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Edited By : Renée Deveney
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Why Are People Filing Biozorb Lawsuits?

Since several BioZorb lawsuits were first filed in November 2024, more women have come forward claiming that the BioZorb 3D Bioabsorbable Marker, a device used in breast cancer surgery, caused serious complications. The lawsuits argue that the company failed to warn them of the risks. They also raised concerns about the BioZorb Marker’s design, manufacturing and marketing.

BioZorb Complications
  • Device erosion (breaking through the skin)
  • Device migration (moving out of position)
  • Discomfort
  • Infection
  • Other complications from feeling the device in the breast
  • Pain
  • Rash
  • Seroma (fluid buildup)
  • Surgery to remove the device

According to a report to the U.S. Securities and Exchange Commission, there were about 100 cases as of early 2025. One lawsuit is in Massachusetts state court, while the rest are in federal court in Massachusetts. Although these cases are not part of a multidistrict litigation (MDL), having multiple lawsuits in the same federal court can still streamline legal proceedings.

Four bellwether trials are planned, with the first to begin on Sept. 8, 2025. A bellwether trial is a test case that helps predict the outcome of a larger group of similar lawsuits. Courts often use bellwether trials in mass personal injury cases, where the same product or incident injures many people.

Hologic denies any wrongdoing and plans to defend itself. However, litigation can be expensive and unpredictable. At this early stage, the company cannot say how the courts or the parties will resolve these cases.

How Biozorb Implants Work

The BioZorb Marker is a small device that helps doctors identify specific soft tissues for future medical treatments. It has two main parts: one is made of a durable titanium metal that stays in the body permanently. The other part is made of a special plastic that eventually breaks down and gets absorbed by the body over time.

The marker is typically used to highlight the site of a tumor or cancer that was removed, but some women report that the device moved within the body or ruptured through the skin.

The BioZorb Recall

In March 2024, Hologic Inc. announced a Class 1 recall of its BioZorb Marker — the most serious recall level. By October 2024, the company issued an additional recall to remove all unused BioZorb devices from the market.

FDA Recommendations for People With BioZorb Devices
  • Contact your doctor if you have any issues or unexpected reactions related to your BioZorb Marker.
  • If you encounter any problems or complications with your BioZorb Marker, please report them to the FDA.
  • If your doctor plans to use radiation therapy, make sure to talk about any potential risks.
  • You typically don’t need to remove the marker unless your doctor advises it.

At the time of the second BioZorb recall, Hologic said that nearly 200 people had reported BioZorb complications to the company.

Out of 91,531 … devices sold since 2015, there have been 399 complaints … out of which 188 were associated with adverse events as of October 16, 2024. As a cautionary measure, Hologic is requesting all lots of unused BioZorb Markers to be returned.

The FDA promised to keep a close eye on adverse event reports and continue to share updates as more information becomes available.

Do I Qualify for a BioZorb Lawsuit?

You may qualify to file a BioZorb lawsuit if you had the device implanted after breast cancer surgery and suffered severe complications.

You May Be Eligible To File a BioZorb Lawsuit if:
  • You had BioZorb implanted during breast cancer treatment
  • BioZorb was not absorbed as intended
  • You experienced severe pain, swelling or infections
  • BioZorb migrated or eroded, resulting in injuries
  • You required additional surgeries due to BioZorb complications

Case Study: Mindy Holcombe’s BioZorb Lawsuit

In June 2021, Mindy Holcombe received a breast cancer diagnosis. She had surgery to remove part of her breast in August 2021 at UAMS Medical Center in Little Rock, Arkansas. During the surgery, doctors placed a BioZorb device to help keep track of the area where the surgery was done.

After her surgery, Holcombe experienced pain, swelling and issues with her BioZorb device. The marker didn’t stay in the right spot as it should have, which led to more problems and discomfort.

Holcombe underwent a double mastectomy in November 2021, during which her BioZorb device was removed. In her lawsuit, she claims Hologic, Inc. failed to inform her and her doctors about the risks of the device, leading to lasting scars and emotional pain.

