CLINICAL BENEFITS

CASE FOR A SAFER CESAREAN SECTION

Four million (4.0M) babies are born in the US annually (1,2).  Five and a half million (5.5M) in EU countries total(2,5,6).  Cesarean sections are performed in two primary patient populations, 1) emergent situations, and 2) scheduled elective cesarean sections.  In the US, cesarean sections account for 25 - 38% of babies born(7).  European rates are higher nearing 44% of births(6).  In Mexico(8), a 38% rate in the general population, and a 50% rate in wealthier populations(8).  Chile a 40% c-section rate.

China is home to the greatest number of births, 16.4 million(2,3,6) annually, with one of the greatest c-section rates of nearly 50%(3).  All c-section rates around the globe are rising annually(1,3,4,5,7).

ANIMATION

C SAFE IN USE

DEVASTATING FETAL INJURIES

 

(a) These numbers represent total physicians. The number of physicians in active patient care is 26% lower on a national basis.


When considering nonvertex c-section deliveries, the injury rate nearly doubles (6.0%(14)) from the numbers found in the above table.

Thirty seven thousand (37,000) active physicians with up to 45,000 laceration injuries annually translate to ratio of 1.2 injuries per physician.  Certainly this is not an accurate depiction of what occurs in the real world.  Physicians practicing for many years have never injured a newborn.  But most likely, if you’ve been practicing for a good number of years, you have seen lacerations or nicks around you.

The case for a safer device, which practically eliminates the possibility for newborn injury, is now available to help you maintain an impeccable track record of safeguarding your newborn patient.

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Many fetal injuries resolve with little or no medical intervention.  This does not in any way minimize the discomfort or tension healthcare workers feel any time a newborn is nicked.  For the parents, any injury is unwelcome news.

Even modest lacerations can have far reaching implications, such as this scar on a 12 year old child.

Photographs are at birth (left), 12 years (right)

The more devastating fetal injuries are painful for everyone, patient – parents, and all healthcare workers involved in the surgical and delivery arena

Lacerations occur over a variety of body locations.  In a retrospective multicenter study of 904 cesarean sections performed, following are a table of presentation and location of fetal lacerations.

Table 2:  Presentation and Location of Fetal Laceration Injury *

Facts from the published literature are that: (8, 10, 14)
 

  • Scalpel injuries do in fact commonly occur
  • 3% of all c-sections
  • 6% in nonvertex cases
  • Scalpel injuries are underreported

  • Many obstetricians don’t recognize the injury, or simply don’t document it
  • There is no follow-up of these injuries

  • Reducing or eliminating fetal injuries and their negative clinical outcomes
  •     minor lacerations to acute injuries
  •     short term to long term complications
  • Medical intervention related costs for managing any fetal laceration
  • Proactively addressing the medicolegal implications related to cesarean sections
  • Patient safety & improvement practices
  • Risk mitigation programs

OUTCOMES ANALYSIS & JUSTIFICATION FOR ADOPTING C SAFE AS AN IN-HOSPITAL OPTION FOR PERFORMING CESAREAN SECTIONS

Current efforts regarding risk management affairs, whether from a clinical or economics outcome perspective, transcend from hospitals to CMS {IPPS Final Rule} to insurers, and of course physicians.  Today’s efforts on Quality Measures continue to grow and impact upon all parts of the healthcare system.

There aren’t many examples of medical devices specifically designed as a safety device that reduces or eliminates negative outcomes.  The C SAFE device has been engineered from the ground up with exactly this concept in mind.  This device is a result of negative health and negative economic outcomes.  It was not developed to replace an existing device, because there is no such cesarean section device available to modern medical practice.

Properly implemented, the C SAFE device should be considered by healthcare parties as part of an overall risk management & quality measures perspective.  One to which an institution may reap the following benefits:

Without a doubt the risk of fetal injuries associated with cesarean section is itself a daunting outcome.  The case for a safer c-section having been made, Brolex offers physicians and hospitals a new medical device that eliminates the inherent risks found with the use of a conventional scalpel to perform an incision in the uterine wall.

With this new device, the C SAFE™®, a new paradigm is born with respect to fiduciary responsibilities on behalf of healthcare facilities and employees, as well as medical malpractice insurance carriers.

Example of a malpractice case for a facial laceration injury during an emergency c-section.

This case settled prior to trial for $800,000.

FUTURE LEGAL & ECONOMIC RAMIFICATIONS

Another OB resident case where verdict awarded was $550,000, injury was a laceration to forehead.

This new paradigm begs the question of how the legal system will work, when there exists a new medical device specifically tailored to eliminate fetal injury due to lacerations from conventional scalpels.

Having stated this paradigm, it is simpler to embrace the new technology, take the possible extra 10 seconds to use the C SAFE™®, and have a smile on each and every time you announce

it’s a Boy;   it’s a GIRL !

