Women Speak Out About Essure Health Problems

Santa Clara,An in-depth investigative piece in the Washington Post highlights the considerable adverse health effects, even pregnancies, that thousands of women have experienced and continue to experience as a result of having Bayer’s Essure contraceptive devices implanted.

Hailed as the next generation of contraception, Essure consists of implantable coils that are permanently inserted via a catheter into a woman' fallopian tubes, to prevent pregnancy. It has been on the market since 2002. Recently, the US Food and Drug Administration (FDA) placed a Black Box warning on Essure.

Thousands of women across the US have had the coils implanted, and subsequently joined support groups on social media to discuss the side effects and medical problems they believe are caused by the device. The most common side effects include pain, hemorrhaging, headaches, menstrual irregularities, weight fluctuation, device migration and suspected nickel allergy. Some women have undergone a hysterectomy or other procedures to remove coils.

Nickel allergy stemming from the Essure device may have been responsible for Keisha Carney needing to have several teeth removed, and well as her hair loss and other side effects. According to the Washington Post piece, “The 2002 package label listed nickel allergy as a “contraindication” (meaning the device should not be used for patients with that condition) and included a directive that physicians screen patients for the allergy." However, in 2011, the FDA granted a request by Conceptus (the company that developed and marketed Essure) ," that the contraindication be downgraded to a “warning,” which doesn’t require physicians to screen patients,” the WP states.

Angie Firmalino underwent Essure implants in 2009 at the age of 45, and subsequently suffered joint problems that she attributes to an autoimmune response to the nickel in Essure. She required surgery to remove the coils, but fragments were left behind and resulted in her having a hysterectomy. She’s still dealing with chronic pain, muscle weakness and blood circulation problems, which she also thinks are autoimmune related, she told the WP.

She started a Facebook group to share her health issues with other women, and a small group began researching the device and submitting requests for federal records. Among the things they discovered was the “Conceptusvice president who presented the application to the Center for Devices’ OB/GYN devices advisory panel, Cindy Domecus, had been an industry representative on that same panel from 1995 to 2001,” according to the WP. It was also this group of women who discovered the revision of the nickel allergy “contraindication” on the packaging for Essure.

In May of this year, the FDA ordered Bayer to conduct a postmarket surveillance study to gather more data about Essure’s benefits and risks. According to the FDA website, the agency approved the study plan on September 2, 2016, and will make interim study results and updates available on the Essure Postmarket Surveillance Study page.