The threat of a hunger strike against the Food and Drug Administration, a Facebook page titled “Essure Problems Lawsuit” and a congressional bill calling for a recall of the female contraceptive manufactured by Bayer have surrounded the device with controversy and raised questions about its safety.
Originally approved in 2002, Essure has garnered more than 5,000 complaints related to efficacy, injury and death. Marketed as a permanent birth-control method, the device is inserted into the fallopian tubes and, after an approximate three months, forms a physical barrier that prevents fertilization. Of the 5,000-plus complaints, more than 600 were from women who experienced unintended pregnancies and, in some instances, ectopic pregnancies. Other complaints included migration of the device to the abdomen, pain in the pelvic region, perforation of the fallopian tubes and rashes.
A CNN story titled “Essure sterilization method under fire” describes the case of a North Carolina woman who conceived a baby girl while using Essure and gave birth three months prematurely to a stillborn.
“I’m so angry and hurt and depressed,” Kristiana Burrell said in the story. “We want the FDA to listen to us and take Essure off the market.”
In all, five fetal deaths and four adult deaths have been attributed to Essure, according to the FDA.
The hunger strike was to take place Sept. 24, 2015, the day the FDA convened a public meeting of its Obstetrics and Gynecology Devices Panel to discuss the effectiveness and results of Essure among a gathering of panel members, presenters and the public.
Essure Studies Far and Few Between
Bayer states Essure is 99-percent effective in preventing pregnancy. The New England Journal of Medicine questions that statistic and the studies leading up to it, calling them “nonrandomized.”
“One postapproval study remains unpublished, and the other was published only recently – 13 years after device approval and 7 years after study completion and reporting to the FDA,” according to an article titled “Revisiting Essure – Toward Safe and Effective Sterilization.” “The recently published study reports no pregnancies during 5 years, suggesting that the device is 100% effective. There are, however, concerns about incomplete follow-up and biased results reminiscent of those in the premarketing studies.”
The adversarial Facebook page has nearly 1,700 likes and links to a law firm’s Web site that asks, “Have You Been Injured by Essure?” It also encourages women who support a recall of the device to sign a petition. In addition to the Facebook page is a Facebook group titled “Essure Problems” that has 24,000-plus members and counting.
“This group is for women who have had the Essure procedure done, and are suffering or have suffered from side effects which may be attributed to Essure,” the group description states. “We are also here to inform women who are considering having this procedure about the potential side effects which can result if you are adversely affected by Essure.”
Among the reasons for the social-media backlash is the fact that Essure, when approved, was categorized as a Class III device. Class III devices are subject to the highest level of scrutiny that, if and when obtained by the FDA, enables the manufacturer to bring the product to market. There’s a catch, though. A 2008 Supreme Court ruling indemnifies manufacturers of Class III devices from being sued.
On Nov. 4, 2015, Republican Pennsylvania Congressman Mike Fitzpatrick introduced a bill aimed at removing Essure from the market, calling for a press conference the same day, 13 years later, that the device received approval. The bill, titled the E-Free Act, warns, “If the FDA and the manufacturer of the device aren’t willing to remove this device from the market, then Congress will.”
As if a planned protest, Facebook campaign and federal legislation weren’t enough, celebrity activist Erin Brockovich also has joined the fight.
“It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are NOT told of the devastating side effects, well that isn’t right,” Brockovich said on her website.