Biozorb Lawsuit

Women who received treatment for breast cancer and suffered injuries are at the heart of BioZorb lawsuits. BioZorb is a small, coiled device with titanium clips that surgeons place at the site of a tumor after it has been removed.

BioZorb litigation began in the United States District Court for the District of Massachusetts in November 2022, according to the court docket and Hologic’s quarterly report.

More attorneys began accepting cases after Hologic, Inc. issued a safety notification and alerted health care providers to injuries related to the devices in February 2024.

In October 2024, Hologic initiated a recall and announced it was voluntarily removing all lots of unused BioZorb Markers from the market.

The 3D BioZorb Bioabsorbable Marker was designed to help doctors locate the soft tissue surrounding a tumor site for observation and treatment. The device slowly dissolves in the body over a year or more, but the titanium clips remain as permanent markers.

Lawsuits claim that the BioZorb Marker led to injuries after the device moved to different areas of the body or broke through the skin. Patients experienced a variety of painful issues that sometimes required surgery, like the marker migrating from the breast to the underarm or poking through the skin of the nipple. In some cases, fluid built up around the surgery site, causing painful swelling and tenderness.

Drugwatch can connect you with experienced BioZorb lawyers to help you file a lawsuit for potential compensation. The service and information we provide is always free.

The bulk of the BioZorb lawsuits remain in Massachusetts District Court under Judge Allison Burroughs. So far, there are about 100 lawsuits pending, according to Hologic’s December 2024 quarterly report. The first trial is scheduled for September 2025.

Hologic, Inc. issued recalls for BioZorb 3D Bioabsorbable Markers in March and October 2024.

March 2024 Recall

Hologic issued a product correction recall in March. A product correction is a repair, modification, relabeling, destruction or inspection that doesn’t require the device be removed from where they are used or sold. The company sent Medical Device Safety Notifications to its customers on March 14, but didn’t require users to send the device back.

The company received complaints about injuries like pain, infection, rash, device migration, device erosion, seroma, discomfort and other complications from feeling the device in the breast.

October 2024 Recall

The October BioZorb recall removed all unused lots of BioZorb Markers from the market. 

According to Hologic, there were 399 complaints out of the 91,531 devices distributed since 2015. 

As of October 16, 2024, there were 188 complaints for injuries connected to the device. Hologic said the recall was a precaution to prevent further injuries.

BioZorb Complications & Risks

Most of the information we have on BioZorb complications and risks comes from the FDA. The agency gathered reports from the public to issue its warnings. These reports are voluntary, so there’s no way for the FDA to ensure their accuracy.

Keep in mind that each person is unique and many women do not experience complications. You may have a BioZorb implant and not experience any issues. If you aren’t suffering complications, there is likely no need to have the device removed.

Some BioZorb complications may occur in as little as thirty days, while others may occur months or even years later.

Recent Studies on BioZorb Complications

Utilization of BioZorb Implantable Device in Breast-Conserving Surgery (Breast Journal)

In this study, researchers looked at 89 patients who had part of their breast tissue removed after being diagnosed with breast cancer. Within the first 30 days after surgery, three patients (3.3%) got infections that needed antibiotics, and two patients (2.2%) developed abscesses that also required antibiotics. None of these patients had the BioZorb device taken out.

At the nine-month check-up, one patient had the BioZorb move from her breast to her underarm, which required surgery to remove. 

Most of the BioZorb Marker is supposed to dissolve into the body in one year or longer. At a median follow-up of just over a year, the BioZorb was still noticeable in 63.6% of patients during clinical exams. Some patients could still feel the device after two and a half years.

Study authors didn’t report any conflict of interest. 

A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer

Researchers from several hospitals and universities across the country worked together to collect data from 818 patients and examine how well BioZorb performed.

This study didn’t report many complications. At thirty days, four patients had breast infections. Researchers said complications were low overall, and BioZorb was safe. As many as 92.4% of patients were satisfied with the cosmetic appearance of their breasts after BioZorb implantation.

The relatively low rate of serious complications in this study are in contrast to the slightly higher rate in the Breast Journal. This highlights the need for more BioZorb studies.

Study authors didn’t report any conflicts of interest.

You may qualify to file a BioZorb lawsuit if you received the BioZorb Marker implant and suffered injuries. Each law firm has its own criteria for accepting cases.

Search for a BioZorb attorney with a lot of experience with lawsuits against medical device companies. Experience bringing a case to trial and negotiating a settlement is also important.

Drugwatch’s legal partners can review your case for free, and it’s easy to sign up. We work with top national firms with the resources to litigate against large corporations. Our partners have a proven track record of helping clients seek compensation for medical device injuries.

Mindy Holcomb’s BioZorb Lawsuit

Breast cancer survivor Mindy Holcomb filed a BioZorb lawsuit in November 2024 in Massachusetts. After she had surgery to remove the tumor, doctors also removed some of the tissue from her left breast in August 2021.

At the same time, her doctor implanted a BioZorb Marker. Mindy suffered from pain, device migration and swelling. Ultimately, she had both breasts removed.

Mindy suffered disfigurement, pain and worry because of BioZorb, according to her lawsuit. The experience left her permanently and physically scared. She claims Hologic knew or should have known about the risks but failed to warn physicians and patients.

It’s best to hire an experienced product liability lawyer to make sure your BioZorb lawsuit is filed and argued properly in court.

If you want to file a lawsuit, you should speak to an attorney as soon as possible. Depending on the state you live in, you could have as little as one year to file a lawsuit. The time limit to file a case is called a statute of limitations, or SOL.

For product liability cases such as a BioZorb lawsuit, the time limit ranges from one to four years, depending on the state. In most cases, the clock starts ticking when you discover your BioZorb injury. In a few states, it starts ticking when you are injured, even if you don’t know BioZorb might have caused the injury.

Your BioZorb lawyer will go over all the types of compensation you may receive and how to claim it in your lawsuit.

Unmarried people in a relationship cannot claim loss of consortium. However, some states will allow parents to file a claim for loss of consortium with their child.

You might be wondering how the BioZorb recall affects you. Not everyone who has a BioZorb implant will suffer injury.

We’ve provided some guidance from the FDA as well as community resources. Support groups can be a good place to seek out other people who have BioZorb implants.

You can also report the problem to the FDA through the MedWatch Voluntary Reporting Form.