Cases

BioZorb® Lawsuit

BioZorb Implant

BioZorb® Implant

BioZorb implants can cause injuries and pain in breast cancer patients.

BioZorb devices were used by doctors in the treatment of some types of breast cancer between 2012 and 2019. BioZorb was marketed as a tumor bed marker to assist in targeted radiation treatment after a lumpectomy. The devices were designed to absorb into the body within 12 months of being implanted. However, many patients have experienced problems with them.

The attorneys at Jinks Crow are here to serve you and help in any way they can to get you the legal relief you deserve. Our attorneys will work with you to develop a plan and determine the best course of action for you and your case.

What is a BioZorb® Implant?

The BioZorb® is an implantable radiographic marker designed for use in marking soft tissues, such as breast tissue, for future medical procedures like radiation therapy or surgical localization. It helps in accurately targeting the area for treatment by being visible on imaging studies. The marker is provided sterile and is intended for single-use implantation. It is particularly used in breast cancer treatment to mark the site of a tumor removal, ensuring precise targeting for subsequent radiation therapy.

What is a BioZorb® Made Of?

BioZorb consists of two main components:

Permanent Component: Made of titanium, this part remains in the body permanently to provide a long-term marker visible in imaging.
Resorbable Component: Made from a biocompatible plastic material that gradually dissolves in the body over time.

BioZorb® Potential Side Effects

BioZorb patients have complained of hard painful lumps in the area of their BioZorb implants. Patients have also experienced deformity of the skin and scarring over the devices. Patients have also complained of sensitivity, itching, and reddening of the skin in the area of the BioZorb implants. Most patients have reported that the devices have not absorbed as they were supposed to.

Some patients with BioZorb® implants have reported the following side effects:

Pain
Infection
Rash
Device migration
Device erosion
Seromas, a collection of serous fluid that builds up under the surface of the skin
Discomfort
Hard, painful lumps
Skin deformity
Scarring
Fluid buildup
Implants not absorbing into the body as claimed by the manufacturer

Controversies Surrounding BioZorb® Medical Implants

Complications and Side Effects:

Inflammation and Infection: Some patients have reported significant inflammation, infection, and adverse tissue reactions to the implant.
Pain and Discomfort: There have been cases of chronic pain and discomfort associated with the implant, necessitating additional medical intervention or removal of the device.
Visibility on Imaging: While designed to be visible on imaging for precise targeting, some reports suggest that the implant can cause confusing imaging results, potentially complicating follow-up diagnostics.

Efficacy and Necessity:

Mixed Outcomes: There are mixed opinions in the medical community regarding the efficacy of BioZorb in improving radiation therapy outcomes compared to traditional markers.
Question of Necessity: Some healthcare professionals question whether the benefits of BioZorb outweigh the risks and whether it is always necessary for all patients undergoing lumpectomy.

Common Allegations in BioZorb Implant Lawsuits

Product Liability:

Design Defects: Plaintiffs may allege that the BioZorb implant has inherent design flaws that make it unsafe for use, leading to complications such as infection, inflammation, and chronic pain.
Manufacturing Defects: Claims that the specific units of BioZorb used in surgeries were defectively manufactured, causing harm to patients.

Failure to Warn:

Inadequate Warnings: Allegations that the manufacturers did not provide sufficient warnings about the potential risks and side effects of the BioZorb implant, leaving patients and surgeons unaware of the full extent of the dangers.
Misleading Marketing: Claims that the marketing materials and information provided by the manufacturer downplayed the risks or exaggerated the benefits of the implant.

Negligence:

Lack of Proper Testing: Allegations that the manufacturers failed to conduct adequate pre-market testing and post-market surveillance to identify potential complications associated with the implant.
Negligent Design and Manufacturing: Claims that the company was negligent in the design and manufacturing process, leading to unsafe products being released to the market.

Breach of Warranty:

Breach of Express Warranty: Allegations that the BioZorb implant did not perform as the manufacturer explicitly promised, leading to patient harm.
Breach of Implied Warranty: Claims that the implant was not fit for its intended purpose or not of merchantable quality.

BioZorb® Recall 2024

In 2024, Hologic issued a recall for its BioZorb Markers due to complications associated with the implanted device. The FDA classified this recall as Class I, the most serious type, which indicates that the use of the device may cause serious injuries or death. This classification came after 71 injuries were reported in connection with the BioZorb Markers.

The recall is categorized as a correction rather than a product removal, meaning that while the device is not being removed from the market, steps are being taken to address and rectify the issues identified.

What to Do if You Have a BioZorb® Implant

If you have a BioZorb implant and are experiencing problems, the experienced defective products attorneys at Jinks Crow can help. Reach out to us today for a free consultation.

Please contact us at 888.297.9592, or complete the contact form below. There is no cost or obligation.