As of last month, over 16,000 women have filed lawsuits alleging injuries caused by Essure, a contraceptive device designed and sold by Bayer. Promoted as an easy, convenient, minimally invasive and permanent birth control solution, reports indicate that the device causes a wide range of serious injuries and health problems.

Patient advocates argue that the history of Essure highlights not only the way in which large pharmaceutical companies often put profits ahead of human health and safety, but also how regulatory agencies fail to protect consumers from questionable products.

The Essure Story

Designed as a “minimally invasive” alternative to tubal ligation surgery, Essure was developed by US medical device manufacturer Conceptus, now a subsidiary of Bayer AG. Resembling a long, cone-shaped wire coil, Essure is made of nickel-titanium and stainless steel held together with solder and polyester fibers. The device is inserted through the vagina and cervix into the Fallopian tubes. Once in place, it causes the formation of scar tissue (fibrosis), blocking the passage and preventing the union of sperm and egg.

Essure was approved for sale in the US by the Food and Drug Administration in 2002. However, that approval was based on very limited safety studies. Out of fewer than 750 women who participated, only a quarter were followed up with for safety outcomes at 24 months.

Approval was given through a controversial FDA process known as 510(k) Pre-Market Notification. This essentially allows a manufacturer of health care products to bypass stringent (and expensive) clinical trials if they can demonstrate that a “new” device or medication is substantially equivalent to a “predicate,” or product already FDA-approved and on the market.

Reports of Injuries Caused by Essure Contradict Safety Claims

A review published in the journal Fertility and Sterility in May 2009 concluded that “…the Essure system appears to be safe, permanent, irreversible, and a less invasive method of contraception compared with laparoscopic sterilization.” However, only five years later, women began reporting serious side effects and injuries, which include:

• migration and resultant internal injuries
• allergic reactions (including skin rash)
• cognitive impairment
• autoimmune symptoms
• nerve damage (numbness)
• joint and back pain
• psychological impact (depression, anxiety)

In addition, the Essure device has been known to fail in its stated purpose of preventing pregnancy. Women who unintentionally conceive while using Essure run a significantly higher risk of ectopic pregnancy, in which the egg is fertilized outside of the uterus.

By October 2013, the FDA had received nearly 950 adverse event reports related to Essure. Less than two years later, that number had risen to over 5000, including seven deaths related to the device.

What is Being Done?

An FDA-mandated “black box” warning has been issued on Essure packaging since February 2016. The following year, health authorities in Brazil and Canada removed the device from the market.

Essure will finally be taken off the US market at the end of this year. Only the power of consumers who “vote with their pocketbooks” has succeeded in stopping domestic sales of Essure. Although Bayer continues to defend the product, the German-based conglomerate has announced that, due to declining sales, it will discontinue Essure as of December 2018.

Have You Been Injured by Essure?

Attorneys and law firms across the nation are investigating cases of individuals who have suffered injuries caused by Essure. Qualified claimants may be able to seek compensatory and punitive damages.