Hologic issues safety alert for breast biopsy needles
Hologic recently issued a safety alert regarding a specific type of its breast biopsy needles.
In late December, the medical technology company sent customers a field safety notice for all lots of its Brevera Breast Biopsy System Disposable 9 Guage Needles. The needles, which are used to retrieve breast tissue samples for histopathology, pose potential danger due to the risk of pieces dislodging during procedures.
The notice was sent following an internal review of the product, which revealed numerous instances of particles either being left in patient breast tissue or in the tissue samples sent for histological analysis. The review covered a period of three years; in total, it uncovered 108 complaints related to the needles and 16 reports of device-related particulate being discovered in tissue. Hologic estimates the needles were involved in 1.6 incidents per 10,000 uses.
The company cautioned its customers that particles left in patient tissue increase the risk of infection, misdiagnosis, adverse reactions and delayed treatment, though the company emphasized that these occurrences would be rare. Internal testing of the materials in the needle indicates that “the long-term presence of these materials in breast tissue poses a negligible toxicological risk to patients,” according to Hologic.
However, the company advised providers who plan to continue to use the needles to discuss the associated risks with their patients prior to procedures. Post-biopsy imaging also could help ensure that no fragments are left behind.
Questions or concerns pertaining to use of the needles can be directed to Hologic via phone at 757-601-9592.
The full field safety notice can be found here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.