How to File a BioZorb Lawsuit

To file a BioZorb lawsuit, you’ll need to gather evidence, find an attorney specializing in medical device lawsuits and beat the deadline to file a lawsuit.

Three Steps to File a BioZorb Lawsuit
Gather Evidence
Before consulting a lawyer, gather relevant health documents, including medical records, prescriptions, hospital bills and any other paperwork about side effects from BioZorb. These will help your lawyer assess your situation and determine potential compensation.
Talk to a Lawyer
Lawsuits involving medical devices like BioZorb can be complex and challenging to navigate. Talking to a lawyer specializing in drug and medical device cases is important. Drugwatch can assist you by connecting you with top medical device attorneys with extensive experience in these types of cases. We're here to help you find the right lawyer for your situation.
File Before Deadline
You have a limited amount of time to file a lawsuit. This statute of limitations can be different depending on where you live. In some places, you may only have a year from when BioZorb caused you harm to take action. That's why it's important to talk to a lawyer as soon as possible.

Lawyers who deal with personal injury cases, like those related to BioZorb, usually only get paid if they win your case. Consultations with these lawyers are usually free, but check with the lawyer first to confirm how their payment process works.

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Resources for Breast Cancer and BioZorb Patients

If you or someone you care about is going through breast cancer treatment or experiencing complications with the BioZorb Marker, finding trustworthy resources can be helpful. Here are five reliable online platforms that offer support, valuable information and advice for those impacted by these issues.

  • Breastcancer.org: This organization offers 24/7 online support and information. Its goal is to provide clear and reliable answers about personal risk, diagnosis, treatment options and surgical choices.
  • Susan G. Komen Foundation: The foundation provides patient education, emotional support and financial assistance. It also features a Breast Care Helpline: 1-877-465-6636. The line is staffed Monday through Thursday from 9 a.m. to 7 p.m. ET and 9 a.m. to 6 p.m. on Friday.
  • Reddit support groups: Reddit is a social media platform comprising online forums focused on specific topics. Subreddits like r/breastcancer can provide support and experience from others, including BioZorb-specific threads.
  • Facebook support groups: Facebook also features groups of people with similar concerns, such as the BioZorb Side Effects Support Group, bringing together people who’ve experienced complications.

If you need information about health, support from others or legal help, these resources can be a good way to start. It’s important to stay informed and connected while going through breast cancer treatment and any difficulties that may arise.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: March 4, 2025

9 Cited Research Articles

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  1. U.S. Securities and Exchange Commission. (2025, February 6). Form 10-Q; Hologic, Inc. Retrieved from https://d18rn0p25nwr6d.cloudfront.net/CIK-0000859737/a97854ee-aaa6-4ac6-b138-0f32ccb9f7e2.pdf
  2. U.S. Food and Drug Administration. (2024, December 18). Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/update-do-not-use-biozorb-marker-implantable-radiographic-marker-devices-fda-safety-communication?utm_medium=email&utm_source=govdelivery
  3. U.S. Food and Drug Administration. (2024, December 18). Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices
  4. U.S. District Court for the District of Massachusetts. (2024, November 5). Holcomb v. Hologic, Inc.; Plaintiff’s First Amended Complaint Retrieved from http://www.pacer.gov
  5. Doherty, K. (2024, October 30). FDA Advises Against Use of BioZorb Markers in Breast Cancer and Other Indications. Retrieved from https://www.onclive.com/view/fda-advises-against-use-of-biozorb-markers-and-biozorb-lp-markers
  6. Hologic, Inc. (2024, October 24). Urgent: Medical Device Recall; BioZorb 3D Bioabsorbable Marker. Retrieved from https://www.hologic.com/biozorb-3d-bioabsorbable-marker-important-recall-information
  7. U.S. Food and Drug Administration. (2024, March 13). Class 1 Device Recall BioZorb LP Marker. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207014
  8. U.S. District Court for the District of Massachusetts. (2024, March 15). Shirkey et al. v. Hologic, Inc.; Complaint. Retrieved from http://www.pacer.gov
  9. U.S. Food and Drug Administration. (2023, December 7). FDA Adverse Event Reporting System (FAERS) Public Dashboard. Retrieved from https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard