Description

The Bulkamid® Needle is an integral component of the Bulkamid® Urethral Bulking System, designed specifically for the treatment of female urinary incontinence, including stress urinary incontinence (SUI) and mixed urinary incontinence (MUI). Developed by Axonics Modulation Technologies, Inc., this device plays a crucial role in enhancing urethral coaptation through the precise delivery of Bulkamid® polyacrylamide hydrogel.

Key Features

• Endoscopic Injection: The needle facilitates the transurethral injection of the hydrogel under cystoscopic control, targeting the midurethra to improve continence.
• Biocompatibility: Crafted from materials that are nonbiodegradable, nonallergenic, nonimmunogenic, and atoxic, ensuring a stable and safe interaction with body tissues.
• Minimal Invasiveness: Offers a favorable safety profile with low complication rates, making it a minimally invasive option for patients.

Administration

• Procedure: Typically performed under local anesthesia, requiring 1–3 injections for satisfactory results.
• Safety: Known for its minimal invasiveness and low complication rates, distinguishing it from other bulking agents.

Recall Information

In July 2021, a recall was issued due to concerns over sterility assurance, linked to suspected falsification of sterilization records by a third-party facility. The recommended actions included identifying, quarantining, and destroying affected devices, with product removal completed by October 31, 2021. It is important to note that Bulkamid® Needles manufactured by Contura International A/S since November 2020 are not affected by this issue.

Clinical Context

The use of Bulkamid® hydrogel aims to create submucosal cushions, enhancing urethral closure and improving continence. The efficacy of this treatment is supported by both objective measures, such as maximum urethral closure pressure and pad tests, and subjective assessments, including visual analogue scale (VAS) and King's Health Questionnaire (KHQ) scores. Considerations for long-term durability and the potential need for repeat injections are part of the clinical landscape.

This detailed understanding of the Bulkamid® Needle underscores its significance in providing effective management of urinary incontinence, while also highlighting the importance of adherence to sterility standards to ensure patient safety.