A Tennessee woman has filed a lawsuit over Essure complications resulting from her use of the contraceptive device manufactured by the defendant. Plaintiff Sherry H. claims that the defendant, Bayer, manufactured and marketed a product that was “adulterated” and “misbranded.”

The plaintiff further claims that the company “failed to report known hazards to the FDA, and failed to comply with Federal laws,” resulting in the complications that caused her injuries.

Sherry’s Essure complications lawsuit is only the latest of thousands that have been filed by women across the country. All of these women have suffered painful, debilitating and in many cases, permanent injury, which they attribute to the defective design of what Bayer has claimed is a “quick and easy,” “highly effective” and “permanent form of birth control.”

A Brief History of Essure Complications

Essure first gained FDA approval in 2002. Since then, Bayer has sold more than 750,000 units around the world. Marketing literature claims that implantation is “minimally invasive…requires no cutting, leaves no visible scars” and can be done as an outpatient procedure. It essentially works by blocking the fallopian tubes; after the device is inserted, it causes small abrasions on the inner surfaces of the fallopian tubes. This results in a buildup of scar tissue over the course of a few days, which in turn, blocks the passage, preventing fertilized eggs from traveling to the uterus.

The Plaintiff’s Allegations

Sherry’s complaint contains a lengthy list of allegations supporting her injury claim and the Essure complications she states are responsible. In addition to Bayer’s alleged misrepresentation and failure to follow federal regulations, the complaint alleges that the company concealed information about serious Essure complications – specifically, product failures that cause the device to fall out of place and perforate internal organs.

The Essure complications lawsuit further alleges that the device “breaks into pieces,” then corrodes. This can have serious consequences for women who have allergies to the materials used in the Essure’s plastic and metal components.

How Did Essure Gain FDA Approval?

The Essure contraceptive device was approved under an FDA program known as 510(k) Pre-Market Notification, also known as “Premarket Approval” (PMA). This allows the manufacturer of a medical device to bypass normally rigorous clinical studies if it can demonstrate that said device is “substantially equivalent” to a “predicate,” or device already approved and on the market.

Under 510(k), a device can be “approved” outright, or “conditionally approved.” According to Sherry’s complaint, Essure was “conditionally approved.” Under those conditions, Bayer was allegedly obliged to provide the FDA with regular reports on patients who participated in clinical tests and monitor physicians who were trained to insert the device. Furthermore, Bayer was required to report on any Essure complications within 10 days of discovery. This is where Bayer allegedly failed in its duty of care to the plaintiff.

More Essure Complications Lawsuits On the Horizon?

Currently, there have been more than 16,000 Essure complications complaints filed. Most of these have been filed since 2016 when the FDA forced Bayer to update its warning advisories and restrict sales. Last July, Bayer stopped selling Essure in the U.S. (a year after it had pulled it from other countries), citing declining sales. Bayer continues to insist that “the benefits of the device outweigh its risks,” however.

Sherry’s Essure Complications Lawsuit is Case No. 2:18-cv-05370-ER, U.S. District Court for the Eastern District of Pennsylvania.