Tortle Corrective Beanies Remain FDA-Cleared Class-I Medical Devices

FDA advises parents not to use head shaping pillows while Tortle Beanies stay safe. 

Download the Full Tortle Press Release Here

ORIGINAL FDA SAFETY COMMUNICATION

DATE ISSUED: 11/3/2022

The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA 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.

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 deformational plagiocephaly), or the more serious condition where the developing infant’s skull bones join together too early (known as craniosynostosis).

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, 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 health care provider about management options. Know that the use 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 head bands 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.

Device Description

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. However, the safety and effectiveness of the use of these medical devices has not been demonstrated.

FDA Actions

The FDA is informing parents, caregivers, and health care providers of the risks associated with use of infant head shaping pillows. The FDA is working with stakeholders to increase awareness of the issue.

Recently, the FDA became 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 communicated our concerns about these promotional materials to 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 Problems to the FDA

If you experience adverse events associated with using an infant head shaping pillow, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Please include the following information in your reports:

• Device Name (Brand Name)
• Manufacturer’s, Importer’s, and/or Distributor’s Name
• Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

If you believe a medical device is being marketed outside the scope of its FDA approval or clearance, you can file a report through FDA's Allegations of Regulatory Misconduct process. You can also contact your local FDA Consumer Complaint Coordinator to report concerns.\

 

Tortle's official FDA registration number:

• FDA Registration #3007842980

The FDA has cleared caps, helmets or head bands 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.

Device Description

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. However, the safety and effectiveness of the use of these medical devices has not been demonstrated.