Needles used to detect breast cancer in shortage from recall

The Food and Drug Administration said that the US is experiencing a shortage of breast biopsy needles after Hologic Inc. recalled the products earlier this year, potentially causing delays in diagnosing the most common cancer in women. The shortage is expected to last through March 2027, the FDA said in a statement. It advised doctors to take measures to conserve their supply of needles. Hologic started a recall in January following reports of metal and plastic pieces dislodging from the needles and getting stuck in patients’ bodies. The company, which was acquired in April by funds managed by Blackstone Inc. and TPG Inc., said at the time of the recall that an internal review of nearly 700,000 needles over a three-year period revealed 108 complaints. The stereotactic biopsy needles are used to take tissue samples from suspicious masses. They’re connected to a small vacuum that uses pressure to quickly remove a tissue sample, according to a guide by the Cleveland Clinic. Hologic is one of the top sellers of imaging and diagnostic devices for women’s health, particularly those used to detect and treat breast cancer. Its products include mammogram machines, biopsy guiding systems and the tiny metal clips that are left inside the patient to mark where a biopsy was performed. The company’s breast-health business generates about $1.5 billion in sales annually. Hologic said in a statement that it aims to bring the needles back on the market by the end of 2026. The company also said that it would enable standalone imaging, increase the supply of its other needle products, expedite product deliveries and stabilize its inventory in the interim. It’s working with the FDA and the American College of Radiology to support the community, the company said. It’s not the first time Hologic products have faced safety-related recalls. Its BioZorb implant was pulled in 2024 after hundreds of women reported the product failed to dissolve in their breasts, leading to infections and sever