FDA: Infant Head Shaping Pillows Unsafe, Potentially Deadly

The more time babies spend in one position on their backs, the more likely they are to develop a flat spot on back of their heads. However, pillows designed with an “indent or hole in the center” intended to cradle a baby’s head as they sleep on their back are not safe, have no proven medical purpose, and may contribute to the risk of suffocation and death, according to the U.S. Food and Drug Administration (FDA).

According to a news release issued November 3, 2022, the FDA recommends that parents and caregivers avoid using infant head shaping pillows intended to alter an infant’s head shape or proportion, or assert an ability to prevent or treat a medical condition.  Head shaping pillows are not FDA-approved, meaning their effectiveness in the prevention of flat head syndrome, deformational plagiocephaly, or craniosynostosis has not been proven. These issues are commonly present in babies because their skulls are relatively soft to allow flexibility during birth. The larger spot toward the front of the head usually closes around 18 months of age, while the smaller spot at the back of the head typically closes by age two to three months.

The FDA gives parents the following recommendations regarding infant head shaping pillows:

• Avoid such pillows due to risk of sudden unexpected infant death syndrome (SUIDS), sudden infant death syndrome (SIDS), suffocation, and death.
• Those owning an infant head shaping pillow are advised to throw it away, as opposed to donating it or giving it to someone else.
• In most cases, flat head syndrome is not painful, does not cause developmental issues, and will resolve on its own as the baby grows.
• If your infant has an unusually shaped head, consult with a health care provider regarding treatment options. The use of infant head shaping pillows can delay the evaluation and management of flat head syndrome, deformational plagiocephaly, and craniosynostosis.
• As recommended by the National Institutes of Health (NIH) and the American Academic of Pediatrics (AAP), infants should sleep on their backs in a bare crib on a flat surface absent of pillows, toys, soft objects, and loose bedding.
• If an infant in your care experiences an injury or adverse impact due to the use of a head shaping pillow, report the incident to the FDA and the pillow manufacturer.

The FDA has approved certain caps, helmets, and head bands intended to increase head symmetry in infants and toddlers three to 18 months of age who have moderate to severe plagiocephaly. However, the FDA is instructing health care providers to discourage the use of infant head shaping pillows and educate parents and caregivers about the dangers associated with using such devices.

Issues with infant head shaping pillows are nothing new. Medical professionals outlined the ineffectiveness and potential danger in a 2021 Consumer Reports article. According to CR, infant head shaping pillows present the same risk of suffocation to a sleeping infant as any other bedding, such as blankets, stuffed toys, and crib bumpers. For example, in 2019, the Boppy Company voluntarily recalled its infant head and neck support accessories. According to the U.S. Consumer Product Safety Commission (CPSC), the head support area could potentially be overstuffed and cause the baby’s head to tilt forward and lead to suffocation.

Am I entitled to compensation if my child was harmed by a head shaping pillow?

Consumers have a right to expect that the products they purchase will work as intended, without injury. However, when a dangerous product, such as an infant head shaping pillow, causes harm to a sleeping child, parents or caregivers may be able to file a product liability lawsuit to recover monetary compensation for the damages sustained. The product liability attorneys at Harris Lowry Manton will:

• Explain your legal options to you;
• Help you determine whether you might be eligible to file a lawsuit;
• Attempt to negotiate a settlement before heading to court;
• Bring your lawsuit in the proper court within the allotted amount of time;
• Build a solid case on your behalf; and
• Try your case in court if a settlement cannot be reached.

At Harris Lowry Manton, our child injury lawyers work on a contingency basis, meaning our team only gets paid if you receive a payout from your product liability lawsuit. To obtain fair compensation for injuries sustained in an infant head shaping pillow incident, contact Harris Lowry Manton LLP at our offices in Atlanta or Savannah, or fill out our contact form to schedule your free initial consultation with a compassionate lawyer today.