Most patients assume that, when they need a medical device implanted, that device has undergone extensive testing by the U.S. Food and Drug Administration (FDA) before it was allowed to be sold or placed inside patients. However, many devices aren’t scrutinized this closely, according to Consumer Reports.
Rather, many medical devices – including the transvaginal mesh implants currently being recalled nationwide – reach the market through what is known as the FDA’s “clearance” process. The clearance process can be used for any device that is substantially similar to a device that has already gone through the full, intensive FDA approval process. While not all devices can use the clearance process, those that can may make it to market simply because the manufacturer paid the necessary fees and submitted paperwork showing their device was “substantially similar” to one already on the market, not because the actual device has been examined closely.
However, “substantially similar” does not mean “identical.” Many of the transvaginal mesh implants currently causing serious problems for patients reached the market by the quicker clearance method, not by the more intensive study and approval process. Often, problems in these devices aren’t identified until actual patients suffer harm.
At Lipton Law, our dedicated Michigan transvaginal mesh implant injury attorneys care about helping injured patients seek justice in the way best suited to their individual lives. If you’ve been injured by a medical device or implant, call us today. Our number is (248) 557-1688, and your initial consultation is free and totally confidential.