Transvaginal Mesh Sales Halted The U.S. Food and Drug Administration (FDA) has ordered makers of transvaginal surgical mesh implants to immediately stop the distribution and sale of the products in the United States. The FDA said that Boston Scientific and Coloplast, the last two companies selling these products in the U.S., have not demonstrated “a… Read More


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


    By Marilyn McGoldrick, Esq. Published on April 3, 2015 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… Read More


By Marilyn T.  McGoldrick, Esq. Posted on Mar 4, 2015 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 medical… Read More


By Michael A. Lesser, Esq. Posted on Sep 25, 2013               Dr. Frances Oldham Kelsey Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with… Read More