BioZorb Lawsuit – Breast Biopsy Marker Recall Lawyer

Breast mammogram

BioZorb recall lawsuits seek compensation for BioZorb implants’ side effects and complications.

Our law firm is investigating cases where patients received one of these implants and suffered effects like pain, infection, rash, discomfort, seroma, or device migration or erosion. 

If you or a loved one received a BioZorb implant and suffered complications, call us today for a free, no-obligation case evaluation. Call (800) 277-1193 or complete a short Free Evaluation Form

About the Hologic BioZorb Lawsuits

Many people are suing Hologic in Massachusetts federal court. Plaintiffs are breast cancer survivors and/or women at risk of breast cancer who received BioZorb marker device implants.

The cases were assigned to Judge Allison Dale Burroughs.

The product lawsuits claim that the device didn’t dissolve and reabsorb as it was supposed to after the patients’ lumpectomy and mastectomy surgeries. This caused the patients to suffer pain and discomfort, infection, and other problems.

Judge Burroughs issued a bellwether order in February 2024, setting the first trial date for July 2025. A bellwether trial is a test trial chosen from a larger group of lawsuits against the same party. These trials help set a standard for the rest of the cases and can help decide settlements for everyone involved.

Problems with the Medical Device’s Product Labels

The BioZorb lawsuits allege Hologic’s product labels failed to warn that the device:

  • Can fail to dissolve
  • Can migrate
  • Can cause pain
  • Can protrude out of the breast and create a hole in the breast
  • Require surgical removal

Ignoring Clinical Evidence

After approval, Hologic found that some patients developed a lump that felt like a tumor, causing severe pain. This was based on studies and reports after the device was on the market.

Hologic also knows that the device can cause infections, movement, tissue death, extra radiation, and more surgeries for mastectomy. The company mentions none of these problems in the current instructions for use (IFU).

Other surgical clip markers that have been on the market longer (but don’t have a spiral shape like BioZorb) have also been known to move from their original placement.

Increased Radiation

Another side effect of using BioZorb stems from the amount of radiation the device requires. Patients can suffer the appearance of telangiectasias, which resemble red spider veins. No woman wants these on their legs, and especially not on their breasts! The IFUs do not mention any increased use of radiation or the resulting disfigurements from implanting the device.

Legal Premise for the BioZorb Lawsuits

The Complaints against the maker of BioZorb are citing the following:

  • Failure to Warn
  • Negligence: Design Defect
  • Breach of Implied Warranty
  • Negligence

What is the BioZorb Marker Device?

BioZorb is an implantable marker that shows up on X-rays (radiographic). The device is supposed to be resorbed by the body. The clips stay in the body permanently to mark the soft tissue site. 

Surgeons use the medical device in surgical procedures for marking soft tissues. One use is to help with the precise delivery of radiation therapy post-surgery.

The radiographic marker consists of two parts:

  • A spiral part that dissolves in 1 or 2 years
  • Titanium clips that stay in place to mark spots in soft tissue

The FDA first approved the medical device in February 2012. The agency gave four more approvals were between 2015 and 2019.

Hologic’s only public Instructions for Use for this medical device do not mention risks of or any related problems.

Where and When Do Surgeons Use This Radiographic Marker?

BioZorb placement can occur:

  • At a biopsy site
  • After removing a breast tumor (partial lumpectomy, mastectomy, or breast conserving surgery)
  • During breast cancer treatment (helps guide future radiation therapy to the right spot)

Manufacturers of the Implants

Focal Therapeutics, located in Portola Valley, CA, created BioZorb. Hologic bought Focal Therapeutics for $125 million in September 2018, making it a part of Hologic. Hologic is based in Marlborough, Massachusetts. Before Hologic bought Focal Therapeutics, BioZorb Marker was the only product Focal Therapeutics sold.

In the year before Hologic bought the company, Focal Therapeutics made about $16 million in revenue.

Why Did Hologic Recall its Marker Devices?

On May 22, 2024, Hologic, Inc. recalled the BioZorb Marker due to complications with the implanted devices. The U.S. Food and Drug Administration (FDA) classified the recall as a Class 1 recall. This classification means that exposure to a faulty product is likely to cause serious health problems or even death. In the case of BioZorb, the recall involves correcting the product rather than removing it from the market.

Hologic started this recall on March 13, 2024, after receiving reports of various complications, including:

  • Pain
  • Infection
  • Rash
  • Device migration
  • Erosion
  • Seroma
  • Discomfort or feeling the device
  • The need for additional medical treatment to remove the device.

There have been 71 reported injuries but no deaths associated with these issues. You can find more details about the recall in the FDA’s recall database.

