FDA’s Warning Letter to Hologic Highlights Ongoing Issues with BioZorb Implant

The U.S. Food and Drug Administration (FDA) has recently issued a critical warning letter to Hologic Inc., a manufacturer of the BioZorb marker, highlighting severe regulatory violations and manufacturing flaws associated with the device. This development comes on the heels of growing concerns over BioZorb’s safety and effectiveness, with 252 reported injuries and over 100 lawsuits filed against the company. The FDA’s findings and subsequent actions mark a pivotal moment in addressing the challenges posed by this breast-conserving surgical device.

Background on the BioZorb Marker

The BioZorb marker, originally developed by Focal Therapeutics and later acquired by Hologic, is a Class II medical device designed to tag breast or other soft tissues for radiographic procedures. It features a bioabsorbable spacer material with six titanium marker clips to facilitate radiation therapy. However, reports of serious complications have emerged, including:

• Pain, swelling, and infections.

• Discomfort due to migration of the marker within the body.

• Failure of the spacer material to resorb, leading to adverse outcomes.

These issues prompted the FDA to issue a Class 1 recall—its most severe designation—indicating the potential for serious injury or death (though no fatalities have been reported).

FDA’s Inspection and Findings

An FDA inspection conducted between July and September 2024 revealed several regulatory violations at Hologic’s manufacturing facility in Marlborough, Massachusetts. Key findings included:

1. Design Control Failures

   • Lack of proper design inputs addressing the intended patient population and anatomical variations.

   • Absence of validation studies to ensure the spacer material resorbs as intended.

   • No verification testing to confirm that the device’s design meets specified requirements.

2. Production Process Deficiencies

   • Inadequate transfer of design specifications to production facilities.

   • Non-compliance with established design control and production procedures.

3. Corrective and Preventive Action (CAPA) Shortcomings

   • Insufficient analysis of complaints and quality data.

   • Delayed corporate response to a significant surge in adverse event reports received in September 2023.

   
   

FDA’s Mandated Actions

In a December 18, 2024, warning letter, FDA officials demanded that Hologic take immediate corrective actions. These include:

• Addressing design deficiencies contributing to adverse events.

• Identifying at-risk patients who may benefit from device removal.

• Providing a comprehensive plan to prevent future violations and ensure compliance with regulatory standards.

Failure to comply could lead to severe consequences, such as product seizures, injunctions, civil penalties, and restrictions on Hologic’s ability to obtain contracts or export certifications.

Hologic’s Response

In response to the FDA’s warning, a Hologic spokesperson stated, “We have been closely coordinating with the FDA and are taking all necessary steps to resolve this matter in a comprehensive and timely manner.” The company emphasized its commitment to maintaining robust quality systems and ensuring the safety and effectiveness of its products.

Despite this assurance, the FDA deemed Hologic’s earlier responses inadequate. Notably, the agency criticized the company for discontinuing the BioZorb product line without addressing existing safety concerns for implanted devices.

Legal and Patient Implications

The FDA’s findings align with the complaints raised in lawsuits against Hologic. Plaintiffs allege that BioZorb’s design flaws, including its inability to resorb properly, have caused significant pain, infections, and long-term health complications.

Patients currently implanted with BioZorb face uncertainty, as the FDA continues to express safety concerns. The agency has urged Hologic to evaluate the risks posed by the device’s presence in the body and provide guidance on potential interventions, including explantation.

What’s Next?

The FDA’s investigation and subsequent warning underscore the importance of rigorous compliance with medical device regulations to ensure patient safety. For Hologic, the road ahead involves addressing these violations comprehensively while managing the fallout from ongoing legal battles and regulatory scrutiny.

For patients and healthcare providers, this development serves as a cautionary tale about the critical role of transparency, design validation, and post-market surveillance in medical device manufacturing. As the situation evolves, Jinks Crow will continue to monitor updates and provide insights into the legal and regulatory landscape surrounding BioZorb and similar devices.