Dive Brief:
- Hologic has recalled more than 53,000 radiographic markers linked to 71 reported injuries, the Food and Drug Administration said Wednesday.
- The devices are staying on the market, but Hologic has asked people to report adverse events such as pain and advised physicians to discuss the benefits and risks with patients.
- Hologic shared the advice with customers two weeks after the FDA warned healthcare providers about the potential risk of serious complications when using the Biozorb markers.
Dive Insight:
Biozorb devices are designed to enable physicians to mark sites in soft tissue where a patient needs radiation to treat cancer. The devices are made of a plastic component that is intended to be resorbed by the body “in one year or longer” and a permanent titanium metal part. The FDA wrote to physicians in February after receiving reports that the plastic can persist for several years and cause complications.
In a Class I recall notice Wednesday, the FDA said complaints about Biozorb devices have included reports of pain, infection, rash, device migration and other adverse events “from feeling the device in the breast.” Some patients have needed additional treatment to remove the device. The FDA said there have been 71 reported injuries and no reports of death.
The Class I notice reiterates the recommendations Hologic made in its letter to customers in March. The company advised patients to contact their healthcare provider if they experience adverse events after receiving a Biozorb marker. Hologic also advised physicians to discuss the benefits and risks with patients and monitor them for complications.
Hologic acquired the devices in its $125 million takeover of Focal Therapeutics in 2018. In 2021, doctors published case reports about an implant that “eroded through” skin at the border of the nipple and a device that created “an open wound.” Plaintiffs have claimed in lawsuits that they sustained injuries related to the implants.