The U.S. Food and Drug Administration said Monday that companies making or hoping to sell so-called dynamic-stabilization systems for spinal surgery must run studies to collect data on “a number of potential safety issues.”
The list of companies includes units of Johnson & Johnson (JNJ) and Zimmer Holdings Inc. (ZMH). There isn’t enough clinical data to determine whether these systems provide enough spinal stability to allow for complete fusion, the FDA said in a release, since system components may loosen, bend or break over time.
“If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures,” the agency said.
It is requiring post-market studies, which are for already approved devices, to review these potential risks. The agency also is asking manufacturers of new systems or components to submit clinical information for agency review before these products are marketed.
These studies must address the fusion rate for dynamic-stabilization systems compared with traditional systems, the FDA said. The studies also must include information on serious events and subsequent surgeries linked to these devices, plus reasons for failure.