References:

1)       U.S. Census Bureau, Statistical Abstract of the United States: 2011
2)       CIA; The World Factbook, 2011
3)       The Beijinger, 2011
4)       Demography Report 2010, Latest figures on the demographic challenges in the EU
5)       Eurostat News Release; EU27 Population Reaches 500M
6)       World Data Bank, 2011
7)       Centers for Disease Control: National Center for Health Statistics, 2007
8)       Women’s Health: OB/GYN Trends Report; VIMO, 2007
9)       Agency for Health Care Research and Quality
10)   CDC NCHS data brief. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/nchs/data/databriefs/db35.htm. Accessed April, 2011
11)   Medscape Reference; Cesarean Delivery; Saju Joy, MD; Chief Editor: David Chelmow, MD.  Accessed April, 2011
12)   United States; DHHS; National Hospital Discharge Survey: 2007
13)   United States Department of Labor; Bureau of Labor Statistics; Occupational Outlook Handbook, 2010-11 Edition
14)   OBGYN.net  Journal Review; Fetal Laceration Injury at Cesarean Delivery, Obstet Gynecol 1997: 90: 344-6, JAMES F. SMITH, MD, CESAR HERNANDEZ, MD, AND JOSEPH R. WAX, MD
15)   Gerber AFI. Accidental incision of the fetus during cesarean section delivery. Int J Gynecol Obstet 1974;12:46-8.
16)   Alexander JM, Leveno KJ, Hauth J, et al. Fetal injury associated with cesarean delivery. Obstet Gynecol. 2006;108:885–90. [PubMed]
17)   Dessole S, Cosmi E, Balata A, Uras L, et al. Accidental fetal lacerations during cesarean delivery: experience in an Italian level III university hospital. Am J Obstet Gynecol. 2004;191:1673–7. [PubMed]
18)   Wiener JJ, Westwood J. Fetal lacerations at cesarean section. J Obstet Gynaecol. 2002;22:23–4.[PubMed]
19)   Preetha, Bhagya, Taizoon, Mangurtena, Schweigd; Complication of emergency cesarean section: Open metacarpophalangeal disarticulation and complete extensor tendon lacerations of the hand in a neonate; Journal of Neonatal-Perinatal Medicine 2 (2009) 131–133
20)   H. Aburezq, K.H. Chakrabarty and R.M. Zuker, Iatrogenic fetal injury, Obstet Gynecol 106 (2005), 1172–1174
21)   D.A. Fuller and J.S. Raphael, Extensor tendon lacerations in a preterm neonate, J Hand Surg 24 (1999), 628–632
22)   D.M. Haas and A.W. Ayres, Laceration injury at cesarean section, J Matern Fetal Neonatal Med 11 (2002), 196–198.
23)   C.A. Kavouksorian and R.B. Noone, Flexor tendon repair in the neonate, Ann Plast Surg 9 (1982), 415–418.
24)   J.M. Okaro and S.E. Anya, Accidental incision of the fetus at caesarian section, Niger J Med 13 (2004), 56–58.
25)   J.J. Wiener and J. Westwood, Fetal lacerations at caesarean section, J Obstet Gynaecol 22 (2002), 23–24.
26)   T. Bergholt, J.K. Stenderup, A. Vedsted-Jakobsen, P. Helm and C. Lenstrup, Intraoperative surgical complication during cesarean section: an observational study of the incidence and risk factors, Acta Obstet Gynecol Scand 82 (2003), 251–256.

The practice of OB/GYN is one of the most sought after forms of health care in the United States(8).  Pregnancy and childbirth related procedures are amongst the most commonly performed in US hospitals.

Cesarean sections cost the health care system in the United States approximately $14,000 - $25,000 per procedure.  With a total gross cost of nearly $37B, it has become the most common surgical procedure.

There are approximately 50,000 OB/GYNs(8) in the United States.  Active OB/GYNs in patient care account for 37,000 physicians(13).  These 37,000 physicians perform the nearly 1.5(7) million c-sections annually.  The numbers of c-sections are growing on an annual basis due to increased births, and more importantly to an increase in c-section rates.

C SAFE device used to prevent nicks or cuts to newborn babies.

Published literature documents there is a 1.5 - 3.0% risk of lacerations or nicks in these c-sections.  There is strong evidence to suggest that this rate is actually higher than reported and documented(14).  At a documented risk of 1.5 – 3.0%, this translates to up to 45,000 newborns that experience some level of laceration injury related to the c-section surgical procedure.  For nonvertex cesarean sections, reports(14) of a 6.0% risk for lacerations nearly double the number of injuries to newborns.

Table 1 presents a distribution of physicians on a state by state basis, along with calculated c-sections and calculated laceration injuries.

Table 1:  Distribution of OB/GYN physicians by State