On March 31, the U.S. Food and Drug Administration (FDA) Mylan’s voluntary recall of the popular EpiPen brand of auto-injector medical device used to treat patients with severe allergies. This announcement came nearly two weeks after a similar recall was issued for the same devices in seven other countries. The recalls were a direct response to consumer complaints that the devices failed to operate as marketed.… Read More


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


Posted by Marilyn McGoldrick on April 3, 2015 3:43:16 PM The Zimmer Persona Trabecular Metal Tibial Knee Implant is being voluntarily recalled after an unexpectedly high complaint rate of 61% for all the procedures in which it was used. The recall was announced by the FDA in March in response to complaints of loosening of… Read More


Posted by Marilyn McGoldrick on Mar 4, 2015 10:01:42 AM   The FDA has announced two important changes to the labeling of testosterone replacement (LowT) products. First, the makers of testosterone replacement medication must change the labels to make clear that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain… Read More


Posted by Marilyn McGoldrick on Dec 3, 2014 12:29:42 PM   The FDA has issued a warning that power morcellators can spread cancer, and now recommends against the tool’s use in most hysterectomies (removal of the uterus) or myomectomy (fibroid removal). Power morcellators are a laparoscopic tool that surgeons use to chop uterine tissue into small pieces. The device makes the surgery less complicated,… Read More


Posted by Marilyn McGoldrick on Sep 19, 2014 12:11:00 PM   A panel of experts appointed to advise the FDA voted 20-1 this week to recommend the FDA warn consumers that testosterone treatments have not been shown to reverse common problems of aging like low libido, muscle loss or energy levels. Testosterone drug makers have… Read More


Posted by Marilyn McGoldrick on Aug 1, 2014 3:39:00 PM   Update: Health insurer Highmark announced Saturday that it will stop paying for the morcellation procedure. One of the largest Blue Cross Blue Shield providers in the U.S. with 5.2 million customers in Pennsylvania, Delaware and West Virginia, Highmark is the first insurer to drop… Read More