The BioZorb marker is a dangerous product. Thanks to the BioZorb recall, this breast cancer marker is off the market.

KBA Attorneys litigate medical device cases. We fight across the country for women victimized by dangerous devices and products like hair relaxers, talc, and implants like BioZorb. Our partner is now helping run the BioZorb lawsuits pending in federal court. We are here to help anyone who had this product by providing information at a minimum.

We do not provide any information that should be relied upon for medical reasons; consult your healthcare provider. Nonetheless, we provide information we have learned about the products we litigate, including BioZorb.

The BioZorb story is incredible. It is yet another example of women suffering needlessly. Cancer is hard enough. Treatment is tough. To have persistent pain, infection, soreness, and the many other complications because of a defective product is actionable. Fortunately, there was a recall and BioZorb is off the market, but it left behind many injured woman, many of whom are just learning of the risks still inside them.

The BioZorb Marker: Benefits, Complications, and Concerns

BioZorb is an implantable device doctors use in breast tissue to mark the location of surgical sites. It is particularly implanted after breast-conserving surgeries such as lumpectomies.

The device consists of a resorbable plastic component that the company designed to dissolve over time. It contains permanent titanium markers that remain in place for future imaging. While it has been useful in guiding post-surgery radiation therapy and marking soft tissue, recent reports raise serious concerns about the potential complications associated with its use. We provide more information for family members of those who have breast related healthcare issues and treatment, have had BioZorb marker implanted, and those who want to file a BioZorb titanium breast marker lawsuit. 

What Is the BioZorb Marker?

In sum, the BioZorb marker is an implantable medical device used during breast cancer treatment to help surgeons and radiologists precisely target radiation therapy. The device consists of:

• A biodegradable framework designed to dissolve over time
• Titanium clips meant to remain in place for future imaging

The company promoted it as a safe and effective tool to improve post-lumpectomy treatment. However, growing evidence suggests that many patients experience severe side effects, sometimes requiring removal surgery.

A good review of the BioZord history is here on our main page:

BioZorb Recall

Complications and Side Effects of BioZorb

Although the BioZorb marker was intended to support healing and radiation accuracy, many women have reported painful and dangerous complications, including:

• Chronic pain and inflammation that worsens over time
  Infections requiring antibiotics or additional surgery
  Device shifting/migration, causing deformities and discomfort
  Delayed wound healing and fluid accumulation (seromas)
  Hard lumps and excessive scar tissue formation
  Necrosis (tissue death) around the implant site
• For many women, these complications led to BioZorb revision surgeries or BioZorb removal surgery where a surgeon takes the implant out —a painful and unnecessary procedure that can affect long-term healing.

Following are frequent questions we have seen about the breast marker, BioZorb and the BioZorb recall.

Common Questions About BioZorb

1. What is the BioZORB Device used for?

The device is primarily used as a surgical marker. It helps radiologists and oncologists locate the site of surgery during follow-up procedures, particularly radiation therapy. It helps guide treatment and ensures that radiation is targeted correctly to the affected area.

2. What Complications do Patients Report?

Patients and healthcare providers report several adverse effects associated with BioZORB. There is a Class I recall—the most serious type of recall.

These complications include infections, pain, fluid buildup (seroma), device migration, and even erosion of the device through the skin. Some patients also reported discomfort from feeling the device in the breast. In severe cases, additional medical procedures including BioZorb removal surgery are needed to fix these complications.

3. What Are Patients Most Concerned About?

Patients and healthcare providers are concerned about the breast biopsy marker side effects. This includes risk of the device migrating from its original position or breaking through the skin. Migration of the device can lead to issues in accurately targeting radiation therapy, therefore impacting treatment outcomes. There is also concern for patients to need BioZorb removal surgery  as a result of these complications. Moreover, reports of infections and discomfort are alarming for patients who had the device implanted as part of their cancer treatments.

4. Why Are Patients Experiencing BioZorb Implant Complications?

The BioZorb marker was marketed as an absorbable medical device that would safely break down over time, leaving behind titanium clips for long-term imaging. However, many patients have reported severe issues, including:

• Pain and inflammation that worsens over time
• Implant shifting or migration, leading to disfigurement
• Infections requiring additional surgery
• Foreign body reactions and scarring
• Necrosis (tissue death) and hard lumps forming around the implant
• Delayed healing, restricting mobility and causing long-term discomfort

5. Why Are Patients Filing Lawsuits Against BioZorb?

Patients who have experienced severe complications from the BioZorb marker are filing lawsuits against Hologic, Inc., the device manufacturer, claiming:

• The device caused unexpected side effects that were not properly disclosed
• The manufacturer failed to warn patients about potential long-term risks
• The device migrates or causes painful inflammation, requiring additional surgery

If you had your BioZorb marker removed or experienced severe complications, you may be eligible for compensation.

6. Is BioZorb Safe For Cosmetic Outcomes?

Although some patients believe the device can help improve cosmetic results by filling space in breast tissue after surgery, the FDA has not approved the device for this purpose. Its primary function is to act as a marker, not a cosmetic filler.

