BioZORB Lack of Warnings Subject of FDA Recall and Notification

The BioZORB device is used to provide a “target” for radiation therapy. The device is designed to resorb in the body while leaving behind tiny radiation markers. However, the device does not always perform as intended and experts have linked it to serious side effects.

This device often lacks sufficient information about potential negative reactions for consumers and doctors. This lack of information is a common problem. It may lead to confusion or unexpected side effects. Providing more detailed information could help prevent these issues.

“Warnings” Listed by the BioZORB Manufacturer

• Physicians trained in surgical techniques should only use the marker. The physician is responsible for its proper clinical use.
•  The marker is sterile when shipped; do NOT re-sterilize any portion of it.
• SINGLE USE only.
• Do NOT use it if the package is open or damaged, or if the temperature indicator has a black center.
• Use the Marker prior to the expiry date shown on the product label.

While the manufacturer of BioZORB warns about proper placement of the marker, and explains who should be placing the device and how to do so, the company does NOT warn users of possible dangers and side effects associated with the device once inside the body.

FDA’s Medical Device Reporting

The FDA has a system for reporting medical devices. Mandatory reporters, such as manufacturers, device user facilities, and importers, must submit reports for adverse events and product problems related to medical devices. Healthcare professionals, patients, caregivers, and consumers can also voluntarily report adverse events, errors, and quality issues with medical devices.

The FDA monitors device performance by using reports from mandatory and voluntary sources. They look for safety issues and evaluate the benefits and risks of the products. The FDA reviews reports from MDR’s and volunteers to keep medical device users safe. This reporting, although not the only surveillance data source for the FDA, is an important one.

FDA reports concerning BioZORB are available here:

https://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication

https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices

BioZORB’s Problems with the FDA

The FDA notified BioZORB about problems with their device. The FDA received reports from both mandatory and voluntary reporters.

Issues with Medical Companies

The medical system sometimes enables companies to sell products without disclosing side effects until much later. This can result in potential harm to consumers.

In the years that this occurs, patients do not receive the full benefit of being warned of potential hazards. They can sometimes be analogized as “guinea pigs” who do not get the full story before consenting to receive the device. The BioZORB recall  is just one example of the damage that medical companies can cause when releasing products without sufficient warnings to the public.

What We Can Do For You?

We handle personal injury cases at our law firm. We provide dedicated support to individuals who have suffered injuries. Our skilled attorneys are committed to helping you navigate the complexities of personal injury law. If you or a loved one has suffered harm from medical devices due to a lack of warnings, please contact us.

KBA continues posting information about BioZorb. Check out the latest here:

BioZORB Marker for Breasts Cancer Patients

Understanding BioZORB: Benefits, Complications, and Concerns