Is There a BioZorb Implant Lawsuit?

BioZorb lawsuits were previously pursued by breast cancer patients who experienced injuries or required removal surgery after receiving the implantable tissue marker. These lawsuits alleged that defects in the BioZorb Marker caused the device to fracture, migrate, or fail to dissolve as intended.

The FDA approved the BioZorb tissue marker in 2012 as an implantable device for individuals undergoing breast cancer treatment who required targeted radiation after a lumpectomy or during treatment for DCIS. The device featured a spring-shaped, bioabsorbable structure with titanium clips designed to help direct radiation therapy while protecting surrounding healthy cells. It was intended to dissolve over time, leaving only the clips for long-term monitoring.

However, many breast cancer patients later reported that the device did not reabsorb as expected, leading to increased scar tissue and encapsulation of the implant. In some cases, the marker eroded or dislodged, resulting in complications such as pain, infections, rashes, seromas, and other adverse effects that often required surgical removal.

As these reports increased, a number of individuals filed BioZorb lawsuits against the manufacturer, alleging that design defects and inadequate warnings contributed to their injuries. As of late 2025, the lawyers at Saiontz & Kirk are no longer pursuing new BioZorb injury claims.

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 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 claimed that the implant manufacturers did not sufficiently alert healthcare providers or patients about potential absorption failures, device migration, and erosion. Lawsuits alleged that information about the possibility that the “bioabsorbable” device might not fully integrate into the body or dissolve as intended was not adequately disclosed to consumers or the medical community, which plaintiffs argued placed patients at increased risk of severe and painful injuries.

BioZorb Absorption Problems

The BioZorb device was made from bioabsorbable polylactic acid (PLA) and was intended to gradually dissolve within the body over a specific timeframe. However, reports later indicated that this process often took longer than anticipated, or did not occur at all, leaving the material in the body for extended periods.

This prolonged presence was associated with inflammation, discomfort, and the development of palpable masses that resembled tumor recurrence, which caused unnecessary stress for patients and, in many cases, led to additional medical evaluations or surgical interventions.

Mechanical Structure and Migration Issues

The device included titanium clips within the PLA material, which were designed to remain in place as markers after the PLA dissolved. When the PLA did not dissolve as intended, the clips could become exposed and migrate within the tissue.

Such migration had the potential to alter the intended location for radiation therapy, which in some cases affected healthy tissue and required additional surgeries to correct or remove the misplaced markers.

Erosion Complications

Erosion of the BioZorb structure was reported to cause fragments of the device to migrate into nearby tissues. This movement was associated with additional tissue damage, inflammation, and infection, often requiring further medical treatment to address these complications.

BioZorb Marker Side Effects

Individuals with BioZorb implants reported a number of adverse effects following their procedures. Common complaints included the development of firm, painful nodules at the implant sites and changes in skin texture that resulted in deformities or scarring. Symptoms such as skin sensitivity, itching, and redness were also frequently described.

Many patients indicated that the implants did not dissolve as expected, contrary to the manufacturer’s representations. Additional complications reported included:

• 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