An Essure lawsuit filed in California alleges dozens of women suffered Essure medical complications beyond what the manufacturer led them to expect.

Women from across the country joined in this mass tort claim, filed in the Superior Court for Alameda County in November 2016. The plaintiffs are all recipients of Essure birth control, an implantable device developed as an alternative to tubal ligation for women seeking permanent sterilization. All claim Essure medical complications.

Essure consists of two implants, one for each fallopian tube, made of nested metal coils and a polyethylene fabric. These implants are placed inside the fallopian tubes where they stimulate the growth of new tissue. Over the course of a few months, and if all goes according to design, the new tissue occludes the fallopian tubes, preventing fertilization.

Essure was developed by Conceptus Inc., then purchased by Bayer in 2015. According to Bayer, around one million women have received Essure implants since they were first approved by the FDA in 2002.

Reported Essure Medical Complications

But since that approval, thousands of women have lodged reports of damaging Essure medical complications – complications many allege greatly exceeded what they were led to expect from the product’s labeling.

Patients report developing autoimmune disorders, abdominal pain, headaches, abnormal bleeding, tumors, abscesses, and allergic reactions to the nickel content of the implants. There have been reports of Essure implants fracturing, puncturing the fallopian tubes, or migrating to other parts of the abdomen.

Other women report the implants failed to prevent pregnancy, and some of those resulting pregnancies resulted in miscarriage.

One patient advocate reports some women have had trouble convincing their care providers that their complaints are genuine. Some insurance providers have allegedly refused to cover the cost of surgery to remove the implants.

Among other allegations, plaintiffs in the California Essure lawsuit say Conceptus failed to adequately warn them of the risks of complications associated with Essure.

They also accuse Essure’s manufacturer Bayer of failing to forward reports of Essure medical complications to the Food and Drug Administration as required. In two different inspections of Conceptus’s facilities in 2010 and 2013, the FDA uncovered over 15,000 adverse event reports that Conceptus had never submitted to the agency.

Plaintiffs also take issue with the device’s design. They allege the stainless steel in the metal coils actually corrodes after implantation, and the polyethylene fabric allegedly degrades at 65 degrees.

Women with nickel allergies also say they were not aware they were being implanted with a device that contained nickel. Essure’s label was originally approved with a nickel allergy warning. But in 2011, Conceptus lobbied the FDA to have that warning removed, in response to heavy competition from another device that was made with no metal content.

In 2016, the FDA responded to reports of Essure medical complications by adding a black box warning to the product’s label. The agency also required Bayer to add a doctor-patient checklist intended to better inform patients of the associated risks.

Patient advocates recognize the new labeling as a small improvement, but they continue to pressure the FDA to withdraw Essure from the market.