Holly Kelly Ennis
Pressure Mounts for Bayer and FDA as Essure Withdrawn in Canada
Declining sales across the globe and most recently, Canada, has led Bayer to announce the withdraw of Essure from the market in Canada. This follows on the heels of Essure being discontinued in Finland, The Netherlands and in the United Kingdom. Essure was also banned by Brazil earlier this year. Declining sales worldwide are evidenced by Bayer's soft recalls of the product in various countries. It is expected that Bayer will discontinue sales in other countries over the summer. The real question is when will Bayer discontinue sales in the United States or, better yet, when will the FDA finally revoke Essure's PMA and pull it from the market.
The Essure device is the subject of thousands of lawsuits across the Country by women significantly harmed by the device, most who were forced to undergo hysterectomies to have the devices removed. Essure is also the subject of a potential class-action in Canada that involves several hundred women, including many who underwent hysterectomies in their 20s and 30s due to complications resulting from the device.
Bayer claims the recent decisions withdrawing the Essure device from various markets are strictly financial ones. In a written statement provided to the Canadian press Bayer noted, "In light of the change in patient demand, Bayer has decided to voluntarily discontinue the sale and distribution of Essure in Canada over the next few months. This decision was taken for commercial reasons, and the favorable benefit-risk profile of Essure remains unchanged. This is not a recall of the product from the market." Tens of thousands of women would beg to differ, however, as thousands of women world-wide have undergone otherwise unnecessary hysterectomies to have the defective devices removed.
As Bayer discontinues the sale of the Essure device or countries ban it outright, this exerts greater pressure on the FDA to take affirmative action regarding pulling the device from the market. For over three years, since the Essure Problems Administrators first shared their valid concerns regarding the device, they have heard the same tired response from the FDA, "We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration." Obviously, the FDA is not hearing the Group's concerns, nor is it a high priority. There is ample evidence that Conceptus and Bayer violated the tenets of the conditional PMA on multiple occasions, thereby rendering the PMA invalid. Accordingly, the FDA should use its authority and revoke the PMA granted for the device immediately as it is the correct and just action to take.
Questions regarding the Essure Sterilization Device can be directed to attorney Holly Ennis at 1-800-856-6405 or visit us online at www.Ennislaw.com.