What is BioZorb, and What are the Health Conditions Linked to Its Use?

In recent years, concerns have emerged regarding the safety of certain medical devices used in breast cancer treatment. One such device is BioZorb, which has been associated with various health complications and subsequent legal actions.

Understanding BioZorb lawsuits is essential for patients and healthcare providers navigating these issues.

What is BioZorb and How Does It Work?

BioZorb is an implantable device designed to aid in the treatment of breast cancer. It serves as a three-dimensional, bioabsorbable marker placed at the site of tumor removal during breast-conserving surgery. The device helps in accurately targeting radiation therapy and assists in follow-up imaging. Over time, the bioabsorbable components are intended to dissolve, leaving behind small titanium clips that mark the surgical site. 

However, what was designed to improve cancer treatment has also led to unexpected complications for some patients. Reports of adverse reactions and device-related issues have raised concerns about its safety and effectiveness. According to data from Hologic, the manufacturer of BioZorb, approximately 91,531 devices have been sold since 2015, and there have been 399 complaints related to the device, with 188 of these associated with adverse events.

Health Conditions Linked to BioZorb Use

Infection

Patients have reported infections at the BioZorb implant site, which can lead to pain, swelling, and fever. In severe cases, these infections require antibiotics or even surgical removal of the device. Infections can occur due to the body rejecting the implant or improper healing after surgery.

Device Migration

There have been instances where BioZorb has shifted from its original placement. This can be problematic as it may interfere with follow-up imaging or radiation therapy. Migration can also cause discomfort and may require a second procedure to reposition or remove the device.

Device Erosion and Extrusion

Some patients have experienced the BioZorb device eroding through the skin or surrounding tissue. This condition, known as extrusion, can be painful and may lead to complications such as infections or open wounds. Patients experiencing extrusion often require surgical intervention to remove the device.

Seroma Formation

A seroma is a buildup of fluid around the implant site. While some seromas resolve on their own, others may require drainage or additional medical intervention. Persistent seromas can cause discomfort, swelling, and an increased risk of infection.

Chronic Pain

Many patients have reported long-term pain at the implant site. This can be due to nerve irritation, inflammation, or the body’s reaction to the foreign material. In some cases, the pain becomes severe enough that patients opt for surgical removal of the device.

Hard Lumps and Tissue Scarring

Some patients have noticed hard lumps or excessive scar tissue formation around the BioZorb implant. These lumps can be mistaken for cancer recurrence during follow-up imaging, leading to unnecessary biopsies or additional medical procedures.

Allergic Reactions and Inflammatory Responses

Although rare, some patients have reported allergic reactions or severe inflammatory responses to the BioZorb material. This can lead to swelling, redness, and discomfort at the implant site.

Conclusion

The safety concerns surrounding BioZorb have led to significant health complications for some patients and have prompted legal actions against its manufacturer. Patients allege that the company failed to adequately warn about the risks associated with the device. In response, Hologic initiated a recall of all unused BioZorb markers, and the FDA has advised against their use due to the associated risks. Patients who have received a BioZorb implant should consult with their healthcare providers to discuss potential risks and appropriate monitoring.

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