Tools for Managing Post-Partum Hemorrhage: Potential Impact on Litigation

Tools for Managing Post-Partum Hemorrhage: Potential Impact on Litigation

March 21, 2023
By Tania Dawood

One of the top causes of maternal death is postpartum hemorrhage. However, there are devices available to obstetrical providers to use in appropriate cases in addressing this potential complication.

Uterine atony, which is a weak or soft uterus after birth, is one of the leading causes of postpartum hemorrhage.  The types of tools that may be used to combat postpartum hemorrhage include a Bakri balloon or a Jada System. A Bakri balloon works as a pipe that is inserted into the uterus and subsequently inflated to stop uterine bleeding.  These devices can be categorized as intrauterine balloon tamponade devices (IBTD). Although the Bakri balloon has been more commonly utilized, the Jada System device recently emerged as a highly effective option. 

What Is the Jada System?

Photo courtesy of Organon, LLC

A recent study has found that the Jada System is safe and effective for postpartum hemorrhage treatment.[1]  The Jada System is an intrauterine device that utilizes low-level vacuum to encourage the natural forces of uterine contraction to control abnormal postpartum uterine bleeding after childbirth. More specifically, it consists of an Intrauterine Loop on the distal end of a tube. The Jada System works through insertion of the Intrauterine Loop into the uterus while the cervical seal is located within the vagina at the external cervical os (the opening of the cervix).

Photo courtesy of Organon, LLC

Bakri balloon and Jada System compared

According to the American Journal of Obstetrics and Gynecology, the Bakri balloon is a commonly utilized IBTD for postpartum hemorrhages that are not responsive to first-line treatments.[2]  According to the study on the cost-effective analysis comparison between the Bakri balloon and Jada device, the Jada device was more cost-effective and cost-saving.  It was the dominant strategy in this particular study, as it led to fewer women receiving blood products, admission procedures, ICU admissions, and maternal deaths.  The annual cost-saving was $145 million dollars. While the study provides limited context as to why the Jada device is safer and more cost-effective, it provides objective data for healthcare entities which provide labor and delivery services to consider.

Why Should We Care?

Due to the potentially adverse impact of post-partum hemorrhage on obstetrical patients, these treatments and devices may be referenced in professional liability claims against obstetrical providers.  Obstetrical care providers (hospitals, physicians and mid-levels) can mitigate their risk of exposure by reviewing and appropriately implementing available tools to manage postpartum hemorrhage.  

Post-partum treatments, such as for hemorrhages, are the types of matters to come into play in medical malpractice cases.  Understanding the mechanics and benefits of the technology that obstetrical treaters use gives defense attorneys an advantage in understanding the significance of allegations which arise in post-partum injury cases.




[1] Petronelli, Morgan. Large, real-world study finds Jada System safe, effective for postpartum hemorrhage. 2023.

[2] Bridges, et al. Bakri balloon vs. Jada device for treatment of postpartum hemorrhage: a cost-effective analysis. 2023.

 

Disclaimer: This publication is not intended to provide legal advice but to provide general information on legal matters. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Readers should seek specific legal and/or medical advice before taking any action with respect to matters mentioned in this publication. The attorney responsible for this publication is Tania Dawood. This post constitutes a form of attorney advertising as defined by some state bar associations.

Previous
Previous

Women’s History Month: Conversation between Marilee Clausing and Tania Dawood

Next
Next

Two HPS Attorneys Elevated to Partner