Members of Congress Pressure FDA to Ban Essure

October 22, 2015 —U.S. Representative Mike Fitzpatrick (R-Pa.) says he will introduce legislation to revoke approval for Essure within 60 days.

Rep. Fitzpatrick said he would introduce a bipartisan bill on November 4 — the 13th anniversary of Essure’s pre-market approval — to ban it due to the risk of health problems, according to the WRIC News. The legislation (PDF) is called the “E-Free Act.”

Earlier this month, Connecticut Congresswoman Rosa DeLauro also wrote a letter (PDF) saying she was “deeply disturbed” by reports of severe adverse events, and said: “Essure’s benefits to not outweigh its risks, and it should be withdrawn from the market.”

Lawsuits against Bayer have been stymied by federal law. Essure was invented by a company called Conceptus, which gained approval for Essure through “pre-market approval” (PMA) process. This process shields device-makers from lawsuits so long as they adhere to rigorous study protocols. Critics say Conceptus falsified medical records and hid adverse events, which could invalidate the PMA clearance. Bayer purchased Conceptus in 2013 and has vigorously defended the safety of Essure.

Last month, the FDA’s Obstetrics and Gynecology Devices Advisory Panel met to consider the safety of Essure. Over 5,000 adverse events have been submitted to the FDA since 2002, with over 70% of those reports in the last two years. Studies have shown that Essure is associated with a 10X higher risk of follow-up surgery compared to traditional “tube-tying” procedures.

Thousands of women say they have been injured and disabled by side effects like chronic pain, heavy bleeding, fatigue, and allergic reactions to nickel-titanium metal in Essure. Other women say the device perforated their uterus or fallopian tubes, migrated into their abdomen, or failed to prevent unwanted pregnancy. At least four fetal deaths have occurred in women who got pregnant while Essure was still implanted in their body.