FDA shares update on breast biopsy needle shortage
The U.S. Food and Drug Administration provided an update on Tuesday regarding the ongoing shortage of breast biopsy needles.
Authorities are indicating the shortage could persist through March of 2027. The supply shortfall pertains specifically to the Brevera Breast Biopsy System Disposable 9 Gauge Needles manufactured by Hologic.
In January, the Marlborough, Massachusetts-based manufacturer issued an alert saying the needles were being recalled due to the potential for them to leave behind metallic particles in tissue. This could cause several adverse effects for patients, including foreign body reactions, hematoma/hemorrhage, infection and the risk of repeat biopsies.
By April, the FDA added the needles to its list of device shortages. Shortly after, the American College of Radiology urged the FDA to take action on the issue, suggesting the supply disruption could have “detrimental” consequences for breast imaging practices, noting that it had already received reports of the shortage creating “substantial challenges for breast imaging practices nationwide, negatively impacting patient access to diagnostic care and, ultimately, critical therapeutic intervention.”
“The current backlog is not an isolated operational inconvenience, but rather, it represents a broader patient safety and public health concern, particularly in high-volume centers and safety-net institutions where alternatives may be limited or unavailable,” ACR CEO Dana H. Smetherman, MD, MBA, MPH, wrote to the agency on May 11.
The FDA says it is actively monitoring the situation, staying in contact with manufacturers and continuing to evaluate “potential solutions for mitigating patient impact.” In the meantime, both the FDA and ACR have offered mitigation tips for practices that might be struggling to maintain patient care as a result of the disruptions. The FDA’s tips can be found here and ACR’s here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.