Baby sleep positioners, a popular product for safety-conscious parents, were supposed to save lives by keeping infants from rolling onto their stomachs.
Instead, they are now being added to the growing list of dangerous nursery products, all but banned in an emphatic move by federal regulators on Wednesday.
The products have been linked to at least a dozen suffocation deaths in the last 13 years, according to the Consumer Product Safety Commission. The products often have foam bolsters on the sides that help keep a baby in one position, but babies can wriggle or roll into unsafe spots. Infants have suffocated on the foam or been trapped between the product and the side of the crib or bassinet.
For years, the American Academy of Pediatrics and others have promoted the scientifically sound advice that babies be put to sleep on their backs to reduce the risk of Sudden Infant Death Syndrome. These products appeal to the safety-minded parent who worries a child will stray from that position. Sales of the products, which often cost less than $20, took off in recent years. In 2008 alone, 1 million were sold, according to the Juvenile Products Manufacturers Association.
Dr. Joshua Sharfstein, a pediatrician who is the No. 2 official at the Food and Drug Administration, said many of these products are "illegal devices" because they tout their ability to reduce the risk of SIDS; none has been approved by the FDA, which must clear products making medical claims.
There is no evidence that they prevent SIDS, also known as crib death, said Dr. Rachel Moon, chair of the American Academy of Pediatrics' SIDS Task Force.
Even if companies withdraw their medical claims, they still could run into regulatory trouble selling sleep positioners, Sharfstein said.
"I would think good sense would stop a company from marketing a product like this knowing that the Academy of Pediatrics, the FDA and the CPSC think that they could be dangerous and potentially lead to the death of children," he said.
However, the Juvenile Products Manufacturers Association, the trade group that represents the makers of these products, said its members will continue to produce and sell the products unless there is further action, such as a recall, from the government.
The positioners join drop-side cribs as products that gained wide popularity but were proven to be hazardous in recent years.
The joint warning from the FDA and the CPSC marks a more aggressive style in tackling hazards in the nursery after an avalanche of recalls of cribs, toys and other baby products. Typically, the CPSC recalls products piecemeal, and parents are left to wonder if similar products share the hazard. While none of these products is subject to a recall, FDA and CPSC officials made it clear they could pursue recalls or other enforcement actions if manufacturers and retailers fail to remove them from the market.
Babies R Us, Toys R Us and Target said they planned to stop selling the products online and in stores, according to spokeswomen for the retailers. At least five manufacturers told the FDA they planned to withdraw their products.
Judy Sage, a New York mother, lost her son Andy when he suffocated on a sleep positioner at 8 weeks of age in 2002. Andy's pediatrician recommended she position the child, a twin, on his side to help with gastroesophageal reflux, a common problem in infants. She said she thought the Graco sleep positioner would keep Andy safe.
Now she can't shake the image of finding him that January night. "Andy would be here today had I not used a sleep positioner," she said.
Sage has spent the last eight years trying to spread word of the dangers of these products and joined the board of Chicago-based Kids In Danger, an organization that pushes for safer products for children. Sage was elated by Wednesday's announcement.
"I felt like I can scream loud but not loud enough to get this heard," she said. "I thought it would take a lifetime."
In a written statement, a Graco spokeswoman said the company extends its sympathies to the Sage family but could not discuss "current or past legal claims." The company distributed a sleep positioner until 2003 and then left the market as more information became available in favor of infants sleeping on their backs, she said.
The Juvenile Products Manufacturers Association said in a written statement that sleep positioners promote safe sleep practices when babies are placed on their backs. Parents have relied on the devices for years, the group said.
The trade group said parents should no longer use the product once babies can roll over.
That warning, common among sleep positioners, is difficult to follow because parents never know exactly when a baby is going to roll for the first time, said Moon, of the American Academy of Pediatrics.
"So I interpret this warning that parents wait until there's evidence that this device could hurt their child before deciding that they shouldn't use it anymore," Moon said. "To me, that doesn't make much sense."
The FDA first approved some sleep positioners in the 1980s to help babies who suffer from reflux or for those whose heads are flattening. In all, 18 products were cleared by the FDA for sale for those purposes. Some of the reflux positioners, for instance, are on an incline so babies' heads are higher than their feet.
Manufacturers that want to continue selling those products will have to show evidence that the benefits of the products outweigh the risks of suffocation, said the FDA's Sharfstein.
Moon said many parents wrongly believe that babies with reflux will get worse if placed flat on their back.
"There's actually no evidence that putting a baby on the back in an elevated position will help reflux, and often it will make it worse," she said.
Parents concerned about SIDS should know that the safest crib is a bare one that has never been recalled: a snug-fitting mattress with a tight-fitting crib sheet and nothing else, said Nancy Cowles, executive director of Kids In Danger. Babies should be put to sleep on their backs, and footed sleepers and sleep sacks should replace loose blankets, she said.