FDA Office of Women’s Health Issues Update on Essure Birth Control System

The Food and Drug Administration (FDA)’s Office of Women’s Health has issue an update on the agency’s safety evaluation of the Essure birth control system.

Essure, a permanent birth control alternative to surgical sterilization, was approved by the FDA in 2002. The review, begun earlier this year, is in response to mounting adverse event reports involving Essure. In September 2015, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider scientific and clinical information about Essure. The panel also heard reports from women about their experiences with the device. The agency is also reviewing information from the public docket, and medical literature and adverse event reports received since the panel meeting. The FDA expects to make its recommendations public at the end of February 2016.

The Essure birth control system, marketed by Bayer, consists of two small, flexible coils that can be inserted into a woman’s fallopian in a doctor’s office procedure without surgical incisions. The coils are inserted through the vagina and cervix into the fallopian tubes, which carry the eggs from the ovaries to the uterus. In about three months, scar tissue forms around the coils, blocking the tubes and preventing conception. This method in considered permanent, the FDA explains, and the coils are not intended to be removed.

Since Essure came on the market, the FDA has received thousands of reports of harm from Essure. The injuries and complications include persistent pain, uterine and/or fallopian tube perforation, migration of the coils from the fallopian tubes, abnormal or irregular bleeding, and allergic reaction to the nickel in the coils. For some women, the complications have led to surgical procedures to remove the device. Device failure has resulted in unintended pregnancies. In some cases, pregnancies occurred because the patient did not receive proper follow-up to ensure that the tubes were in fact blocked. Some women experienced ectopic pregnancy, where the embryo implanted outside the uterus. Ectopic pregnancy can be life-threatening.

The FDA convened the expert panel under pressure to address mounting safety concerns. The panel is considering material submitted prior to and at its meeting and also comments submitted until October 24, 2015. The agency is reviewing all 2,800 comments in the public docket.

Among the new material since the panel meeting is a research study in the British Medical Journal that found that women implanted with Essure had 10 times as many surgeries to correct problems as women who had undergone surgical sterilization, according to NBC News. In their study, Dr. Art Sedrakyan of Weill Cornell Medical College in New York and his colleagues analyzed data from 8,048 women in New York State who had Essure inserted between 2005 and 2013, and compared them with 44,278 women who had standard sterilization surgery. The women with Essure had a “more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery,” Sedrakyan said, and he called this “a serious safety concern.” While he did not call for Essure’s removal from the market, he said women need to understand that Essure implantation is not a “low-risk procedure.”  He calls for more careful screening to identify women who may not be appropriate candidates for Essure. Sedrakyan recommends that women considering Essure be tested for nickel allergy prior to insertion in order to prevent allergy complications.

 

 

from Parker Waichman http://www.yourlawyer.com/blog/fda-office-of-womens-health-issues-update-on-essure-birth-control-system/