Bakri Postpartum Balloon

Essential Prescribing Information about Bakri Postpartum Balloon

INDICATIONS:

Intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

CONTRAINDICATIONS:

• Arterial bleeding requiring surgical exploration or angiographic embolization
• Cases indicating hysterectomy
• Pregnancy
• Cervical cancer
• Purulent infections in the vagina, cervix, or uterus
• Untreated uterine anomaly
• Disseminated intravascular coagulation
• Surgical site that would prohibit device from effective controlling bleeding.

WARNINGS:

• Device should not be left indwelling for more than 24 hours
• Do not exceed maximum inflation volume of 500 ml
• Clinical data supporting the safety and effectiveness of this device in the setting of uterine atony are limited; patients should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation. In such cases, emergency intervention should be performed per hospital protocol
• No clinical data exist to support the use of this device in the setting of DIC
• Signs of deteriorating or non-improving condition should lead to more aggressive treatment and management of patient uterine bleeding.

PRECAUTIONS:

Avoid excessive force when inserting balloon into uterus.