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 severe pain.
The device was supposed to help breast cancer patients heal after a lumpectomy, which is the surgical procedure to remove tumors while keeping much of the breast intact. But some women ended up needing additional surgeries and even mastectomies to remove the breast to resolve the harms caused by BioZorb.
For years, Hologic didn’t report many of those complaints to the FDA despite federal law requiring them to tell the agency within 30 days, Bloomberg previously reported.
Read More: A Faulty Implant Tormented Cancer Patients for Years
The FDA has received about 20 adverse event reports since the start of this year related to Hologic’s biopsy system. One woman reported a plastic piece sticking out of her biopsy site, while another returned to doctors five months after her biopsy to learn that a lump she felt was a 4 centimeter (1.6 inch) piece of plastic tube along the biopsy path. Others had plastic beads emerge from their biopsy sites.
The shortage is creating “immediate and substantial” challenges to breast imaging practices across the US, American College of Radiology Chief Executive Officer Dana Smetherman wrote in a letter to the FDA in May. Needle scarcity can lead to delayed diagnosis, increased uncertainty of outcomes and the need for more invasive diagnostic methods like surgery.
Risks from particulate matter being left behind in patients include infection, delays in diagnosis and interference with MRI scans, according to Hologic’s customer letter from January. It added that customers may have to undergo additional procedures to remove the fragments.
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