ROCKFORD (WREX) – Earlier this summer a major drug manufacturer announced it would halt sales of a permanent birth control device at the end of the year. While Bayer says the decision to stop sales of Essure was purely a business move, thousands of lawsuits have been filed by women who claim the device seriously harmed them.
Latisha Montgomery of Rockford and Ela Woolger of South Beloit are two of those women involved in the class action lawsuit.
“You get this birth control thinking, ‘Ok, I’ve done the best thing for me and my family,’ and it turns out to be the worst decision of your life,” says Latisha. “It’s constant, it’s constant pain.”
“I went through hell for five years, absolutely hell,” says Ela. “There were days I didn’t want to take care of my kid because I was so sick I couldn’t get out of bed.”
Both women say after deciding they didn’t want to have more children, Essure was recommended by doctors as an alternative to Tubal Ligation surgery. But shortly have the device was inserted, the women say side effects took over their lives.
“My main [issue] was the pelvic pain and the numbness of my legs,” says Ela. “It was horrible.”
“Hair loss, deterioration of my teeth, back pain, really severe bad back pain,” says Latisha. “I had to change careers where I don’t do all the standing and lifting and all that.”
“This is permanent, this is not considered reversible,” says Dr. Time Durkee. “This is considered permanent sterilization. A TV camera like a hysteroscope is put in and there’s a port in there and you thread the device into the fallopian tube. How the device works, you sort of retract the inserter and metal springs come loose and fill the portion of the fallopian tube and over time it scars the fallopian tube shut.”
Dr. Durkee says the procedure was typically done in the office and took roughly ten minutes. Inserted properly in the correct patient, Durkee says it was the right choice.
“The effectiveness of Essure it still remains high,” says Durkee. “It’s still, in the right patient, a valuable procedure. You could still have it. Different people react differently to different procedures.”
And while Dr. Durkee says he’s unaware of any of his patients having issues from the coils, he says other women have been documented have allergic reactions to the metals and other complications. And the FDA took notice of these complaints. A statement posted on the agency’s website from FDA Commissioner Scott Gottlieb, M.D. says in part:
“The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns.”
Despite those actions being taken, more than 26,700 complaints about Essure were filed with the FDA between 2002 and 2017, leading the FDA to restrict sales in April of 2018, which was followed by Bayer discontinuing sales at the end of the year.
Meanwhile, Bayer says it sticks by Essure’s safety and results. A statement posted on the manufacturer’s website says in part:
“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades. Several factors have contributed to declining interest in Essure among women in the U.S., including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate and misleading publicity about the device.”
Essure will officially be off the market at the end of this year. But Latisha and Ela say for them, it’s too little too late.
“Had I had this type of information going in I would have known the information to ask,” says Latisha.
“I wish they would have talked earlier, I wish I would have talked earlier, maybe I would have gotten help earlier,” says Ela.
Dr. Durkee stresses that if women have been implanted with Essure and have no complaints or serious side effects there is no reason to worry or have the device removed.