FDA Alerts on Shortage of Breast Biopsy Needles

The FDA informed healthcare providers about disruptions in the supply of stereotactic breast biopsy needles that will likely persist through March 2027.

According to the agency, the disruption is expected to impact patient care and “may require adjustments to the clinical management of patients indicated to undergo a breast biopsy.”

Earlier this year, Hologic issued a customer letter reporting that all lots of the Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed due to a risk for dislodgement of metal and plastic particles from the device during use.

Particulate matter originating from the device that is left behind in a patient post-biopsy could cause a foreign body reaction, hematoma/hemorrhage, or infection, the FDA said. An additional biopsy procedure could also be required if a specimen is contaminated by particulate matter.

A class II recall of the product was initiated in February.

In May, Dana Smetherman, MD, MPH, CEO of the American College of Radiology, sent a letter to the FDA, detailing the organization’s concerns about the needle shortage.

“According to widespread reports from the breast imaging community, these shortages are creating immediate and substantial challenges for breast imaging practices nationwide, negatively impacting patient access to diagnostic care, and ultimately, to critical therapeutic intervention,” Smetherman wrote. “The current backlog is not an isolated operational convenience, but rather, it represents a broader patient and public health concern, particularly in high-volume centers and safety-net institutions where alternatives may be limited or unavailable.”

The FDA is recommending providers adopt needle conservation strategies in order to have supply for patients at greatest risk, including:

• Expanding supplier networks with vendor diversification
• Diversifying and utilizing all needle gauges and lengths to avoid dependence on limited “standard” inventory
• Utilizing prior-generation devices where clinically appropriate
• Limiting unnecessary opening/wasting of devices

In addition, healthcare providers are urged to be transparent in communication delays to patients, offer alternative biopsy sites where biopsy needles are available if alternatives aren’t suitable, and to maintain their focus on minimizing delays in cancer diagnosis and treatment.