Essure Birth Control Case Filed On Behalf Of 24 Women Who Experienced Problems

One the latest cases involving Essure birth control problems was brought by a group of 24 women who experienced painful and debilitating injuries, including one woman who died, alleging that Bayer Healthcare sold an unreasonably dangerous and defective medical device. 

The complaint (PDF) was filed earlier this month in the U.S. District Court for the Eastern District of Pennsylvania, involving claims for two dozen women residing in 20 states different nationwide, including Colorado, Connecticut, Arkansas, Missouri, Florida, Texas, West Virginia, Georgia, Kentucky, California, New York, Mississippi, Massachusetts, Idaho, Ohio, North Carolina, Oregon, Tennessee, Utah and Virginia.

Essure is a form of permanent sterilization device that can be implanted as an out-patient procedure, where bendable coils are placed into the fallopian tubes. The procedures causes scar tissue to form around the coils and block the tubes.

Although it is marketed as a safe and effective means of preventing pregnancy, thousands of women have surfaced in recent years on Facebook, Twitter and other websites describing problems where the coils migrated, perforated the uterus, caused severe allergic reactions, infections, abdominal pain and other problems.

This recent lawsuit joins a growing number of Essure birth control cases filed on behalf of women nationwide, involving painful injuries, which may be fatal in some cases.

According to allegations raised in the lawsuits, Bayer failed to properly report more than 16,000 adverse events involving injuries or deaths with the Essure implant. In addition, a number of other manufacturing violations have been found by federal regulators involving the product, leading some experts to suggest that the FDA should require an Essure recall.

“Defendants actively concealed these violations and never advised Plaintiffs of the same,” states the lawsuit filed May 5. “Had Plaintiffs known that Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same, they never would have had Essure implanted.”

Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the agency announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks. Bayer has also been ordered to conduct additional studies to better understand the safety of the implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.

An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.

As Essure injury lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face hundreds, if not thousands, of lawsuits in courts throughout the U.S.