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.
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.
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.
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.
