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Table Of Contents
What is the BioZorb Marker?
According to Hologic, BioZorb is a 3D implantable marker that consists of a spiral, bioabsorbable framework embedded with 6 permanent, titanium clips designed to mark a surgical excision site, including breast tissue [1.]. The device is also indicated in situations where the soft tissue site needs to be marked for future medical procedures.
BioZorb is composed of 2 parts: a plastic component that is intended to be dissolved completely in the patient’s body, and a titanium metal component that is permanent.
BioZorb Markers were approved by the U.S. Food and Drug Administration (FDA) in 2012.
What’s the Problem?
On October 25, 2024, the FDA issued a press release [2.] stating that Hologic was recalling the following lots of BioZorb Markers after they were linked to serious adverse events occurring in patients who had the devices implanted in breast tissue:
Version or Model | Device Brand Name | Device Description | Device Identifier (DI) Number |
---|---|---|---|
F0405 | BioZorb Bioadsorbable Marker | BioZorb Marker 4cm x 5cm | 15420045514065 |
F0404 | BioZorb Bioadsorbable Marker | BioZorb Marker 4cm x 4cm | 15420045514058 |
F0304 | BioZorb Bioadsorbable Marker | BioZorb Marker 3cm x 4cm | 15420045514010 |
F0303 | BioZorb Bioadsorbable Marker | BioZorb Marker 3cm x 3cm | 15420045514003 |
F0203 | BioZorb Bioadsorbable Marker | BioZorb Marker 2cm x 3cm | 15420045513990 |
F0202 | BioZorb Bioadsorbable Marker | BioZorb Marker 2cm x 2cm | 15420045513983 |
F0331 | BioZorb LP Bioadsorbable Marker | BioZorb Marker 1cm x 3cm x 3cm | 15420045514041 |
F0231 | BioZorb LP Bioadsorbable Marker | BioZorb Marker 1cm x 3cm x 2cm | 15420045514034 |
F0221 | BioZorb LP Bioadsorbable Marker | BioZorb Marker 1cm x 3cm x 2cm | 15420045514027 |
BioZorb Complications
Adverse events associated with BioZorb Markers include:
- Infection – Biozorb markers consist of two key parts: a permanent titanium piece and a plastic component designed to be absorbed by the body over time. However, if the plastic component fails to resorb as intended, it can cause a range of infections. If left untreated, these infections may lead to severe complications, making early medical intervention crucial.
- Device migration (moving out of position) – Migration refers to the movement of a surgical implant from its initial placement. In the case of Biozorb markers, migration can lead to significant risks, such as blockages in the chest area. Additionally, it can heighten the chances of infections, cause the Biozorb marker to pierce the skin, and result in other serious complications.
- Device erosion (breaking through the skin) – A significant danger linked to Hologic, Inc.’s defective Biozorb Markers is the potential for these devices to migrate and pierce the skin, leading to improper resorption. This condition, referred to as “erosion,” can be both alarming and painful. Additionally, it increases the risk of infections and other severe health complications.
- Seroma (fluid buildup) – The migration or incomplete resorption of a Biozorb marker can lead to fluid accumulation in the chest, a condition called seroma. In certain instances, seromas may resolve without intervention, but in other cases, surgical drainage via a tube may be required. Importantly, as one surgeon notes, seromas can pose a significant issue for cancer patients, as they may occasionally delay further cancer treatments.
- Pain / discomfort – If a Biozorb marker is defective and leads to complications such as infection, fluid accumulation, migration, or erosion, it may also result in ongoing pain and discomfort. Medical devices implanted during surgery should improve your quality of life, not cause additional suffering. If you experience pain or discomfort from a faulty implant, you may have legal grounds to pursue compensation for your injuries.
- Other complications from feeling the device in the breast
“In some instances, additional medical treatment, including having the device removed from the body (explantation), was needed,” FDA said.
FDA Recommendation
As a result of these problems, the FDA is urging patients and their families to seek immediate medical attention if they have any concerns.
While the agency has not entirely discouraged the use of Biozorb Markers, it does advise healthcare providers to closely monitor patients who have had these markers implanted.
Additionally, the FDA recommends that doctors discuss the potential risks with patients before considering Biozorb Markers for breast cancer surgeries.
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Get a Free BioZorb Marker Lawsuit Evaluation With Our Law Firm
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in BioZorb Marker Lawsuits.
We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential BioZorb Marker Lawsuit Evaluation: Again, if you or a loved one suffered complications related to a BioZorb implant device, you should contact a lawyer immediately for a free case evaluation.
You may be entitled to financial compensation for medical bills, legal fees, and punitive damages by filing a BioZorb Marker Lawsuit and our legal team can help.
References:
1. https://www.hologic.com/hologic-products/breast-health-solutions/biozorb-3d-bioabsorbable-marker
2. 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