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What are Head Shaping Pillows?
Infant head shaping pillows are typically small pillows with an indent or hole in the center intended to cradle the back of a baby's head while the infant lays face up on his or her back. Others are rectangular with no hole or indent. Head shaping pillows may be marketed with claims that they can prevent or improve an infant’s head shape or symmetry.
Infant Head Shaping Pillows Can Cause Suffocation: FDA Warning
The FDA issued a Safety Communication  on Nov. 3, 2022, warning parents, caregivers and healthcare providers that the safety and effectiveness of infant head shaping pillows has not been established for the prevention or treatment of flat head syndrome (positional plagiocephaly), deformational plagiocephal, or craniosynostosis.
"The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose," FDA said. "The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death. Infant head shaping pillows are not FDA-approved."
What is Plagiocephaly?
Plagiocephaly refers to a flat spot on a baby's head. The condition develops when a baby spends too much time lying on their back. The flat spot is typically most noticeable when looking at the baby's head from above. The cheekbone and ear on the flat side may look pushed forward.
Is Plagiocephaly a Disability?
Most cases of positional plagiocephaly do not cause issues with the baby's brain growth or function. However, if plagiocephaly is left untreated, children are at risk of developmental, neurological, or psychological difficulties.
Can Babies Grow Out of Plagiocephaly?
The heads of infants with positional plagiocephaly may not return to a completely perfect shape, but by the time they're 1 or 2 years old any flattening will be barely noticeable. More severe cases will also get better over time, although some flattening may remain.
FDA Recommendation on Head-Shaping Pillows
If you own an infant head shaping pillow or similar device, you should keep it out of the reach of children and throw it away immediately. Do not donate it or give it to anyone else.
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Recommendations for Pediatricians
Pediatricians should continue to remind parents not to use infant head shaping pillows and to discard them. Healthcare providers can educate their communities about the importance of a safe sleep environment for babies and associated management options for positional plagiocephaly.
Are There Safe Alternatives to 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 babies ages 3-18 months who suffer from moderate to severe non-synostotic positional plagiocephaly.
Get a Free Head Shaping Pillow Lawsuit Evaluation With Our Attorneys
The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in head shaping pillow Lawsuits. We handle individual litigation nationwide and accept new cases in all 50 states.
Again, if your child or other loved one was asphyxiated, suffocated or died after using a head shaping pillow, you should contact our law firm immediately. You may be entitled to compensation by filing a Head Shaping Pillow Lawsuit and our product liability lawyers can help.