Traumatic Birth Injuries
On May 21, 1998, the FDA issued a public health advisory entitled, "Need For Caution When Using Vacuum Assisted Delivery Devices."[i] The Advisory stated that:
"Vacuum assisted delivery devices may cause serious or fatal complications . . ."
The Advisory went on to say that:
"While no instrumental delivery is risk free, we are concerned that some health care professionals who use vacuum assisted delivery devices, or those who care for these infants following delivery, may not be aware that the device may produce life-threatening complications."
The American College of Obstetricians and Gynecologists practice bulletin entitled Operative Vaginal Delivery - Practice Bulletin Number 17 June 2000 states: "Other potential neonatal complications associated with vacuum deliveries include intracranial hemorrhage, hyperbilirubinemia, and retinal hemorrhage."
Of significant importance is the final statement that:
"As with forceps procedures, there should be a willingness to abandon attempts at vacuum extraction if satisfactory progress is not made.[ii]"
Since the indications for vacuum extraction are essentially the same as for forceps delivery, the cervix should be completely dilated, the membranes should be ruptured, and the fetal head should be engaged. With regard to the determination of station, significant caput formation can lead an obstetrician to misjudge where the bony part of the head actually is located.[iii] The contraindications,[iv] therefore, include:
- CPD
- Face or brow presentation
- Breech presentation
- Unengaged fetal head
- Premature infant
- Incompletely dilated cervix
In Shoulder Dystocia and Birth Injury, Prevention and Treatment,[v] Dr. James O'Leary warns that "both the perturbations of difficult high or mid-forceps delivery or a vacuum extraction of a head wedged within an inadequate tight, bony birth canal, present grave danger of fetal, skull and brain injury. . ."
FDA Public Health Advisory: "Need For CAUTION When Using Vacuum Assisted Delivery Devices," May 21, 1998.
[1] ACOG Technical Bulletin Number 196, August 1994, "Operative Vaginal Delivery."
[1] ACOG Technical Bulletin Number 196, page 2.
[1] Creasy, Resnick, et. al., Maternal Fetal Medicine, 4th Ed., W.B. Saunders Company, 1999.
[1] James A. O'Leary, M.D., Shoulder Dystocia and Birth Injury, Prevention and Treatment, McGraw-Hill, Inc., 1992.
[1] James A. O'Leary, M.D., Shoulder Dystocia and Birth Injury, Prevention and Treatment, McGraw-Hill, Inc., 1992.
If your family has suffered a traumatic birth injury or obstetrical malpractice, please contact Andrew E. Greenwald at the law firm of Joseph, Greenwald & Laake, P.A. His birth trauma and obstetrical malpractice services are offered on a contingency basis. Therefore there is no fee if there is no recovery.
