BioZorb Lawsuit – December 2024 Update

Strict Deadlines to File

See If You Qualify!

Individuals are filing BioZorb lawsuits against Hologic, Inc. (formerly Focal Therapeutics) due to severe injuries from the device, including device migration, infection, seroma, and erosion. BioZorb, which is a soft tissue marker, aids in administering treatments to women with breast cancer. In May of 2024, the FDA issued a Class I recall of BioZorb because of the dangers of using the device. In October 2024, Hologic asked physicians to quarantine and stop using the product. As of November 2024, there are BioZorb lawsuits pending on behalf of over 80 plaintiffs. The lawsuit is currently in the early stages. 

BioZorb Lawsuit – 2024 Update

December 10, 2024: Researchers Warned of Complications of Using BioZorb For Years

For years, researchers tracked multiple types of adverse complications patients experienced after having BioZorb implanted in their breasts. For example, one patient had BioZorb removed just one year after implantation because of repeated infections and the device eroding through the area around her nipple. Researchers in another study noted other complications from BioZorb, like infections, the formation of abscesses, migration of the devices, and pain associated with the placement. Even though the device is no longer available, many women still have the devices implanted. Many women who currently have Biozorb implants or previously had implants and experienced complications have filed lawsuits.

December 5, 2024: FDA Asks for Patients and Physicians to Report BioZorb Complications

When the FDA announced a recall of all BioZorb devices, they cautioned patients and physicians to watch for warning signs of device complications. Many women have this device currently implanted, and they may experience a complication in the future. The FDA is encouraging patients who have experienced complications from BioZorb to immediately contact their healthcare providers. Additionally, they asked any patients who have issues with their devices to report that event via the FDA’s MedWatch Online Voluntary Reporting System.

October 25, 2024: FDA Warns Consumers and Healthcare Providers Not to Use BioZorb Marker Devices

In a Safety Communication dated October 25, 2024, the U.S. Food and Drug Administration warned consumers, healthcare providers, and healthcare facilities not to use BioZorb Markers and BioZorb LP Markers manufactured by Hologic, Inc. The warning comes on the heels of a Class I recall and a number of reports of serious adverse events. 

October 24, 2024: Hologic Announces Urgent Medical Device Recall of Biozorb® 3d Bioabsorbable Marker

On October 24, 2024, Hologic, Inc., the manufacturer of BioZorb Bioabsorbable Markers, issued a voluntary recall of all lots of unused BioZorb Markers and BioZorb LP Markers from the market. At the time, Hologic had received 399 complaints related to the advice, 188 of which were associated with adverse events.

September 26, 2024: Judge Denies Hologic Motion for Summary Judgment

Judge Allison D. Burroughs has denied Hologic’s motions for summary judgment in Case 1:22-cv-11895-ADB out of the U.S. District Court for the District of Massachusetts. It is expected that the cases will be consolidated into multidistrict litigation (MDL) by 2025. 

May 3, 2024: Class I Recall Issued by Hologic

On March 13, 2024, Hologic issued a recall of its BioZorb Marker-BioZorb 3D Bioabsorbable Marker. The recall was classified as a Class 1 recall by the FDA because of the device’s potential to cause serious injury or death. Complications associated with the product include pain, discomfort, device migration, infection, and seroma.

February 27, 2024: Safety Notification Issued by Hologic

Hologic, the maker of BioZorb Markers, issued a medical device safety notification to patients and healthcare providers about potential health risks associated with the product. The notification notes that the manufacturer received concerning reports of complications associated with the device, including migration, erosion, infection, and more.

About the BioZorb Lawsuit:

Understanding the BioZorb Lawsuit

Individuals nationwide are filing lawsuits against the maker of BioZorb, alleging that the company, Hologic, Inc., produced a dangerous device and failed to adequately warn patients and healthcare providers about the potential risks of using the product. Legal documents suggest the product contained a defective design, which resulted in serious injuries. 

Reports of adverse events include device migration, erosion, and complications requiring further surgery. Complaints also include the device causing chronic pain, seroma formation (fluid buildup,) and severe scarring. Legal claims against Hologic include product liability, negligence, and breach of warranty.

