Is There a BioZorb Implant Lawsuit?
Yes. The product liability lawyers at Saiontz & Kirk, P.A. are investigating BioZorb lawsuits for breast cancer patients who have suffered injuries or required removal surgery due to alleged design defects caused by the BioZorb Marker fracturing, migrating or failing to dissolve.
The FDA approved the BioZorb tissue marker in 2012 as an implantable device for individuals undergoing breast cancer treatment that require targeted radiation treatment post-lumpectomy or as part of a DCIS treatment regimen. Designed with a spring-shaped, bioabsorbable structure and titanium clips, the tumor bed marker precisely targets the radiation area while protecting healthy surrounding cells. Over time, the device is intended to dissolve, leaving only the clips for ongoing monitoring and future radiation treatment and medical procedures.
However, certain breast cancer patients have reported experiencing issues with the implantable marker, stating the BioZorb failed to reabsorb as advertised, leading to increased scar tissue and encapsulation of the implant. In many reports, individuals have reported that the marker eroded or dislodged, causing significant complications including pain, infections, rashes, seromas, and discomfort, often necessitating surgical removal of the device.
In response, a growing number of individuals affected by BioZorb complications are filing lawsuits against the manufacturer, alleging the dangerous design defects and inadequate disclosures to patients and medical professionals led to their injuries.
Who Qualifies For A BioZorb Lawsuit? Financial compensation through a BioZorb lawsuit settlement may be available for individuals who had an BioZorb breast tissue marker implanted, and experienced any of the following injuries or side effects;
- Migration
- Erosion
- Severe Pain
- Swelling
- Infections
- Necrosis
- Delay in treatment
- Fluid buildup (Seroma)
- Removal surgery
- Other complications
Was the BioZorb Implant Recalled?
Yes. Hologic, Inc. issued a BioZorb Marker recall in early 2024 after identifying at least 71 injuries related to the device, including infections, seromas (fluid buildup), device migration, breakage, pain, discomfort, rashes, extended resorption times, and other complications requiring additional medical interventions for device removal. Reports also described incidents in some certain breast cancer patients where the device eroded through the skin of the nipple and migrated from its implanted position.
Due to these serious adverse events, the U.S. Food and Drug Administration (FDA) classified the BioZorb recall as Class I, indicating that continued use of the recalled BioZorb breast tissue markers could lead to serious health consequences or death.
Although BioZorb remains on the market, Hologic issued a Medical Device Safety Notification to healthcare providers in March 2024. This notification alerted radiologists, surgeons, oncologists, and other healthcare providers to the potential risks and advised them to monitor breast cancer patients with an implanted BioZorb Marker or BioZorb LP Marker for signs of adverse events.
BioZorb Marker Design Defects
BioZorb lawsuits claim the implant manufacturers do not sufficiently alert healthcare providers and patients about device absorption failures, device migrations and erosion. Information about the possibility that the “bioabsorbable” device may not fully integrate into the body or dissolve effectively has been withheld from consumers and the medical community, placing patients at an increased risk of severe and painful injuries.
BioZorb Absorption Problems
The BioZorb device is made from bioabsorbable polylactic acid (PLA), intended to gradually dissolve within the body over a specific timeframe. However, it has been noted that this process often takes longer than anticipated or may not occur at all, leaving the material in the body for extended periods.
This extended presence can cause inflammation, discomfort, and the development of palpable masses that resemble tumor recurrence, leading to unnecessary stress and potential surgical interventions.
Mechanical Structure and Migration Issues
The device includes titanium clips within the PLA material, designed to remain as markers after the PLA dissolves. If the PLA does not dissolve as intended, these clips can become exposed and migrate within the tissue.
This migration can alter the precise location needed for radiation therapy, potentially harming healthy tissues and requiring surgeries to correct or remove the misplaced markers.
Erosion Complications
The erosion of the BioZorb structure can lead to fragments migrating into nearby tissues. This can cause additional tissue damage, inflammation, and infection, necessitating further medical treatments to address these complications.
BioZorb Marker Side Effects
Individuals with BioZorb implants have reported several adverse effects following their procedures. Common complaints include the formation of firm, painful nodules at the implant sites and alterations in skin texture, leading to deformities and scarring. Additionally, symptoms such as skin sensitivity, itching, and redness have been frequently noted.
Many users have reported that the implants do not dissolve as expected, contrary to the manufacturer’s claims. Other complications noted include:
- Severe Pain and Discomfort: BioZorb’s stiff or fragmented pieces can cause significant pain when they break, shift, or fail to integrate properly. Symptoms may include sharp, localized pain and increased sensitivity that worsens with movement or pressure.
- Swelling and Immune Response: The body’s immune response to BioZorb’s foreign material can cause swelling and inflammation, especially if the implant breaks or migrates. Symptoms may include swelling, warmth, redness, and a sensation of tightness at the implant site.
- Infection Risks: Displacement or erosion of BioZorb can create pathways that increase the risk of bacterial infection. Symptoms may include rising pain and swelling, fever, and discharge from the site.
- Fluid Buildup and Seroma: If the BioZorb implant does not absorb properly or irritates surrounding tissues, it can disrupt normal fluid dynamics and lead to fluid buildup. Symptoms may include noticeable swelling, a feeling of heaviness, and discomfort upon touching the area.
