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More Congress Members Asking FDA to Remove Essure® Approval

December 16, 2015 · FLEMING | NOLEN | JEZ, L.L.P.

We recently reported that Pennsylvania Congressman Mike Fitzpatrick introduced the E-Free Act before congress, a legislation looking to ban the birth control device Essure®. Representative Fitzpatrick asked the house to pass a bill that would require the Food and Drug Administration (FDA) to remove their approval for the device. It appears that Rep. Fitzpatrick is not the only congress member concerned about the adverse effects and general safety hazard of Essure®.

Congresswoman Rosa DeLauro, from Connecticut, has also voiced her opposition to the birth control mechanism. In her letter to the FDA, DeLauro articulated her concern about the dangers of using Essure®. She notes that the FDA has received over 5,000 reports of negative side effects, which include four adult and five fetal deaths. After asking a series of questions analyzing the results and harm of the device, Rep. DeLauro urges the removal of the device. In her closing statements, she articulates

Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market.

Bayer HealthCare, the manufacturers of the sterilization device, still support their product. They contend that years of research asserts their decision to stand by their device. In a statement to WRIC, Bayer claimed

the safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure® was first developed.

During an FDA hearing, the committee recommended restricting the use of the sterilization device. However, other than the recommendation, the FDA has not made a decision on the matter yet.

At Fleming | Nolen | Jez, LLP, we understand the dangers and suffering that comes from medical device injuries. We believe that you should not be responsible for the pain caused by the Essure® device. It is the responsibility of the FDA and the manufacturers to ensure safe products go on the market. If you or a loved one has suffered an injury because of the birth control device, contact our Essure® injury attorneys. We aggressively fight on behalf of our clients and can help review your case!