After outcries of still-births, ectopic pregnancies, and miscarriages and thousands of pleas for withdrawal of a sterilization implant device Essure, the Food and Drug Administration announced Monday that it will call on German drug maker Bayer AG to conduct more tests on the device. The FDA also drafted language for a "box warning" on the product.
Essure has been on the market since 2002 and is advertised as safe alternative to tubal ligation (commonly known as having your tubes tied). The device consists of two small nickel-titanium coils inserted into the fallopian tubes; the scar tissue that develops around the coils is thought to prevent pregnancy. According to Reuters, Bayer estimates that there about 750,000 women currently using the device, with 70 percent of them living in the United States.
Facing increasing pressure from patients and a mounting list of formal "adverse event" reports, the FDA invited patients to testify at a hearing about Essure last year. The FDA has maintained that Essure's benefits outweigh its risks, but promised after the hearing to conduct its own investigation into Essure, which led to today's announcement.
Angie Firmalino, a mail carrier in New York City, says she experienced the painful side effects immediately when she received Essure 2009. It took her several years to find a surgeon to help her remove the device—Firmalino suffered one botched surgery and then a radical hysterectomy to get the coils completely out of her body. After enduring all of that, Firmalino started a Facebook group called "Essure Problems" to connect with other women who were similarly experiencing disturbing medical problems due to Essure. "Women I didn't know started joining the group and telling similar stories and it has just snowballed," Firmalino says. Now, the group lists 27,000 members and has matured into a powerful, grassroots activism network.
Using the online page, the women began organizing in-person protests outside of gynecology conferences and letter-writing campaigns to doctors and journalists, and they've convinced famous activist Erin Brockovich and several gynecologists to join their cause. They have also published their own reports and research into the murky federal system that brought Essure to the market.
'Wow, I didn't know this device had nickel in it. I didn't know my teeth would fall out. I didn't know the device would puncture or perforate my organs.'
Now the group of thousands of women who call themselves "E-sisters" have a powerful ally in, of all places, a Republican male Congressman who is trying to take Essure off the market because of the safety issues.
Essure has been linked "extreme pelvic and abdominal pain, heavy bleeding, migraines, allergic and hyper-sensitivity reactions to nickel," Congressman Mike Fitzpatrick, a Republican in Pennsylvania, told reporters in a telephone press conference on February 17. "Some [women] had auto immune reactions, some had loss of hair, loss of teeth, and in some cases the actual [device] would actually break and migrate throughout the body. Yet even with all this, Essure remains available."
Fitzpatrick was joined on the call by several organizers of the Essure Problems Facebook group, including Firmalino. "One of the things that is disturbing to me is that these issues only came to light because of the work of victims," Fitzpatrick says.
Fitzpatrick's office hired an independent medical researcher, Madris Tomes, who used to consult for the FDA to look into the number of fetal deaths connected to the device, which occurred after women became pregnant despite having the coils inserted to prevent conception. Tomes says she found 303 reports linking Essure to fetal deaths. (According to official statements from the FDA, Essure has only been linked to five reports of fetal deaths, a fraction of the FDA reports Tomes says she uncovered.)
Tomes says she also found inconsistencies in the number of women who reported to the FDA that they had suffered an allergic reaction to the nickel in the Essure. In all, Tomes says, there are 10,558 "adverse event" reports concerning Essure filed with the FDA by patients, their doctors, or even the manufacturer. Tomes says some of these women who really had no idea what was happening to them; now that they see these patterns, they say, "'Wow, I didn't know this device had nickel in it. I didn't know my teeth would fall out. I didn't know the device would puncture or perforate my organs.'"
Patricia Rhodes, another Essure patient, wishes that the FDA had taken the opportunity to do something more aggressive, like recalling Essure from the market, rather than simply conducting more studies. Rhodes received Essure in the early, clinical trial phase, and says she was never told that the device contains nickel, which she is allergic to. "I'm pissed!," she says, via email. "How many women have to suffer, how many women and babies have to die because of those stupid things? How many women like myself have to lose their reproductive organs because of them?"