The FDA said it has requested that Allergan plc, of Dublin, withdraw its Biocell line of textured breast implants due to the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) along with the tissue expanders used in the implant procedure. The agency said Allergan has agreed to withdraw its implants from all markets, adding that the risk of anaplastic large-cell lymphoma is six times higher than seen in other implants. The FDA analysis disclosed 573 unique cases of the condition across the globe, 481 of which were reported in patients with Biocell implants. Thirty-three fatalities were included in those reports, and the FDA said it will continue to assess whether the increased risk is associated with only specific models and types of implants rather than with all rough-textured implants. The agency is not recommending explant of all devices "due to the low risk of developing" BIA-ALCL, adding that the Biocell units account for only 5% of all implants sold in the U.S., while textured implants as a whole account for only 10% of the total.
The French Agency for the Safety of Health Products (ANSM) has published a draft set of recommendations for medical device cybersecurity, the work product of a committee formed in 2017 directed toward this end. The agency said the culture of cybersecurity is "very heterogeneous" among device manufacturers, a state of affairs chalked up to lack of awareness of the risks and the absence of regulations. ANSM said it shared its work with the European Commission and that it is taking comment through Sept. 30.
The U.S. Preventive Services Task Force (USPSTF) recommended that all pregnant women be tested for hepatitis B at their first prenatal visit, a recommendation that carries an A recommendation. The task force said rates of maternal hepatitis B have increased by more than 5% per year since 1998, although infants are now routinely vaccinated against the condition. USPSTF also said, however, that the primary source of infant hepatitis B is maternal transmission.
The FDA said the class I recall of the Cardiosave line of intraaortic balloon pumps by Maquet Medical's Datascope subsidiary is due to several conditions, including failure of unit batteries to hold a charge. Other concerns are associated with unexpected stoppage and shortened run time, which may cause stoppage when relying only on the battery for power. The manufacturer is advising customers to ensure the units are plugged in while not in use and to refer to the user's manual for direction on portable operation during patient transport. The recall affects all of the more than 22,800 units manufactured under the Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i lines.