FDA warns against sleep positioners

Some manufacturers have advertised that their sleep positioners prevent SIDS; gastroesophageal reflux disease, in which stomach acids back up into the esophagus; or flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull.


However, the FDA has never cleared an infant sleep positioner that claims to prevent or reduce the risk of SIDS.


The FDA had previously approved some of these products for  flat head syndrome. But because the agency learned in 2010 that these products have a risk of suffocation, the FDA then required manufacturers of FDA-cleared sleep positioners to submit data showing that the products’ benefits outweigh the risks.


In 2010, the FDA asked manufacturers to stop marketing these products as a prevention for Flat Head Syndrome.


The two most common types of sleep positioners feature raised supports or pillows that are attached to the mattress, or a wedge to raise a baby’s head. The positioners are intended to keep a baby in a specific position while sleeping and are intended for infants under 6 months old.


The problem with pillows / positioners is that they can

- raise a babys head in relation to thier body and therefore reduces the airways

- end up on top of or against the baby's face

- reduce the babies ability to move its head freely


Doctors often advise that helmets are an effective way to treat flat head syndrome and htat these should be worn 23 hours a day - only removing them at bathtimes. There is no evidence that we are aware of that suggests that there is a danger from soffication from the use of these helmets.


Mattresses that are designed to reduce the risk / treat flat head syndrome do not raise the baby's head above the line of thier body and as such do not restrict the airways (unlike pillows).


The curve in mattresses such as the Sleepcurve mattress do not move and remain under the baby. There is a chance that when your baby is moving around they can end up in the curve but there is no evidence of a higher risk of suffocation.