US safety officials have advised parents to stop using infant sleep positioners, as they can be dangerous for babies.
The Consumer Product Safety Commission (CPSC) and Food and Drug Administration warned parents and child care providers to stop using the bolster pillows, saying they have received a dozen reports of infants between the ages of one and four months who died using the devices.
Most of the infants suffocated and died after rolling from a side-sleeping position onto their stomachs, but others suffocated after becoming trapped between the sleep positioner and the side of their bed.
In addition to the deaths, the CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions in or next to them.
The deaths and incidents involving sleep positioners happened over a period of 13 years, the two agencies said.
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep," CPSC chairwoman Inez Tenenbaum said.
The two main types of infant sleep positioners are flat mats with side bolsters or wedge mats with side bolsters. They are supposed to keep an infant from rolling onto his or her back while sleeping, to avoid SIDS, which has been linked to stomach-sleeping.
The FDA said Wednesday that there is no evidence that the devices prevent SIDS and urged parents, health care professionals, and childcare providers to stop using them.
It also ordered manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA to stop marketing those products, and asked manufacturers whose sleep positioners have been cleared by the FDA to submit clinical data showing that their products' benefits outweigh any risks.