Biopsy Marker Clip Side Effects

The FDA has received reports about complications that highlight risks of BioZorb Marker and the BioZorb LP Marker when used in breast tissue. These complications include:

  • Infection
  • Fluid buildup (seroma)
  • The device moving out of position (migration)
  • The device breaking through the skin (erosion)
  • Pain
  • Discomfort
  • Rash
  • Other issues

Some patients may need additional medical treatment to remove the device. The FDA is also aware of similar reports in medical literature.

If you or a loved one received a BioZorb implant and suffered such side effects, contact us today for a free, no-obligation case evaluation. Call us at (800) 277-1193 or fill out our brief Free Evaluation Form.

What Happens if Your Titanium Marker Migrates or Erodes?

If the device moves out of its intended position, it could have severe consequences, potentially even life-threatening ones. It might break through the chest cavity or blood vessels. Additionally, the device’s migration could affect future radiation treatments.

It’s important to note that the FDA has not approved these markers for filling tissue space or improving cosmetic outcomes after procedures. The FDA is actively working with Hologic Inc. to assess the safety of these devices when used in breast tissue. If you have any concerns, consult your healthcare provider for personalized advice.

Which BioZorb Marker Implant Devices Were Recalled?

The product code for the BioZorb Marker device is NEU. The recall applies to and it includes nine different models:

  • F0405 BioZorb Marker 4cm x 5cm
  • F0404 BioZorb Marker 4cm x 4cm
  • F0331 BioZorb Marker 1cm x 3cm x 3cm
  • F0231 BioZorb Marker 1cm x 3cm x 2cm
  • F0221 BioZorb Marker 1cm x 3cm x 2cm
  • F0304 BioZorb Marker 3cm x 4cm
  • F0303 BioZorb Marker 3cm x 3cm
  • F0203 BioZorb Marker 2cm x 3cm 
  • F0202 BioZorb Marker 2cm x 2cm 

The affected devices were distributed between April 29, 2019, and April 1, 2024. In total, Hologic is recalling 53,492 devices in the U.S.

How Patients Can Identify Affected Devices

Patients can identify affected devices through the product’s serial number and manufacturing date.

The device manufacturer or your healthcare provider can provide this information. They can also guide you on how to check your device.

If you suspect you have an affected device, contact your healthcare provider immediately. They can confirm if your device is part of the recall.

Steps for Patients with BioZorb Implants

If you have a BioZorb implant, it’s important to know the steps to take. Your health and safety should be your top priority.

First, identify if your device is part of the recall. Contact your healthcare provider for this information.Next, monitor your health closely. Report any unusual symptoms to your doctor immediately.

Here are some steps to follow:

  1. Identify if your device is part of the recall.
  2. Monitor your health.
  3. Report any unusual symptoms.
  4. Stay informed about the recall updates.
  5. Consult with your healthcare provider regularly.

Medical Literature About the Risks of the BioZorb Marker Devices

  • Srour & Chung (2020): Retrospective study of 89 patients identified one patient in which the device migrated
  • Kaufman et al (2021) Retrospective study of 818 patients reported one patient in which a “visible hard lump in lumpectomy bed” was “thought to be [BioZorb] clip migration”
  • Ju & Tsai (2021): Case report describing a patient who presented with repeated infections and eventual erosion of a BioZorb implant through her nipple-areolar complex, requiring surgical debridement and excision of her nipple-areolar complex and BioZorb implant 1 year postoperatively
  • Ram & Dietsche (2021): Case series reporting fat necrosis, foreign body reaction, new or enlarging masses, pain, skin changes and delayed resorption (4-5 years). “The use of BioZorb at our institution was subsequently stopped due to concerns regarding these patient symptoms post BioZorb placement”.

Legal Actions: Lawsuits and Patient Rights

The Biozorb recall has prompted Hologic lawsuits. Patients affected by the recall may have the right to to pursue a civil action to recover damages.

Although each case varies, some of the types of recoverable damages include:

  • Medical treatment and expenses
  • Loss of wages
  • Pain and suffering

A medical device lawyer or product liability attorney can guide you on your rights and potential compensation.

Moving Forward: Monitoring and Alternatives

Patients with Biozorb implants should consider seeking regular monitoring. This ensures early detection of any potential complications.

There are alternatives to Biozorb. Discuss these options with your healthcare provider.

You Might Be Eligible to Receive Compensation for Your BioZorb Implant

The Biozorb recall is a significant event. It underscores the importance of patient safety in medical device use.

Have you or a loved one suffered complications after receiving a BioZorb implant? Reach out to us today for a free case evaluation with no obligation. Call (800) 277-1193 or complete our short Free Evaluation Form.