Is there A Lawsuit Against BioZorb?
Once again, we find ourselves talking about a defective medical device that never should have made it to market. The BioZorb lawsuit is quickly gaining traction, exposing yet another case of a big-name manufacturer—Hologic, Inc.—pushing out a product without fully considering the long-term impact on patients. Instead of prioritizing safety, they sold a device that’s now the subject of growing litigation, severe injuries, and an FDA recall. And now, the fallout begins.
What Is BioZorb?
BioZorb is a small, implantable device designed to help guide radiation therapy after a lumpectomy. In theory, it’s supposed to make treatment more precise by marking the area where tissue was removed. The problem? The so-called “dissolvable” device isn’t exactly dissolving as promised. Instead, many women have been left with chronic pain, infections, migration of the device, and additional surgeries to remove it—all complications that should have been caught before this thing ever hit the market.
Hologic is now facing lawsuits claiming that they failed to warn doctors and patients about these risks, misrepresented the safety of the device, and even promoted it for uses beyond its original FDA approval. If this all sounds familiar, that’s because it is. The cycle repeats: companies rush products to market, patients suffer, lawsuits pile up, and only then do we get the truth.
Serious Complications Linked to BioZorb
While Hologic marketed BioZorb as a game-changer for post-lumpectomy treatment, the reality has been far from that for many women. Some of the most severe complications reported include:
- Chronic Pain: Ongoing pain that has forced some patients into pain management treatments or additional surgeries.
- Device Migration: BioZorb has been found shifting from its original location, causing tissue damage, interference with scans, and even issues detecting cancer recurrence.
- Infections: Some women have developed severe infections at the implant site, leading to hospitalization and more medical intervention.
- Scarring and Disfigurement: In many cases, the implant has led to unwanted cosmetic changes and long-term scarring.
- Failure to Dissolve: BioZorb was supposed to resorb naturally over time, but instead, patients are finding out years later that it’s still sitting inside them.
- Interference with Radiation Therapy: Some reports suggest that BioZorb can actually disrupt radiation treatment rather than aid it, which defeats its entire purpose.
- Additional Surgeries: Many patients have been forced to go back under the knife to remove the implant after experiencing these painful and unexpected side effects.
The FDA Steps In: BioZorb Recall and Warnings
The FDA finally got involved after patient complaints and lawsuits started stacking up. In May 2024, the agency classified a Class I recall for BioZorb—the most serious type, reserved for products that pose a high risk of injury or death.
The recall came with some damning details. The FDA found that Hologic never adequately tested BioZorb’s ability to fully dissolve in the body, despite marketing it as a “bioabsorbable” device. Even worse, the company was caught failing to report serious injuries linked to the device—something that should never happen when patient safety is at stake.
By January 29, 2025, the FDA issued another warning, this time making it clear that the risks associated with BioZorb were even greater than previously thought. Turns out, Hologic knew about these complications for years and still pushed the device on patients. Now, they’re facing serious legal consequences.
BioZorb Lawsuits: The Legal Battle Against Hologic
Hologic is being hit with lawsuits across the country, with plaintiffs alleging that the company:
- Failed to properly warn doctors and patients about the risks.
- Marketed BioZorb as a cosmetic benefit to fill in space left by lumpectomies—despite no FDA approval for that purpose.
- Designed a defective product that can cause long-term harm instead of aiding in recovery.
And the lawsuits aren’t slowing down. As of late 2024, over 100 lawsuits have been filed—a number that is only expected to grow.
Recent Developments in the BioZorb Lawsuit
February 7, 2025: No MDL Yet, But It’s Coming
Right now, there isn’t a Multi-District Litigation (MDL) consolidating these cases, but that could change very soon. With over 100 plaintiffs already involved, centralizing these lawsuits would make legal proceedings far more efficient. For now, all cases are being handled in the U.S. District Court for the District of Massachusetts under a bellwether trial process.
January 16, 2025: Judge Rules in Favor of Plaintiffs
On January 16, 2025, Judge Allison D. Burroughs denied Hologic’s motion for summary judgment, a huge win for the plaintiffs. The company tried to argue that stronger warnings wouldn’t have made a difference. The judge disagreed, ruling that a jury should decide whether patients and doctors would have chosen differently had they been given the full story. This means cases will move forward—and Hologic is in real trouble.
January 01, 2025: Bellwether Trials Are Scheduled
Judge Burroughs has scheduled the first bellwether trial for September 8, 2025, with another following in January 2026. These trials will test the strength of the evidence and could influence settlement negotiations down the line.
How Much Are BioZorb Settlements Worth?
It’s still early, but based on similar defective medical device cases, individual settlements could range from $150,000 to $500,000 for moderate cases. Severe cases—especially those requiring multiple surgeries or resulting in permanent damage—could see payouts exceeding $500,000. And if these cases go to trial? Juries could award millions in damages, especially if they find that Hologic knowingly put patients at risk.
Why The BioZorb Lawsuit Matters for Patient Safety
The BioZorb case is another reminder of just how flawed the FDA approval process can be. Many medical devices, including BioZorb, are fast-tracked through the 510(k) process, meaning they don’t require rigorous clinical testing. This loophole has allowed countless dangerous products to hit the market—leaving real people to suffer the consequences.
If pharmaceutical and device manufacturers actually did their due diligence upfront, these lawsuits wouldn’t have to happen in the first place. But instead, companies like Hologic treat injuries and deaths as an acceptable cost of doing business. And once the lawsuits pile up, they try to buy their way out of accountability instead of fixing the root of the problem. That’s not just unethical—it’s downright reckless.
What Should BioZorb Patients Do?
If you or someone you love has suffered complications from BioZorb, now is the time to act. Lawsuits are already being filed across the country, and waiting too long could affect your ability to seek compensation. There are strict statutes of limitations in place, so talking to a lawyer sooner rather than later is crucial.
Who is the best lawyer for The BioZorb Lawsuit?
Contact Litigation Connect to be connected with the best possible lawyer to handle your BioZorb claim.
When choosing the best lawyer for the BioZorb lawsuit, experience matters. You do NOT want a lawyer who has never handled more than a car accident claim jumping on the bandwagon and duping you into signing a contract with them.
You need an attorney who has successfully handled mass tort cases, understands the science behind the BioZorb claims, and has a track record of taking on major corporations.
The ideal lawyer will have decades of experience with pharmaceutical and medical device lawsuits, a history of securing substantial settlements in those cases, and the resources to fight against the very well-funded defense teams that these pharmaceutical companies can hire. Believe me, they have a limitless budget when it comes to defending their profits.
If you're looking for strong legal representation, Litigation Connect can help.
We will connect you with an attorney who has sued some of the largest companies and mega-corporations in the U.S. and around the world, knows how to navigate complex medical device litigation, and offers compassionate service to keep you informed every step of the way.
Get in touch with us today to find out how we can help with your claim.