A national shortage of the needles used to take tissue samples during mammogram-guided breast biopsies is now expected to last into next year, and the federal government has told hospitals to start deciding which patients get scheduled first.
The U.S. Food and Drug Administration told health care providers in a formal letter that the supply of stereotactic breast biopsy needles has been interrupted because of supplier problems, and that the disruption is expected to run through the end of the first quarter of 2027. The agency said the shortfall is expected to affect patient care and "may require adjustments to the clinical management of patients" scheduled for a breast biopsy.
For families, that translates into something concrete. A woman who gets a callback after a screening mammogram, is told she needs a biopsy of calcifications that only show up on mammography, and is then handed an appointment date weeks out may be experiencing the shortage without ever being told its name.
The Device Behind the Delay
A stereotactic breast biopsy is not a screening test. It comes after something suspicious has already been seen. The procedure uses mammogram images from two angles to pinpoint a target the radiologist cannot feel and often cannot see on ultrasound, most commonly a cluster of microcalcifications. A hollow needle then removes small tissue cores for the pathology lab.
The shortage traces back to a manufacturer action in January. Hologic told customers that all lots of its Brevera Breast Biopsy System disposable 9-gauge needle were being removed because metal and plastic particles could break loose from the device during use. The FDA notice states that particles left in the breast after a biopsy may cause a foreign body reaction, bleeding, or infection, and that particles landing in the tissue sample itself can contaminate the specimen and force a repeat procedure.
The FDA added stereotactic breast biopsy needles to its Medical Device Shortages List in March under product code KNW, then reverified the shortage in June and extended the estimated duration to the first quarter of 2027.
Hologic said on its Brevera product page that it is targeting a return to market by the end of calendar year 2026 and is expanding manufacturing shifts to increase supply of its Eviva biopsy needles, which are allocated to customers based on prior ordering patterns and procedure volume. Those figures come from the company and have not been independently verified.
Which Patients Radiologists Are Told to Move to the Front
The most practical guidance for patients sits in the mitigation document the American College of Radiology published in May with its Commission on Breast Imaging.
ACR advises practices to prioritize BI-RADS 5 lesions, which are the findings radiologists consider highly suggestive of cancer, along with highly suspicious masses and calcifications, patients being worked up before chemotherapy given ahead of surgery, surgical planning cases, and high-risk lesions where imaging and pathology disagree.
The group also tells practices to consider delayed scheduling for low-suspicion BI-RADS 4A findings and for nonurgent repeat biopsies, and to shift stereotactic and MRI-guided biopsies to ultrasound-guided procedures whenever that is clinically feasible.
That last point matters for anyone told their biopsy method has changed. An ultrasound-guided biopsy is not a downgrade in care when the target is visible on ultrasound. It is a different route to the same tissue sample.
ACR CEO Dana Smetherman wrote to the FDA in May that the shortages were "creating immediate and substantial challenges for breast imaging practices nationwide," according to a report by EMJ. The letter described effects on patient access to diagnostic care and, in turn, to treatment.
Where the Burden Is Likely to Land Unevenly
The FDA recommended that health systems centralize inventory tracking across breast imaging sites, forecast needle use against scheduled biopsy volumes, and distribute supply across facilities. It also told providers to communicate delays transparently and to offer patients alternative locations where needles are available if a different biopsy device is not appropriate.
Those instructions describe an advantage that large multi-site health systems have and that standalone imaging centers do not. A patient inside a big metro system in Chicago, Houston, or Atlanta may be redirected to a sister facility across town. A patient at a single rural or independent breast center has no internal network to draw on, and the alternative may be a longer drive or a later date.
Insurance is a second uneven pressure point. A biopsy moved to a different facility or a different modality can land with a different network status or a different cost share. Patients who are redirected should confirm the new site is in network before the appointment rather than after.
Reasonable Steps While the Supply Recovers
If you have an abnormal mammogram result and a biopsy has been recommended, the useful question is not whether needles are short. It is where your finding sits on the suspicion scale and whether ultrasound guidance is an option for your specific lesion. Ask for your BI-RADS category and ask whether the delay being offered is one your radiologist considers clinically acceptable.
If you are given a date that feels long, ask whether the practice can place you on a cancellation list, whether another site in the same system has supply, and whether a surgical consultation should be started in parallel. ACR specifically advises practices to expedite surgical consultation when a biopsy delay could affect care.
Do not let a scheduling problem become a reason to skip screening. The shortage affects the biopsy step, not the mammogram itself.
The FDA said it is working with manufacturers and providers to monitor supply, evaluating options to reduce patient impact, and will inform the public as new information becomes available. Health care providers can report supply problems to the agency, and both providers and patients can submit reports through MedWatch. MedicalDaily will monitor the FDA shortage list for the next reverification and any change to the projected 2027 end date.
The confirmed situation is a federally recognized shortage with an estimated end in early 2027, affecting patients who need mammogram-guided breast biopsies. The most reasonable action is a direct conversation about lesion suspicion level and alternative guidance methods. The central uncertainty is whether manufacturer supply recovers on the timeline the company has projected.
Frequently Asked Questions
What exactly is in short supply? Stereotactic breast biopsy needles, the disposable needles used to take tissue samples during a biopsy guided by mammogram imaging. The FDA lists them under product code KNW on its Medical Device Shortages List.
Does this affect screening mammograms? No. Screening mammograms are unaffected. The shortage applies to the biopsy step that follows an abnormal imaging result.
Why did the shortage start? Hologic removed all lots of its Brevera 9 gauge disposable needle in January because metal and plastic particles could dislodge from the device during use, which could leave material in the breast or contaminate the tissue sample.
Am I at risk if I already had a Brevera biopsy? The FDA notice describes potential effects including foreign body reaction, bleeding, and infection if particles were left behind, and notes specimen contamination may require a repeat biopsy. Anyone with concerns about a past procedure should raise them with the physician who performed it rather than acting on a news report.
Will my biopsy be canceled? Not necessarily. Practices are being told to prioritize the most suspicious findings and to shift cases to ultrasound guidance when the lesion can be seen on ultrasound. Some low-suspicion cases may be moved to short-interval follow-up instead.
How long is this expected to last? The FDA currently estimates the shortage will extend through the end of the first quarter of 2027. The manufacturer has said it is targeting a return to market by the end of 2026. Those two timelines do not match, and the agency estimate is the one being used for planning.
What should I ask my care team? Ask for your BI-RADS category, whether ultrasound-guided biopsy is possible for your lesion, whether another facility in the system has supply, and whether the offered delay is clinically acceptable for your specific finding.
