Boston, Mass. — Women treated for breast cancer are at the center of ongoing lawsuits against Hologic, Inc. over allegations that its BioZorb Marker, a device designed to assist in post-surgical monitoring of tumor sites, has caused serious health complications.
Legal action commenced in the U.S. District Court for Massachusetts in November 2022, following mounting reports of injuries allegedly linked to the BioZorb Marker, a small, coiled device with titanium clips. In early 2024, Hologic issued a safety notification, alerting healthcare providers to the risks associated with the product, prompting more attorneys to take on cases. By October 2024, the company had initiated a recall, voluntarily removing all unused BioZorb Markers from circulation due to escalating concerns.
The BioZorb Marker was intended to dissolve naturally in the body over time while the titanium clips remain as permanent markers, allowing physicians to locate surrounding tissues for treatment. However, lawsuits contend that the device often migrates within the body or protrudes through the skin, leading to painful conditions that may require surgical interventions. Patients have reported complications including significant pain, swelling, and tissue erosion, sometimes manifesting as fluid buildup around the surgical site.
As of December 2024, approximately 100 lawsuits involving BioZorb were consolidated in the Massachusetts District Court, overseen by Judge Allison Burroughs. The first trial is slated for September 2025. Legal experts suggest that the outcomes of these initial trials could influence subsequent cases and settlement negotiations.
A timeline of key legal developments reveals that Judge Burroughs has denied attempts by Hologic to dismiss claims concerning design defects of the device. Recent court orders have laid out a schedule for future proceedings, including a pre-trial conference set for September 2025, which aims to facilitate discussions among plaintiffs and defendants regarding potential settlements.
In addition to the lawsuits, the Food and Drug Administration has issued warnings regarding the risks associated with BioZorb Markers. Hologic has reported receiving over 399 complaints related to the device since its introduction in 2015, with 188 incidents specifically tied to injuries as of October 2024.
Patients with BioZorb implants are advised to consult healthcare professionals if they experience any complications. Medical experts emphasize that not every implant recipient will encounter issues, yet prompt communication with physicians is critical for addressing potential risks.
Individuals who believe they have been harmed by the BioZorb Marker may qualify for legal action. Those considering a lawsuit should seek experienced legal counsel to navigate the complex litigation process. It’s important to act swiftly, as statutes of limitations for filing such claims vary from one to four years depending on the state.
As the legal battles continue, many are closely watching the ensuing courtroom dramas, which could shape the landscape for similar medical device lawsuits in the future.
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