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BioZorb Lawsuit

BioZorb Lawsuit

BioZorb lawsuits are being filed by breast cancer survivors who were injured by severe side effects like pain, infection, device migration, scarring, erosion, or needing another surgery.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting BioZorb induced injury cases in all 50 states. If you are a breast cancer survivor who was injured by BioZorb Markers, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: BioZorb Markers Recalled After Breast Cancer Survivors File Lawsuits

In October 2024, Hologic recalled all BioZorb Markers due to serious health risks when the devices are used in breast tissue. The recall was issued after dozens of BioZorb lawsuits were filed by women who survived breast cancer, but were seriously injured by BioZorb Markers.

Why Are Breast Cancer Survivors Filing Lawsuits?

Doctors told women with breast cancer that BioZorb Markers would help “preserve their breast” and improve cosmetic outcomes by filling the space following a lumpectomy (surgery to remove breast tumors).

Instead, many women developed severe complications that ultimately required surgery to remove the BioZorb — and the rest of their breast.

Now, a growing number of BioZorb Lawsuits are being filed by women who accuse Hologic of aggressively marketing BioZorb Markers for unapproved uses, and failing to warn women about potential risks.

What is the Problem?

BioZorb Markers were recalled due to a risk of serious injuries when they are used in breast tissue. Tragically, many victims are breast cancer survivors who are now suffering from long-term health issues because doctors used BioZorb Markers in their breast cancer surgery.

BioZorb Health Risks & Serious Injuries

BioZorb Markers have been linked to serious injuries, such as:

  • Pain
  • Infection
  • Rash
  • BioZorb migration (moving out of position)
  • BioZorb erosion (breaking through the skin of the breast or nipple)
  • Fluid buildup (seroma)
  • Discomfort
  • Feeling a BioZorb device in the breast
  • BioZorb not resorbing in the body
  • Needing surgery to remove BioZorb devices
  • Life-threatening complications like the BioZorb breaking through the chest cavity, and/or blood vessels
  • Other medical treatment
  • And more

What is the BioZorb Device?

BioZorb Markers are implantable medical devices that were created by Hologic. Each device consists of a 3D spiral-shaped plastic component that is supposed to dissolve in the body, which is embedded with 6 titanium metal clips that show up on an X-ray. The clips act like “markers” in the body for future medical treatments.

What Happened?

BioZorb Markers have been used in thousands of breast cancer patients to help doctors precisely target sites for future treatments.

Many surgeons put BioZorb Markers in women with breast cancer who were having a “lumpectomy,” which is a surgical procedure to remove a breast tumor and some tissue, but not the entire breast.

The women were told that BioZorb Markers would dissolve over time, make their breast look better after surgery by filling up space where the tumor used to be, and mark targets for future radiation therapy.

Unfortunately, the FDA never approved BioZorb Markers for these uses. According to an FDA Safety Communication on October 25, 2024:

“Be aware the FDA has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment.”

Hologic Recalls All BioZorb Markers Due to Health Risks

On October 24, 2024, Hologic recalled all lots of unused BioZorb Markers that were still remaining on the market due to serious safety concerns.

In the recall, Hologic said there were “399 complaints and out of which 188 were associated with adverse events as of October 16, 2024.”

Hologic previously warned doctors about BioZorb health risks in a Medical Device Safety Notification in February 2024, but did not pull it off the market.

In May 2024, the FDA upgraded Hologic’s safety warning for BioZorb to a Class 1 recall due to a risk of “serious injuries or death.” There were 71 injuries reported at the time.

How Many People Were Injured?

As of October 2024, around 188 injuries were linked to BioZorb Markers. Hologic said the reports involve “serious injuries such as pain, infection, rash, device migration, device erosion, seroma, discomfort, and/or other complications from feeling the device in the breast, and in some limited instances, additional medical treatment.”

How Many BioZorb Markers Were Recalled?

The original BioZorb Marker recall included about 53,492 devices that were distributed in the U.S. between April 29, 2019 and April 1, 2024.

In October 2024, the recall was expanded to include all lots of unused BioZorb Markers. Approximately 91,531 devices were sold since 2015.

FDA Warning for Life-Threatening BioZorb Health Risks

In February 2024, the FDA warned about a risk of severe, life-threatening complications when BioZorb Markers migrate (move out of position from where it was implanted) and break through the chest cavity and/or blood vessels. The “migration of the device may also impact future targeting of radiation to the intended site,” according to the FDA warning.

BioZorb Lawsuits Filed by Breast Cancer Survivors

In September 2024, a BioZorb Lawsuit was filed by a group of 5 women who all needed surgery to remove BioZorb Markers due to severe complications like pain, scarring, infection, device migration, and disfigurement. Case Number 1:24-cv-12472.

BioZorb Lawsuits Claim It Failed to Dissolve

Other lawsuits involve BioZorb Markers that failed to dissolve. For example, this BioZorb Lawsuit was filed by Laura N., a breast cancer survivor who will likely need surgery to remove a BioZorb Marker that failed to absorb into her body, and instead formed a hard, painful lump. This future surgery may involve removal of her entire breast due to severe pain and scarring. Case Number 1:24-cv-12495.

Where Are Lawsuits Being Filed?

Nearly all BioZorb lawsuits have been filed in Massachusetts, where Hologic is headquartered. The cases are pending in the U.S. District Court for Massachusetts, where they are overseen by U.S. District Judge Allison D. Burroughs. Early trial dates are set for July 2025.

Can I Join a Class Action?

Instead of a class action lawsuit, BioZorb lawsuits are being filed as individual cases by women who were injured by severe side effects.

There are many advantages of filing an individual lawsuit, which is why class actions are not usually filed for people who were injured by defective medical devices. Like a class action, these individual BioZorb lawsuits may still be coordinated in one court for efficiency.

How Much Is My Lawsuit Worth?

There is no way to know how much money each BioZorb lawsuit is worth, but the injuries are very severe, and the victims are breast cancer survivors. Many women are still suffering from permanent injuries like pain, scarring, disfigurement, or they will need surgery.

In general, lawsuits involving more severe injuries can potentially end in higher payouts through a settlement or jury verdict. Lawsuits will typically seek compensation for past and future injuries and expenses.

If you were injured by BioZorb Markers, you may be able to file a lawsuit and seek compensation for your pain and suffering, medical bills, lost income, decreased quality of life, disfigurement, and more.

Do I Have a BioZorb Lawsuit?

The Schmidt Firm, PLLC is currently accepting BioZorb induced injury cases in all 50 states. If you are a breast cancer survivor who was injured by BioZorb Markers, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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