Legal Briefs
Did Vacuum Extraction Use Cause Brain Injury?
Maureen E. Sims, MD*
*Department of Pediatrics, University of California, Los Angeles, Los Angeles, CA
AUTHOR DISCLOSURE Dr Sims has disclosed
that she has been compensated for reviewing
records and providing testimony in some of
the cases highlighted in Legal Briefs. This
commentary does not contain a discussion of
an unapproved/investigative use of a
commercial product/device.
ABBREVIATIONS
CT computed tomography
IVH intraventricular hemorrhage
MRI magnetic resonance imaging
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A 33 4/7 weeks’ gestation, 1,900-g female infant was born to a 21-year-old mother
whose pregnancy was complicated by hypertension. The mother was admitted to
the hospital and given magnesium sulfate 5 days before delivery. After a course of
antenatal corticosteroids, the obstetrician induced labor because of worsening
hypertension. Spontaneous rupture of membranes occurred 4 hours after oxy-
tocin was started. Variable decelerations occurred, for which the obstetrician
ordered an amnioinfusion. The obstetrician retained by the plaintiff was critical of the
amnioinfusion, stating that the salt load given to the mother during this procedure was
contraindicated because of the mother’s hypertension. Nine hours after oxytocin was
started, when the cervix was completely dilated, the mother had 2 brief seizures.
The fetal heart tracings were normal during the seizures. Ten minutes later, the
obstetrician placed a vacuum device on the fetus and delivered the infant. The
plaintiff’s obstetrical expert pointed out that the literature and the manufacturer’s
guideline state that a fetus of less than 34 weeks’ gestation should not have a vacuum-
assisted delivery. The treating and defense obstetrician said that the vacuum extraction
was warranted because of the mother’s seizures. The Apgar scores were 8, 9, and 9 at
1, 5, and 10 minutes, respectively.
The infant’s physical examination showed molding, cephalohematoma, facial
bruising, retinal hemorrhage, a normal head circumference of 32 cm, and a low
blood pressure of 53/21 mm Hg with a mean of 31 mm Hg, for which a 20-mL bolus
of normal saline was given. The initial hematocrit was 63.9%. The magnesium level
was 3.8 mEq/L (1.9 mmol/L). The infant began having more apnea and required
intubation at 9 hours because of increasing severity of apnea. The treating and
defense neonatologist said the apnea was secondary to the magnesium and/or apnea of
prematurity. The plaintiff neonatologist said while those were possibilities, the fact that
the infant was delivered by vacuum extraction, was only of 33 4/7 weeks’ gestational age,
and had hypotension, required the physicians to consider head trauma as a potential
cause of the apnea; neuroimaging was required. The defense said only supportive care
would be warranted. The plaintiff neonatologist disagreed and pointed out that
knowledge of intracranial pathology was important for several reasons: 1) if subdural
hemorrhage were present it might need evacuation; 2) if intraventricular hemorrhage
were present, it needed to be followed for possible progressive ventriculomegaly and
subsequent ventriculoperitoneal shunting; 3) if any abnormalities were found, follow-up
evaluations were needed; and 4) to inform the family of the problem. He pointed out that
the apneic episodes might have been seizure equivalents, but could not testify whether it
was more probable than not that they were. He testified that the intracranial pathology
resulting from the vacuum should be part of the differential, but agreed that supportive
care was indicated. Apnea of prematurity was possible, but unlikely in an infant of al-
most 34 weeks’ gestation. Furthermore, he testified that the molding and cephalohematoma
in an infant who is only 1,900 g is unusual and was probably the result of the vacuum
application. These clinical signs should have led the clinicians to perform neuroimaging
and to strongly consider head trauma. At 6 hours, the hemat-
ocrit had decreased to 57.3%. By the following day, the
magnesium level was 3.1 mEq/L (1.5 mmol/L).
