Why Women Are Filing BioZorb Lawsuits: A Q&A With Attorney Marlene Goldenberg
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BioZorb lawsuits first began trickling into the United States District Court for the District of Massachusetts toward the end of 2022. After device maker Hologic, Inc. pulled more than 91,000 devices off the market in October 2024, the litigation has gotten more attention.
The BioZorb Marker and BioZorb LP Marker are implantable radiographic markers used to mark soft tissue, most commonly breast tissue. They have two components: a permanent, titanium metal component and a resorbable, plastic component that is intended to be resorbed in the body in one or more years.
Hologic removed the device from the market following reports of serious adverse events in people who had the devices implanted in breast tissue. Hologic reported complaints of pain, infection, rash, device migration, discomfort and device migration. In some cases, patients require additional medical treatment.
While anyone who uses BioZorb may have complications, women implanted with the device in breast tissue are most likely to be affected.
In this interview with Drugwatch, attorney Marlene Goldenberg, a founding partner at Nigh Goldenberg Raso & Vaughn, discusses why people are filing BioZorb lawsuits. She explains how those injured by the device can qualify for a claim.
Q: Why are people filing BioZorb lawsuits?
On Oct. 24, 2024, Hologic issued a Class I recall of its BioZorb LP Markers (K152070), citing serious adverse health consequences including but not limited to pain, infection, rash, device migration, device erosion and seroma.
Q: Who qualifies to file a BioZorb lawsuit?
For a person to qualify to file a BioZorb lawsuit, they must have received an implant of the BioZorb marker radiographic device after 2015. Our firm doesn’t accept any clients who were implanted after the recall date Oct. 24, 2024.
You must have experienced device migration, device erosion or seroma and had at least one doctor’s visit because of your injuries. Just having pain or a rash isn’t enough to file a claim.
Q: What was the reason for the BioZorb recall?
The recall is due to reported serious adverse health consequences including but not limited to pain, infection, rash, device migration, device erosion and seroma.
Q: Who does BioZorb affect, and who is an example of a typical client?
BioZorb may affect anyone who has received an implantable radiographic marker to mark soft tissue. A person who has a tissue marker implant during a breast biopsy procedure could be an example of a likely client.
Q: What should people expect when they contact a law firm to file a BioZorb lawsuit?
Law firms will want to discuss any related medical treatment and injuries. Firms will need to obtain medical records to support the client’s claim.
Q: How large do you expect this litigation to become?
While it is impossible to know at this time how many patients have suffered complications from implantation of a BioZorb device, Hologic, Inc. [previously Focal Therapeutics] has sold over 91,000 of the devices since they first began marketing them in 2015 and has received hundreds of reports of complications. A Class I recall, the most serious type of recall, has been instituted.
Q: What is the most important thing people should know about BioZorb lawsuits?
BioZorb lawsuits have been consolidated in the United States District Court for the District of Massachusetts. While this litigation began prior to the Class I recall instituted in October 2024, it is expected to grow now that patients are learning about the recall.