KANSAS CITY, Mo. — Some Missouri women who watched the new Netflix documentary "The Bleeding Edge" were moved to tears as they listened to women share their stories of pain they claim was caused when they were implanted with the permanent birth control device Essure. But Bayer, the pharmaceutical giant that makes Essure, is firing back, calling the documentary misleading and inaccurate.
"The Bleeding Edge" was released on Netflix on July 27, 2018. It targets some medical devices, including Essure, concluding that medical devices are often fast-tracked through the U.S. Food and Drug Administration without thorough testing which can lead to some patients suffering serious side effects.
Days before the documentary debuted, Bayer announced it will no longer sell Essure in the United States. Bayer executives said they decided to stop selling Essure because of plunging sales, insisting that it's safe and effective.
Essure is a permanent birth control device doctors insert into a woman's fallopian tubes. It's a tiny coil that causes the body to react, building up scar tissue around the coil to block sperm, thus preventing pregnancy.
According to Bayer executives, 97 percent of women were satisfied to very satisfied five years after their Essure implants. But according to the group Essure Problems, 34,000 women worldwide have complained about side effects after getting their Essure implants and more than 16,000 women in the United States have filed lawsuits claiming vaginal bleeding, abdominal discomfort, and allergic reactions.
Joleen Fuller of Pleasant Hill, Missouri, said she was in so much pain she had the device removed and is feeling better. But Fuller said she is worried that her son, James, could be experiencing side effects from Essure.
"I have a son [James] who was breastfed while I was implanted who now has an autoimmune disease. There is guilt because now I don't know if I did that to him," Fuller said, pausing to hold back tears.
In "The Bleeding Edge," women told similar stories of painful side effects following Essure implants. But Bayer issued a Fact-Check statement that said in part, "Bayer takes any concerns regarding its medicines and devices seriously. Still, it is notable that not a single woman who is satisfied with Essure is included in the film."
Chandra Farmer, of Mountainstown, Missouri, is part of the Missouri Essure Victims Group. Farmer said she was implanted with Essure in 2012. She said complications forced her to have it removed in 2014. She suffers from autoimmune disorders.
"When my hysterectomy doctor removed my Essure he said the coil was laying up against my bladder, and he said it looked to him that my body was attacking the fallopian tube and the bladder at the same time because your body can't tell anymore and it was attacking both," she explained.
Now Farmer and other members of the group are fighting to get Congress to approve the Medical Device Safety Act.
Right now, manufacturers of medical devices are often exempt from lawsuits. The proposed Medical Device Safety Act would remove those protections so manufacturers of bad devices could be sued.
"If you are getting an implant, investigate what it is, what the materials are made out of and be your own advocate," Farmer concluded.
Jean Esther, who is a leader with the Missouri Essure Problems Group, called "The Bleeding Edge" a victory for women who developed problems.
"It's not hashtag winning anymore. It's hashtag won," Esther said.