BioZorb Markers for breast cancer treatment and biopsies have been recalled due to severe, life-threatening complications and a growing number of lawsuits.

Need a Texas BioZorb Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured by BioZorb Markers, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

What Are BioZorb Markers?

BioZorb Markers® are spiral-shaped 3D markers that are implanted in soft-tissue sites, including breast tissue. They have been sold by Hologic since 2012.

BioZorb devices are small, about the size of a walnut. Each one has a spiral-shaped plastic component that dissolves in the body, which is embedded with 6 permanent titanium clips. The clips show up on an X-ray and identify sites for future medical treatments, such as radiation.

BioZorb Used In Thousands Of Breast Cancer Patients

BioZorb is a titanium breast marker that was implanted in thousands of women who had breast cancer surgery. Hologic claimed that BioZorb would help doctors precisely target radiation to areas of the breast where tumors grew, which would preserve more healthy tissue and improve cosmetic outcomes.

What is the Problem?

The problem is that some doctors used BioZorb Markers for cosmetic reasons that had no medical purpose, like filling tissue voids, or improving aesthetic results. These uses were not FDA-approved, according to an FDA Safety Communication in October 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.”

What Happened?

Despite a lack of safety studies, BioZorb Markers were implanted in thousands of women who were having a type of surgery for breast cancer called a “lumpectomy.”

Many women had BioZorb Markers implanted simply to fill up the empty space in their breast after the tumor was removed. Doctors said it would dissolve over a few years, and make their breast look better.

Instead, many women were seriously injured. These injuries are especially tragic because they involve breast cancer survivors. Many women are now cancer-free, but still suffering from health problems.

What Is The Risk?

BioZorb Markers are linked to hundreds of complaints and reports of serious injuries, such as:

  • Pain
  • Infection
  • Rash
  • Device migration (BioZorb moving out of position)
  • Device erosion (BioZorb breaking through the skin)
  • Seroma (fluid build-up)
  • Discomfort
  • Other complications from feeling the BioZorb device in the breast
  • Needing another surgery
  • And more

Painful Complications Linked to BioZorb

BioZorb Markers are associated with many painful complications. They may fail to dissolve and create a hard painful lump on the breast. Some women can feel BioZorb Markers in their breast and suffer pain or discomfort. There is also a risk of infections, abscesses, and fluid-build-up (called a “seroma”).

BioZorb Rashes & Allergic Reactions

BioZorb Markers have been linked to reports of skin rashes, severe itching, swelling, inflammation, and pain. These symptoms may be due to titanium sensitivity, or an allergic reaction to other materials in BioZorb Markers that trigger an immune response as they dissolve in the body.

BioZorb Migration & Erosion

One of the most serious complications occurs when BioZorb Markers move out of position (migrate) away from where they were originally implanted. They can erode into nearby tissues, and eventually pierce through the skin of the breast or nipple. This is an extremely painful complication that may require reconstructive surgery on the breast. BioZorb Markers can also puncture blood vessels or the chest cavity, which is a rare but life-threatening complication, according to the FDA.

Women May Need Another Surgery To Remove BioZorb

Another tragedy is that BioZorb Markers were advertised to help preserve breast tissue, but some women suffered the loss of their remaining breast tissue when doctors had to remove BioZorb Markers.

This is a problem, because Hologic advertised BioZorb for “Breast Conserving Surgery,” in which surgeons try to remove tumors without fully removing the breast. Hologic also claimed that “BioZorb minimizes radiation to healthy tissue” to reduce damage in the remaining breast tissue.

Lawsuits have been filed by women who ultimately had to have another surgery to remove BioZorb Markers, along with their remaining breast tissue. They were left with permanent scarring, severe disfigurement, as well as emotional suffering and physical pain.

BioZorb Lawsuits

BioZorb lawsuits are being filed by people who suffered from painful side effects, long-term injuries, scarring and disfigurement, or they needed surgery to remove BioZorb Markers from their body.

These BioZorb lawsuits accuse Hologic of selling a defective medical device, failing to adequately warn patients and doctors about safety risks, and aggressively advertising BioZorb for unapproved uses.

Hologic Recalls BioZorb To Warn About Complications

In March 2024, Hologic recalled BioZorb Markers to warn doctors about reports of serious complications. At the time, Hologic did not pull BioZorb devices off the market.

Soon afterward, the FDA upgraded the warning to a Class 1 Recall, which is the highest-level recall for devices that “may cause serious injuries or death.”

No deaths were reported, but Hologic said the recalled BioZorb Markers were linked to dozens of serious injuries, including:

“Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device.”

Hologic Pulls All Unused BioZorb Off The Market

On October 25, 2024, Hologic expanded the BioZorb recall and pulled all remaining BioZorb Markers and BioZorb LP Markers off the market. At the time, Hologic said there were 188 reports of injuries.

How Many People Were Injured?

Hologic said it received 399 complaints, including 188 reports of injuries associated with BioZorb Markers as of October 16, 2024. However, the actual number of injuries is likely higher. For perspective, Hologic sold about 91,531 BioZorb Markers since 2015. They were implanted in thousands of people nationwide, but some people may not even realize that they have BioZorb Markers in their body.

Other Names For BioZorb Markers

Doctors sometimes use other names for BioZorb Markers, for example:

  • Breast Markers
  • Biopsy Marker
  • Titanium Breast Marker
  • Bioabsorbable Marker
  • 3D Bioabsorbable Tissue Marker
  • Surgical Marker
  • Breast Tissue Marker
  • Tissue Clip
  • Biodegradable Breast Tissue Marker Clips
  • Implantable Radiographic Marker

Do I Qualify to File a Lawsuit?

Our lawyers would like to speak to anyone who was implanted with a BioZorb Marker and experienced side effects. The first lawsuits were filed by breast cancer survivors, but other patients may also qualify. Hologic recalled all BioZorb Markers, including devices that were used in other surgeries in addition to breast cancer. It is important to talk to a lawyer as soon as possible if you think you might qualify.

How Can A Lawsuit Help?

If you file a lawsuit, you may be able seek justice and financial compensation for your injuries. There is no way to know how much money each lawsuit could be worth, but in general, people who were injured by defective medical devices will usually seek compensation for physical and emotional pain and suffering, lost income, medical bills, long-term injuries like scarring, and decreased quality of life.

Can I Join a BioZorb Class Action?

Dozens of BioZorb lawsuits have been filed, but not as part of a class action. Instead, they are individual lawsuits that are mostly being filed in Massachusetts, where Hologic is headquartered. All of these lawsuits accuse Hologic of failing to warn patients about the risk of side effects from BioZorb Markers.

Need a BioZorb Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.

Meet Your Attorney

Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

To contact Collen, please fill out the contact form below:

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