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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.
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.
The BioZorb lawsuits allege Hologic’s product labels failed to warn that the device:
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.
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.
The Complaints against the maker of BioZorb are citing the following:
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:
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.
BioZorb placement can occur:
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.
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:
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.
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:
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.
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.
The product code for the BioZorb Marker device is NEU. The recall applies to and it includes nine different models:
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.
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.
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:
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:
A medical device lawyer or product liability attorney can guide you on your rights and potential compensation.
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.
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.
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