Essure, the only non-surgical form of permanent female sterilization on the market, was approved by the U.S. Food and Drug Administration (FDA) on Nov. 4, 2002.

The Essure device is comprised of two small coils that are inserted trans-vaginally into the fallopian tubes during a standard doctor’s visit. This convenience factor added tremendously to its appeal.

Essure health problems reported in several women, however, have sparked a class action lawsuit investigation.

Theoretically, a woman seeking permanent sterilization is much more at risk by undertaking tubal ligation rather than being inserted with Essure coils. This is because ligation is done under general anesthesia and involves surgical incisions into the abdomen.

But some of the Essure health problems that have been reported—at least 4,500 adverse medical events reported to the FDA—have been quite dramatic and risky. These Essure health problems have included organ and bowel perforation, out-of-control bleeding, ectopic or tubal pregnancy, and allergic reactions.

Essure coils are manufactured by Bayer Healthcare Inc. and are made of a flexible metal and polyester combination. Once inserted via the vagina and cervix with an applicator, they require three months to stimulate the growth of new tissue inside the Fallopian tubes, so as to completely occlude access to ova released each month by the ovaries.

Recipients of the Essure coils are advised that they should rely on alternate methods of birth control until the three-month time marker is reached and complete occlusion is tested by a radiologist with a hysterosalpingogram. Nevertheless, despite positive testing outcomes, reported Essure health problems have included dangerous ectopic pregnancies.

Pre-market Controversy

Essure coils remain on the domestic market despite the excessive number of Essure health problems reported. This is not the case in some other countries. The European Union has suspended the license for the coils as of August 2017 for a minimum of three months, pending further investigation.

The manufacturer has voluntarily withdrawn the product from the marketplace in Canada, the Netherlands, United Kingdom, and Finland. Regulators have initiated recalls of Essure coils in France and Ukraine.

Essure coils were approved by the FDA through a short-cut approval process, since they offered a non-surgical alternative to tubal ligation, with faster recovery times. According to a reputable online encyclopedia, only 92% of the original participants in the pre-market study were followed up with at a year for safety outcomes.

Only 25% were followed up with for effectiveness at the two-year mark. Of two post-marketing safety studies, one was not published until Essure coils were on the market for 13 years and the second was never published.

Meanwhile, the excessive number of Essure health problems that women have reported after implantation with the coils continued to go public. This motivated activist Erin Brockovich to start a website where women can share their stories regarding the product.

Women have shared stories in which they experienced nausea and vomiting, fainting, autoimmune disease symptoms, heavy metal toxicity and brain fog to name a few.