BioZorb Implant Recall Lawsuits

Lawyers are now filing claims for those who suffered complications from defective BioZorb breast cancer treatment implants.

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Those who have suffered the following complications may be entitled to substantial compensation:

  • Severe pain
  • Mass growth or scarring
  • Device migration or extrusion
  • Limited range of motion
  • Disfigurement or asymmetry
  • Delayed wound healing
  • Surgical removal of the device.
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BioZorb is a surgical marker implant manufactured by Hologic Inc. that was designed to help with radiation targeting and imaging in breast cancer patients following tumor removal.

biozorb lawsuit

BioZorb Breast Cancer Implant Recalled for Safety Risks

Made primarily of bioabsorbable polylactic acid (PLA), the device was intended to gradually dissolve, leaving behind only small titanium clips. Following FDA approval in 2012, Biozorb was believed to improve outcomes and follow-up care among breast surgeons. 

The manufacturer even promoted it for additional uses such as filling tissue space and improving cosmetic results. 

Unfortunately, experts have now identified risks of BioZorb implants not dissolving, or migrating from the placement site. Patients have experienced a number of complications, including:

  • Abnormal scarring
  • Severe pain and inflammation
  • Hardened mass growth 
  • Device movement or extrusion (protruding from skin) 
  • Fluid buildup around theimplant 
  • Pain or limited motion 
  • Disfigurement
  • Delayed wound healing 
  • Additional surgeries or device removal.

Holigic and the FDA first issued a warning to patients and doctors about these potential risks in February 2024. Then, in October 2024, the FDA issued a do-not-use notice as the manufacturer implemented a Class-I recall of all remaining BioZorb devices on the market. 

Experts fear that tens of thousands of patients may have been affected by dangerous BioZorb implants before they were recalled from use. Records also show the company may have continued selling the devices long after learning about the risks. 

Lawyers are now filing lawsuits on behalf of those who’ve been injured or had to endure additional medical care to mitigate the risks of the implant.

Do I Qualify for a BioZorb Lawsuit? Latest 2025 Updates

The BioZorb recall applies to all implant models and sizes used since 2012. Experts have determined the risk of failure outweighs any benefit of continuing to use the device. 

In addition to removing BioZorb from the market, doctors have been advised to monitor those patients who received the implants for complications such as:

  • Severe pain
  • Mass growth or scarring
  • Device migration or extrusion
  • Limited range of motion 
  • Disfigurement or asymmetry 
  • Delayed wound healing
  • Additional surgeries
  • Removal of the device. 

If you experienced any of these problems from your implant, or required repeat surgery, you may qualify for a lawsuit. Lawyers believe thousands of patients may be affected.  

Cases have already been consolidated to a special court venue, and the first BioZorb lawsuit trial is scheduled to start in September of 2025. However, victims may not have that long to file a claim in every situation. To ensure your legal rights don’t expire, it is recommended you speak with a lawyer as soon as possible. 

For more information on the BioZorb Recall lawsuits, or to discuss your case and legal options directly with a lawyer, contact DrugNews today.

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Timeline of BioZorb Lawsuits

Latest Information on the BioZorb Litigation

2025
Sept
First BioZorb trial scheduled to begin in MDL court. 
2024
Oct 25
FDA issues alert to consumers and health care providers not to use BioZorb Markers.
2024
Oct 25
Hologic announces a voluntary recall of all unused BioZorb Markers on the market.
2024
Sept 28
Court denies attempts by BioZorb maker to dismiss all lawsuits, allowing victims’ claims to proceed.
2024
July
Judge Burroughs orders parties in the growing BioZorb MDL lawsuit to select ten cases as potential Bellwether test cases to gauge future outcomes.
2024
May
FDA Classifies BioZorb safety warning as a ClassI Recall.
2024
Feb
Hologic and the FDA issue initial safety notices acknowledging potential migration and infection risks with the BioZorb marker.
2017
Biozorb promoted as improving outcomes and follow-up care to the American Society of Breast Surgeons.
2012
FDA approves BioZorb for post-surgical marking of breast tissue areas.

Is There a BioZorb Recall Class Action Lawsuit?

No. Instead of organizing all claims under one class action lawsuit, judges have created a special court where individual BioZorb cases can be handled at the same time.

At this time BioZorb injury cases have been consolidated in the U.S. District Court for the District of Massachusetts, presided over by Judge Allison D. Burroughs. Judge Burroughs has ordered that several Bellwether test cases be selected and prepared to start trials in September 2025.

Instead of creating a single class action lawsuit for BioZorb injuries, the MDL court allows those affected to band their individual cases together to seek damages against the company. 

This multidistrict litigation court (MDL) process is often more beneficial for consumers than a class action lawsuit. In a class action lawsuit, a group of lawyers will gather together class participants who must share whatever is awarded.  

However, individual participants in an MDL can select their own lawyer, exercise more control over their case and whether it settles, and reap higher award amounts for their separate lawsuit.

Lawyers expect thousands of lawsuits will eventually be filed in the BioZorb MDL court. 

DrugNews works only with lawyers that are integrally involved in defective drug MDL litigation or are active on the influential MDL Plaintiff Steering Committees.

Choosing a BioZorb Implant Lawyer

If you or a loved one have suffered injury, complications or repeat surgery from a defective BioZorb implant, it's important to have your case examined by a legal expert to see if you have the right to recover damages.  

Our qualified medical device injury lawyers will fully investigate your case, reviewing medical records, safety warnings and recent studies that your doctor may not normally discuss.

Most states allow you several years to file a lawsuit after you suffer an injury or discover it may be linked to a dangerous product. However, you should begin the process as early as possible to make sure your lawyer has time to get necessary records and prepare your case.   

DrugNews works only with attorneys and law firms that have successfully handled tens of thousands of lawsuits involving injury or death from drugs and medical devices. And, you can speak directly with a lawyer or patient advocate today, so you’ll be able to decide if you want to proceed.   

We make it easy to get help, find out if you qualify, and quickly file a claim. Our service is offered at no cost to you, and you won’t pay anything to your attorney unless you receive an award. Also, our qualified lawyers can handle most aspects of your case without you ever having to leave your home.   

For more information, or to learn about your options - call, chat or email us today.

Free Case Review

Our attorneys specialize in defective medical implant litigation. "The free evaluation is always confidential."

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