On June 28, 20222, the U.S. Food and Drug Administration (FDA) issued a warning to parents, guardians, health care providers, and caregivers not to use neck floats with babies for water therapy interventions. The warning announcement also states that the neck floats should also never be used with babies with special needs, developmental delays, spina bifida, Down […]
On June 28, 20222, the U.S. Food and Drug Administration (FDA) issued a warning to parents, guardians, health care providers, and caregivers not to use neck floats with babies for water therapy interventions. The warning announcement also states that the neck floats should also never be used with babies with special needs, developmental delays, spina bifida, Down syndrome, spinal muscular atrophy (SMA) type 1, or cerebral palsy. The FDA warns that these neck floats can lead to death or severe injury.
The FDA Provides the Following Recommendations for Parents and Caregivers:
FDA Recommendations for Medical Professionals:
According to the FDA, neck floats are inflatable plastic rings worn around a baby’s neck that help babies float freely in the water. Some neck floats products are retailed and marketed for premature babies and infants as young as two weeks old. They are intended to cradle a baby’s head as their body dangles in the water. People have used neck floats while bathing babies, while babies are swimming, and as a physical therapy tool for babies with disabilities and developmental delays.
The FDA acknowledges that some manufacturers claim these neck float products support water therapy interventions in babies who have special needs or developmental delays, and their benefits include greater flexibility, increased muscle tone, better range of motion, better sleep quality, increased lung capacity, and increased nervous system and brain stimulation. The effectiveness and safety of neck floats to promote motor development, for use as a physical therapy tool, or for strength building have not been established by the FDA.
According to the FDA warning letter, the risks of using baby neck floats include strain, injury to a baby’s neck, and fatalities due to drowning and suffocation. Babies who have special needs, including SMA Type 1 or spina bifida, have a significantly increased risk for serious injury.
The FDA knows of at least one baby’s death and another baby who was hospitalized in connection with the use of baby neck floats. In these incidents, the babies were harmed because their caregivers were not monitoring them.
Although the FDA believes that severe injury or death caused by neck floats are rare, parents, medical professionals, and caretakers should be knowledgeable about these incidents can and these incidents can happen. It is possible that incidents have not been reported to the FDA.
The FDA is currently informing the public about the danger to babies who use neck floats, particularly babies with special needs or developmental delays, as the FDA works with external stakeholders to raise awareness of the problem.
The FDA recently became knowledgeable of companies marketing their neck float products as a water therapy tool without prior FDA approval or clearance. The FDA has expressed its concerns about promotional materials used by these companies, and the FDA will continue to monitor any promotional claims and materials for these neck float devices. The FDA will continue to inform the public about new, significant information as it becomes available.
If your child experiences injury or death associated with neck floats, we encourage you to contact our firm for your free case review and file a claim against the manufacturer.
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).