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

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

Posted by Marilyn McGoldrick on Sep 12, 2014 4:18:00 PM Taking only one day to deliberate after hearing evidence, a Dallas jury has awarded a 42-year old woman more than $70 million ($23.5 million in compensatory and $50 million in punitive) in damages related to her defective Boston Scientific transvaginal mesh implant. After hearing about… Read More