Breast cancer is kinda becoming more and more common these days, and if detected early, it can very well be treated with surgery, and that’s where the BioZorb Marker comes into play. But the thing is, later down the line, even after the FDA approval and all that, there were some huge issues with this and that led to a lot of women straight up suing the company that made these. That’s what this Titanium Breast Marker Lawsuit is all about.
What Was the BioZorb Marker Used For?
It may be that you don’t know much about it yet, beyond the surface-level knowledge, if that’s the case, then just know that the BioZorb marker was designed as a breast cancer recovery aid. It’s basically a small implant consisting of a dissolvable plastic coil and six tiny titanium clips. And how do medical experts go about it? Oh, it’s an effective procedure where the surgeon places the implant at the site of surgery so that doctors can easily locate the exact area during subsequent imaging or radiation treatment.
The plan was for the plastic component to dissolve over one to two years, leaving only the titanium clips as a permanent marker. It all sounds too good on paper, and that’s why it grabbed a lot of hype out there. But the thing is, quite a few patients have complained that the device failed to dissolve properly. And? Sure enough, that resulted in a lot of pain, inflammation, scarring, and in a few cases, it even broke through the skin. That’s scary stuff right there!
When Did Problems Start?
If we go into the backstory of it a bit, see, the BioZorb marker received the approval of the U.S. Food and Drug Administration in 2012 via the 510(k) process. And sure enough, if you know a thing or two about it, this route permits devices to get to the market sooner if they are similar to already existing products. In addition to being quicker, it also means fewer long-term safety checks are performed. Right?
But later down the line, actually in 2020, the complaints of so many people started to pile up, and that’s when it became a BIG matter. Women have shared experiences of persistent pain, swelling, infections, device displacement, and hard lumps that sometimes felt like new tumors. Moreover, doctors found that the marker frequently remained solid when it was supposed to dissolve.
Why Did the FDA Issue a Recall?
Not a single doubt in the fact that it became a very serious situation by the time 2024 rolled around. The FDA declared a Class I recall, which is the most extreme type, when they warned that the BioZorb marker might cause major injuries. Doctors were urged by the agency to discontinue the use of the device straight away.
And then, even later down the line, the FDA discovered that the manufacturer, Hologic, had not conducted adequate safety tests of the BioZorb over a long period. Likewise, they failed to properly inform the physicians about the correct and incorrect ways of using the device. There were almost 400 reports of adverse events by the end of 2024, many of which were associated with severe complications.
What’s Happening With the Lawsuits?
So, talking about the situation right now, see, more than a hundred women took legal actions separately suing Hologic by the beginning of 2025. A majority of these cases are currently being dealt with in a Massachusetts federal court. The nature of the claims is similar: the product did not dissolve, it resulted in prolonged pain, changed the shape of the breasts, and in many cases led to subsequent surgery.
The lawsuits allege that Hologic had defective designs, did not provide adequate warnings, and conducted insufficient testing. And then, the court in January 2025 gave the green light to these cases for continuation. The first bellwether trials that help determine the direction of future settlements are due in September 2025.
