Dive Brief:
- U.K. regulators Thursday alerted healthcare professionals to potential problems with curved intraluminal surgical staplers manufactured by Johnson & Johnson's Ethicon, highlighting a field safety notice from the company reporting potential for the staple line to fail.
- That error could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding, the Medicines and Healthcare products Regulatory Agency (MHRA) said. A root cause investigation is underway.
- The safety advisory came days after U.S. regulators more broadly proposed increasing oversight of surgical staplers for internal uses, citing hundreds of reports of related deaths and other complications.
Dive Insight:
The MHRA alert spotlights a March 29 field safety notice from Ethicon's Endo-Surgery unit warning customers of an increased risk of malformed staples and possible associated anastomotic failure with the company's curved intraluminal staplers.
Ethicon said its field safety corrective action involves 247 lots of the devices distributed in the U.K. The affected devices were manufactured beginning in March 2018 and have expiration dates in 2023.
Surgical staplers, which can shorten procedure times compared to manual suturing, are widely used in operations ranging from gastrointestinal to gynecologic and thoracic surgery. J&J said alternative products to complete required surgeries may not be available due to worldwide supply issues with intraluminal staplers, and it provided a detailed list within its field safety notice of actions customers should take if continuing to use its staplers.
Anastomotic leakage, defined as an interruption of the continuity of the bowel, is a severe complication after abdominal surgery and carries a risk of mortality that has been described as considerable in a recent study.
The MHRA alert comes just days after the FDA proposed reclassifying all surgical staplers sold in the United States as higher-risk Class II devices subject to stronger controls, after an analysis of its adverse event database found more than 41,000 individual reports associated with the devices, including 366 deaths, over a seven-year period. Of the stapler-related deaths, FDA said the cause was linked with the opening of the staple line or malformation of staples in 159 reports.
FDA's proposed order followed on the heels of a Kaiser Health News investigation that cast light on an alternative, internal database where the agency collected reports of incidents with surgical staplers and other medical devices. FDA alerted healthcare providers to stapler malfunctions after the report and also released a draft guidance with new labeling recommendations for surgical staplers and staples.
Problems in the U.K. with the J&J device were identified after customers complained of malformed staples and returned the staplers to the company. After investigating the complaints and returned products, J&J said it confirmed the occurrence of uncut washers and malformed staples that can compromise staple line integrity.
The affected staplers should be quarantined and returned to the company, and alternative devices should be used if available, MHRA and J&J said. If alternatives are not available, J&J's staplers should be used only after a local risk assessment and according to guidance in the J&J Ethicon field safety notice.
J&J said it expects the product failure rate to remain below 0.1%, based on its analysis of complaints and estimated device usage.
FDA will discuss the proposed reclassification of surgical staplers from Class I to Class II at a May 30-31 meeting of its General and Plastic Surgery Devices Panel.
