On December 7, 2024, the FDA announced a recall of the BioZorb 3D Bioabsorbable Marker, a device manufactured by Hologic. This recall has raised serious concerns about patient safety, particularly for individuals who have relied on the BioZorb marker after breast cancer surgery. At Jenner Law, we are dedicated to helping those affected by defective medical devices, and this recent recall underscores the critical importance of holding manufacturers accountable. If you have questions or would like to discuss further, contact Jenner Law to talk to a Biozorb lawsuit lawyer today.
Understanding the BioZorb Recall
The BioZorb device was designed to assist surgeons in targeting radiation therapy after breast cancer surgeries. Made from bioabsorbable material, the device was intended to dissolve safely over time. However, reports of severe complications, including inflammation, infection, and adverse tissue reactions, led Hologic to initiate the recall. These risks not only jeopardize patient recovery but can also result in significant long-term health consequences.
“Patients who trusted this device to aid in their recovery deserve better,” says Robert Jenner, founding partner of Jenner Law. “When a device intended to heal instead causes harm, it’s a betrayal of that trust.”
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The Science Behind the Harm
The BioZorb device, composed of bioabsorbable polymers, was designed to gradually dissolve within the body over time. However, in some patients, the material has triggered adverse immune responses. This can lead to chronic inflammation, localized infections, and scarring at the implantation site. Additionally, fragments of the device can become lodged in surrounding tissues, causing pain and further complications.
“The human body often reacts unpredictably to foreign materials,” explains Elisha Hawk, partner at Jenner Law. “In the case of BioZorb, the bioabsorbable materials that were supposed to integrate seamlessly have instead caused harm to patients by provoking immune system overreactions.”
This immune response may also impair healing after surgery, as the body focuses on fighting the perceived foreign threat rather than repairing damaged tissues. Over time, the presence of the device can exacerbate pain, delay recovery, and require additional surgeries to address complications.
What a Recall Means
A recall occurs when the FDA or a manufacturer identifies significant risks associated with a product. In the case of BioZorb, the recall involves halting distribution of the device and notifying healthcare providers and patients of the risks. For those who already have the device implanted, the recall does not automatically mean removal but does warrant immediate consultation with a healthcare provider to assess potential risks and necessary next steps.
Elisha Hawk, partner at Jenner Law, emphasizes the importance of transparency in such situations: “When recalls like this happen, patients often feel left in the dark. Our role is to ensure they’re informed, supported, and empowered to take the next steps to protect their health and legal rights.”
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The Broader Issue of Defective Medical Devices
Unfortunately, the BioZorb recall is not an isolated incident. Over the years, several prominent medical devices have faced recalls due to unforeseen complications or inadequate testing:
- Metal-on-Metal Hip Implants: Johnson & Johnson’s recall highlighted risks of tissue damage and metal poisoning.
- Medtronic’s Heart Devices: Battery failures led to recalls that put patient lives at risk.
- Breast Implants: Certain textured implants have been linked to rare forms of cancer, prompting global recalls.
- Zantac (Ranitidine): Although not a device, the contamination with a potential carcinogen showcases the broader issue of safety in medical products.
These examples demonstrate the recurring challenges in ensuring that medical products are both effective and safe for patients.
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What Patients Should Do
If you or a loved one has been affected by the BioZorb recall, it’s essential to take the following steps:
- Consult Your Doctor: Discuss any potential complications and whether the device should be removed or monitored closely.
- Document Your Symptoms: Keep a detailed record of any health issues you’ve experienced since receiving the device.
- Seek Legal Guidance: Understanding your rights and potential claims is critical in ensuring accountability and compensation for harm caused.
At Jenner Law, we offer compassionate and experienced legal representation to individuals harmed by defective medical devices. Our team is here to help you navigate this difficult time and hold manufacturers accountable for the harm caused by their products.
Advocacy for Justice
“When corporations prioritize profits over patient safety, it’s our job to step in,” says Robert Jenner. “We’ve seen the devastating impact that defective medical devices can have on patients and their families. Through legal advocacy, we aim to ensure justice and bring about systemic changes to prevent future harm.”
Elisha Hawk echoes this sentiment: “Patients shouldn’t have to shoulder the burden of a manufacturer’s negligence. That’s why we’re here — to provide the support and advocacy they need during this challenging time.”
Experience You Can Trust
At Jenner Law, we have extensive experience leading significant cases against manufacturers of defective medical devices. Robert Jenner has served as Co-Lead Counsel in the GranuFlo medical device case in Massachusetts state court, a pivotal lawsuit involving serious health risks linked to dialysis treatments. Additionally, he was Liaison Counsel in the Smith & Nephew hip replacement cases in the United States District Court in Maryland, which addressed complications caused by defective metal-on-metal hip implants.
“Our experience in these landmark cases has prepared us to take on even the most challenging battles against powerful manufacturers,” says Robert Jenner. “We know how to fight for justice and achieve meaningful outcomes for our clients.”
Elisha Hawk adds, “These cases demonstrate our firm’s ability to hold corporations accountable and our unwavering commitment to ensuring that patients’ voices are heard.”
How Jenner Law Can Help
Our firm has a proven track record of representing clients harmed by defective medical devices. We understand the complexities of these cases and are committed to achieving the best possible outcomes for our clients.
The BioZorb recall serves as a stark reminder of the need for rigorous oversight in the medical device industry. It also highlights the critical role of patient advocacy in ensuring accountability. At Jenner Law, we remain steadfast in our mission to fight for justice for those harmed by defective medical products.
If you have questions about the BioZorb recall or believe you may have been affected, please don’t hesitate to contact us. Our team is here to provide the guidance and support you need to move forward.
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