I am in pain every day. Some days are worse than others.
The Day They’d Been Waiting For At 5:39 a.m. on September 24, 2015, Krystal Donahue, 39, steered her blue Ford Flex through the mist of the Maryland White Marsh Mall parking lot. This was a day she and other members of the Essure Problems Facebook group had been demanding through statewide meet-ups and media posts for a long time: The first hearing on Essure at the FDA headquarters. Donahue, another of the Facebook group’s administrators, would be one of the women to speak alongside Ervin. She felt a combination of stage fright, anger, and concern that despite the hearing, the agency wouldn’t take any meaningful action to protect women. Donahue says the Essure coil procedure left her feeling fatigued and nauseous for days afterward, and that her symptoms escalated to extreme pain, heavy bleeding, and a trip to the emergency room. She went back and forth between doctors for two years before finding one who could remove her coils, finally having them taken out on her 37th birthday. “It was a birthday gift to myself,” she says. By the time of the hearing, the women, who were demanding an outright ban on the device, had received the attention of medical providers and researchers who shared their concerns about its safety. Hundreds of attendees, including physicians and women with Essure, traveled from across the country to see what was to become of the device. On the way to the FDA hearing, Donahue picked up fellow E-Sister and Syracuse resident Sheila Pitt. It was the first time they had ever met in person, but the two women embraced in the parking lot. “I don’t know if I have any tears left,” Pitt said at the time. Unlike most of the women at the FDA hearing, Donahue wasn’t hopeful that the FDA would recall Essure. She was too realistic about the political realities that could keep the device on the market. A lot of powerful people are making a lot of money from the device, she said. Deborah Kotz, an FDA spokeswoman, says that it is not unusual to have a public hearing about a medical device, “but we certainly don’t do it for every device.” A few times a year, the FDA will conduct hearings about the safety of a device if there is a noticeable increase in adverse events. The organization will then evaluate the post-market approval by consulting with a panel of manufacturers and physicians.
Despite the thousands of women harmed and despite all the data presented here today, Bayer and the FDA have difficulty seeing the causal relationship between Essure and our health due to limited data.
“What the (profanity) is an Essure coil doing in her vaginal tract?” the doctor reportedly said.