The FDA has issued a public health advisory to health professionals on the need for caution when using vacuum-assisted devices for obstetrical deliveries. The advisory states that the devices may cause serious or fatal complications and provides guidance to minimize risk. The agency is concerned that, while the total number of deaths and serious injuries reported from the devices remains small in relation to the total use of the devices (averaging 5 a year over the last 4 years), at least some of these complications might be avoidable.
Nightingale SL. Advisory on Need for Caution With Use of Vacuum-Assisted Delivery Devices. JAMA. 1998;280(1):12. doi:10.1001/jama.280.1.12-JFD80006-2-1