Essure, Bayer’s permanent birth control device, was recently ordered to carry a black box warning by the Food & Drug Administration (FDA). A black box warning is the FDA’s highest level of regulation, meaning that the product may cause death or serious injury. In addition, all patients must now complete a Patient Decision Checklist before having the device implanted. This action by the FDA follows years of complaints by women who received the Essure implant and suffered a number of serious injuries which they attribute to the device.… Read More


The Zecuity Migraine Patch (sumatriptan iontophoretic transdermal system) is being investigated by the FDA for potentially causing serious burns and permanent scarring. The manufacturer, Teva Pharmaceuticals, has temporarily stopped selling, marketing and distributing the Zecuity skin patch after receiving what the FDA described as “a large number” of serious adverse skin reactions. … Read More


Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.… Read More


Antibiotic-resistant superbug infections caused by duodendoscopes have become more and more common. In an effort to prevent future infections, the FDA has ordered the three manufacturers of duodenoscopes to perform postmarket surveillance on how the devices are being cleaned and sterilized (reprocessed) in clinical settings.… Read More