Navigating the FDA's BioZorb Warning: A Crucial Update for Breast Cancer Patients and Medical Innovators

April 22, 2024

Disclaimer: The information provided in this article is accurate as of its publication date. Given the dynamic nature of legal proceedings and FDA findings, the current status may have changed. Readers are urged to consult the most recent sources for the latest information before drawing conclusions or making decisions based on this article.


Breast cancer patients and the bustling medical device industry were met with an unexpected turn of events when the Food and Drug Administration (FDA) recently issued a safety communication about BioZorb, a product designed to improve breast cancer treatment. The unique marker has been touted as a revolutionary tool for both patients and doctors. However, the new warnings raise critical concerns that the community cannot afford to overlook.

 This blog post dives deep into the FDA's message, explores the technology behind BioZorb, and uncovers what this means for the future of breast cancer treatment.

A Closer Look at BioZorb Promise

Developed to aid in the visualization and targeting of the tumor bed in patients with breast cancer, BioZorb is a 3D marker that improves the accuracy of radiation treatment, keeps the breast's natural shape, and promotes tissue repair. Surgeons implant the marker directly into the breast, where it acts as a guidepost for both clinicians and patients. This innovation sparked hope within the medical community upon its introduction, as it appeared to offer both a technical edge for practitioners and a comfort for those experiencing the traumatic process of cancer treatment.


The BioZorb Marker and BioZorb LP Marker have two components: a resorbable plastic component that is intended to be resorbed completely by the patient's body in one year or longer, and a titanium metal component that is permanent.


The FDA's Disquieting Notice

The FDA's recent safety communication highlighted several distressing observations regarding the use of BioZorb in breast tissue. The alert was issued after numerous patient reports and medical studies detailed instances of complications such as pain, infection, and migration of the device. Additionally, concerns were raised about the need for repeat procedures due to BioZorb-related issues. The thorough analysis by the FDA extended to questions about the long-term safety and effectiveness of the product, prompting a reevaluation of its use in clinical settings.


Potential Risks Associated with the Use of BioZorb Marker and BioZorb LP Marker devices in Breast Tissue

The device moving out of position (migration) and breaking through the chest cavity and/or blood vessels can have severe, life-threatening consequences. It may also affect future radiation targeting at the intended site. The concerns highlighted by the FDA's safety communication regarding the BioZorb and BioZorb LP Marker devices can be categorized into a few critical risk areas.


Pain and discomfort have been reported by numerous patients, varying from mild to severe, and may persist longer than initially anticipated.

The risk of infection is another significant concern, with the implanted device potentially acting as a nidus for bacterial growth, leading to serious health complications if not promptly addressed.


The necessity for repeat procedures due to issues directly related to the BioZorb device poses not only a health risk to patients but also increases the psychological and financial burden on them.


These potential risks underline the importance of a careful and informed approach to the use of BioZorb and BioZorb LP Marker devices in breast tissue treatment, emphasizing patient safety and well-being above all.

Patient and Provider Protocols in the Wake of Warnings

The issuance of FDA warnings necessitates immediate action. Patients who currently have BioZorb in place are advised to remain vigilant for any signs of complications, consult their healthcare providers, and consider alternative treatments. Meanwhile, healthcare professionals are urged to thoroughly discuss the risks associated with BioZorb and explore alternative therapeutic strategies. Both parties are encouraged to maintain open communication and ensure that patient safety is of the highest priority.


FDA Actions

The FDA is collaborating with Hologic Inc. to comprehensively assess the safety of BioZorb Marker and BioZorb LP Marker devices in breast tissue and address potential risks associated with their use.


Continual monitoring of adverse events by the FDA will ensure prompt updates to the public should significant new information arise.

In Conclusion: A Shared Journey Toward Safer Solutions

The FDA's announcement regarding BioZorb is a signal for all involved in the breast cancer community to take stock and redouble efforts towards patient safety and informed treatment options. By heeding the warnings and engaging in an open exchange of insights and challenges, we can collectively drive the evolution of medical devices toward greater effectiveness and reliability. Breast cancer patients and survivors are at the center of this pivotal moment, empowered to share their stories and advocate for treatments that honor their voices and experiences. The road to a safer tomorrow is shared, and the strides we take today will define the standards we set for the innovations that hold the promise of a healthier, brighter future.



If you or someone you know has been negatively affected by any of the symptoms/effects mentioned above via BioZorb device, knowing your legal rights is imperative. Reach out to us at Jason Joy & Associates for a free legal consultation today. It's vital that victims understand the potential for recourse and the importance of advocating for their health and wellbeing. Legal professionals specializing in medical device litigation can provide essential insights and guidance, ensuring that patients receive the support and compensation they deserve.