The infant underwent extubation and was given nasal
continuous positive airway pressure, then proceeded to
receive high-flow nasal cannula over the next few days. On
day 3, she was started on caffeine treatment, and gavage feed-
ings were initiated. She had several large emeses, for which
metoclopramide was started. On day 5, the hematocrit was
40%. The defense neonatologist said this drop in hematocrit was
secondary to hemodilution from the bolus of 20 mL of normal
saline and the intravenous fluids. The plaintiff neonatologist
pointed out that the infant received a standard amount of fluid
and, in fact, the day the hematocrit was 40%, the weight was
almost 200 g less than birthweight. Therefore, hemoconcentra-
tion rather than hemodilution would be the more probable
scenario. Furthermore, the plaintiff neonatologist said the cir-
culating blood volume was approximately 170 mL and that 20
mL given initially and the subsequent standard maintenance
fluids would not cause this drop in hematocrit because water loss
from urine output, stool, and insensible losses accounted for all
the fluid the infant had received. The drop in hematocrit was
probably from blood loss secondary to intracranial hemorrhage.
That evening, tremors, posturing, and increased hyperto-
nicity were noted and the physician was notified; he ordered
1 dose of 5 mg/kg of phenobarbital. The plaintiff neonatologist
was critical of the dosage because it was a maintenance dose, not
a loading dose. The defense claimed that because the seizures
stopped until the next day, the dosage was adequate. The plaintiff
neonatologist quoted pages from the Volpe text that showed the
adverse impact of seizures on metabolic and cardiovascular
systems, which ultimately affect the neurodevelopmental out-
comes of infants whose seizures are not controlled.
On day 6, the infant began having seizures again. Com-
puted tomography (CT) showed a massive intraventricular
hemorrhage (IVH), dilated lateral ventricles, and subdural
and subarachnoid hemorrhages. The plaintiff neonatologist
pointed out that the intracranial hemorrhage was probably
caused by the vacuum extraction. The defense neonatologist said
that hemorrhages were common in preterm infants and were
secondary to prematurity. The plaintiff neonatologist disagreed.
He pointed out that it is rare for a 33- to 34-week gestation infant
to develop an intracranial hemorrhage unless the infant has a
very stormy course, such as infection with disseminated intra-
vascular coagulopathy or profound cardiovascular instability.
Furthermore, fewer than 2% of infants of more than 1,500 g have
IVH; subdural hemorrhage was a well-known complication of
vacuum-assisted deliveries. A loading dose of phenobarbital
was provided and the child was sent to a referral center for
evaluation by a neurosurgeon. Magnetic resonance imaging
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(MRI) performed at age 5 weeks showed dilated lateral
ventricles and extensive encephalomalacia of the left hemi-
sphere, with cortical thinning and scattered infarctions. At
6 weeks, a ventriculoperitoneal shunt was placed for rapidly
progressing posthemorrhagic ventriculomegaly and the child
was discharged at 2 months of age.
At the 6-year follow-up examination, the child had right-
sided weakness, cognitive deficits, behavioral issues, and
developmental delays. A mistrial was declared, but a set-
tlement agreement was reached before another trial was
performed.
DISCUSSION
Vacuum-assisted deliveries occur in approximately 5% of
vaginal births, but they are very uncommon in preterm
deliveries. Because the preterm skull is more compliant, the
brains of these infants are more vulnerable to mechanical
injury. Potential indications for vacuum-assisted vaginal
delivery include prolonged second stage of labor, nonreas-
suring fetal testing, elective shortening of the second stage
of labor, and possibly maternal exhaustion. Contraindica-
tions to vacuum-assisted delivery include fetal bleeding
disorder, fetal demineralizing diseases, incomplete dilation
of the cervix, intact fetal membranes, unengaged vertex, fetal
malpresentation, suspected cephalopelvic disproportion, esti-
mated gestational age less than 34 weeks or estimated fetal
weight less than 2,500 g, and failure to obtain informed
consent. Unlike acute global hypoxia or ischemia from pla-
cental insufficiency or cord compression which clinically
manifests immediately after birth, symptoms of head trauma
may be masked for hours or even days after delivery, unless
there is concomitant placental or cord compromise, or an
associated large hemorrhage causing significant hypovolemia.
When the clinical signs of serious mechanical trauma evolve,
symptoms ranging from apnea, seizures, unusual posturing,
color changes, and poor feeding, to signs of cardiovascular or
respiratory instability will appear.
Extracranial trauma associated with a vacuum-assisted
delivery includes scalp bruises and lacerations, facial nerve
palsy, caput succedaneum, chignon, cephalohematoma, and
subgaleal hemorrhage. Bruises and scalp lacerations are
generally superficial and occur about 16% of the time.
