Date of issue: 03/11/2022

The United States Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to alter the shape or symmetry of an infant’s head or to claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit of using infant head shaping pillows for medical purposes. The use of head-shaping pillows can create an unsafe sleeping environment for infants and may contribute to the risk of choking and death.

Infant head shaping pillows are not FDA approved. The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome (also known as positional plagiocephaly or deforming plagiocephaly), or the more serious condition where the bones of the developing infant’s skull come together too soon (known as craniosynostosis).

Recommendations for Parents and Guardians

  • Do not use pillows to shape an infant’s head due to the risk of Sudden Unexpected Infant Death Syndrome (SUID), including Sudden Infant Death Syndrome (SIDS), choking and death.
  • If you have a pillow to model a baby’s head, throw it away; do not give it or give it to anyone else.
  • Be aware that infant head shaping pillows are not safe or effective in preventing or treating flat head syndrome or other medical conditions.
  • Be aware that, in most cases, flat head syndrome will go away on its own as the infant grows, is not painful, and does not cause any developmental problems.
  • If your baby has an unusual head shape, talk to their healthcare provider about management options. Be aware that using pillows to shape an infant’s head may delay needed evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis .
  • To promote a safe sleeping environment, the National Institutes of Health (NIH) and the American Academy of Pediatrics (AAP) recommend that infants sleep on their backs in a bare crib on a flat (non-tilted) surface without pillows, toys , soft objects, or loose bedding. The AAP’s guidelines for 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 sleep environments by visiting the FDA’s recommendations for parents/caregivers on the use of baby products.
  • If an infant in your care experiences an injury or adverse event while using a head molding 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 pillows to shape infants’ heads. Review this safety communication with your colleagues, care teams, parents and caregivers who recommend, use or may use infant head molding 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 childhood death, such as suffocation, which can occur with the use of head shaping pillows.
  • The FDA has cleared caps, helmets, or headbands for use as cranial orthotic devices intended to improve cranial symmetry or form in infants and toddlers 3 to 18 months of age with nonsynostotic positional plagiocephaly moderate to severe. Some cranial orthoses are also intended for supplemental use in infants 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate to severe non-synostotic positional plagiocephaly.
  • Increase the awareness and understanding of your colleagues and care communities regarding a safe sleep environment for infants, and the etiologies and associated management options for Flat Head Syndrome.
  • If a parent or caregiver reports a problem with an infant head pillow, advise them to discontinue use and report it to the FDA and the manufacturer. Prompt reporting of issues can help the FDA identify and better understand the risks associated with medical devices.

Description of the device

Infant head shaping pillows are usually small pillows, with an indentation or hole in the center designed to cradle the back of an infant’s head while the infant is lying face up, flat on the back. Sometimes these pillows do not have a notch or hole in the center and are rectangular in shape. These medical devices are marketed with claims to improve the shape and symmetry of an infant’s head and claim to prevent or treat flat head syndrome or other medical conditions. However, the safety and efficacy of using these medical devices have not been demonstrated.

FDA measures

The FDA informs parents, caregivers, and health care providers of the risks associated with using pillows to shape the heads of infants. The FDA is working with stakeholders to raise awareness of the issue.

Recently, the FDA has become 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 raised our concerns about these promotional materials with 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.

Reporting Issues to the FDA

If you experience any adverse reactions associated with the use of an infant head shaping pillow, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.

Please include the following information in your reports:

  • Device name (brand name)
  • Name of manufacturer, importer and/or distributor
  • Details of adverse event and medical and/or surgical procedures (if applicable)

If you believe a medical device is marketed outside the scope of its FDA approval or clearance, you may file a report through the FDA regulatory misconduct allegation process. You can also contact your local FDA Consumer Complaints Coordinator to report concerns.

Questions?

If you have any questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796- 7100.