Medical devices can be lifesaving, and they can make a big difference for doctors who are providing medical treatment. Especially when it comes to cancer treatment, medical devices and implants can save lives. However, there are always risks to any medical procedure or any foreign material you place in your body. If you’ve been faced with a breast cancer diagnosis and have had a BioZorb implant, you may have noticed that the device can cause adverse events. Some of these can be painful, serious, and even require surgery to correct. 

Here, we’ll review what BioZorb is, why it was recalled, why it’s dangerous, and what you can do if you have been negatively affected by a BioZorb device. 

What is BioZorb? 

It’s made of both a permanent and resorbable component. The permanent component is made of titanium and is designed to stay in the body forever or until removed, while the resorbable component is made of plastic that dissolves over time. While the marker is most commonly used for breast cancer treatment, it can be used for other conditions as well. 

BioZorb FDA Recall

Despite how helpful BioZorb can be for breast cancer treatment, the device was recently recalled by the FDA under a Class 1 Recall, which is the most serious type of recall. According to the FDA, use of the device can lead to serious complications or adverse events. 

Currently, the FDA is working with Hologic Inc. to evaluate the safety of the devices and to address the risks patients assume when having the devices implanted. They’re also continuing to monitor the situation, and they encourage anybody who has had an issue with BioZorb to report it by using the MedWatch Online Voluntary Reporting Form. 

Why is BioZorb Dangerous? 

The FDA lists a number of serious complications that can arise from BioZorb implants, including: 

• Infection
• Fluid buildup (seroma)
• Device moving out of position (migration)
• Device breaking through the skin (erosion)
• Pain
• Discomfort from feeling the device in the breast
• Rash
• Extended resorption time (resorbable component of the device not resorbing in the patient's body for several years)
• The need for additional medical treatment to remove the device
• Device breaking through the skin of the nipple (erosion)

The complications of BioZorb are often painful and sometimes require surgical intervention. This, in turn, can leave patients with physical deformities. 

To complicate this further, some healthcare providers disagree on the effectiveness of and necessity for Biozorb. Some providers find that the implant does not improve outcomes, and some even find that it can make imaging more confusing. In some cases, the risks of BioZorb may not be worth the benefits, if there are any benefits at all. These dangers have led many people who have had a BioZorb implant to be rightfully angry, and many have already filed lawsuits and sought compensation. 

BioZorb Lawsuit 

Since the recall has been announced, many BioZorb lawsuits are currently pending. People who have used BioZorb and experienced complications have filed lawsuits and made various claims regarding the implants. Some complaints are regarding defects of the device. People claim that there are both flaws in the design of the device and in the manufacturing. These defects can inherently lead to harm and have led to claims of negligence. 

Some other complaints involve the manufacturer failing to warn consumers of the risks and side effects of using a BioZorb implant. Similarly, people claim that the marketing materials for the implant were misleading and didn’t allow consumers to fully understand the benefits and risks. A lack of proper testing may also have led to issues, and people claim that Hologic Inc. did not do their due diligence in both pre-and post-market testing and surveillance. 

If you believe you have been harmed by a BioZorb marking device, you may be eligible to file a lawsuit as well. For example, those who have experienced device erosion or migration and who have required surgery to correct complications have filed lawsuits against Hologic Inc. 

We care about you, and we want to make sure you get the compensation you deserve if you were harmed by a BioZorb device. We can help connect with a lawyer who can examine your case to determine if you are eligible to file a lawsuit.