US Faces Breast Biopsy Needle Shortage Following Hologic Recall
The United States is experiencing a shortage of breast biopsy needles due to a recall initiated by Hologic Inc. earlier this year. This scarcity, which the Food and Drug Administration (FDA) projects to last through March 2027, could lead to delays in diagnosing breast cancer. Hologic recalled the products after reports of metal and plastic pieces detaching from the needles and remaining in patients' bodies.
The U.S. Food and Drug Administration has confirmed a shortage of breast biopsy needles across the nation, stemming from a product recall by Hologic Inc. This shortage has the potential to delay diagnoses of breast cancer, the most common cancer among women. The FDA has indicated that the shortage is expected to persist until March 2027 and has advised medical professionals to implement measures for conserving their existing supply of needles.
Hologic initiated the recall in January following reports of metal and plastic fragments dislodging from the needles and becoming embedded in patients. An internal review conducted by the company over three years examined nearly 700,000 needles and identified 108 related complaints.
The affected products are stereotactic biopsy needles, which are utilized to collect tissue samples from suspicious masses. These needles are typically connected to a small vacuum system that rapidly extracts tissue samples.
Hologic, a prominent supplier of imaging and diagnostic devices for women's health, particularly those used in breast cancer detection and treatment, generates approximately $1.5 billion annually from its breast-health business. The company has stated its aim to reintroduce the needles to the market by the end of 2026. In the interim, Hologic plans to enable standalone imaging, augment the supply of its alternative needle products, accelerate product deliveries, and stabilize its inventory. The company is collaborating with both the FDA and the American College of Radiology (ACR) to address the situation.
This is not the first instance of Hologic products facing safety-related recalls. In 2024, the company recalled its BioZorb implant after numerous women reported the device failed to dissolve as intended, leading to complications such as infections and severe pain. The BioZorb implant was designed to aid healing after a lumpectomy, but some patients required additional surgeries or even mastectomies to resolve issues.
Since the beginning of this year, the FDA has received approximately 20 adverse event reports concerning Hologic's biopsy system. These reports include instances of plastic pieces protruding from biopsy sites, a 4-centimeter plastic tube found along a biopsy path five months post-procedure, and plastic beads emerging from biopsy sites. The American College of Radiology Chief Executive Officer, Dana Smetherman, conveyed in a May letter to the FDA that the shortage poses "immediate and substantial" challenges to breast imaging practices nationwide. Risks associated with needle scarcity include delayed diagnoses, heightened uncertainty regarding patient outcomes, and the potential necessity for more invasive diagnostic procedures like surgery. The presence of particulate matter in patients carries risks such as infection, diagnostic delays, and interference with MRI scans, potentially requiring further procedures for removal.
According to Fortune, Hologic was acquired in April by funds managed by Blackstone Inc. and TPG Inc.
