As of Jan. 1 the controversial, highly-litigated Essure method of permanent birth control, the first and only nonsurgical alternative to tubal ligation sterilization available to women in the United States, is no longer available. Healthcare providers and facilities were required to return all unused Essure birth control devices to manufacturer Bayer by Dec. 31, 2019.

Essure consists of two inch-long, flexible coils made of metal and fiber inserted vaginally through the cervix into the fallopian tubes. The coils gradually cause the buildup of scar tissue over a period of about three months, thereby blocking the fallopian tubes and preventing pregnancy.

The Food and Drug Administration approved Essure in 2002, which was manufactured by Conceptus at the time. According to Bayer, which acquired Conceptus in 2013, more than 750,000 Essure devices have been sold worldwide.

In September 2017, Bayer announced it was ceasing Essure sales in all foreign markets due to “commercial reasons,” the Washington Post reported, making the United States the sole remaining country where Essure was still accessible to the consumer — until now.

Essure Troubles

On Dec. 31, 2018 Bayer voluntarily stopped selling and distributing Essure birth control in the United States, a decision the company had announced six months earlier in July. According to the New York Times, Bayer’s withdrawal of Essure was a response to “a lengthy campaign by health advocates and thousands of women to get the device off the market.”

Bayer, on the other hand, the Times reported, attributed its withdrawal of Essure from the market on declining sales due to women choosing other birth control options and denied that the action had anything to do with safety issues or mounting lawsuits. MedTech Dive reported that Bayer blamed “inaccurate and misleading publicity about the device” for declining sales.

An October 2018 quarterly report from Bayer stated that it faced lawsuits from approximately 18,000 Essure plaintiffs seeking compensatory and punitive damages, with alleged issues including perforation (typically of the uterus or fallopian tubes), pain, bleeding, hysterectomy (uterine removal), weight gain, unwanted pregnancy and depression.

But the list of Essure problems is quite long.

According to former FDA Commissioner Scott Gottlieb, another serious issue is migration of the Essure coils into the pelvis or abdomen. Additionally, as presented by experts at a 2015 FDA hearing and reported by the Washington Post, Essure may cause allergic or autoimmune responses.

Following Essure’s approval in November 2002 through December 2018, the FDA received 32,773 medical device reports related to Essure through the agency’s Manufacturer and User Facility Device Experience (MAUDE) database.

The most commonly reported Essure problems are listed below. Most patients reported experiencing more than one problem. Fifteen adult deaths were reported.

·        Pain/abdominal pain (26,244)

·        Heavier menses/menstrual irregularities (13,114)

·        Headache (8,398)

·        Fatigue (6,912)

·        Weight fluctuations (5,853)

·        Patient-device incompatibility (e.g. possible nickel allergy) (5,206)

·        Depression/anxiety (5,175)

·        Hair loss (4,880)

·        Hypersensitivity/rash (4,807)

·        Migration of device or a component (3,410)

·        Unintended pregnancies (including losses) (2,230)

·        Dislodged or dislocated device (1,632)

·        Device breakage/material fragmentation/fracture (1,533)

·        Device operating differently than expected (1,058)

·        Pregnancy loss (1,055)

According to the FDA, women with allergies to nickel, titanium, iron, chromium, silver-tin, platinum, stainless steel and a plastic material called polyethylene terephthalate (PET), which Essure contains, are at risk for potential reactions including itching, hives, chest pain, difficulty breathing, nausea, diarrhea or vomiting.

The Essure Problems Facebook group currently has more than 42,600 members. Angie Firmalino, an injured Essure patient featured in the 2018 Netflix medical device risks documentary “The Bleeding Edge,” founded the group in early 2011. Firmalino is also the founder of ASHES (Advocating Safety in Healthcare E-Sisters) non-profit and the administrator of the Medical Device Problems coalition.

Essure Regulatory Timeline Highlights

In order to address concerns that not all Essure patients were receiving birth control device risk warnings, in April 2018 the FDA restricted Essure sales to healthcare providers and facilities that agreed to review an Essure "Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement" with patients prior to Essure implantation.

In February 2016, the FDA issued draft guidance to provide better information about the risks and potential complications of Essure. The guidance announced proposed language for a product label black box warning of serious or life-threatening risks and a Patient Decision Checklist. Final guidance was published in October 2016.

The draft guidance also required Bayer to conduct post implantation surveillance of Essure risks in a “real-world environment” and to also study why some patients weren’t having three-month confirmation tests to ensure Essure was properly inserted.

In December 2018, the FDA increased the required length of post-market patient surveillance from three to five years following implantation.

A post-market study on Essure, which began in 2016, remains in motion — tracking 329 women who had Essure inserted, according to the FDA.

Diana Zuckerman, president of the National Center for Health Research, noted that the original clinical data supporting FDA's approval of Essure was insufficient.

As the E-Sisters affected continue to share their stories, it's increasingly evident that the administration lacks effective approval processes necessary to guaranteeing the safety of a device before it is placed on the market. "Women deserve that,..." Zuckerman told MedTech Dive, "to be able to make a decision based on solid information rather than advertising, and they did not have that."

Metal-containing implants, including Essure, were discussed at an FDA meeting for the Immunology Devices Panel of the Medical Devices Advisory Committee that took place Nov. 13-14.

For all affected by the permanent birth control device that harmed thousands of women, Jan. 1 was more than a start to the new decade. It was a reminder that truth prevails.