Last month, it looked like the thousands of women who have suffered detrimental side effects from the birth control device “Essure” were finally being heard.
After receiving a thousands of complaints about the device, the FDA announced June 24 that it would add additional risks and complications to Essure's label. The FDA also scheduled a meeting on Sept. 24 with the women of “Essure problems,” a facebook group of nearly 20,000 women who have experienced the negative side effects of the device and want it off the market.
It looked like a win.
That was until the “Essure problems” women realized who else would be in town Sept. 24. On that same day, Pope Francis will give the first-ever papal address to the United States Congress — an event likely to draw all media attention away from the FDA-Essure meeting.
“I was born and raised Catholic, and to use the Pope against us? That's not ok,” Angela Desa-Lynch, an administrator for the Facebook group “Essure Problems,” told CNA July 24.
A mom of three who had her Essure coils removed after severe complications, Desa-Lynch said the conflict with the Pope’s visit seemed intentional, since visits with heads of state are usually planned months, if not years, in advance.
When asked whether the meeting was deliberately scheduled to be overshadowed by the Pope, the FDA denied any intentional conflicts.
“The meeting was not timed in any way with the Pope’s address to Congress,” Deborah Kotz, a press officer for the FDA, told CNA in an e-mail interview.
“As an FYI, FDA announced the meeting date for Essure on June 24, and the Vatican announced the Pope’s itinerary for his U.S. visit on Tuesday, June 30.”
However, according to CNA reports, the Pope’s Sept. 24 address to Congress was announced to the public as early as Feb. 5 of this year.
Bayer, the manufacturer and distributor of Essure, deferred comment on the meeting to the FDA.
Desa-Lynch said in earlier meetings with some members of the group, the FDA has made it clear that they have no intentions of considering pulling the device from the market, despite the five reported deaths it has directly caused. Other side effects of the device include: perforated organs, coil migration, fetal disfigurement and death, nickel poisoning, chronic pain, and depression.
But the women of “Essure Problems” are not going to let the papal address overshadow their demands to pull Essure off the market.
“We’re not willing to leave without an absolute,” Desa-Lynch said.
And that’s why a group of women and doctors who support the recall of Essure are planning a hunger strike outside of the FDA after their meeting in September.
“Hunger strikes have a 100 percent success rate,” Desa-Lynch said. “It’s our only chance.”
It’s a drastic, last-ditch effort that worked for women’s suffrage in the early 20th century, and for Guantanamo detainees in the 2000s who demanded better conditions.
“I've never been more ready and willing to go to jail or die for that matter. It's sad that women's health and safety is still not equal in 2015,” Desa-Lynch said.
“Besides,” she added, “a hunger strike will show the FDA on the outside what their lack of action is already doing to our health on the inside.”
It is impossible to know the exact percentage of women who’ve been implanted with Essure and experienced complications. Both Bayer and the FDA know that 750,000 devices have been sold worldwide.
However, sometimes women will be implanted with multiple Essure devices, despite labels that specifically state that only one coil per tube should be used. One woman may also submit multiple complaints, making the exact number of women with complications difficult to pinpoint.
“From Nov. 4, 2002, Essure's approval date, through May 31, 2015, the FDA received 5,093 Medical Device Reports related to Essure. Starting in mid-2013, there has been an increase in the number of reports received related to Essure,” Kotz said.
“The majority of reports received since that time have come from voluntary reporters, mostly from women who have had received Essure implants. Because some adverse events may go unreported to FDA, and because the precise number of implants is not known, FDA cannot provide a percentage to calculate the incidence of these events.”
Among those who will be present to show their support for the Essure hunger strike (though they will not be participating) include Erin Brokovich, the legal clerk and single mother made famous from a 2000 film about her life. Brockovich has a website dedicated to filing complaints against Essure and has joined the women in the legal fight against the device. There are several other people and interest groups hurt by the FDA who are joining the "Essure problems" women as well.
"(This) isn't just about Essure anymore. This is about anyone that's fallen a victim or been hurt by a faulty FDA process, bad laws and lack of oversight," Desa-Lynch said. "The FDA has to much blood on its hands to continued to be ignored."
“I will stay there, I don’t care if I’m the last one there,” she added. “I’m not leaving until they listen to us.”