You know those sleep positioners that are so great at keeping baby right where she’s supposed to be? Stop using them.
The Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) cautioned caregivers on Wednesday against using the positioners after two babies died recently, bringing to 12 the number of infant deaths known to be associated with the products.
“We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep,” says CPSC chairman Inez Tenenbaum. (More on Time.com: Similac Recall Outrages Parents: Are Beetles Bad?)
The “Back to Sleep” campaign urging parents to put babies to sleep on their backs has proved so successful that it’s spawned an infant product unknown to our parents’ generation: the sleep positioner, which typically features cushiony wedges or bolsters Velcroed to a thin mat. Some manufacturers advertise that they prevent Sudden Infant Death Syndrome (SIDS) and other variations claim to ease reflux, where stomach acids back up into the esophagus, or plagiocephaly, commonly known as flat head syndrome, which results from pressure on one area of the skull.
“At this time, there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners,” says Susan Cummins, an FDA pediatric expert.
The irony is that the positioners are now thought to have caused the infant deaths they sought to prevent; they are linked to suffocation after most of the babies rolled from their sides to their stomachs.
I used sleep positioners with my two younger daughters after my son developed a severe case of plagiocephaly (that’s worth another post of its own). Determined that my younger two wouldn’t wind up with flat heads, I distinctly remember a worried call to the pediatrician after one of them defied the positioner and rolled onto her belly at just a few weeks old. (More on Time.com: ‘Formula Powered’? Lactivists Tussle with Old Navy)
“What do I do?” I asked, with visions of SIDS coursing through my head.
“Nothing,” he replied. “Take out the positioner. If she’s strong enough to go from her back to her belly on her own, she’s fine.”
The message was clear: those positioners, as is the case with so much baby gear, were unnecessary. Now we’re learning they’re dangerous as well.
The U.S. government received reports of the related deaths within the past 13 years; it’s also recorded dozens of instances in which babies using the products were later found in unsafe positions. The FDA has approved several products aimed at reflux and plagiocephaly, but the agency will now require those manufacturers to submit evidence that the health benefits outweigh the risks. (While the FDA conducts a review, it has asked these manufacturers to stop marketing their products. Non-FDA-approved manufacturers must immediately stop marketing their products.)
The CPSC offers this advice to parents and caregivers:
Stop using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.
Never put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.
Always place a baby on his or her back at night and during nap time.
Report an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission by visiting www.cpsc.gov/cgibin/incident.aspx or calling 800-638-2772, or going to FDA’s MedWatch program.
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