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Is Bayer’s Essure device safe?

Published on Sep 2, 2015 at 4:08 pm in Product Liability.

The Essure device is a small coil made of metal that is designed for insertion into the fallopian tubes of women. It is a sterilization procedure whereby the device will irritate the fallopian tubes upon insertion and that will cause a scar tissue formation whereby the fallopian tubes will be blocked and prevent fertilization.

Essure is thought to be a less invasive and a more convenient alternative to the tubal ligation procedure for women who happen to want permanent sterilization.

However, Erin Brockovich, a mother of two, is now standing up to create awareness regarding the harms of using the Essure device that Bayer brought into the market.

The Unsafe Sterilization Device

Brockovich has cited many reports that have been filed with the FDA regarding the adverse conditions that have resulted due to Essure. This includes perforated organs, excessive bleeding, as well as injuries that resulted in emergency hysterectomies along with even a death.

According to Brokovich, there is definitely a defect in this device, and it’s dangerous. The number of injured women proves it.

What Bayer Has To Say

The acquiring of this device by Bayer AG took place in 2013, when a major stake was bought by the company, into the manufacturer of the device – Conceptus, Inc. A hearing has been scheduled by the FDA for 24th September to find out further about the effectiveness and safety of the product usage.

In its defense, Bayer has stated that while it empathizes with all those women who have suffered, the product had been backed by the FDA as well as science, which deemed the product was safe for use.

Bayer also stated that as many as 750,000 women had gotten this procedure done and did not endure any major side effects. The FDA has stated that Essure is the only available choice in sterilization within the US that does not require a skin incision. In addition, the procedure is effective by as much as 98.3% if it is used in a correct manner. The FDA has maintained that most of the women who have had this procedure performed have returned home, and resumed their normal lives without incurring any negative side effects.

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Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

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