Lawsuit Claims Essure Coil Complications Led To Migraines, Hair Loss, Hysterectomy

Bayer faces another product liability lawsuit over their Essure coils, involving allegations that the birth control implant caused a Tennessee woman to suffer severe complications, including migraines, hair loss and other physical problems that ultimately led to the need for a hysterectomy to remove the device.

The complaint (PDF) was filed by Sonya Wilson in the U.S. District Court for the Eastern District of Tennessee on June 2, alleging that Bayer failed to adequately warn women and the medical community about the risk of complications following Essure procedures to place the bendable coils into the fallopian tubes to prevent pregnancy.

Essure coils are designed to provide permanent sterilization for women following the out-patient procedure, as scar tissue forms around the coils and blocks a woman’s tubes. Although the device has been 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.

Wilson indicates that she had Essure coils implanted in June 2006, and began to suffer severe headaches, migraines, pelvic pain, fatigue, hair loss, joint pain and heavy menstrual bleeding. As a result of the complications, she had the Essure removed in December 2015 via a hysterectomy.

The case is one of a growing number of Essure coil lawsuits filed by women nationwide, alleging that Bayer hid information from the FDA and medical community about complications associated with the device.

“The Defendants conduct not only violated its federal regulatory duties and its duties under Tennessee law, but also buried a massive amount of information that should have been shared with the medical and scientific community and the public,” the lawsuit states. “Because the Defendants failed to timely, completely, or accurately report their knowledge of the risks and complications associated with the Essure device, the public’s knowledge of the risks associated with the Essure device were seriously hampered and delayed. This endangered patient safety, including Plaintiff’s safety.”

Wilson and other women who have filed complaints in courts throughout the U.S. allege that 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.

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.