Hologic has recalled all BioZorb Markers after lawsuits were filed by women who suffered serious injuries after breast cancer surgery.
On October 25, the FDA announced the BioZorb recall and warned doctors not to use BioZorb Markers due to “serious adverse events occurring in patients who had the devices implanted in breast tissue.”
The FDA warned that it never approved BioZorb markers to improve cosmetic outcomes after surgery to remove breast cancer tumors, fill up spaces in tissue, or to be a marker for future radiation treatment.
BioZorb Markers are spiral-shaped devices that are implanted in soft-tissues, including breast tissue. Each device has a spiral-shaped plastic component that dissolves in the body, which contains 6 titanium metal clips that are permanent and show up on an X-ray.
The titanium clips are called “markers” because they were designed to precisely mark the surgical excision site. Hologic went further in advertising BioZorb Markers, claiming the devices would provide “3D targeting for radiation therapy,” and improve cosmetic outcomes.
As a result, many doctors began using BioZorb devices for unapproved uses like filling up empty spaces in breast tissue following surgery to remove tumors, as well as marking tissues to target radiation therapy.
Doctors told patients this would make their breast look better after surgery to remove lumps, and the device would dissolve over time.
Instead, many women experienced severe side effects like pain, infection, rash, device migration (moving out of position), device erosion (breaking through the skin of the breast or nipple), seroma (fluid build-up), or discomfort from feeling the BioZorb devices, according to the FDA.
Some women also needed additional medical treatment, like surgery to have BioZorb devices removed from the body (called “explantation”).
In recent months, several women have filed BioZorb lawsuits against Hologic. These lawsuits claim that Hologic aggressively marketed BioZorb Markers for breast cancer patients, without adequate warnings about the risks.
For example, a lawsuit was filed by Laura N., a woman who “suffers from a hardened mass and scar tissue” near the BioZorb device. She said she “can ‘feel’ what she believes is likely the non-absorbed device.” She also suffers from severe pain, redness, burning, and cannot “even move without pain, which radiates throughout her left breast,” according to the lawsuit.
Her lawsuit was filed against Hologic Inc. on September 30, 2024 in the U.S. District Court for the District of Massachusetts — Case Number 1:24-cv-012495.
Source: Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication