A California woman has joined dozens of other plaintiffs in multidistrict litigation over the Essure birth control device that was manufactured by defendant Bayer.

Plaintiff Isabel C. has claimed that the product in question was “adulterated and misbranded,” due to Bayer’s failure to report Essure birth control device problems and defects to the Food and Drug Administration.

Isabel and other plaintiffs allege severe injuries because of their reliance on Bayer’s statements about the Essure birth control. According to their complaints, Essure was represented as a safe and reliable form of birth control but was prone to fracturing, migration and other problems that ultimately led to serious and debilitating health consequences.

What is the Essure Birth Control Device?

Bayer advertised and marketed Essure as a form of permanent, non-hormonal contraception. The Essure birth control device was originally manufactured by Conceptus Inc. and approved by the FDA in 2002. Conceptus became a subsidiary of Bayer in 2013.

Consisting of a small, metal coil, Essure was promoted as a non-surgical alternative to tubal ligation. It is inserted into the Fallopian tubes, where over the course of several weeks, it causes a build-up of scar tissue, creating a blockage that prevents the egg from descending into the uterus.

Patients Challenge Testing Methods

Although the Essure birth control device was promoted as being “permanent” birth control, its approval was based on short-term studies. Of nearly 750 women who participated in the original pre-market studies, none were followed up beyond two years.

According to Isabel’s complaint, the FDA discovered a spreadsheet in May 2013, which contained more than 16,000 adverse event reports involving the Essure birth control device – none of which had been properly reported. Bayer claimed this was not done because the patients in question were “not – at last contact – experiencing pain,” and that such “trivial damage…does not rise to the level of a serious injury.”

Injuries Were Not “Trivial”

At least 20 serious side effects have been experienced by women who have used the Essure birth control device. Among them:

• migration (the device falls out of place)
• punctures of the uterine walls
• device failure (including ectopic pregnancies)
• menstrual complications
• nausea
• allergic reactions to the materials
• skin rash
• mental impairment, anxiety disorders, and depression
• alopecia
• neuropathy of the extremities
• menstrual complications and heavy bleeding

In addition, victims have experienced dyspareunia or painful intercourse – leading partners and spouses to file claims for loss of consortium due to the Essure birth control device.

Did Bayer Break the Law?

Isabel’s complaint also says that Bayer “concealed and altered the medical records of its own trial participants to reflect favorable data.” If this is indeed the case, Bayer could face even more serious consequences.

As for Bayer, the company continues to stand by its product. It has discontinued manufacturing and marketing the Essure birth control device, but the company says this is due to declining sales rather than any inherent safety problems.

Plaintiff Isabel C.’s Essure birth control device lawsuit is Case 2:18-cv-05367-JP Court of Common Pleas, Philadephia County.