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If you are trusting a medical device to help you to heal after breast cancer surgery, but instead face pain, infections, and additional surgeries, it can feel depressing and unfair. Most of the BioZorb implant users face this situation. Instead of helping recovery, these devices have caused unexpected and serious complications, leaving patients in pain.
Let’s explore what BioZorb is, what’s happening with it, and what plaintiffs and medical professionals need to know.
What Is BioZorb Implant?
BioZorb implant is a radiographic marker device designed for use in breast cancer treatments. It is a small, spiral or helical-shaped implant made from a bioabsorbable material. Manufactured by Hologic, Inc., the device also contains titanium clips that help doctors identify the location for targeted radiation therapy.
The bioabsorbable component was intended to dissolve naturally over time, while the titanium clips would remain in place for ongoing imaging purposes.
Doctors place the BioZorb device in the breast during or after a lumpectomy (a surgery to remove a breast tumor). Its purpose is to mark the area where the tumor was removed. This helps guide radiation therapy and follow-up imaging, ensuring that treatment targets the right spot while preserving healthy tissue. However, in many cases, the dissolve hasn’t happened as expected, leading to complications.
BioZorb was marketed as a device that aids in radiation therapy and, without FDA approval, was also promoted for enhancing cosmetic outcomes by helping maintain breast shape after surgery.
Risks with BioZorb Marker Implants
Many patients have reported a range of problems after receiving the BioZorb implant. Some of the most common issues include:
- Device Migration
The implant can move out of its original position. This may cause blockages or discomfort and may require surgery to correct.
- Erosion
In some cases, the device breaks through the skin due to improper resorption of the bioabsorbable material. This condition, known as erosion, can be painful and lead to infections.
- Infections
The implant can cause infections if it doesn’t dissolve properly. These infections may require antibiotics or even surgical removal of the device.
- Fluid Buildup (Seroma)
Some patients develop pockets of fluid around the implant. This condition can delay additional cancer treatment and sometimes requires surgery to drain.
- Long-Term Pain and Scarring
Many patients report chronic pain and visible scars at the implant site. These complications can impact your quality of life and emotional well-being.
- Need for Removal Surgery
If the implant doesn’t dissolve or causes severe issues, patients often need surgery to have it removed.
BioZorb Recall 2024
In March 2024, Hologic issued a Class I recall for the BioZorb Markers, indicating that the devices pose a high risk of serious injury or death. This recall affects a total of 53,492 units distributed between April 29, 2019, and April 1, 2024. While there have been 71 reported injuries, no deaths have been linked to the device.
The issues raised by the recall include failure of the resorbable plastic to dissolve properly, which can lead to complications.
The complications listed in the FDA’s notice include
- Infection
- Skin erosion
- Fluid buildup
- Device migration
- Pain and discomfort
In October 2024, the FDA issued a separate removal order for all unused BioZorb Markers, prompting medical professionals to stop using the device. The recall and removal process are intended to protect patients from further risks associated with the device.
If you have received a BioZorb Marker and are experiencing complications, it’s important to take action and consult with a legal professional to understand your rights.
BioZorb Lawsuit Update 2024
The number of women filing BioZorb breast tissue marker lawsuits has grown significantly, reaching over 100 plaintiffs, and this number is expected to rise as more people learn about complications from the device.
As of December 4, 2024, titanium breast marker lawsuits from 100 plaintiffs had been filed in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters is located. All the breast biopsy marker lawsuits were consolidated under Judge Allison D. Burroughs to streamline the process and address shared issues.
To prepare for BioZorb settlements, Judge Burroughs introduced a “bellwether” trial process. In August 2024, each side picked five cases to form a discovery pool for the first trials. Currently, there are 22 lawsuits before the court, many involving multiple plaintiffs.
By December 16, core depositions in the 10 selected cases were completed. Afterward, each side removed three cases, leaving four that may proceed to trial. The trials are scheduled to start in September 2025.
On December 19, 2024, the parties identified the four cases:
- Cynthia Kresh (South Carolina): Received BioZorb during a lumpectomy in October 2020. She suffered lymphedema, abscesses, infections, and a broken implant that required surgery in 2022 to remove.
- Kimberly Taylor (New York): Implanted in June 2021. The device failed to absorb, and she needed a mastectomy to remove it.
- Beth Deuel (Michigan): Implanted in May 2018. The device caused severe pain, stuck out of her chest, and was removed in May 2022.
- Pamela Gibson (Colorado): Implanted in June 2020. She reports ongoing pain, scarring, and other complications but hasn’t had the device removed.
The parties were expected to submit a case management order by December 19, outlining how the remaining bellwether trials will be handled. However, there was disagreement on whether to conduct multi-plaintiff or single-plaintiff trials.
On December 18, 2024, the FDA upgraded the recall to a Class I designation, the most serious type, emphasizing the potential for serious harm. As of now, 252 injuries have been reported, though no deaths have been linked to the implant.
Doctors have been instructed not to implant BioZorb in any new patients and to return all unused products to Hologic. For patients who already have the implant, the FDA advises monitoring for adverse effects and discussing risks with healthcare providers, particularly before undergoing radiation therapy. Device removal is not necessary unless deemed appropriate by a doctor.
To manage the growing litigation, Judge Burroughs has initiated a bellwether trial program, with representative cases undergoing pretrial preparations for early trials starting in September 2025. The second trial is expected to begin in January 2026.
How to File a BioZorb Implant Lawsuit?
If you or a loved one has suffered complications from a BioZorb radiographic marker, filing a BioZorb implant lawsuit can help you to hold the manufacturer accountable. This process begins with a consultation of an experienced lawyer.
You’ll need to provide all relevant details, such as medical records, evidence of complications, and documentation of financial losses.
Next, you and your lawyer will gather and organize evidence to strengthen your claim. Once the evidence is compiled, your lawyer will file the lawsuit, formally initiating legal action against Hologic, Inc. Filing a BioZorb implant lawsuit can help you recover financial losses and compensation for your suffering.
How to Know If You Are Eligible to File BioZorb Lawsuits?
To file a BioZorb implant lawsuit, you must meet certain criteria. First, you must need the proof of complications or injuries caused by BioZorb. This could include physical issues like infections, implant migration, permanent scarring, and psychological issues. Medical records and expert testimony often serve as critical proof in establishing causation.
It’s also crucial to file your BioZorb recall lawsuit within the statute of limitations in your state. If you believe you qualify for a BioZorb marker lawsuit, it’s essential to act quickly. An experienced lawyer can guide you through the process, protect your rights, and ensure your case is filed correctly and on time.
To sum up,
If you’ve suffered complications from a BioZorb implant, you deserve answers and support. Take the first step by reaching out to a lawyer who understands the challenges you’ve faced.
