Vacuum extractors have been increasingly used in the United States to facilitate vaginal deliveries.
The increased use of vacuum extractors by obstetricians has corresponded with a parallel decrease in the use of forceps. As a result, many obstetricians who have been trained and exclusive use vacuum extractors have little to no experience in the safe use of obstetrical forceps.
The basic elements of an obstetrical vacuum extractor are an attachment device or cup which is typically applied to the baby’s head, a tube which connects the cup to an air evacuation or “vacuum” apparatus, and a hand or electric air pump which permits the obstetrician or obstetrical nurse to control the level of the vacuum force applied to the baby’s head.
Many pregnant patients are provided with little to no information regarding the perceived benefits or potential risks associated with vacuum-assisted delivery. In fact, to the uninformed patient, a vacuum extractor may seem to be a much more benign and safe device to assist in the delivery of a baby than forceps.
However, there is increasing evidence that the improper or injudicious use of vacuum extractors can cause a baby to suffer potentially permanent neurologic injury or even death.
On May 21, 1998, the United States Food and Drug Administration issued a Public Health Advisory emphasizing the need for caution in vacuum-assisted deliveries.1
The FDA emphasized, “This is to advise you that vacuum assisted delivery devices may cause serious or fatal complications, and to provide guidance to minimize the risk.”
In particular, the FDA emphasized that the improper or injudicious use of a vacuum extractor can cause a massive hemorrhage in the baby’s head, also known as a subgaleal hematoma or a subgaleal hemorrhage.
Subgaleal hemorrhage occurs when veins are damaged as a result of the forces applied to the baby’s head by the vacuum extractor. When this occurs, the baby can suffer a massive hemorrhage, leading to a condition known as disseminated intravascular coagulation, or DIC.
Signs of subgaleal hemorrhage include swelling of the head or scalp which may extend from the nape of the neck to the orbits of the eyes. Depending on the extent of the hemorrhage, the baby may suffer hypovolemic shock, as evidenced by a decrease in the baby’s blood pressure, increased respiratory rate and elevated heart rate, known as tachycardia.
If not promptly diagnosed and managed by competent medical practitioners, subgaleal hemorrhages caused by vacuum extractors can quickly lead to permanent neurologic injury or even death.
Injuries caused by vacuum extractors are most typically related to their improper or injudicious use by unsafe and careless practitioners.
For example, if a vacuum extractor cup is improperly placed on the baby’s head, or at or near the baby’s eyes, optical injuries or trauma to the baby’s face can occur.
In other cases, unsafe practitioners will continue to use a vacuum extractor despite numerous “pop offs” and might otherwise apply dangerous levels of traction forces to the baby’s head and scalp, thereby traumatically injuring the baby.
In other cases, the untrained or careless practitioner will apply a vacuum extractor when the baby is high in the pelvis or when the baby is “stuck” in the birth canal, for instance, because of a shoulder dystocia.
Because many practitioners mistakenly believe that a vacuum extractor is easier to use and safer than forceps, they fail to in any way provide information to their patients regarding the potential risks associated with vacuum-assisted delivery.
The manufacturers of obstetrical vacuum extractors typically include detailed warning and cautionary information describing how a vacuum extractor should be safely used. Unfortunately, in many cases, a careless or unsafe practitioner will ignore the manufacturer’s recommendations and warnings.
The Law Firm of Dugan, Babij, Tolley & Kohler, LLC has extensive experience in representing families whose loved ones have died or been injured as a result of medical malpractice associated with vacuum-assisted deliveries.