- Necrosis: BioZorb can cause tissue death if it obstructs blood supply or places excessive stress on tissues, particularly if it migrates. Symptoms may include skin discoloration, persistent severe pain, the formation of ulcers, and a foul odor.
- Hard or Sore Lumps: The body may form hard or sore lumps as a reaction to the foreign material of BioZorb, attempting to isolate the implant. Symptoms may include hard, tender lumps that cause pain when palpated.
Allegations Raised in BioZorb Lawsuits
Individuals throughout the United States are currently pursuing product liability lawsuits against Hologic Inc., raising similar allegations, including;
- Failure to adequately design and test the durability and strength of the material used to make BioZorb implants;
- Falsely advertised and misrepresented the safety of the breast tissue markers;
- Failure to disclose reports of the BioZorb failign to dissolve, migrating or eroding.
- Failure to provide adequate warnings to healthcare providers about the unreasonably dangerous and defective design of the implanted tissue markers;
- Failure to issue proper warnings or issue a timely BioZorb recall.
BioZorb Lawsuit FAQs
Which BioZorb implants have been recalled?
This BioZorb recall issued in 2024 impacts 53,492 BioZorb Markers that were distributed from April 29, 2019, to April 1, 2024, involving several model numbers, including;
- F0405 BioZorb Marker 4cm x 5cm
- F0404 BioZorb Marker 4cm x 4cm
- F0331 BioZorb Marker 1cm x 3cm x 3cm
- F0231 BioZorb Marker 1cm x 3cm x 2cm
- F0221 BioZorb Marker 1cm x 3cm x 2cm
- F0304 BioZorb Marker 3cm x 4cm
- F0303 BioZorb Marker 3cm x 3cm
- F0203 BioZorb Marker 2cm x 3cm
- F0202 BioZorb Marker 2cm x 2cm
How long does it take for BioZorb implant to dissolve?
The BioZorb device, made from bioabsorbable polylactic acid (PLA), is designed to gradually dissolve within the body over a period typically ranging from one to two years. However, this dissolution timeline can vary based on several factors, including the individual patient’s biology and the specific conditions within the tissue where the implant is placed.
Unfortunately, there have been numerous reports by individuals and healthcare professionals indicating that the BioZorb does not always dissolve as expected. In some cases, the device remains in the body far beyond the anticipated timeframe, causing a range of complications. Prolonged presence of the BioZorb can lead to inflammation, discomfort, and erosion and the formation of palpable masses that may mimic tumor recurrence.
What to do after suffering a BioZorb injury?
If you or someone close to you has been harmed by a BioZorb implant, it’s important to act quickly to secure your health and uphold your legal rights.
Here are first steps to take if you or someone you love has suffered a BioZorb injury:
- Seek Immediate Medical Attention: Seek medical treatment to address and record any injuries or problems caused by a BioZorb Marker.
- Report the Incident to the FDA: Notify the FDA’s MedWatch program about the incident. This can be done online, or by mail or fax, to help monitor and address adverse effects related to medical devices.
- Gather and Preserve Evidence: Save all medical documents, device details, and any communication regarding your BioZorb implant.
- Keep a Detailed Record of Your Experience: Document all symptoms, medical visits, and the overall impact of the injury on your life.
- Contact a Lawyer Specializing in Medical Device Litigation: Contact a product liability lawyer for a free consultation to determine whether you may be eligible for a BioZorb lawsuit settlement from the manufacturer.
Who is the BioZorb lawsuit against?
BioZorb lawsuits are being filed against Hologic, Inc., the manufacturer of the BioZorb implant. Individuals are filing BioZorb lawsuits to seek compensation for injuries and damages allegedly caused by design defects that allow the breast tissue marker to migrate, erode or fail to absorb as advertised.
What damages can I receive through a BioZorb lawsuit settlement?
- Medical Expenses (past and future): Compensation for all healthcare costs incurred due to complications from the BioZorb implant. This includes payments for surgeries, hospital stays, medications, and ongoing medical treatments required to manage your condition.
- Pain and Suffering: Financial recovery for the physical discomfort and emotional distress experienced as a result of complications from the BioZorb implant. This compensation addresses the impact on your quality of life.
- Lost Wages: Reimbursement for wages lost due to missed work and diminished earning capacity caused by the complications of the BioZorb implant. This also includes potential future lost earnings if you are unable to return to work at the same capacity.
Are There Any Costs to Hire a BioZorb Lawyer?
There are absolutely no out-of-pocket costs to review your case or hire our attorneys. Potential claims are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis.
Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their BioZorb lawsuit — regardless of their individual financial resources.
You pay nothing up front to hire our Biozorb implant lawsuit lawyers, and we only receive an attorney fee or expenses out of the money that is obtained from the manufacturers. Our law firm receives nothing unless we win your case!
What are the steps in a BioZorb case evaluation?
Complete Our Case Evaluation Request Form. Providing contact information and some information about your BioZorb injury case.
Get Contacted by Saiontz & Kirk, P.A. You will be contacted by our law firm to help determine if financial compensation may be available for you and your family.
You Decide If You Want to Move Forward. If our lawyers determine that we can help with your case then you decide whether to move forward and hire us to pursue compensation.