What Is BioZorb and How Does It Work?

BioZorb is a bioabsorbable 3D implant used in lumpectomy and partial mastectomy breast cancer surgeries. The device was approved for marking breast tissue sites after breast cancer surgery. It has not been approved for use to improve cosmetic outcomes after a procedure, to be used as a marker for radiation treatment, or to fill space in the tissue, although it is frequently used for these purposes. 

BioZorb Marker Components:

• A plastic component intended to dissolve completely in a year or longer
• A permanent titanium metal component

Functions of BioZorb Markers:

• Radiographic marking of sites in soft tissue to help oncologists more accurately target the affected area
• Marking soft tissue sites for future medical procedures, including follow-up imaging

The benefits of the BioZorb 3D markers include the fact that they can assist in preserving breast shape after surgery and support tissue reformation around the surgical site.

BioZorb Complications and Complaints

Shortly after coming to market, patients began to report serious complications related to the BioZorb 3D marker they had implanted. Some of the complications and complaints included infection, device migration, and erosion through the skin. In some instances, the conditions required additional surgeries to repair. 

Infections

Infections around the implant site may occur, requiring antibiotics or further surgical intervention. Chronic infections could lead to severe health risks and additional treatments. In some instances, the infection may cause chronic pain and other serious side effects. 

Device Migration

According to adverse event reports received by the FDA, the BioZorb 3D marker can shift from its original position. The migration can interfere with follow-up imaging and may cause severe pain or complications. In some instances, this can require surgery to correct. 

Erosion Through the Skin

Reports also indicate that the BioZorb marker can erode through the skin. This complication can lead to pain and visible device parts that may require surgery to remove. 

Persistent Pain and Discomfort

The marker may also cause chronic pain and discomfort, particularly at the site of implantation. This may be due to incomplete biosorption or interference with a nerve.

Seroma Formation and Fluid Buildup

Seromas (fluid pockets) can form around the implant, causing swelling and requiring draining or additional interventions.

Scarring and Disfigurement

Unfortunately, the BioZorb marker has been known to cause permanent scarring or even changes in the appearance of tissue near the site of implantation. 

Need for Additional Surgery

Complications like infection, migration, or erosion may lead to the need for corrective surgeries to remove the device or repair tissue damage.

Studies Linking BioZorb Markers to Complications

Multiple studies have found a link between BioZorb markers and serious complications, including a study from researchers at Cedars-Sinai that found an infection rate of over 3% and device palpability in 63.6% of patients even after 2 years.

Primary Study: Utilization of BioZorb Implantable Device in Breast-Conserving Surgery

• Published: October 2019, The Breast Journal
• Authors: Marissa K. Srour, MD & Alice Chung, MD at Cedars-Sinai Medical Center
• Findings: Study of 89 patients showed a 3.3% infection rate, 2.2% abscess formation, and one instance of migration to the axilla. The device was palpable in 63.6% of patients, even after 2.8 years.

Other Notable Studies to Highlight Findings:

• Kaufman et al. (2021): Retrospective study of 818 patients found one “visible hard lump” attributed to possible BioZorb clip migration. There were also cases of mastitis, injury, and poor wound healing.
• Ju & Tsai (2021): Case report on device erosion through the nipple-areolar complex requiring surgical excision after repeated infections.
• Ram & Dietsche (2021): Case series detailing fat necrosis, foreign body reaction, new/enlarging masses, pain, skin changes, and delayed device resorption (sometimes taking 4-5 years).

BioZorb Manufacturer and FDA Recalls to Date

BioZorb 3D markers have been recalled from the market. In February 2024, Hologic, the manufacturer of BioZorb, issued a statement to consumers and healthcare providers notifying them of potential health risks associated with BioZorb use. These risks included pain, infection, migration, and erosion due to the device not dissolving. The manufacturer subsequently issued a recall on March 13, 2024, which the FDA categorized as a Class I recall due to its potential to cause serious injury or death. 

