BioZorb Implant Lawsuit 2024

A series of lawsuits have been filed against Hologic, Inc., maker of the BioZorb Marker, a radiographic implant tool designed to guide radiation therapy in breast cancer patients. Hologic has been seen as an expert in breast cancer diagnostic tools for almost 40 years, but claimants believe the medical devices company has been negligent in the design of the BioZorb Marker and failed to adequately warn patients about the potential of the device to cause serious injury. The lawsuits are currently being consolidated, with bellwether trials set for 2025.

As of early fall 2024, the FDA is asking anyone who is having issues with BioZorb Marker implants to report it to the FDA. Those with concerns should also contact their healthcare provider. While the FDA carries out its evaluation, the lawsuits against Hologic are gathering pace. At least 40 lawsuits have been filed against Hologic, with hundreds more under evaluation by personal injury lawyers. Law firms are accepting cases from people who have been injured by BioZorb devices. Bellwether trials – test cases – are expected to begin at some point in 2025.

The BioZorb Marker is a device used by surgeons on some patients with breast cancer. It locates soft tissue in the breast after tumor removal, helping guide radiation therapy by marking the tumor/cancerous site. The implant is composed of permanent titanium clips shaped like a coil and a bioabsorbable ‘scaffold,’ the latter of which is supposed to dissolve gradually within about 12 months. However, complications with the scaffold not dissolving have caused serious issues with patients, some of whom have experienced pain and infections and required further surgeries to remove the device.

The FDA has determined that the recall is a Class 1 Recall, which is the most serious category and reserved for recalls with serious risk of injury. The FDA is currently working with Hologic to evaluate the safety of BioZorb Marker going forward.

Hologic has issued a recall (dated May 22^nd, 2024) for BioZorb Markers. The recall impacts over 50,000 implant devices, distributed from April 2019 to April 2024.

Which BioZorb Devices Were Recalled?

1. Version or Model: F0405

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description: BioZorb Marker 4cm x 5cm
• Device Identifier (DI) Number: 15420045514065

2. Version or Model: F0404

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description: BioZorb Marker 4cm x 4cm
• Device Identifier (DI) Number: 15420045514058

3. Version or Model: F0304

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description: BioZorb Marker 3cm x 4cm
• Device Identifier (DI) Number: 15420045514010

4. Version or Model: F0303

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description: BioZorb Marker 3cm x 3cm
• Device Identifier (DI) Number: 15420045514003

5. Version or Model: F0203

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description:BioZorb Marker 2cm x 3cm
• Device Identifier (DI) Number:15420045513990

6. Version or Model: F0202

• Device Brand Name: BioZorb Bioadsorbable Marker
• Device Description: BioZorb Marker 2cm x 2cm
• Device Identifier (DI) Number: 15420045513983

7. Version or Model: F0331

• Device Brand Name: BioZorb LP Bioadsorbable Marker
• Device Description: BioZorb Marker 1cm x 3cm x 3cm
• Device Identifier (DI) Number: 15420045514041

8. Version or Model: F0231

• Device Brand Name: BioZorb LP Bioadsorbable Marker
• Device Description: BioZorb Marker 1cm x 3cm x 2cm
• Device Identifier (DI) Number: 15420045514034

9. Version or Model: F0221

• Device Brand Name: BioZorb LP Bioadsorbable Marker
• Device Description: BioZorb Marker 1cm x 3cm x 2cm
• Device Identifier (DI) Number:15420045514027

Any surgery can cause serious complications, so it is possible to have an issue with the BioZorb Marker unrelated to the potential defects of the device mentioned in the BioZorb lawsuits. Issues can arise with the titanium coil, which may move around and cause damage to the surrounding tissue. It is possible that complications may require further surgery.

Patients who have had a BioZorb Marker implant have reported side effects that include device migration, failure to dissolve, swelling, infection, scarring, tissue damage, fluid build-up, and hard lumps. If you have had side effects from your BioZorb implant, contact your healthcare provider.

The main complaint about BioZorb Marker relates to the bioabsorbable scaffold, which has failed to dissolve as expected in some patients. In some cases, this has meant further corrective surgery is required to remove the device.

There are some concerns that having a BioZorb implant may impact MRI safety. Generally, it is considered safe to have an MRI scan with the implant in your body. However, certain precautions may need to be taken as the titanium may interfere with MRI imaging.

The BioZorb lawsuits are being handled as mass tort litigation and are centralized in the District of Massachusetts, where Hologic is headquartered. In a mass tort lawsuit, each claimant files an individual lawsuit, but the cases are combined in the courts for reasons of efficiency and expediency. Claimants' settlements and payouts in the BioZorb lawsuit would be evaluated on an individual basis based on the level of injury, negligence on behalf of Hologic, etc.

What Is a BioZorb Implant?

A BioZorb implant is a device made up of a titanium coil and bioabsorbable (absorbs naturally in the body) scaffold. The implant is used as a marker on the tissue to help with accuracy in therapies like radiation.

Who Makes BioZorb For Breast Cancer?

Hologic, Inc., a company headquartered in Massachusetts, makes BioZorb Marker and other breast cancer medical devices.

Is BioZorb FDA approved?

Yes. BioZorb Marker is FDA-approved. However, it is subject to a Class 1 FDA Recall due to potential defects.

Is BioZorb MRI safe?

Generally, it is considered safe to have an MRI scan with a BioZorb implant. However, patients should inform their healthcare provider as certain precautions may need to be taken. 

What are the complications of BioZorb?

The main problem with BioZorb marker implants is a defect with the bioabsorbable scaffold, which – at least in some patients – may not dissolve or dissolve only partially. This has led to complications with infections, pain, inflammation, and other issues. It may require corrective surgery.

What are the side effects of a titanium clip in the breast?

The titanium clips in BioZorb Markers are generally considered safe as titanium is biocompatible. However, BioZorb implant patients may experience problems such as allergic reactions, device migration, and other issues accompanied by pain and inflammation.

What is a BioZorb breast marker?

A BioZorb breast marker is used to mark an area of soft tissue on the breast, usually after a tumor has been removed. It helps surgeons get a better read of areas of good and potentially cancerous tissue, enabling treatments like radiotherapy to be more accurate.

What is the latest treatment for breast cancer?

There are numerous innovations in treating breast cancer. For more information, contact your healthcare provider.