October 28, 2015 · FLEMING | NOLEN | JEZ, L.L.P.
United States Representative Mike Fitzpatrick plans to introduce a bipartisan bill aiming to ban Bayer HealthCare’s product, Essure®. Fitzpatrick, serving Pennsylvania’s eighth congressional district, wants the birth control device removed from the market to protect women from further damage.
Bayer released Essure® and marketed the non-surgical device as a permanent method of birth control. The Essure® system consists of two metallic coils that doctors insert into the fallopian tube. Attached to the coils are polyester fibers that create inflammation and eventually cause the tissue to scar, thus preventing fertilization.
Many women have reported a number of complications with the device. There have been thousands of cases filed against the manufacturers, with many asserting the device should never have been approved by the Food and Drug Administration.
Fitzpatrick plans to introduce the bill on November 4, the 13th anniversary of when the device first received the FDA’s premarket approval. In a statement he issued, the U.S. representative states:
Bayer is a trusted name in the industry. However, right now, one of their products, the Essure® device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.
Bayer representative, Tara DiFlumeri, declares that the company stands behind the device and believes in the benefits it produces. The FDA committee held a hearing about Essure’s® safety and effectiveness. As of yet, they have not submitted any decisions to the FDA.
At Fleming | Nolen | Jez, L.L.P., we understand how traumatic a failed medical device can be. If you or someone you know has suffered after receiving the birth control device, you may be eligible for compensation. Our Houston personal injury lawyers will explain the legal process and inform you of your rights. Contact us today for a free consultation.