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Vacuum Extraction: Perils, Problems and Pearls by Andrew E. Greenwald


Andrew Greenwald is a founder of Joseph, Greenwald & Laake P.A. located in Greenbelt, MD. He is currently the Co-Chair of the Birth Trauma Litigation Group of the Association of Trial Lawyers of America. He has been listed as a Top Lawyer by Washingtonian magazine. He is listed in Best Lawyers in America and will be listed in the upcoming new addition under the specialties of Medical Malpractice Law and Personal Injury Litigation. He is a former reviewer for the American Journal of Obstetrics and Gynecology. He has lectured extensively on medical malpractice and has authored numerous articles in Trial magazine.


Introduction


On May 21, 1998, the FDA issued a public health advisory entitled, “Need For Caution When Using Vacuum Assisted De- livery Devices.” 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 as- sisted delivery devices, or those who care for these infants following deliv- ery, may not be aware that the device may produce life-threatening compli- cations.


The FDA noted that it had received


over the past four years, reports of twelve (12) deaths and nine (9) serious injuries


among newborns on whom vacuum as- sisted delivery devices were used. The FDA mentioned, however, that the num- ber of serious complications “reported” to them from vacuum assisted delivery de- vices remains small in relation to the total number of births per year.


The types of complications that the FDA discussed were subgaleal hematomas and intracranial hemorrhages. In September of 1998, ACOG issued a committee opinion. Among other things, the ACOG Committee On Obstetric Practices, stated that:


. . . As with any other obstetric proce- dure, obstetric care clinicians using vacuum-assisted delivery devices to ef- fect operative vaginal deliveries should be appropriately trained and familiar with the indications and contra-indi- cations for the use of the device, as well as with its proper application and trac- tion procedure.


The Committee expressed concerns re-


garding the implications of the FDA Advisory, specifically that, given the decline in forceps use in the United States, any de- crease in the use of the vacuum device resulting from the Advisory might result in a higher cesarean section delivery rate or the increased use of forceps by some who have not had adequate training.


Technical Bulletins In February 1991, ACOG issued a Tech-


nical Bulletin dealing with operative vaginal delivery. Under the heading of “Clinical Management” the Bulletin stated:


The indications, preparation of the pa- tient, definitions, and prerequisites for vacuum extraction delivery are the same as for forceps deliveries.


Additionally, the ACOG Bulletin stated:


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