarding a safe sleep environment are intended to help reduce the risk of SUID as described in the NIH Safe to Sleep Campaign.
• Learn more about safe sleeping environments by visiting FDA’s Recommendations for Parents/Caregivers About the Use of Baby Products.
  If an infant in your care experiences an injury or adverse event when using a head-shaping pillow, we encourage you to report it to the FDA and the manufacturer. Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices.
• Be aware that infant head-shaping pillows do not treat craniosynostosis.

Recommendations for Health Care Providers

• Discourage the use of infant head-shaping pillows. Review this safety communication with your colleagues, care teams, parents, and caregivers who recommend, use, or may use infant head-shaping pillows.
• Educate your care communities, regarding the association of head-shaping pillows with an unsafe sleep environment, which is associated with SUID, SIDS, and other causes of infant death, such as suffocation, that may occur with the use of head-shaping pillows.
• 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 from 3 to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly. Some cranial orthosis devices are also intended for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe non-synostotic positional plagiocephaly.
• Improve awareness and understanding among your colleagues and care communities regarding a safe sleep environment for infants, and etiologies and associated management options for flat head syndrome.
• If a parent or caregiver reports a problem with an infant head-shaping pillow, advise them to discontinue its use and report it to the FDA and the manufacturer. Prompt reporting of problems can help the FDA identify and better understand the risks associated with medical devices.