BioZorb Marker Lawsuit Cases [2024]: Have You (or A Loved One) Suffered Injury or Complications From a Recalled BioZorb Implantable Breast Tissue Marker Implant?

If you or a loved one suffered complications or injuries from a BioZorb implantable breast tissue marker, you may be entitled to recover compensation from a BioZorb lawsuit or settlement.

A team of medical device injury lawyers and class action attorneys is investigating claims of women who have suffered from complications and injuries after receiving a BioZorb implantable breast tissue marker.

A BioZorb marker is an implantable medical device with a 3D radiographic bioabsorbable marker that is used to mark soft tissue sites, such as breast tissue, for medical procedures or radiography. It is most commonly used to mark radiation therapy sites in breast cancer patients’ breasts following a lumpectomy or partial mastectomy (i.e., surgical procedure to remove a breast tumor) and provides a target to aim radiation therapy at the tumor to minimize damage to healthy tissue.

Unfortunately, on October 25, 2024, the FDA announced that BioZorb Markers and BioZorb LP Markers were subject to a Class 1 recall (i.e., a situation in which there is a reasonable probability that the use of or exposure to a product may cause serious adverse health consequences or death) due to reports of serious adverse events by patients who had a BioZorb implanted in breast tissue, including, complaints of pain, infections, rash, device migration (device moving out of position), device erosion (device breaking through the skin), fluid buildup (seroma), discomfort and other complications from feeling the device in the breast.

BioZorb Recall Lawsuit & Settlement Cases

BioZorb lawsuit and settlement cases potentially being investigated include claims of women who, after receiving a BioZorb implantable breast tissue marker, suffered serious problems, injuries, side-effects or complications including, among others:

• Migration of BioZorb implant
• Erosion of BioZorb implant
• Surgery to remove the BioZorb device
• Swelling
• Infection
• Abscess
• Chronic and/or severe pain
• Necrosis (tissue death)
• Seroma (fluid buildup)
• Hard lump
• Telangiectasias (red spider veins)
• Scarring
• Need for additional surgery
• Other BioZorb injury lawsuit cases

BioZorb injury lawsuits have alleged, among other things, that defendant knew, or should have known, of the risk that BioZorb marker devices could cause serious injury, including, possible infection, migration, necrosis, additional radiation, and additional surgery, but failed to disclose these risks to patients, who suffered injury as a result. BioZorb lawsuit complaints have asserted causes of action for strict liability and/or negligent failure to warn, strict liability and/or negligent design defect, breach of implied warranty of merchantability, and negligence.

Plaintiffs in the BioZorb lawsuit cases seek, among other things, compensation for economic and non-economic losses, including medical expenses, loss of earnings, pain and suffering, mental anguish, and emotional distress, punitive and/or exemplary damages, attorneys’ fees, expenses, and costs of litigation and pre- and post-judgment interest.

Defendants in the BioZorb lawsuits have included Hologic, Inc. (f/k/a Focal Therapeutics), the manufacturer of BioZorb devices. BioZorb lawsuits filed in federal district courts have not yet been consolidated and/or transferred into multi district litigation or MDLs, though it is expected that the cases will be consolidated.

BioZorb Breast Cancer Tissue Marker Injury Cases

BioZorb Markers have two parts: a plastic component that is intended to be dissolved completely in the patient’s body in one year or longer, and a titanium metal component that is permanent. The BioZorb device is comprised of a circular or spiral component made primarily of polylactic acid that is embedded with six (6) titanium radiopaque marker clips that serve as “targets” for radiation therapy. The bioabsorbable spacer material is supposed to be resorbed by the body leaving the radiopaque clips as a permanent indicator of the soft tissue site.

The BioZorb recall involves more than 53,000 BioZorb implants, distributed between April 2019 to April 2024. The BioZorb recall calls for the removal of all lots of unused BioZorb Markers. According to the FDA, “There is no need to have the device removed from your body (explanted) unless advised by your health care provider.”

In February of 2024, prior to the BioZorb recall, the FDA issued a safety communication about the potential risk of serious complications with the use of BioZorb Marker devices. On February 27, 2024 Hologic alerted health care providers about possible health risks reported with respect to the BioZorb Marker implantable devices. On March 13, 2024, pursuant to FDA direction, an Important Medical Device Safety Notification was sent to affected patients about possible health risks reported with respect to the BioZorb Marker and BioZorb LP Marker implantable devices.

It has been reported that Hologic received patient complaints that described complications/adverse events that include serious injuries such as pain, infection, rash, device migration, device erosion, seroma, discomfort, and/or other complications from feeling the device in the breast, and in some limited instances, additional medical treatment.

Various research studies have also found a possible connection between BioZorb markers and risk of serious injury, including infections, hard lump from migration, erosion of device, and necrosis, among others.

Time Is Limited To File A BioZorb Marker Lawsuit

Deadlines known as statutes of limitation and statutes of repose may limit the amount of time that women have to file a BioZorb Marker lawsuit to try to recover compensation for complications and injuries they claimed to have suffered after having a BioZorb Marker device implanted.

This means that if a BioZorb lawsuit claim is not filed before the applicable time limit or deadline, the injured party may be prohibited from ever pursuing litigation or taking legal action regarding their BioZorb injury claim. That is why it is important to connect with a BioZorb Marker injury lawyer or attorney as soon as possible.

If you or someone you love suffered injuries or complications from a BioZorb implant, you may be entitled to recover compensation from a BioZorb lawsuit case or settlement claim. Contact a medical device injury lawyer to request a free case review.

*If you or a loved one are experiencing health issues, side effects or complications from a medical device (i.e., BioZorb breast tissue marker), we urge you to promptly consult with your doctor or physician for an evaluation.

**The listing of a company (e.g., Hologic, Inc.) or product (e.g., BioZorb) is not meant to state or imply that the company acted illegally or improperly or that the product is unsafe or defective; rather only that an investigation may be, is or was being conducted to determine whether legal rights have been violated.

***The use of any trademarks, tradenames or service marks is solely for product identification and/or informational purposes.

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