Introduction
BioZorb® implantable markers were introduced as a medical innovation designed to assist physicians in marking soft tissue sites after surgery, particularly in breast-conserving procedures. However, over time, BioZorb complications have raised serious safety concerns among patients, physicians, and regulators. Reports of chronic pain, infection, device migration, and erosion through the skin ultimately led the U.S. Food and Drug Administration (FDA) to issue its most serious type of recall and to advise healthcare providers to stop using the device altogether.
This article explains what BioZorb is, how it entered the market, what the FDA has said and done, the complications reported by patients, and why individuals harmed by BioZorb may want to seek legal guidance.
What Is the BioZorb Marker?
BioZorb® is an implantable radiographic marker developed by Hologic, Inc. (formerly Focal Therapeutics). The device is three-dimensional and spiral-shaped, designed to be surgically implanted into soft tissue to mark a site for future imaging or medical procedures.
The BioZorb device consists of two primary components:
- A permanent titanium marker, which remains in the body and is visible on imaging
- A bioabsorbable polymer framework, intended to gradually dissolve over approximately one year or longer
BioZorb markers were most commonly used in breast-conserving surgery following lumpectomy. In clinical practice, some physicians used the device to help localize the surgical site for follow-up imaging and radiation planning. Although some clinicians believed BioZorb helped maintain breast contour during healing, the FDA later clarified that BioZorb was not cleared or approved for cosmetic improvement, space filling, or radiation targeting. Any such use was considered off-label.
How BioZorb Entered the Market: FDA 510(k) Clearance Explained
BioZorb did not receive FDA approval through the Premarket Approval (PMA) process. Instead, it entered the market through the FDA’s 510(k) Premarket Notification pathway, which is a clearance mechanism—not an approval.
Under the 510(k) process, a manufacturer must demonstrate that its device is “substantially equivalent” to a legally marketed predicate device. Importantly:
- Clinical trials in humans are usually not required
- Long-term safety and effectiveness data may be limited or absent
- Devices cleared under 510(k) cannot be marketed as “FDA-approved”
Hologic received FDA 510(k) clearance for the original BioZorb marker in 2012, followed by clearance of a lower-profile version, BioZorb LP, in 2015.
FDA Oversight, Recall, and Safety Communications
As time went on and reports of adverse events accumulated, BioZorb became the subject of increasing regulatory scrutiny. Here’s why:
Recall Timeline
- March 2024: The manufacturer initiated recommendations to recall certain BioZorb products due to reports of serious adverse events.
- May 2024: The FDA classified the recall as a Class I recall, the most serious type, indicating a reasonable probability that continued use could cause serious injury. At that time, the FDA characterized the action as a correction rather than a full device removal.
- October 25, 2024: The FDA issued a Safety Communication instructing healthcare providers to stop using and implanting BioZorb devices, quarantine and return unused units, and enhance monitoring of patients who already have BioZorb implants.
The FDA explicitly warned that BioZorb devices could migrate from their original placement and, in severe cases pose potentially life-threatening risks.
Reported BioZorb Complications
Although BioZorb was intended to be bioabsorbable, patients have reported symptoms long after the expected absorption period. According to a report in January 2021, physicians published that a patient with the BioZorb implant experienced erosion through her skin at the border of the nipple. Documented and reported complications include but are not limited to:
- Persistent or chronic pain
- Hard or palpable lumps
- Infection and inflammatory reactions
- Rash or delayed wound healing
- Fluid buildup under the skin (seroma)
- Device migration from the implantation site
- Skin erosion and extrusion of the device
- Need for additional surgeries or hospitalization
How Many Injuries Have Been Reported?
Injury figures have varied depending on the reporting timeframe:
- As of March 2024, the FDA recall summary documented 71 reported injuries
- Later reports referenced higher numbers, including over 250 injuries, reflecting broader or more recent reporting
Impact on Patients
For some patients, BioZorb complications can result in more than just physical harm. Individuals can experience emotional distress, anxiety, financial strain, and the burden of additional medical procedures. In some cases, patients undergoing systemic cancer therapy could face treatment delays due to infections or wound complications associated with the implant.
Why Patients Need a Medical Device Injury Lawyer
Patients who experienced harm after BioZorb implantation—or who required revision surgery—may have legal rights. Medical device injury cases are complex and often involve detailed analysis of regulatory history, manufacturer conduct, and medical records.
An experienced medical device injury attorney can:
- Evaluate whether BioZorb complications are linked to the device in medical records
- Assess eligibility for compensation related to medical costs, pain, and suffering
- Navigate litigation involving defective or unsafe medical devices
An experienced attorney like Tom Plouff of Chicago, IL can help you assess the specific details of your case to determine its strength and potential for compensation. The legal process surrounding medical device claims can be daunting, but a skilled lawyer can help guide you and ensure you are advocated for effectively.
Attorney Tom Plouff has over a decade of experience representing clients who have suffered harm from transvaginal mesh devices. As an advocate for women who have experienced device-related injuries, Tom has taken to trial or settled various other cases representing millions of dollars of damages paid to his clients.
Frequently Asked Questions (FAQs)
Was BioZorb FDA approved?
- BioZorb was FDA-cleared under the 510(k) process, not FDA-approved.
Is BioZorb still being used?
- As of October 2024, the FDA advised healthcare providers to stop implanting BioZorb devices.
What is the most serious BioZorb complication?
- Reported complications include device migration, skin erosion, infection, and the need for surgical removal.
Did the FDA issue a recall?
- BioZorb was subject to a Class I recall, the FDA’s most serious classification.
How long was BioZorb supposed to last in the body?
- A portion of the device was intended to resorb over approximately one year or longer, while the titanium marker remains permanently.
Can patients take legal action?
- Patients harmed by BioZorb complications may have legal options and should consult a qualified attorney.
Conclusion
BioZorb markers were introduced with the goal of improving surgical site identification but later revealed significant safety concerns. Cleared through the FDA’s 510(k) process rather than rigorous premarket approval, BioZorb devices have been linked to serious complications, prompting a Class I recall and a nationwide recommendation to stop their use. Contact Plouff Law now for more information and to request an evaluation of your case.