See FDA announcements about BioZORB here:

https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication

https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices 

7. What should You Do If you Or Someone You Know Has a BioZorb Implant?

If you have the BioZorb titanium marker implant, it is crucial to monitor for any signs of breast biopsy marker side effects and complications. This can include pain, redness, infection, or feeling the device move under the skin. Consult with your healthcare provider immediately if you notice any issues. The FDA encourages patients to report any adverse events to their healthcare team or through the MedWatch system. Patients who have suffered because they have had BioZorb complications or removal surgery can also file a BioZorb lawsuit.

8. Who Can File a BioZorb Lawsuit?

You may qualify for a BioZorb lawsuit if you:

• Had a BioZorb implant after a lumpectomy
• Suffered from chronic pain, infections, or tissue damage
• Required surgical removal of the device due to complications
• Experienced scarring, deformity, or long-term discomfort

9. What could BioZorb Compensation cover?

• Medical expenses (surgery, hospital stays, medications)
• Lost wages due to recovery and treatment
• Pain and suffering from ongoing discomfort and emotional distress
• Punitive damages if we can prove egregious conduct

Did Your BioZorb Implant Cause Pain, Infection, or Require Removal?

If you had a BioZorb marker after breast cancer surgery and later experienced severe pain, shifting, infections, or required implant removal, you may be eligible for financial compensation.

The company made the BioZorb marker to improve radiation therapy targeting after a lumpectomy, was marketed as a safe, absorbable device. However, many patients have reported serious complications, including chronic pain, device migration, infections, and severe inflammatory reactions—sometimes leading to revision surgery to remove the implant.

At Ketterer, Browne & Associates, we are actively investigating defective BioZorb claims and helping affected patients hold the manufacturer accountable. If you or a loved one suffered unexpected complications, you may qualify for a BioZorb lawsuit.

We share a lot of information to try to help people. For more information, check out KBA’s prior coverage here:

BioZORB Medical Device Problems/Lack of Warnings

BioZorb Marker for Breasts Cancer Patients

How Would I know if I have a breast marker claim?

Every case is different and we need to investigate medical records. Generally speaking, the BioZorb marker may be a problem if  you are experiencing pain in you breast where doctors previously placed markers. If a woman had a bioabsorbable marker for breast cancer radiation therapy and notices the following signs or symptoms, she may have a claim:

Possible Symptoms of Marker Complications

1. Pain or Discomfort – Persistent pain at the surgical site that last longer than the expected healing period.
2. Swelling or Inflammation – Unusual or prolonged swelling, redness, or warmth around the area where the doctor placed the marker.
3. Hard Lump or Mass Formation – Some BioZorb patients report feeling a hard lump where the marker was placed, which could be due to scar tissue, inflammation, or an unusual reaction.
4. Infection Signs – Fever, drainage (pus), or increased tenderness could indicate an infection at the marker site.
5. Delayed Absorption or Migration – In rare cases, the device may not absorb as expected or could shift, causing discomfort or a visible lump.
6. Skin Changes – Some women who had a marker report dimpling, thinning of the skin, or other texture changes over the implant site.
7. Allergic Reaction or Foreign Body Response – If the body reacts negatively to the implant material, persistent irritation, a chronic inflammatory response, or similar symptoms might occur.
8. Imaging Concerns – Some patients only become aware of an issue with a marker when a radiologist sees an unexpected mass or distortion on follow-up mammograms or MRIs. Reviewing one’s records is helpful because observations do not always make it to the patient.

Next Steps for BioZorb patients

If a woman notices any of these symptoms, she should:

• Contact her surgeon or oncologist for an evaluation.
• Request imaging (mammogram, ultrasound, or MRI) to check the status of the Biozorb implant.
• Discuss treatment options if complications arise, which might include monitoring, medication, or in some cases, surgical removal.
• Start an investigation with a BioZorb marker lawyer.

Contact KBA Today

While BioZORB titanium marker has proven beneficial in marking surgical sites and guiding radiation therapy, it’s important for patients to be aware of the potential risks. If you or a loved one has been implanted with a BioZORB device, stay informed about the symptoms to watch for and discuss any concerns with your healthcare provider. The ongoing recall highlights the importance of safety monitoring, and both patients and providers should carefully weigh the benefits and risks of using this device in breast cancer treatment.

Our law firm is currently investigating the BioZORB recall and can litigate a titanium breast marker lawsuit for you. Contact us if you have been injured by the BioZorb implant. 855-KBA-LAWS (522-5297), Intake@KBAattorneys.com

How Ketterer, Browne & Associates Can Help

Our team of defective medical device lawyers has extensive experience in mass tort claims, helping individuals fight back against medical manufacturers for unsafe products. We offer:

• Free, no-obligation case evaluations
• No upfront fees—we only get paid if we win your case
• Aggressive, compassionate legal representation

If you or a loved one suffered due to a BioZorb implant, we are here to help.

Take Action Today: Contact Us for a Free Case Review

If you had a BioZorb implant removed or experienced painful complications, don’t wait to take legal action. Time is limited to file a claim.

Call us today for a FREE consultation or fill out our online form to find out if you qualify. No fees unless we win your case.