FDA Decision on Essure Imminent

fda-essure-imminent

In response to claims made by thousands of women of adverse side effects from Essure, the FDA will announce a judgment this month following a review of the birth control procedure.

From the date of its approval until May 31, 2015 the FDA received 5,093 medical device reports related to Essure. Overall, more than 25,000 women have come forward to share their Essure horror stories on a website now hosted by famed advocate Erin Brockovich.

The women that have come forward complained of abdominal pain, menstrual irregularities, headaches, fatigue, weight fluctuations, hair loss, device migration, allergic reactions, and device breakage.

In response to these claims the FDA held a hearing about the procedure on September 24, 2015, and planned to release the findings of its review in February.

Essure is the only permanent birth control that women can get through a nonsurgical procedure. The procedure involves two small, metal coils being inserted into both fallopian tubes so scar tissue can form around the coils in order to clog the fallopian tubes and prevent eggs from forming.

Since its approval by the FDA in 2002 thousands of women have complained of serious side effects never mentioned as part of the deal by current Essure owner, Bayer AG.

As a result of these adverse side effects, women usually opt to have the coils removed through a surgical procedure they had originally hoped to avoid when they first chose the Essure procedure.

While they wait for the FDA decision the “E-Sisters,” what the women who’ve been negatively affected by the procedure call themselves, are heading to Washington in order to speak with Congressional members to garner support for the “E-Free Act.”

The act was proposed by Rep. Mike Fitzpatrick (R-Pa.) in an attempt to get the FDA to remove their approval for the procedure. Until the FDA withdraws its approval of  Essure its marketer, Bayer AG, is free from facing legal action from the women adversely affected by Essure because of the FDA status it enjoys.

As of now the FDA status that Bayer enjoys protects it from legal action based on a Supreme Court decision in Riegel v. Medtronic, Inc. The decision grants medical devices with pre-market approval (PMA), immunity from product liability as long as they follow strict rules during clinical trials. Passing the “E-Free Act” would not only give women the right to sue Bayer but also force them to remove it from the birth control market. A lawsuit has also recently been filed challenging that Bayer wasn’t fully honest during pre-market trials.

For the duration of this ordeal, Bayer has stood by the safety of their procedure.

Both sides are now eagerly awaiting the forthcoming decision from the FDA. By no means the end of this conversation, the FDA decision will either open the legal flood gates on Bayer or delay their opening until final decisions are made on the pending “E-Free Act”, and court case contesting PMA status. Either way, the discussion over Essure is just getting started.

Morgan & Morgan is currently pursuing a mass tort against Bayer Healthcare for the product Essure. Our attorneys have decades of experience fighting for the rights of victims who encountered surprising and unwanted side effects from drugs and medical devices. If you or someone you know has been adversely affected by Essure contact Morgan & Morgan by completing our form, and you will be able to speak with one of our attorneys for a free consultation.

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