BioZorb Recalls and Warnings: 

October 25, 2024: FDA Warning 

• Reason: The manufacturer issued a medical device recall after receiving 399 complaints related to the BioZorb markers.

October 24, 2024: Manufacturer Medical Device Recall:

• Reason: At least 399 complaints were received by the manufacturer, 188 of which were associated with adverse events. 
• Recalled Devices:
  • F0405 BioZorb Bioabsorbable Marker – BioZorb Marker 4cm x 5cm – 15420045514065
  • F0404 BioZorb Bioabsorbable Marker – BioZorb Marker 4cm x 4cm – 15420045514058
  • F0304 BioZorb Bioabsorbable Marker – BioZorb Marker 3cm x 4cm – 15420045514010
  • F0303 BioZorb Bioabsorbable Marker – BioZorb Marker 3cm x 3cm – 15420045514003
  • F0203 BioZorb Bioabsorbable Marker – BioZorb Marker 2cm x 3cm – 15420045513990
  • F0202 BioZorb Bioabsorbable Marker – BioZorb Marker 2cm x 2cm – 15420045513983
  • F0331 BioZorb LP Bioabsorbable Marker – BioZorb Marker 1cm x 3cm x 3cm – 15420045514041
  • F0231 BioZorb LP Bioabsorbable Marker – BioZorb Marker 1cm x 3cm x 2cm – 15420045514034
  • F0221 BioZorb LP Bioabsorbable Marker – BioZorb Marker 1cm x 3cm x 2cm – 15420045514027

March 13, 2024 Recall – Manufacturer Recall:

• Reason: Reports of severe complications like pain, infection, and device migration.

May 22, 2024 – FDA Warning:

• Classification: FDA’s Class I recall (indicating serious risk)

August 9, 2022 Recall:

• Reason: Incorrect expiration dates on BioZorb LP Marker labels, leading to possible health risks.
• Details: Product #F0221, Lot 22A0RL, expiration was mistakenly labeled as January 2022 instead of July 2024.

Eligibility Criteria to File a BioZorb Lawsuit

Prior to filing a BioZorb lawsuit, plaintiffs must meet certain eligibility requirements. These requirements include proof of implantation of a BioZorb marker and documented complications. 

Eligibility requirements in a BioZorb lawsuit:

Implantation: Must have had a BioZorb marker implanted during breast cancer surgery.

Documented Complications: Must be able to prove complications directly related to the BioZorb implant, such as:

• Infection at the implant site.
• Migration of the device. 
• Erosion of the device through the skin.
• Chronic pain or seroma formation (fluid build-up).
• Proof of additional surgery for BioZorb removal.

Evidence Needed to File a BioZorb Lawsuit

To file a BioZorb lawsuit, plaintiffs must gather the necessary evidence to substantiate their case. This evidence may include a complete medical history showing proof of implantation of a qualified device, images of scarring or other deformities, surgery history, doctor communications, prescription records, and proof of lost wages. 

Evidence needed to file a BioZorb lawsuit:

• Medical Records: Proof of implantation of a BioZorb 3D marker and documentation of complications (e.g., infections, pain).
  
• Photos: Images of complications like scarring, visible device parts, and deformities caused by the implant.
• Surgery and Treatment Documents: Records of any corrective surgeries or treatments and proof of the initial implantation.
• Doctor Communication: Notes or statements linking BioZorb to complications.
• Lost Wages: Income verification showing time taken off work due to chronic pain, infection, or corrective surgery.
• Impact on Quality of Life: Personal or witness statements showing how the complications affected your daily activities.

Recoverable Damages in the BioZorb Lawsuit

Plaintiffs in a BioZorb lawsuit may be entitled to economic and non-economic losses. These damages may include compensation for past and future medical expenses, lost wages and loss of future earning capacity, pain and suffering, disfigurement and disability, out-of-pocket costs, and more. It is critical to consult with an attorney as early in the process as possible to determine the potential value of your case. 