Disclaimer: The information provided in this document, including but not limited to, discussions related to health, treatments, and devices such as BioZorb markers, is for general informational purposes only. It is not intended as, nor should it be considered a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of your physician or other qualified health provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen. Do not disregard professional medical advice or delay in seeking it because of something you have read in this document.


Contact Us

By submitting this form you agree to receive text messages.

A retracted study on Roundup reignites debate over its potential cancer risk (Washington Post)

By Rebecca Rivera • December 9, 2025
As reported in the Washington Post December 5th, 2025 by Amudalat Ajasa A prominent scientific journal, Regulatory Toxicology and Pharmacology, has retracted a widely cited 2000 study that previously concluded the active ingredient in Roundup, glyphosate, posed no cancer risk to humans. The retraction was initiated after evidence emerged suggesting the study was heavily influenced by the herbicide's seller, Monsanto (now owned by Bayer), in an apparent effort to disguise potential health risks. Specific concerns cited by the journal include the strong possibility that Monsanto employees contributed to the writing without proper acknowledgment, that the authors may have received undisclosed payments from the company , and that the findings were based solely on unpublished Monsanto studies. This misconduct, discovered through internal company emails during federal litigation, is significant because the faulty research served as a bedrock for regulatory decisions regarding glyphosate for decades. Summary of Alleged Faulty Study and Monsanto's Influence The Study and Its Conclusion: The retracted paper, published in 2000, was a "bedrock study" that concluded: "under present and expected conditions of new use, there is no potential for Roundup herbicide to pose a health risk to humans." The Retraction: The scientific journal retracted the study due to a loss of confidence in its results and conclusions, citing the need to "maintain the integrity of the journal." Evidence of Undisclosed Influence: The co-editor in chief cited evidence suggesting that Monsanto employees "may have contributed to the writing of the article without proper acknowledgment as co authors." Undisclosed Payments: The retraction also noted that the study's authors may have been paid by Monsanto without disclosing it . Basis of Findings: The journal stated that the study's findings about cancer risk were "solely based on unpublished studies from Monsanto." Discovery of Influence: Monsanto's influence over the study was reportedly discovered through internal emails released during federal litigation against the company in 2017. Impact: The study "had a significant impact on regulatory decision-making regarding glyphosate and Roundup for decades," and was one of the most-cited papers on glyphosate safety, underpinning federal regulations for the pesticide. The Environmental Protection Agency (EPA) even cited it in its 2016 review of glyphosate. Context and Aftermath Bayer's Defense: Bayer (which acquired Monsanto in 2018) defended the chemical's safety and argued that Monsanto's involvement was appropriately cited in the acknowledgments, stating that glyphosate is the most extensively studied herbicide and that the "vast majority of published studies on glyphosate had no Monsanto involvement." Regulatory Stance: The EPA stated the retraction would not affect its current stance —which is that glyphosate is "not likely to be carcinogenic to humans"—because the agency does not directly rely on review articles like this one, but uses them to find other relevant individual studies. Litigation: Bayer has spent approximately $10 billion to settle lawsuits arguing the company did not warn customers about the negative health impacts of using Roundup. Read the full article in the Washington Post

BSA Bankruptcy Update with Curtis Garrison and Jason J Joy

By Rebecca Rivera • November 14, 2025
In this series premiere episode, Founder & President of SOSCSA, Child Sexual Abuse Survivor & BSA Bankruptcy Claimant, Curtis Garrison interviews attorney Jason J Joy for an update on the BSA bankruptcy and discussing childhood abuse litigation for which Jason is an outspoken and experienced advocate. Jason's firm is actively litigating cases for many clients his law firm represents. This podcast is recommended for clients already represented, and for those who are still contemplating coming forward to establish a claim. Topics covered in this episode: Recent BSA Bankruptcy Trust report Lajun Claimants (Guam) v. Boy Scouts of America and their recent Petition For A Writ Of Certiorari to the U.S. Supreme Court The 1.5% initial payment, possible second payment time / total percentage Future Claims, BSA Councils, BSA Charters (churches, schools, etc) which there are over 100,000 entities possibly getting free of liability Mixed Claims explained We did not vote for this plan, they promised we would be paid in “Paid in Full” Plans to file an Amicus Brief Statute of Limitations 

Boy Scouts Abuse Case Update | Curtis Garrison & Jason Joy

By Rebecca Rivera • November 6, 2025
The Boy Scouts of America bankruptcy case, involving tens of thousands of survivors of childhood sexual abuse, is among the largest and most contentious mass tort proceedings in U.S. history. In this podcast, Attorney Jason Joy breaks down the latest ruling from the Third Circuit Court, which leaves many survivors of childhood sexual abuse with drastically underfunded compensation.