FDA Expects Breast Biopsy Needle Shortage to Last Through March 2027

The US shortage of stereotactic breast biopsy needles is expected to last through the end of March 2027, the Food and Drug Administration said in a June 16 letter to health care providers.

The agency said the country is experiencing interruptions in supply of the needles because of recent supplier issues, and that the manufacturing disruption is expected to affect patient care and may require adjustments to the clinical management of patients scheduled for a breast biopsy. The FDA first added stereotactic breast biopsy needles, product code KNW, to its Medical Device Shortages List on March 13.

Origin of the shortage

The letter points to a January 2 customer letter from Hologic, which said all lots of its Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed because of a risk of metal and plastic particles being dislodged from the device during use. Hologic told customers to quarantine and return the affected devices, MedTech Dive reported on June 17.

MedTech Dive reported that the FDA's update extended the expected duration of the shortage. Hologic said on its website that it is expanding manufacturing shifts and expediting orders to increase supply, and that it has updated its Brevera system so it can be used as a standalone imaging unit, according to the publication. The American College of Radiology warned in May that "limited alternatives have not fully met clinical demand, which has broadly strained the supply chain," MedTech Dive reported.

What the FDA is asking providers to do

The agency recommended that providers facing shortages develop strategies to conserve the needles and use clinical judgment in doing so. Its suggestions include expanding supplier networks, using all available needle gauges and lengths rather than relying on limited standard inventory, using prior-generation devices where clinically appropriate and limiting unnecessary opening or wasting of devices.

For inventory, the FDA suggested centralizing tracking across breast imaging sites, keeping a daily or weekly dashboard available to all radiologists who perform biopsies, and forecasting use from scheduled biopsy volumes so needles can be distributed across health systems. It also advised communicating delays transparently, offering alternative biopsy locations where needles are available and keeping the focus on minimizing delay in cancer diagnosis and treatment.

The FDA said it is working with manufacturers and providers to monitor the situation, evaluating potential solutions to limit the impact on patients and will inform the public as new information becomes available. Under section 506J of the Federal Food, Drug, and Cosmetic Act, the agency must keep a public, up-to-date list of devices it has determined to be in shortage, and it reviews each 506J notification it receives to decide whether a device is in shortage. The FDA asked providers to report supply chain problems to its device shortages mailbox.