• Under-Reported, Under-Estimated, and PREVENTABLE
• Documented Incidence: 0.7% to 3.12%
• Represent 65% of documented Fetal Injuries at C-Section
• 70% occurred on face, head, and ear
• Annual injuries in the U.S. projected at 10,500 to over 45,000
The Evidence Supports
The Need For Better Outcomes
CESAREAN FETAL LACERATIONS
• Ruptured membranes
• Non-low transverse hysterotomy
• Active labor
• Emergent/urgent C-section
• Breech presentation
• Inexperienced surgeon
RISK FACTORS
• Quality Care
• Cost of medical intervention
• Risk management
• Sharps injury risk
• Patient satisfaction
Not Simply a COSMETIC Complication
• Innovative tip protects baby when entering the uterus
• C SAFE cuts up and away from baby
• Designed to produce cleaner cuts, promoting better healing
• Protects surgical team from accidental sharps injury
• FDA approved, Non-DEHP, and Latex Free
SAFER FOR BABY AND SURGICAL TEAM
• Atramatic fascial entry
• Blunt entry into the uterus; using a single pass or multiple passes
• Extend hysterotomy incision
• Eliminates need for scalpel at hysterotomy
• C SAFE is listed as one option for preventing fetal laceration at hysterotomy
ONE DEVICE DOES IT ALL
UNIQUELY DESIGNED TO MAKE FETAL LACERATIONS A NEVER EVENT
“In trial use during a cesarean delivery, C SAFE worked exactly as expected. Push the blunted plastic tip through the uterus, nend your hand, push the device, and voila – a hysterotomy with almost no laceration risk to the baby”
“C SAFE is another example of a truly simple device that someone should have thought of sooner but didn’t”
“C SAFE won me over. With all the wasted money we throw at the sacred altar of Patient Safety, this product actually makes sense and is worth the marginal cost. I think it is time we made newborn lacerations a “never” event and C SAFE is one tool to get us there.”
“In trial use during a cesarean delivery, C SAFE worked exactly as expected. Push the blunted plastic tip through the uterus, nend your hand, push the device, and voila – a hysterotomy with almost no laceration risk to the baby”
MedReviews
Editor JAMES A. GREENBERG, MD
Brigham and Woman’s Hospital, Faulkner Hospital, Harvard Medical School, Boston, MA
[Rev Obstet Gynecol]