Potential damages in a BioZorb lawsuit:

• Past and Future Medical Expenses: Plaintiffs in a BioZorb lawsuit may be entitled to compensation for initial implant costs, treatments for complications, and future medical care, including revision surgeries and counseling.
  
• Lost Wages and Loss of Future Earning Capacity: BioZorb patients who had to miss work or are unable to return to work in their previous capacity may be able to secure compensation for lost wages or long-term job impact.
  
• Pain and Suffering: Plaintiffs may also be able to recover damages for physical and emotional suffering from the complications related to their BioZorb implant.
  
• Disability and Disfigurement: If the complications related to the BioZorb marker caused visible scarring or tissue damage, a plaintiff may be able to recover additional damages.
• Out-of-Pocket Costs: BioZorb patients may also be able to recover travel or other expenses due to treatment and care, as well as attorney costs and fees.

How to File a BioZorb Lawsuit

Successful BioZorb lawsuits follow a precise legal process. An attorney can provide guidance about the process and help you to navigate each step. 

Steps for Filing a BioZorb Lawsuit:

1. Initial Consultation: The first step in a BioZorb lawsuit is to contact an attorney who is experienced in medical device litigation. During your initial consultation, an attorney will help to determine whether you meet the eligibility requirements necessary to file a lawsuit. During this case review, it is imperative to bring records of surgery and complications.
2. Compile Evidence: Gather medical records, photographic evidence, and other documentation to help substantiate your case.
3. File the Claim: Your attorney will draft a formal complaint for submission at the appropriate courthouse. During this time, your attorney will ensure your case meets all legal deadlines, including filing within the statute of limitations.
4. Enter the Discovery Phase: Once the case is filed, your claim will enter the discovery phase. During this time, both parties will gather and exchange information.
5. Negotiations and Settlement: Throughout the case, your attorney may negotiate with the other party to obtain a fair and favorable settlement. Accepting a settlement can expedite the resolution of the case.
6. Go to Trial: If a favorable settlement cannot be negotiated, the matter may be set for trial. At trial, both parties will present their cases, and a judge or jury will decide the outcome.

Statute of Limitations in a BioZorb Lawsuit

The statute of limitations in a BioZorb lawsuit is state-specific but generally ranges between 1 and 4 years from the date of injury or discovery of complication. Under most circumstances, the statute begins when the injury is discovered; however, several exceptions may apply. 

For instance, the recalls that were issued by Hologic may toll (pause) the statute of limitations in some states. Due to the complexities of the legal deadlines, it is strongly recommended that BioZorb patients consult with an attorney as early as possible.

BioZorb Lawsuit Settlement and Payout Amounts

BioZorb lawsuits are expected to settle for between $150,000 and $500,000, depending on the severity of the injuries and the strength of the case. Cases with significant scarring, chronic pain, or additional surgeries could result in settlements or payouts of $500,000 or more. The estimated payout per person in a BioZorb lawsuit is expected to be around $300,000. 

Factors Influencing the Payout Amount

Several factors may influence the potential settlement or payout in a BioZorb lawsuit. The best way to determine the estimated value of your case is by speaking with an attorney who is well-versed in medical device defect cases. 

Factors that may influence the payout amount in a BioZorb lawsuit:

• Severity of the Injury: More severe injuries, particularly where the device has migrated or eroded, requiring surgery to repair, may increase the payout of your lawsuit.
• Lost Income or Loss of Future Earning Capacity: If the injury or its treatment has resulted in lost income or affected your ability to earn income in the future, you may be entitled to additional income.
• Pain and Suffering: Cases with significant mental impact or physical pain may increase damages.
• Strength of Evidence: Clear links between BioZorb and complications boost payout potential.

Contact a BioZorb Lawyer

Individuals who have suffered adverse reactions or complications after having a BioZorb marker implanted are encouraged to seek legal counsel. Depending on the circumstances of the case, affected BioZorb patients may be entitled to compensation, including coverage of their medical bills, lost wages, and more. 

The attorneys at King Law can help ensure you receive the compensation you deserve. They have the experience and expertise you need to get the best possible outcome in your case.

Frequently Asked Questions (FAQs)