BioZorb Lawsuits

After the U.S. Food and Drug Administration (FDA) informed patients of the potential risk of serious complications from using BioZorb Marker and BioZorb LP Marker devices, Phillips Law Group is investigating and pursuing BioZorb Lawsuits. If you or a loved one was injured after the use of a BioZorb medical device, please contact our firm without delay to discuss your legal options. 

What Is BioZorb?

According to the FDA, “The BioZorb Marker made by Hologic (previously Focal Therapeutics), is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures, such as radiation.”

Unfortunately, the BioZorb Marker was recalled as a result of complications and reported with the implanted devices. The implants were supposed to dissolve into the patient’s body within 12 months after implantation, but for many, the device did not dissolve at all, leading to discomfort, pain, and suffering.

By the end of May, the FDA had reported a total of 71 reported injuries and no reports of death. But it’s possible the number of injuries related to adverse health events from the use of a BioZorb device could be much higher. 

Health Issues Linked to Defective BioZorb Implants

Some of the reported BioZorb implant side effects include:

  • Device erosion
  • Device migration
  • Differences in size, shape, and texture between implanted and non-implanted breasts
  • Discomfort
  • Discomfort 
  • Hard and sore lumps
  • Increased sensitivity
  • Infection
  • Pain
  • Puncturing of the breast
  • Rash
  • Scarring
  • Seroma (buildup of fluid in the body)
  • Other complications from feeling the device in the breast
  • The need for additional medical treatment to remove the device
  • …and more

BioZorb Lawsuits Compensation

Pursuing a BioZorb lawsuit can potentially help you secure compensation including:

  • Medical expenses
  • Lost wages
  • Pain and suffering
  • …and more 

FDA Recall of BioZorb Implants

In May 2024, the FDA reported that the agency had “classified the actions of Hologic notifying customers of the risks associated with BioZorb Marker and BioZorb LP Marker devices as a Class I recall, the most serious type of recall.”

On March 13, 2024, Hologic, Inc. sent all impacted customers an Important Medical Device Safety Notification that requested patients get in touch with their healthcare provider if they experience any negative events following the placement of a BioZorb Marker and report any problems or complications encountered following the placement of BioZorb Marker devices to Hologic, as well as the FDA’s MedWatch Adverse Event Reporting program.

People Who May Be Affected by the BioZorb Recall

According to the FDA’s medical device recall announcement about BioZorb Markers, individuals who may be impacted by the recall include:

  • Individuals who were implanted with the BioZorb marker device
  • Individuals who receive radiation guided by the BioZorb marker, which may have relocated
  • Individuals who receive systemic cancer treatments because treatments may be delayed due to complications with BioZorb implants
  • Radiologists, surgeons, oncologists, and other health care providers and professionals who use BioZorb devices for the treatment of their patients

Sadly, many patients who trusted the advice of their medical professionals and agreed to the use of BioZorb Markers may have actually prolonged their treatment and faced additional health challenges and pain from using the devices. If you or a loved one suffered after the implantation of a BioZorb device, you may have legal options and be able to pursue financial compensation for your suffering.

Get Help From Phillips Law Group

If Hologic failed to properly warn victims of BioZorb’s risks, the company should be held accountable, and affected patients may be entitled to legal representation and potential financial reimbursement. The team at Phillips Law Group may be able to help.

Please contact our firm to learn more about Biozorb lawsuits and your legal options after discussing your situation in a free, no-obligation consultation. This evaluation is confidential and you owe us nothing unless we pursue and win your case.

Phillips Law Group has been in business for more than 30 years and our lawyers have a great deal of experience handling defective and dangerous medical device cases. Call us today to find out how we may be able to help you.