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The Food and Drug Administration (FDA) has issued a warning on Hologic’s BioZorb devices, marking a major development in the medical landscape. These coil-shaped markers, strategically implanted into soft tissue such as within breast tissue during conservation surgeries, serve as locators for lumpectomies or similar procedures. Their primary function is streamlining subsequent medical assessments, radiation therapies, and follow-up examinations.
However, despite obtaining FDA clearance in 2012, the BioZorb finds itself under renewed scrutiny as the subject of the FDA’s recent safety advisory. The agency’s alert, predicated on a myriad of undisclosed reports and comprehensive literature review, underscores a spectrum of adverse events following the implantation of these markers.
Crafted from a resorbable plastic material, the spiral design of the BioZorb markers is engineered to gradually integrate into bodily tissues over an extended period, typically spanning at least one year. Concomitantly, six titanium clips adorning the spiral structure are intended to maintain a permanent presence, effectively demarcating the site of tumor excision for the foreseeable future, even as surrounding tissue undergoes regenerative processes.
Hologic’s acquisition of the BioZorb portfolio, as part of its strategic buyout of Focal Therapeutics in 2018, exemplifies the company’s commitment to innovation and expanding its product offerings within the medical field.
Of paramount concern are instances of migration, whereby the markers exhibit displacement from their intended positions, and erosion, culminating in the breach of skin integrity. Should migration progress to infiltration of vital anatomical structures such as the chest cavity or vasculature, the ramifications could be dire, potentially precipitating life-threatening scenarios, as warned by the FDA. Moreover, the litany of reported adverse events encompass infections, seroma formation, discomfort, and dermatological manifestations, accentuating the multifaceted risks associated with BioZorb deployment.
The prolonged presence of resorbable plastics within the body poses an additional layer of complexity, potentially engendering protracted complications necessitating remedial interventions, as corroborated by documented patient experiences. In response to these concerns, the FDA has affirmed its commitment to vigilant oversight, pledging to meticulously monitor all adverse reports about BioZorb implants in collaboration with Hologic, the device manufacturer.
In the interim, healthcare practitioners and patients are enjoined to exercise heightened vigilance, remaining conscious of the potential perils associated with BioZorb markers. Patients are urged to promptly relay any adverse symptoms to their healthcare providers. At the same time, practitioners are tasked with maintaining a keen clinical acumen to promptly detect and address any emergent complications.