Despite thousands of complaints since 2002 of severe pelvic and abdominal pain, internal bleeding, miscarriages, and even death, the implantable permanent birth control system, Essure®, has remained on the market. Essure victims have even had their hands tied by the legal system, which has protected the drug’s manufacturer, Bayer AG, due to Essure’s classification by the U.S. Food and Drug Administration (FDA) as a Class III device. Class III devices that undergo the FDA’s stringent Premarket Approval (PMA) process are generally immune from state law claims challenging safety and effectiveness. Such claims are preempted.
A ray of hope appeared recently, though, when a U.S. federal judge allowed 5 Essure victims to proceed with 2 counts against Bayer — negligent misrepresentation and negligent failure-to-warn.
U.S. District Judge John R. Padova of the Eastern District of Pennsylvania dismissed 5 other counts, which included negligent training, negligent risk management, breach of express warranty, fraudulent representation, and negligent manufacture, but he did give the plaintiffs more time to amend their complaint. These are individual cases and not a class-action lawsuit.
With lawsuits moving forward, it looks like women injured by Essure may finally have their voices heard in the court system — and receive the long-awaited opportunity to hold Bayer accountable for allowing this dangerous medical device to be sold in the first place.
What Is Essure and Why Is It So Harmful?
Essure has been marketed as a non-surgical, permanent form of birth control. Two nickel alloy coils are inserted into the fallopian tubes, and after about 3 months, enough scar tissue is supposed to form around the inserts to prevent conception. Bayer claims “the Essure procedure is 99.3% effective based on first year reliance in a recent clinical study.” To date, the company says approximately 750,000 women worldwide have undergone the procedure.
Since Essure was approved in 2002, the FDA has been receiving reports through its Manufacturer and User Facility Device Experience database (MAUDE), which allows anyone — patients, doctors, manufacturers — to report injuries, malfunctions, or death. The FDA recently reported that from November 4, 2002 until December 31, 2015, they received 9,900 medical device reports related to Essure. Of those reports, the most frequently reported patient problems included:
- Pain/abdominal pain – 6,989 reports
- Heavier menses/menstrual irregularities – 3,210
- Headache – 2,990
- Fatigue – 2,159
- Weight fluctuation – 2,088
Problems with the device itself were reported as:
- Patient-device incompatibility (usually related to a nickel allergy) – 2,016
- Migration of the device or device component – 854
- Device operating differently than expected – 490
- Device breakage – 429
- Device difficult to remove – 280
- Malposition of the device – 199
- Device difficult to insert – 187
There were also 26 reports of death, which include adult deaths, pregnancy loss, and infant deaths.
Number of Essure Victims May Be Much Larger Than Reported
Thousands of women who underwent the Essure procedure have banded together to both support each other and fight against the manufacturer that allowed them to endure such pain. The women made enough noise to get the attention of the FDA, which held a panel about Essure in September 2015.
For the first 3 hours, the FDA and Bayer explained pre- and post-approval study findings; those studies had been conducted by Conceptus, which Bayer bought in 2013. Then, 22 of these women were given the opportunity to stand up, tell their stories, and explain how Essure had negatively impacted their lives.
Since that panel, the FDA has finally begun responding to complaints. They are now requiring that Bayer provide a “black box warning” label with Essure, which is the FDA’s most restrictive label that lets users know about potential severe side effects. Bayer must also conduct a “surveillance study” to investigate “the risks of the device in a real world environment;” this would compare the risks of Essure with tubal litigation (a woman having her “tubes tied”).
Has Essure Injured You or a Loved One?
With lawsuits beginning to move forward against Bayer and their Essure product, victims and their families may finally be able to get the justice and compensation that they deserve. Contact Sokolove Law for a free, confidential legal consultation to learn about what options may be available to you now.