The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company Hologic Inc. over concerns it hasn't done enough to prevent harm from a plastic component in the company's Biozorb implantable radiographic markers.
Hologic's Biozorb marker is an implantable radiographic marker used to mark soft tissue, such as breast tissue, for future medical procedures. The device has two components: a permanent component made of titanium, and a component made of polylactic acid (PLA) that is intended to dissolve over time, according to FDA.
The Dec. 18 letter stated that FDA found Hologic failed to meet design requirements, including ensuring the PLA spacer component in the marker is absorbed by the body within a defined length of time.
Hologic put a stop ship notice on the Biozorb device on Sept. 29, 2024, and it is no longer manufacturing the product. But it does not intend to perform "any specific design studies to address the deficiencies," the letter said.
The FDA concluded that response was "not adequate," due to "safety concerns for patients in whom this device has been implanted."
"Hologic does not have any verification testing to demonstrate that the bioabsorbable spacer material is absorbed by the body," the letter said. "[Hologic's] design description document … includes a user requirement that the Biozorb medical device spacer material is resorbable into soft body tissue. [Its] verification testing report … only documents the inherent viscosity profile of the spacer during in-vitro degradation and does not provide sufficient data to support the claim that that spacer material is absorbed by the body."
Hologic has received complaints and filed medical device reports to the FDA regarding devices requiring removal. One complaint report stated the device failed to dissolve for almost five years, it added.
The company "should address the contribution of the device design to adverse events and identify those patients who may be at risk for adverse events," the letter said. It must also evaluate the device's design to establish the potential of device interference with cancer detection devices, whether in-vivo radiation treatments can impact the performance of the device, the intended patient population and anatomy types, and surgical requirements such as appropriate placement, fixation and depth.
FDA also requested Hologic review and revise its design control procedures and include documentation with its "retrospective review" of its products and "any remediation efforts that may be warranted," it said.
Hologic failed to detect recurring problems or calculate the occurrence rate accurately when it first began receiving complaints, due to leaving out the patient population as a consideration in its health risk assessment procedure, the letter said.
FDA identified the recall as Class I recall, the most serious type, in an Oct. 25 notice, which said: "Use of these devices may cause serious injuries or death."
Other complaints about the device included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort or other complications from feeling the device in the breast. There have been 71 reported injuries and no reports of death, the notice said.
The company also failed to submit a medical device report for each adverse event within the required 30-calendar-day time frame, the letter said.
Failure by Hologic to address the matter "may result in regulatory action being initiated by the FDA without further notice," it said. "These actions include, but are not limited to, seizure, injunction, and civil money penalties … Other federal agencies may take your compliance with the FD&C Act … into account when considering the award of federal contracts."
Hologic acquired Biozorb when it bought Focal Therapeutics in 2018.