1. The simple solution for postpartum hemorrhage.

2. 2

3. Content Discussion Introduction Indications
Steps for balloon application
Comparison to existing manual treatments
References
Support info

4. Discussion

5. Discussion
Postpartum hemorrhage (PPH) is defined as bleeding that occurs immediately after the placenta is delivered.
PPH remains in the top five causes of maternal death in both developed and developing countries.

6. Discussion PPH is an emergent situation.
The decision for appropriate treatment must be made in a matter of minutes.
Proper treatment of PPH is multifactorial and can range from simple options to complex treatment.
Patients with PPH can deteriorate very quickly.

7. Introduction

8. Introduction
Severe bleeding is the single most significant cause of maternal death worldwide.
More than half of all maternal deaths occur within 24 hours of delivery, most commonly from excessive bleeding.*
*American College of Obstetricians and Gynecologists. ACOG practice bulletin: clinical management guidelines for obstetrician-gynecologists number 76. Obstet Gynecol ;108(4):

9. Introduction Various management measures are used to control bleeding.
Uterotonics
Packing
Manual compression
Embolization
Laparotomy
Hysterectomy

10. Introduction An ideal management option would:
Be easily administered and removed
Control capillary/venous bleeding and surface oozing
Gauge success of treatment in real time
Avoid hysterectomy to preserve the patient’s reproductive potential

11. Introduction The Bakri Postpartum Balloon from Cook Medical:
Is easily administered
Allows quick determination of effectiveness
Gauges ongoing blood loss through inner lumen
Removes easily without need for separate surgical procedure
Conservatively manages hemorrhage

12. Introduction The Bakri Postpartum Balloon: Is easily administered
Will easily pass through a dilated cervix
May be passed retrograde through a cesarean incision
May be inflated quickly
May be deflated quickly and removed if needed

13. Introduction The Bakri Postpartum Balloon:
Effectiveness can be quickly ascertained
Tamponade may be quickly ascertained when the balloon is placed
If not effective, it may be easily removed
May help temporize a patient while preparations for more aggressive treatments are made

14. Introduction The Bakri Postpartum Balloon:
Gauges ongoing blood loss through inner lumen
Drainage lumen of catheter with distal sideports allows real-time assessment of ongoing blood loss
May prevent delayed treatment of concealed hemorrhage above level of the tamponade balloon

15. Introduction The Bakri Postpartum Balloon:
Removes easily without need for separate surgical procedure
Deflates in minutes
Removes easily transvaginally

16. Introduction The Bakri Postpartum Balloon:
Conservatively manages hemorrhage
Is a simple yet effective tool that may help control uterine bleeding when uterotonic therapy fails

17. Indications

18. Indications
The Bakri Postpartum Balloon catheter is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

19. Indications
NOTE:
While the device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding, the application of this device should be concomitant with close monitoring for signs of arterial bleeding and/or disseminated intravascular coagulation (DIC).

20. Contraindications

21. Contraindications
The use of this product is contraindicated in the presence of:
Arterial bleeding requiring surgical exploration or angiographic embolization
Cases indicating hysterectomy
Pregnancy

22. Contraindications
The use of this product is contraindicated in the presence of:
Cervical cancer
Purulent infections of the vagina, cervix or uterus
Untreated uterine anomaly

23. Contraindications
The use of this product is contraindicated in the presence of:
Disseminated intravascular coagulation
A surgical site that would prohibit the device from effectively controlling bleeding

24. Application

25. Application Vaginal Delivery: Transvaginal Placement
Determine that the uterus is clear of any retained placental fragments, arterial bleeding or lacerations.
Determine approximate uterine volume by ultrasound or direct examination.
Under ultrasound guidance, insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium.

26. Application Vaginal Delivery: Transvaginal Placement (cont.)
Note: Avoid excessive force when inserting the balloon into the uterus.
If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.
To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine- or antibiotic-soaked vaginal gauze at this time.

27. Application Cesarean Delivery: Transabdominal Placement
Determine that the uterus is clear of any retained placental fragments, arterial bleeding or lacerations.
Determine uterine volume by intraoperative direct examination or postoperative ultrasound examination.

28. Application Cesarean Delivery: Transabdominal Placement (cont.)
From above (via access of the cesarean incision), pass the tamponade balloon, inflation port first, through the uterus and cervix.
Have an assistant pull the shaft of the balloon through the vaginal canal, until the deflated balloon base comes in contact with the internal cervical ostium.

29. Application Cesarean Delivery: Transabdominal Placement (cont.)
Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.
If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.
NOTE: Inflate the balloon after the hysterotomy incision is closed to avoid balloon puncture.

30. Application Cesarean Delivery: Transabdominal Placement (cont.)
To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed at this time with iodine- or antibiotic-soaked vaginal gauze.

31. Application Instructions for balloon inflation:
Note: Always inflate the balloon with sterile liquid. Never inflate with air, carbon dioxide or any other gas.
Note: Do not overinflate the balloon. Please refer to product label for maximum inflation volume.
Ensure that indwelling Foley is placed in patient bladder at this time.

32. Application Instructions for balloon inflation (cont.):
To ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than solely relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.
Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.

33. Application Instructions for balloon inflation (cont.):
Apply gentle traction to the balloon shaft to ensure proper contact between the balloon and tissue surface. To maintain tension, secure the balloon shaft to the patient’s leg or attach to a weight, not to exceed 500 grams.
Note: If balloon becomes dislodged due to shaft tension and cervical dilation, deflate, reposition and reinflate. Use of vaginal packing may be indicated at that time to aid in balloon placement.

34. Application – Balloon Dislodged

35. Application Patient Monitoring:
Once balloon is placed and inflated, connect the drainage port to a fluid collection bag to monitor hemostasis.
IMPORTANT: To adequately monitor hemostasis, the balloon drainage port and tubing should be flushed clear of clots with sterile isotonic saline.
Patient should be monitored continuously for signs of increased bleeding, uterine cramping or a deteriorating condition.
Patient monitoring should include, but not be limited to: Blood pressure, pulse, urine output, cramping, pallor and active bleeding.

36. Application Patient Monitoring (cont.):
IMPORTANT: Signs of deteriorating or unimproving conditions should indicate more aggressive treatment and management of patient uterine bleeding.
IMPORTANT: This device is not a substitute for surgical management and fluid resuscitation of life-threatening postpartum hemorrhage.
IMPORTANT: Device should not be left indwelling for more than 24 hours.

37. Application Balloon Removal:
Note: Maximum indwell time is 24 hours. Balloon may be removed sooner upon physician determination of hemostasis or the need to apply more aggressive treatment.
Remove tension from balloon shaft.
Remove any vaginal packing.
Using an appropriate syringe, aspirate the contents of the balloon until fully deflated.
Gently retract the balloon from the uterus and vaginal canal and discard.
Continue to monitor the patient for signs of uterine bleeding.

38. Comparison

39. Comparison Bakri Postpartum Balloon Uterine Packing with Gauze
Packaged with syringe and stores like other surgical tools.
May be applied quickly and easily
Open inner lumen allows for direct measurement of ongoing blood loss
Silastic® balloon conforms to uterine cavity, decreasing chance of uterine trauma
Can be removed quickly without additional invasive procedure
Uterine Packing with Gauze
Nominal material cost
Possible concealed hemorrhage
No record of blood loss
Potential uterine trauma during application
Removal post-treatment can require an additional trip to OR
Silastic is a registered trademark of Dow Corning Corporation.

40. Comparison Sengstaken-Blakemore Balloon Foley Catheters Inexpensive
Nasogastric balloon for tamponade of esophageal varicoceles and the introduction of contrast media
Does not necessarily take uterine shape
Expensive
Contains latex
Not indicated for management of PPH
Foley Catheters
Inexpensive
Generally ineffective in a large, postpartum uterine cavity
Application of multiple Foleys is cumbersome and less effective than the Bakri Postpartum Balloon
If applied individually without an overbag, Foleys do not readily conform to uterine anatomy
Foleys applied jointly in a plastic covering or overbag do not allow for proper drainage and can conceal uterine hemorrhage
Contains latex
Not indicated for management of PPH

42. Bakri Postpartum Balloon

43. Bakri Postpartum Balloon
100% silicone (no latex)
Ductile shape allows it to conform to uterine anatomy and shape
It allows for hemostatic cushion application and limits clot adhesion
The large diameter lumen in the shaft and multiported, nonabrasive tip allows for constant drainage, so an ongoing uterine hemorrhage does not go undetected post-application
Once deflated, the Bakri Balloon is easily removed transvaginally without the need for an additional surgical procedure
FDA 510(k) clearance for specific application to postpartum hemorrhage

44. References

45. References
American College of Obstetricians and Gynecologists. ACOG practice bulletin: clinical management guidelines for obstetrician-gynecologists number 76. Obstet Gynaecol. 2006;108(4):
Bakri YN, Amri A, Abdul Jabbar F. Tamponade-balloon for obstetrical bleeding. Int J Gynaecol Obstet. 2001;74(2):
Condous GS, Arulkumaran S, Symonds I, et al. The “tamponade test” in the management of massive postpartum hemorrhage. Obstet Gynecol. 2003;101(4):
Dabelea V, Schultze P, McDuffie R. Intrauterine balloon tamponade in the management of postpartum hemorrhage. Am J Perinatol. 2007;24(6):
Nelson WL, O’Brien JM. The uterine sandwich for persistent atony: combining the B-Lynch compression suture and an intrauterine Bakri balloon. Am J Obstet Gynecol. 2007;196(5):e9-e10.
B-Lynch C, Keith L, Lalonde A, et al., eds. A Textbook of Postpartum Hemorrhage: A Comprehensive Guide to Evaluation, Management and Surgical Intervention. Duncow, Kirkmahoe, Dumfriesshire, UK: Sapiens Publishing; 2006.
Bakri YN. Balloon device for control of obstetrical bleeding. Eur J Obstet Gynecol Reprod Biol. 1999;86:S84.

46. Support

47. Support FDA 510(k) Cleared: #KO62438
Tamponade Uterine Balloon Catheter Set
Regulation Number: 21 CFR
Regulation Name: Obstetric-gynecologic specialized manual instrument
Class: II
Product Code: 85 KNA
Market Clearance: 10/27/2006
Order Number: J-SOS
Global Product Number: G30673