Hologic boosts production of alternative biopsy needle amid ongoing shortage
Hologic is taking steps to help lessen the impact from its shortage of breast biopsy needles.
In January, the Marlborough, Massachusetts-based manufacturer issued an alert saying its Brevera Breast Biopsy System Disposable 9 Gauge Needles were being recalled due to the potential to leave behind metallic particles in tissue. This could cause several adverse effects, including foreign body reactions, hematoma/hemorrhage, infection and the risk of repeat biopsies.
By April, the needles made their way onto the U.S. Food and Drug Administration’s list of device shortages; earlier this month the FDA provided an update indicating that the shortage could persist through early 2027 and encouraged users to find alternative devices to use during breast biopsy procedures.
Both the FDA and American College of Radiology have provided guidance on how practices can work around the shortage until it has resolved. Hologic also recently detailed what it is doing to help organizations get by in the interim, including increasing the supply of Eviva biopsy needles, made possible by “major investments in our internal manufacturing.” The company also has increased staffing and expanded manufacturing shifts to compensate for the lack of Brevera needles.
The Eviva products are being distributed “through a multipronged approach that considers historical ordering patterns prior to the field action, procedure volume and inventory levels to support planning.” Although they require different procedural protocols, Hologic is hopeful that their use can help providers maintain breast biopsy availability, especially in cases where timely diagnosis is critical.
The company also reassured customers that the Brevera system can be used as a standalone specimen radiography system by manually placing excised tissue into the filter for imaging.
For more information on the Eviva needles, click 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.