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Risk Management

1) ANALYSIS & JUSTIFICATION FOR ADOPTING C SAFE FOR PERFORMING C-SECTIONS
2) RISK MANAGEMENT OF CESAREAN SECTION FETAL LACERATIONS AND INJURIES

Content for Physicians

The following link contains graphic content and is intended for physicians.

Press Releases

Brolex LLC: December 12, 2012:
Brolex LLC:  June 28, 2012:​

Clinical Benefits

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…

Research and Development

1) RESIDENCY TRAINING PROGRAM
2) COOPERSURGICAL MOBIUS ELASTIC RETRACTOR + C SAFE SURGICAL DEVICE COMBINATION KIT
3) DEVICE REGISTRY TRIAL: 3,000 C Sections

UpToDate

UpToDate, on Cesarean delivery: Technique

"Intraabdominal procedures"

 

MedReviews

Editor Dr. JAMES A. GREENBERG, MDBrigham and Woman’s Hospital, Faulkner Hospital, Harvard Medical School, Boston, MA...

PR Newswire

Brolex C SAFE cesarean section safety device receives top scores

 

• 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

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MedReviews

Editor JAMES A. GREENBERG, MD
Brigham and Woman’s Hospital, Faulkner Hospital, Harvard Medical School, Boston, MA

[Rev Obstet Gynecol]