FDA Warns of Breast Biopsy Needles Shortages

The US Food and Drug Administration (FDA) on June 16 issued a letter to healthcare providers describing interruptions in the supply of stereotactic breast biopsy needles due to supplier issues. The manufacturing disruption, which is expected to extend until March 2027, may impact patient care and require adjustments in the clinical management of patients indicated for breast biopsy.

Per the letter, the shortage is the result of a letter from medical device manufacturer Hologic, which issued a customer letter stating:

“…  all lots of the Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed because there is a risk of metal and plastic particles being dislodged from the device during use. If particulate matter originating from the device is left behind in a patient post-biopsy, potential adverse effects such as foreign body reaction, hematoma/hemorrhage, and infection may arise. If particulate matter enters a biopsy specimen, an additional biopsy procedure may be required due to contamination of the specimen.”

The FDA recommends that hospitals and health systems experiencing supply interruptions develop strategies to conserve stereotactic breast biopsy needles and preserve supply for patients at highest risk. The agency asks healthcare providers to consider the following:

Needle Conservation Strategies

• Expand supplier networks with vendor diversification.
• Diversify and utilize all needle gauges and lengths to avoid dependence on limited “standard” inventory.
• Utilize prior-generation devices where clinically appropriate.
• Limit unnecessary opening/wasting of devices.

Inventory and Supply Chain Management

• Centralize inventory tracking across breast imaging sites.
• Monitor inventory with a daily/weekly inventory dashboard available to all radiologists performing biopsy procedures.
• Forecast utilization trends based on scheduled biopsy volumes and distribute biopsy needles appropriately across health systems/facilities.

Patient Communication/Clinical Care

• Communicate delays transparently.
• Offer alternative biopsy locations/sites where biopsy needles are available if alternative biopsy devices are not suitable.
• Maintain focus on minimizing delay for cancer diagnosis/treatment.

The American College of Radiology also has published an mitigation strategies for breast cancer care providers.

Breast cancer screening and biopsy are key tools in the early detection and diagnosis of breast cancer, and these shortages may affect cancer treatment centers accredited by the ACS Commission on Cancer and the National Accreditation Program for Breast Centers. The ACS will provide additional updates on this manufacturing shortage as the situation develops.