- FDA will ask its General and Plastic Surgery Devices panel Thursday whether it is on the right track with an April proposal to require premarket review for surgical staplers for internal use.
- Amid identification of adverse tissue reactions, infections and complications associated with device malfunction and user error — and 412 reports of death — the agency has pitched moving the devices from Class I to Class II with special controls.
- Of 195 malfunction reports FDA reviewed, the most common problems were: malformed staples or staple lines (31.8%); staples lines not forming or staples missing (19.5%); sticking, locking or jamming of devices (15.9%); and tissue damage or leaks (14.9%). Other problems noted include staplers misfiring, breaking or not cutting, and cartridges not loading properly, the agency revealed in more detailed data released Tuesday.
Questions posted Tuesday indicate FDA wants the panel to weigh in on whether FDA's understanding of the safety concerns is accurate and thorough; whether there's reasonable assurance the devices are safe and effective; whether its list of proposed special controls are appropriate; and ultimately, whether the devices belong in Class I or Class II.
Special controls laid out by FDA as part of the reclassification order include specific labeling features, detailed testing for performance, usability and biocompatibility, and demonstration of sterility.
A manual or powered surgical stapler for internal use can be used in open, minimally invasive or endoscopic surgeries removing part of an organ, cutting through organs and tissues, or creating connections between structures, according to FDA. A final rule in 1988 established regulation of the devices using only general controls.
A recent literature review conducted by the agency revealed a median stapler malfunction rate of 1.8%. But awareness of the issue seems more common among clinicians.
"In surveys of surgeons conducting surgeries with surgical staplers, up to 73% reported personal experience of, and 86% reported knowing of someone experiencing stapler misfire or malfunction during surgery," FDA meeting materials said.
A retrospective study of colorectal resections reviewed by FDA showed stapler malfunctions led to higher incidence of unplanned proximal diversions, ileus, gastrointestinal bleeding and blood transfusions. In cases of liver transections, consequences included higher likelihood of transfusion, greater blood loss, and morbidity and mortality. FDA also noted anastomotic leaks caused by malfunctions have been associated with an increased risk of cancer recurrence.
Surgical stapler-related deaths were most common in cardiothoracic, bariatric or hindgut procedures. Of deaths FDA reviewed, 72% involved a linear stapler and 17% involved a circular stapler.
Confirmed participants in Thursday's meeting include the ECRI Institute and stapler manufacturer Medtronic.
Staplers made by Johnson & Johnson's Ethicon unit have come under particular FDA scrutiny, with the agency labeling a recent recall of 92,000 circular staplers as high risk.