The U.S. Food and Drug Administration (FDA) has warned against the use of head shaping pillows for babies, infants and newborns, citing the risk of sudden unexpected infant death syndrome (SUID), sudden infant death syndrome (SIDs) and suffocation, also known as positional asphyxiation.
Head shaping pillows, also known as flat head pillows marketed for the treatment of flat head syndrome and craniosynostosis are included in the safety communication. The FDA has stated that it is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose.
The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death. – FDA
Owners of head shaping pillows and flat head pillows are instructed to stop using them immediately and throw them away rather than donating or giving them to someone else.
Flat head syndrome is not painful, and is not associated with developmental illnesses. The more serious condition of craniosynostosis, in which a baby’s skull bones fuse too quickly, is not prevented or treated through the use of pillows.
Some head shaping pillows sold to “treat” flat head syndrome come with a hole or indent in the middle, meant to cradle the back of the head while a baby lies on its back; others are rectangular in shape.
Are Head Shaping Pillows Safe?
Safety issues with head shaping pillows have previously been raised. A 2021 story in Consumer Reports features medical professionals outlining how the pillows are not only ineffective, but potentially dangerous.
The Chairman of the AAP Council on Injury, Violence, and Poison Prevention has stated, “these devices, essentially a small pillow with an indent or a hole in the center, are unnecessary and even dangerous.”
These products pose the same suffocation risk to your sleeping baby as does any other soft bedding, such as padded crib bumpers and blankets.
Head Shaping Pillow Risks
Some of the known safety issued with head shaping pillows are as follows:
- Asphyxia / asphyxiation
- Suffocate / suffocation
- Stops or stopped breathing
- Cut off air supply
Flat Head Syndrome Treatment
Parents worried about flat head syndrome should be aware the condition is “is benign and temporary,” according to Consumer Reports, “and doesn’t lead to any long-term developmental problems.”
According to Consumer Reports, steps can be taken to alleviate flat head syndrome, including supervised time with the baby face-down, switching regular positions used during feeding and changing diapers, and neck stretches. If necessary, a doctor may prescribe a head-shaping helmet as treatment.
Helmets, headbands, and caps to treat flat head syndrome, also known as positional or deformational plagiocephaly, are approved for use by the FDA.
Parents or caregivers aware of an infant who suffers an injury due to specialty flat head pillows or head shaping pillows are advised to file a report with the FDA.
The FDA has also communicated its concerns over the pillows with manufacturers who market their products as a cure for flat head syndrome.
Questions About a Head Shaping Pillow Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If your baby or a loved one has been injured or suffered from suffocation, asphyxia or unfortunately died due to the use of a head shaping pillow or flat head pillow, you may want to speak with the lawyers at Johnson//Becker. We are pursuing head shaping pillow lawsuits across the country, and you may be entitled to financial compensation for your injuries.
We offer a Free Case Evaluation. To learn more about Johnson//Becker’s product liability cases, or to arrange a free, no obligation case review, please contact us using the form below or call Johnson//Becker directly at (800) 279-6386.