FDA threatens Hologic with punishment for reported errors in making troubled breast device

The U.S. Food and Drug Administration is threatening radiology vendor Hologic Inc. with possible punishment after reported errors in the manufacturing of a troubled device. 

Authorities communicated their concerns in a December warning letter to the Marlborough, Massachusetts company, posted online Tuesday.  They’re troubled by Hologic’s production of the BioZorb marker, implanted in soft tissue to indicate the site for radiographic procedures. Last month, the FDA shared reports of 252 injuries stemming from use of the device, and Hologic has been hit with lawsuits from over 100 plaintiffs because of the marker. 

In the letter, regulators charge that the company is “not in conformity with the current good manufacturing practice requirements.” Alleged issues include “failure to establish and maintain procedures to control the design of the device” and not properly identifying the product’s “intended patient population.” 

“Your firm should take prompt action to address any violations identified in this letter,” Sean M. Boyd, MPH, director in the FDA’s Office of Regulatory Programs, wrote to Hologic’s CEO on Dec. 18. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction and civil money penalties.”

Other agencies also may take Hologic’s noncompliance with the Federal Food, Drug, and Cosmetic Act into account when considering awarding contracts to Hologic, Boyd added. Plus, the feds may not grant requests for Certificates to Foreign Governments. The FDA gave Hologic 15 business days to notify authorities, detailing steps it has taken to address the noted violations, along with how it plans to prevent them from occurring again. 

A company spokesperson issued a statement in response to the letter on Wednesday. 

“We have been closely coordinating with the FDA and are taking all necessary steps to resolve this matter in a comprehensive and timely manner,” the representative told Radiology Business. “Ensuring safe, effective and high-quality products is our most important priority and we are committed to maintaining robust quality systems and procedures to fulfill this commitment.”

As reported in December, the FDA has received reports of injuries stemming from the implantation of BioZorb markers. These have included discomfort from feeling the marker in the breast, infection, pain, rash, fluid buildup and other complications. The agency has issued a Class 1 recall for the device, its most severe designation, indicating use of the BioZorb can cause “serious injury or death” (though there have been zero reported fatalities). Hologic is now working to remove the devices from where they are used or sold.

Multiple individuals have filed lawsuits against Hologic over the BioZorb issue. The device (previously made by Focal Therapeutics) is used to tag the breast or other soft tissue for future procedures. BioZorbs are typically implanted with six titanium radiopaque marker clips that serve as “targets” for radiation therapy. The spacer material is supposed to be resorbed by the body, leaving the clips as permanent indicators of soft tissue sites. However, women have complained of the product failing to resorb and sometimes migrating away from their intended location, causing pain, swelling and infections. 

In last month’s letter, Director Boyd also charged that Hologic did not have proper testing to verify if the spacer material absorbs into the body. He cited one alleged incident in which a BioZorb implanted in a woman had not dissolved five years after implantation. Hologic also allegedly failed to consider variations in soft tissue types and patient anatomies that could impact the product’s performance. 

“FDA continues to have safety concerns for patients in whom this device has been implanted,” Boyd noted. “Your firm should address the contribution of the device design to adverse events and identify those patients who may be at risk for adverse events and therefore potentially benefit from intervention by device explantation,” he added later. 

Hologic also purportedly received a rash of adverse event complaints in September 2023. However, the FDA said company management downplayed the need for corporate corrective action and did not do so until May 2024. 

“We reviewed your firm’s response and concluded that it is not adequate,” the letter added.