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.

Was the BioZorb Implant Recalled?

Yes. Hologic, Inc. has issued two BioZorb Marker recalls throughout 2024 after identifying the use of the BioZorb breast tissue implants could lead to serious health consequences or death.

BioZorb Recall Over Erosion and Migration Injuries

The first BioZorb recall was announced by the U.S. Food and Drug Administration (FDA) in March 2024, after receiving reports of 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.

While the recall notice did not remove the products from the market, the recall 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 Recall Removes Breast Tissue Implants From the Market

Just months after the initial recall was issued, Hologic issued an Urgent BioZorb Medical Device Recall on October 24, 2024, removing all lots of unused BioZorb Marker and BioZorb LP Marker (BioZorb Marker) from the market.

According to the manufacturers notice, there have been 399 BioZorb complaints received, out of which 188 were associated with adverse events as of October 16, 2024.

In an updated safety communication by the FDA issued just a day later, officials stated the agency has continued to monitor BioZorb patients for severe adverse events which have included:

• Pain
• Infection
• Rash
• Device migration (moving out of position)
• Device erosion (breaking through the skin)
• Seroma (fluid buildup)
• Discomfort
• Other complications from feeling the device in the breast

Healthcare providers are being instructed to closely monitor individuals who have already received a BioZorb marker for signs of any 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.

BioZorb Lawsuit FAQs

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.

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