#8 Vacuum-Induced Uterine Tamponade Device for Postpartum Hemorrhage

Overview

Postpartum hemorrhage (PPH), a devastating complication of childbirth, might feel like a problem for our ancestors, but the complication remains unpredictable and continues to occur worldwide. And though modern medicine has developed treatments that have reduced death rates and disabilities, many of these are limited to developed societies.

Characterized as excessive bleeding after having a baby, PPH affects anywhere from one to five in 100 women who give birth (1 to 5%). Several studies on PPH have revealed a disproportionate effect on the child-bearing population – Black, Hispanic, Pacific Islander, and Asian women are known for an increased risk. Those in less developed areas of the world are at heightened risk as well, but be Sub-Saharan Africa or New York City; no woman is immune to this complication.

If the uterus does not contract strongly enough after delivery of a baby and the placenta (postpartum), the blood vessels in the area where the placenta was attached remain open, leading to continued bleeding/hemorrhage due to uterine atony (failure to contract). Uterine atony is the most common cause for PPH. The aim of treatment for PPH is to find and stop the cause of the bleeding as quickly as possible. Mothers experiencing PPH may require blood transfusions, drugs which may cause dangerous side effects, long uncomfortable procedures, and even emergency hysterectomy with loss of fertility. Non-surgically, the use of a balloon to compress bleeding inside the uterus is popular. Known as uterine balloon tamponade, this method has a high success rate for PPH and has been used for some time. But the newest advancement in this space is that of vacuum-induced uterine tamponade.

More physiological than uterine balloon tamponade, which applies outward pressure to the inside of the uterine wall distending the uterine cavity, vacuum-induced tamponade involves negative pressure created inside the uterus causing the cavity to collapse. A device comprised of a teardrop-shaped, soft silicone ring is placed into the uterus, where gentle suction causes it to contract and shrink in size – compressing the blood vessels so bleeding stops. The contraction motion achieved with the vacuum suction is natural to the body and mimics that of contraction after successful child birth. The vacuum-induced device represents another minimally-invasive tool for clinicians as they battle the frightening complication. It also provides a low tech solution that is potentially translatable to developing countries with low resource availability.

Many startup companies have created investigational devices, but there are a few that have fully developed products to treat PPH. In a clinical trial of one such company’s product, hemorrhage was controlled within 2 minutes, with no recurrence and very little blood loss after treatment initiation in all women involved. The company ran a follow-on clinical study involving fifteen leading US hospitals to fully evaluate the safety and effectiveness of the system. Data from this trial is being gathered to support an application for US FDA marketing clearance – the study was completed in July 2020.

A new method still finding its place in the OB workflow, vacuum-induced uterine tamponade is another innovation ensuring PPH is a thing of the past and that families in waiting rooms across the globe hear, “mom and baby are doing great.”

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