8 Must-Know Facts About the BioZorb Recall

Posted: January 23, 2025

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1. BioZorb Tissue Markers Are Used in Breast Cancer Treatment.

In recent years, medical advancements have brought groundbreaking tools to improve patient care. Not all innovations succeed as planned. Hologic’s BioZorb tissue marker, a device used in breast cancer treatment, is a warning example.

BioZorb is a device used in breast cancer treatment. It has been linked to serious complications. This has led to a recall and raised legal and health concerns for patients affected. Here’s what you need to know about the device, its recall, and your options if you’ve been impacted.

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2. What Is BioZorb and How Does It Work?

BioZorb is a bio-absorbable implant designed to mark the site of a breast cancer tumor after surgical removal. Shaped like a small coil, the device contains titanium clips embedded in a polylactic acid (PLA) framework.

It is intended to help doctors visualize and target the area for radiation therapy or future imaging. Over time, the PLA material is supposed to dissolve naturally in the body, leaving only the titanium clips behind.

BioZorb has caused problems for many patients. This has led to serious health issues and a recall.

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3. Why Was BioZorb Recalled?

Hologic issued a recall of the BioZorb tissue marker after reports surfaced of adverse effects, including:

* Chronic pain and inflammation at the implantation site.
* Infections that required antibiotic treatment or surgical removal of the device.
* Migration of the implant, leading to complications in surrounding tissues.
* Difficulty in removal, which posed additional risks during follow-up surgeries.

The recall was classified as Class II by the FDA, meaning the device posed a health risk that could be mitigated with corrective action but was not deemed immediately life-threatening.

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4. FDA Sent a Warning Letter to Hologic.

In a warning letter issued to Hologic, the U.S. Food and Drug Administration (FDA) cited concerns over the manufacturing processes for BioZorb. The letter noted:

* Deficiencies in quality control measures.
* Failure to properly report adverse events associated with the device.
* Non-compliance with regulatory standards designed to ensure patient safety.

The FDA’s warning underscored the serious nature of the problems linked to BioZorb, emphasizing that Hologic’s actions fell short of the safeguards required for medical devices.

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5. A Court Rejected Hologic’s Motion for Summary Judgment.

On January 3, 2025, an important legal event took place. A judge denied Hologic’s request for summary judgment in lawsuits about BioZorb.

This ruling allows claims from plaintiffs to move forward, signaling that the court found sufficient evidence to question whether Hologic adequately warned patients and healthcare providers about the risks of the device.

For affected patients, this development strengthens the possibility of holding the manufacturer accountable for harm caused by BioZorb. The decision may lead to more examination of Hologic’s actions. It could also result in settlements or verdicts for the plaintiffs.

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6. Research Highlights BioZorb Problems.

Several studies have raised red flags about BioZorb’s performance and safety profile. Research published in medical journals has documented:

* Cases where the PLA framework failed to dissolve as expected, causing persistent pain and complications.
* Evidence of inflammatory responses triggered by the implant’s materials.
* Difficulties in imaging due to the migration or degradation of the device.

These findings have led doctors to wonder if BioZorb’s benefits are worth the risks. This is especially true since there are other tissue markers that have fewer complications.

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7. What to Do If You Have a Recalled BioZorb Implant

If you or a loved one has received a BioZorb implant, here’s what you should consider:

* Consult Your Doctor Right Away: Talk to your healthcare provider to see if the implant is causing problems or risks to your health. Imaging studies or other diagnostic tests may be necessary.

* Monitor for Symptoms: Be vigilant about signs of infection, pain, or unusual changes near the implant site. Early detection of complications can help prevent more serious issues.

* Consider Removal: If the implant is causing harm or presents risks, your doctor may recommend removing it. Be sure to discuss the potential risks and benefits of such a procedure.

* Document Everything: Keep records of your medical treatments, communications with healthcare providers, and any adverse effects you’ve experienced. This documentation can be crucial if you decide to pursue legal action.

* Seek Legal Advice: Consider consulting an attorney who specializes in medical device litigation. They can help you understand your rights. They will evaluate your case. They can also see if you may get compensation for medical expenses, pain, suffering, or other damages.

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8. Patients Have the Right to Know the Risks of a Medical Device.

The BioZorb recall has sparked a broader conversation about the safety and oversight of medical devices. Critics argue that regulatory agencies need to strengthen post-market surveillance to identify and address problems more quickly.

Patients and healthcare providers, meanwhile, are calling for greater transparency from manufacturers about the risks associated with their products.

The issues surrounding BioZorb also highlight the importance of informed consent. Patients have the right to know the possible benefits of a medical device. They should also understand the risks and uncertainties that come with it.

When patients are fully informed, healthcare providers can help them make choices that focus on their safety and well-being.

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