During application of the vacuum cup on the fetal head,
a collection of interstitial fluid and microhemorrhages, or
chignon, may fill the internal diameter of the vacuum cup.
This fluid collection resolves within 12 to 18 hours without
any sequelae. Cephalohematoma occurs in 6% to 10% of
vacuum extractions, compared with 1% to 2% of spontane-
ous vaginal deliveries. Uncomplicated cephalohematomas
Vol. 18 No. 1 JANUARY 2017 e61
 usually resolve within a few weeks, and except for ele-
vated bilirubin levels from the occult blood, they tend to not
require treatment. However, cephalohematomas may be
the marker for underlying skull fractures and/or intracra-
nial injury. A subgaleal hemorrhage develops from accu-
mulation of blood in the subaponeurotic space between the
periosteum of the skull and the galea aponeurotica. Beneath
the galea aponeurotica, the loose subaponeurotic layer con-
tains large veins which connect the dural sinuses and the
scalp veins. This space has the capacity to accumulate up to
260 mL in term infants. Traction force applied during
instrumental delivery pulls the aponeurosis from the cra-
nium, thus avulsing the subgaleal space and causing hem-
orrhage. Subgaleal hemorrhage can result in hypovolemic
shock, disseminated intravascular coagulation, multiorgan
failure, and neonatal death in up to 25% of cases.
Prompt recognition of this disorder starts with appreci-
ating that the fetus delivered by vacuum extraction has
serious risks and care providers need to be highly vigilant
for any abnormalities, especially low blood pressure and
cardiovascular instability. The initial physical examination
findings may be normal, but within minutes or hours, a
boggy scalp, pitting edema, and progressive spread of the
blood toward the neck with lateral spreading around the ears
may occur. Periorbital swelling and ecchymosis are com-
monly observed. Hypotension, pallor, tachycardia, and a
falling hematocrit count will be noted. The clinician should
be aware of the occasional “silent” presentation, in which a
fluctuant mass is not initially apparent despite serial clinical
examinations. Emergency transfusion may be necessary to
stabilize the infant. If the subgaleal hemorrhage is large
enough to cause symptoms, neuroimaging is required. This
is because if the forces were great enough to display symp-
toms of the subgaleal hemorrhage, intracranial hemorrhage
or ischemia are often present as well. Close monitoring is
particularly important in those infants who appear to be
stable enough to go to a normal newborn nursery.
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Neuroimaging is crucial to determining the location and
extent of lesions associated with parturitional head trauma.
Cranial ultrasonography is inadequate because it would fail
to diagnose the outer lesions, such as subdural hemorrhage
or ischemic injury at the peripheral area of the brain as well
as encephaloceles from trauma. A CT scan is required and if
clinically stable, an MRI is warranted.
American Board of Pediatrics
Neonatal—Perinatal Content
Specifications
• Know the indications for and perinatal complications of operative
vaginal delivery (forceps, vacuum extraction, etc) and of vaginal
delivery after cesarean delivery
• Know the indications for and limitations of various neuroimaging
studies and be able to recognize normal and abnormal structures
and changes during development and growth
Suggested Reading
Hanigan WC, Morgan AM, Stahlberg LK, Hiller JL. Tentorial
hemorrhage associated with vacuum extraction. Pediatrics. 1990;85
(4):534–539
Jeltema HR, Hoving EW. Iatrogenic encephalocele: a rare complication
of vacuum extraction delivery. Childs Nerv Syst. 2011;27
(12):2193–2195
US Food and Drug Administration. FDA Public Health Advisory: Need
for caution when using vacuum assisted delivery devices. http://
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
PublicHealthNotifications/ucm062295.htm. Accessed October 10,
2016
Volpe JJ. Neurology of the Newborn. Philadelphia, PA: Saunders; 2008
Yeomans ER. ACOG Practice Bulletin No. 17, Operative vaginal delivery.
Obstet Gynecol. 2010;115(3):645–653
 Legal Briefs: Did Vacuum Extraction Use Cause Brain Injury?
Maureen E. Sims
NeoReviews 2017;18;e60
DOI: 10.1542/neo.18-1-e60

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 Legal Briefs: Did Vacuum Extraction Use Cause Brain Injury?
Maureen E. Sims
NeoReviews 2017;18;e60
DOI: 10.1542/neo.18-1-e60

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://neoreviews.aappublications.org/content/18/1/e60

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